Gastroenterology Today Spring 2025

Volume 34 No. 9 Spring 2025

CONTENTS

CONTENTS

Gastroenterology Today

4 EDITOR’S COMMENT

This issue edited by:

Samuel Lim

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7 FEATURE Optimal endoscopy timing in elderly patients

presenting with acute non-variceal upper

gastrointestinal bleeding

17 FEATURE Health-care resource use and costs associated with

inflammatory bowel disease in northwest London:

a retrospective linked database study

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EDITOR’S COMMENT

EDITOR’S COMMENT

“The

management

of inflammatory

bowel disease

(IBD) presents

a significant

healthcare and

economic burden,

particularly in

high-income

countries where

prevalence is

increasing.”

Health-care resource use and costs associated with inflammatory bowel disease in northwest London: a

retrospective linked database study and Optimal endoscopy timing in elderly patients presenting with acute

non-variceal upper gastrointestinal bleeding

The management of inflammatory bowel disease (IBD) presents a significant healthcare and economic

burden, particularly in high-income countries where prevalence is increasing.

In this edition of Gastroenterology Today we highlight a recent retrospective study analysing real-world data

from northwest London which provides valuable insight into resource utilisation and healthcare cost with IBD

management.

The findings from Ul-Haq et al demonstrate that active disease is more expensive and resource-intensive,

with both greater mean use of healthcare resources and greater healthcare costs seen in active disease.

Inpatient hospital care - both elective and non-elective - was identified as the primary cost driver,

emphasising the financial impact of poorly controlled IBD.

There are several limitations associated with this study, the most notable being a definition of active disease

based on changes of medication or dose rather than the standard clinical, biochemical, endoscopic or

histologic parameters, and the narrow geographical scope of the participants.

Nonetheless, the overarching message reinforces the economic and clinical rationale for early intervention

and the proactive use of effective therapies to induce and maintain remission so as to enhance patient

outcomes and reduce long-term healthcare costs associated with IBD.

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Samuel Lim


Publishers Comment

On behalf of everyone involved with the publishing of Gastroenterology Today I would like to say a big

thank you to our contributors for their input and a special thank you to our advertisers as without their

ongoing support we would not be able to print and despatch copies of this very unique publication to all

Gastroenterology Departments and Endoscopy Units.

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Publisher

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FEATURE

Rethinking

gastroscopy

OPTIMAL ENDOSCOPY TIMING IN

ELDERLY PATIENTS PRESENTING

WITH ACUTE NON-VARICEAL UPPER

GASTROINTESTINAL BLEEDING

Yavuz Cagir 1* , Muhammed Bahaddin Durak 2 and Ilhami Yuksel 1,3

Cagir et al. BMC Gastroenterology (2024) 24:444 https://doi.org/10.1186/s12876-024-03541-z

referrals

to improve

RESEARCH

Abstract

Background To evaluate the optimal endoscopy time in elderly

patients with nonvariceal upper gastrointestinal bleeding (NVUGIB)

based on clinical outcomes.

Highlights

• UGIB is a significant clinical concern in older persons, who

have higher rates of hospitalized adverse events and death than

young patients.

• Because mortality tends to be higher in older patients with UGIB,

determining the best endoscopic time becomes even more difficult.

• Close monitoring, risk stratification, and good endoscopic and

medical treatment are important approaches for decreasing poor

case-selection

Detects atrophic gastritis before endoscopy

Prioritise referrals according to clinical need

Methods Patients over 65 years of age presenting with NVUGIB

are three patient groups based on endoscopy timing: very early

endoscopy (< 12 h), early endoscopy (12–24 h) and late endoscopy (>

24 h). Endoscopic intervention was undertaken during the first 12 h for

patients who had unstable hemodynamic settings, ongoing bleeding,

or a low hematocrit despite transfusion. The clinical outcomes

investigated were: The primary endpoint was 30-day mortality, with the

need for endoscopic intervention, rebleeding, and length of hospital

stay considered as secondary endpoints.

clinical outcomes in the elderly with UGIB.

• Very early endoscopy group over the age of 65 is associated with

less surgical/radiological intervention and lower 30-day mortality.

• The establishment of a health assessment strategy for older patients

presenting with acute UGIB should be advantageous, considering

the rise in comorbidities associated with aging concomitant

medications, and various chronic diseases that have contributed to

morbidity and death.

• Early endoscopy may be beneficial in the therapy of acute UGIB,

particularly in the elderly with significant comorbidities and

Results The study population was 468, 260 of whom were ≥ 65 years.

severe bleeding.

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Based on the timing of endoscopy, very early endoscopy (within 12 h)

was performed in 180 (69.2%) patients aged > 65 years and 150 (72.1%)

younger patients (p > 0.05). Early endoscopy (12–24 h) was performed in

patients aged > 65 years and younger patients 53 (20.4%) vs. 41 (19.7%),

respectively, while late endoscopy (24–48 h) was performed in 27

(10.4%) vs. 17 (8.2%) patients, respectively (p > 0.05, for all parameters).

The clinical results of subgroups based on endoscopy time in the ≥

65 population and comparisons between groups. When groups were

compared, it was found that the very early endoscopy group had a

considerably lower likelihood of need for surgical/radiological intervention

than the late endoscopy group [3 (1,7) vs. (3,7), p = 0.016], and 30-day

mortality rates by the endoscopy timing were statistically significantly

different in the very early group (15.6%), early endoscopy group (7.5%),

and late endoscopy group (29.6%) (p < 0.05, for all groups). Endoscopy

time within 24–48 h (late) (OR: 3.133, 95%Cl: 1.127–8.713, p: 0.029) was

an independent predictor of rebleeding during the hospital stay.

Conclusions Early endoscopy may benefit the management of acute

UGIB, especially in the elderly population with high comorbidities and

the severity of bleeding.

*Correspondence:

Yavuz Cagir

yvzcgr@hotmail.com

Full list of author information is available at the end of the article

Keywords Upper gastrointestinal bleeding, Early endoscopy, Elderly

patient, 30-day mortality

Introduction

Acute upper gastrointestinal bleeding (UGIB) is among the top causes

of morbidity and mortality [1, 2]. Endoscopy is commonly suggested

for patients with UGIB not only for diagnosis but endoscopic treatment

in active bleeding lesions also [3, 4]. The European Society of

Gastrointestinal Endoscopy (ESGE) recommends performing UGIB

endoscopy during the first 24 h of presentation to identify the origin

of the bleeding, risk-stratify patients, and suggest viable endoscopic

therapies [5].

UGIB is a major clinical concern in older adults, who have higher

rates of in-hospital adverse events and mortality than those who

are younger, regardless of improvements in endoscopic hemostasis

and diagnostic and treatment options [6, 7]. Factors including the

patient’s characteristics, the cause of the bleeding, and the timing of


7

FEATURE

FEATURE


therapy all have a significant impact on the mortality and morbidity

outcomes linked to UGIB. It is estimated that 35–45% of UGIB

presentations include individuals over the age of 60 [8, 9]. This

population is more vulnerable to UGIB complications, most likely owing

to a higher proportion of concomitant diseases and the widespread

use of nonsteroidal anti-inflammatory drugs (NSAIDs) or antiplatelet

agents [10, 11].

Despite effective endoscopic hemostasis reduces mortality and

hospital stay, early endoscopy is associated with numerous

consequences (aspiration pneumonia, acute coronary syndrome, etc.)

[12, 13]. Optimal endoscopy timing becomes even more complicated

when taking into account the higher probability of mortality in the

elderly presenting with UGIB.

The current study aimed to evaluate the optimal endoscopy time in

elderly patients based on clinical outcomes.

Materials and methods

Study population and data collection

This study includes patients with nonvariceal upper gastrointestinal

bleeding (NVUGIB) who were hospitalized in the emergency

department of a tertiary referral center between January 2019 and

April 2020. The analysis excluded patients under 18, patients with

missing data, individuals who refused endoscopy, and those who

could not undergo endoscopy due to poor clinical status. Based on the

endoscopy timing, patients with acute UGIB are categorized into three

patient groups: very early endoscopy (< 12 h), early endoscopy (12–24

h), and late endoscopy (> 24 h). The institutional review board approved

this study (E1/22/2951).

Prospectively, information was obtained about the hemodynamic

state, previous medical history, laboratory and endoscopic findings,

and symptoms associated with bleeding. The hospital’s electronic

medical records system was used to document hospitalization, blood

transfusions, endoscopic procedures, interventional radiology or

surgery, rebleeding, and 30-day mortality. At admission, the AIMS65

score, the Clinical Rockall Score (CCRS), and the Glasgow Blatchford

Score (GBS) were evaluated. Following endoscopy, the Complete

Rockall Score (CRS) was obtained. In the first and fourth weeks,

they were evaluated during an outpatient clinic scheduled when

hospitalization was not required.

Patient management and clinical endpoints

All patients presenting with NVUGIB received an immediate 8 mg/h

proton pump inhibitor infusion after an 80 mg bolus. The standard

approach for fluid resuscitation was 3–5 ml/kg/hour infusion following

a 10 ml/kg bolus saline infusion, in cases of hypotension bolus dose 20

ml/kg. Based on blood pressure and urine output, the infusion rate was

titrated. The goal mean arterial pressure was > 65 mmHg and urine

output were > 0.5 ml/kg/hour. Regarding the patient’s comorbidities,

aggressive fluid resuscitation was avoided in normotensive individuals

to prevent volume overload. Erythrocyte suspension transfusion

was administered to increase the target hemoglobin level to > 9 g/

dl in patients over 65 years, with chronic lung disease or coronary

artery disease; in younger patients, the target hemoglobin level was

7–9 g/dl. During the first twelve hours, endoscopic intervention was

performed on patients who continued bleeding, had an unstable

hemodynamic state, or had a lower hematocrit even after transfusion.

Within the first 12 to 48 h, patients who were clinically stable and had

not experienced severe bleeding underwent an endoscopy. Each

patient’s time of ES admission and the beginning of the endoscopic

examination were recorded, and the gap between them was called the

“time to endoscopy.” In endoscopic treatment, the endoscopist applied

depending on the characteristics of the lesion either thermal contact or

mechanical techniques combined with adrenaline injection. Adrenaline

injection alone was not evaluated as an endoscopic treatment. Once

an upper gastrointestinal endoscopic examination failed to detect

a lesion, a colonoscopy was performed. For individuals whose

colonoscopy identified no bleeding lesions or evidence of ongoing

bleeding, no further procedure was carried out. An attempt was made

to identify the bleeding focus in individuals with bleeding continued or

rebleeding by computed CT angiography. In patients whose bleeding

focus could not be detected, angiography by interventional radiology

or double balloon enteroscopy was performed. Severe bleeding that

did not respond to endoscopic therapy was referred for surgical or

interventional radiology. CT angiography was performed on all patients

who could not be stabilized despite intense resuscitation. Interventional

radiologists performed coil embolization regardless of bleeding rate

when extravasation was identified. Endoscopy was performed at

the ICU bedside when extravasation failed to be detected. Once

endoscopic therapy and coil embolization failed, surgery was the

only option. All patients were followed up outpatient clinic visits in the

second week and the first month after hospitalization. Study data were

obtained following hospitalization by telephone visits or by scanning

the national electronic registration system for patients who missed

outpatient clinic visits.

The following clinical endpoints were investigated: The primary

endpoint was 30-day mortality, with the need for endoscopic

intervention, rebleeding, and length of hospital stay considered as

secondary endpoints. The term was determined very early endoscopy,

within the first 12 h, considering that a 12-hour period would be

more appropriate to ensure hemodynamic stabilization of the patient,

fix the clot, and reduce the risk of aspiration before endoscopy,

especially in elderly patients. Chronic lung disease refers to chronic

obstructive pulmonary disease or interstitial lung disease. Coronary

heart disease was defined as > 70% stenosis in coronary arteries on

conventional angiography or CT angiography, and congestive heart

failure, New York Heart Association functional heart failure class

II-III-IV. Severe bleeding was defined as hemodynamic instability

(mean arterial pressure < 65 mmHg and pulse rate > 100 beats/

min) despite adequate fluid resuscitation and evidence of ongoing

bleeding (hematemesis or a decrease in hematocrit despite blood

transfusion). Rebleeding was determined by a second-look endoscopy

to be defined as a hemoglobin loss higher than 2.0 g/dL along with

bleeding symptoms. A second-look endoscopy was performed as

soon as hemodynamic stability was achieved following rebleeding. Any

death that occurred within 30 days after the bleeding incidence was

considered mortality.

Statistical analysis

Data was evaluated by IBM SPSS Statistics for Windows, version 25.0

(IBM Corp., Armonk, New York, USA). We applied the Kolmogorov-

Smirnov test to figure out the normality of the distribution of continuous

variables. Continuous variables with usual distributions were given as

mean ± standard deviation, while non-normally distributed variables

were presented as median (interquartile range). Grouping variables

were presented as occurrences and percentages. Between the two

groups with constant data, the Student’s t-test was used for variables

with a typical distribution and the Mann-Whitney U test for abnormally

distributed variables. The Chi-Square test or Fisher’s Exact test

was employed to compare variable categories across two-group

comparisons, as applicable. For comparisons of clinical outcomes

in more than two groups, the Kruskal-Wallis test or the Chi-Square

test was applied. The significance level of the P value was set as <

0,05. Considering the impact that age ≥ 75 years has on mortality

risk, with a mortality rate of 8.9% [14], taking the effect size as 0.189 of

absolute difference, α = 0.05, and power (1-β) = 0.80, the total study

population was determined as 464 patients at a 95% confidence level

with a G power program. Multiple variate logistic regression analysis

that included clinically relevant variables were performed to identify

independent predictors of secondary outcomes (endoscopic, surgical,

or radiological interventions and rebleeding). Results were expressed

as Odds ratio (OR), 95% confidence interval (CI), and p-value. For

determining independent predictors for 30-day mortality, a multiple

variate Cox regression analysis was done that included statistically

significantly differed variables in subgroups (Aged < 65 years and Aged

≥ 65 years) comparisons. Results were given as Hazard ratio (HR),

95% CI, and p-value.

Results

While 208 (44.4%) of the study population was under 65 years of

age, 260 (55.6%) was over 65 years of age. Male patients in the <

65years population had a rate of 77.4% (161), compared to 59.2%

(154) in the ≥ 65 years population, which was statistically significant (p

< 0.001). The most common symptom in the entire study group and

subgroups was melena (68.2%), followed by hematemesis (50.9%).

Hypertension (HT) (44.4%) was the most common comorbidity across

all research groups and subgroups, followed by coronary heart

disease (CHD) (34.4%). Those over 65 had significantly higher rates

of chronic heart failure (CHF), arrhythmia, CHD, chronic kidney failure

(CKD), cerebrovascular disease (CVD), HT, and diabetes mellitus

(DM) (p < 0.001, for all parameters). The ≥ 65 years population had a

considerably higher rate of malignancy than the < 65 years population

[(39 (15) vs. 17 (8,2), p = 0.024)]. Proton pumps inhibitor (PPI) (31.9%

vs. 13.9%), antiplatelet (38.8% vs. 18.8%), and anticoagulant (22.3%

vs. 6.7%) use was considerably higher in the ≥ 65 age group (p <

0.001, for all parameters). The ≥ 65 age group used fewer nonsteroidal

anti-inflammatory drugs (NSAIDs) (11.2%, n = 29 vs. 21.2%, n = 44,

p = 0.003). Table 1 shows the characteristic features, clinical and

laboratory data of the entire study group and subgroups based on age.

While hemoglobin [9,34 ± 2,71 vs. 10,67 ± 3] and serum albumin

[35 (31–38) vs. 38,5 (34–43)] concentrations upon admission were

statistically substantially lower, urea [92 (56–141) vs. 55 (36–81)] and

INR [1,19 (1,08 − 1,36) vs. 1,09 (1,02 − 1,17)] values were higher in aged

patients (p < 0.001 for all parameters). GBS, AIMS65 score, CCRS,

and CRS were much higher in the older than 65 population (p < 0.001,

for all parameters). The ≥ 65 population had a considerably higher

rate of high-risk individuals (p < 0.001, for all criteria), as assessed by

scores (Table 1).

The ≥ 65 age group experienced considerably longer hospital

stays (5 (0–11) vs. 3 (0–6), p < 0.001). The 30-day mortality rate was

substantially higher in the ≥ 65 age group than in the younger (15.4%,

n = 40 vs. 4.8%, n = 10, p < 0.001). Further clinical outcomes showed

no statistically substantial variations among the groups (p > 0.05 for all

parameters) (Table 2).

The most common endoscopic finding was duodenal ulcer (34%),

followed by gastric ulcer (16.5%). Duodenal ulcer was seen in 30% (78)

patients in the ≥ 65 age group, while it was seen in 38.9% (81) patients

in the < 65 years population (p = 0.042). Angioectasia was statistically

significantly more common in the ≥ 65 years population [15 (5,8) vs. 2

(1), p = 0.006]. Further endoscopic results revealed no considerable

variations among the groups (p > 0.05 for all parameters) (Table 3).

Among patients > 65 years, 180 (69.2%) underwent endoscopy within

the first 12 h, 53 (20.4%) within 12–24 h and 27 (10.4%) within 24–48

h. When analyzed between subgroups based on endoscopy timing

and age the mortality rate within 30 days was higher in the ≥ 65 years

population (15.6% vs. 5.3%, p = 0.003) in very early endoscopy group,

and (29.6% vs. 0%, p = 0.016) (Table 4).

The clinical results of subgroups based on endoscopy time in the

≥ 65 population and comparisons between groups. When groups

were compared, it was found that the very early endoscopy group

had a considerably lower likelihood of need for surgical/radiological

intervention than the late endoscopy group [3 (1,7) vs. (3,7), p = 0.016].

In patients > 65 years old, 30-day mortality rates by the endoscopy

timing were statistically significantly different in the very early group

(15.6%), early endoscopy group (7.5%), and late endoscopy group

(29.6%) (p = 0.035). The remaining intergroups showed no statistically

significant differences (p > 0.05, for all parameters) (Table 5).

12–24 h endoscopy timing was an independent predictor for

endoscopic, surgical, or radiological intervention (OR: 0.551, 95%Cl:

0.312–0.976, p: 0.041). Previous history of UGIB bleeding (OR: 0.227,

95%Cl: 0.105–0.489, p: <0.001), serum albumin value (OR: 0.921,

95%Cl: 0.860–0.986, p: 0.019), 24–48 h (late) endoscopy time (OR:

3.133, 95%Cl: 1.127–8.713, p: 0.029) were independent predictors

for rebleeding during hospital stay. Univariate and multivariate Cox

regression analysis showed that chronic renal failure (HR: 2.474, 95%

Cl:1.040–5.887, p:0.041), hemoglobin level (HR: 1.327, 95% Cl:1.100-

1.603, p:0.003), serum albumin level (HR: 0.870, 95% Cl:0.813–0.931,

p:<0.001), and Complete Rockall score (HR: 1.520, 95% Cl:1.121–

2.060, p:0.007) were found to be independent predictors for 30-day

mortality. It was determined that patients over 65 had no significant

impact on the 30-day mortality predictions (HR: 1.041, 95% CI: 0.355–

3.055, p: 0.942) (Table 6). Clinical Rockall was not an independent

risk factor for 30-day mortality, while the Complete Rockall score (HR:

1.520, 95% Cl:1.121–2.060, p:0.007) was.

Discussion

Acute UGIB poses a significant threat to older adults, with patients

aged over 60 accounting for 35–45% of acute UGIB cases. UGIB

remains a major clinical concern in older persons, who have higher

rates of in-hospital adverse events and mortality compared to those

who are younger. Designing an assessment approach for older


8 9

FEATURE

FEATURE

Cagir et al. BMC Gastroenterology (2024) 24:444

Page 5 of 9


Page 6 of 9

Table 1 Patient characteristics, clinical and laboratory data of the study group and subgroups by age x

Study group

(n = 468)

Aged < 65 years

(n = 208)

Aged ≥ 65 years

(n = 260)

Age, years 67 (51–78,75) 49 (38–58) 77 (70,25–84) < 0,001

Gender, male, n (%) 315 (67,3) 161 (77,4) 154 (59,2) < 0,001

Presenting symptoms, n (%)

Hematemesis

Melena

Hematochezia

Syncope

Comorbidities, n (%)

CHF

Arrhythmia

CHD

CRF

CVD

CLD

HT

DM

Malignancy

238 (50,9)

319 (68,2)

39 (8,3)

41 (8,8)

53 (11,3)

84 (17,9)

161 (34,4)

51 (10,9)

38 (8,1)

10 (2,1)

208 (44,4)

98 (20,9)

56 (12)

112 (53,8)

139 (66,8)

17 (8,2)

17 (8,2)

6 (2,9)

11 (5,3)

28 (13,5)

10 (4,8)

10 (4,8)

6 (2,9)

48 (23,1)

27 (13)

17 (8,2)

126 (48,5)

180 (69,2)

22 (8,5)

24 (9,2)

47 (18,1)

73 (28,1)

133 (51,2)

41 (15,8)

28 (10,8)

4 (1,5)

160 (61,5)

71 (27,3)

39 (15)

P

0,247

0,579

0,911

0,688

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

0,351

< 0,001

< 0,001

0,024

PPI usage, n (%) 112 (23,9) 29 (13,9) 83 (31,9) < 0,001

Previous history of UGIB, n (%) 99 (21,2) 42 (20,2) 57 (21,9) 0,649

Previous history of GIS surgery, n (%) 16 (3,4) 11 (5,3) 5 (1,9) 0,046

Medication, n (%)

NSAIDs

Antiaggregants

Anticoagulants

ASA

DAPT

Warfarin

DOACs

73 (15,6)

138 (29,5)

125 (26,7)

13 (2,8)

72 (15,4)

41 (8,8)

31 (6,6)

44 (21,2)

37 (17,8)

32 (15,4)

5 (2,4)

14 (6,7)

14 (6,7)

-

29 (11,2)

101 (38,8)

93 (35,8)

8 (3,1)

58 (22,3)

27 (10,4)

31 (11,9)

0,003

< 0,001

< 0,001

0,660

< 0,001

0,165

< 0,001

Pulse, > 100 beats/min, n (%) 198 (43,2) 82 (39,4) 116 (44,6) 0,259

Systolic blood pressure, < 90 mmHg, n (%) 34 (7,3) 10 (4,8) 24 (9,2) 0,067

Hgb level on admission (g/dL) 9,93 ± 2,92 10,67 ± 3 9,34 ± 2,71 < 0,001

Urea level on admission (mg/dL) 71 (47–113) 55 (36–81) 92 (56–141) < 0,001

INR on admission 1,13 (1,05 − 1,27) 1,09 (1,02 − 1,17) 1,19 (1,08 − 1,36) < 0,001

Serum albumin level on admission (g/L) 36 (32–40) 38,5 (34–43) 35 (31–38) < 0,001

Serum platelet level on admission (10 9 /L) 253,5 (201,25–332,75) 246 (204,25–315,5) 263,5 (196–349,5) 0,226

Endoscopy time, n (%)

< 12 h

12–24 h

24–48 h

GBS

≤ 1 * , n (%)

≥ 7 ** , n (%)

AIMS65 score

= 0 * , n (%)

≥ 2 ** , n (%)

CCRS

= 0 * , n (%)

≥ 3 ** , n (%)

CRS

≤ 2 * , n (%)

≥ 8 ** , n (%)

330 (70,5)

94 (20,1)

44 (9,4)

150 (72,1)

41 (19,7)

17 (8,2)

180 (69,2)

53 (20,4)

27 (10,4)

0,683

0,496

0,857

0,415

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

< 0,001

Table 2 Results and comparisons of clinical outcomesx

Study group

(n = 468)

Aged < 65 years

(n = 208)

Aged ≥ 65 years

(n = 260)

Length of hospital stay, days 4 (0–8) 3 (0–6) 5 (0–11) < 0,001

Need for endoscopic hemostasis, n (%) 137 (29,3) 58 (27,9) 79 (30,4) 0,555

Need for surgical/radiological intervention, n (%)

Radiological intervention

Surgical intervention

2 (0,4)

6 (1,3)

Rebleeding, during hospital stay, n (%) 36 (7,7) 11 (5,3) 25 (9,6) 0,081

30-day mortality, n (%) 50 (10,7) 10 (4,8) 40 (15,4) < 0,001

x Results are expressed as: median (interquartile range), or frequency (%)

Significant P values are in bold

Table 3 Results and comparisons of endoscopic findingsx

Study group

(n = 468)

1 (0,5)

-

Aged < 65 years

(n = 208)

1 (0,4)

6 (2,3)

Aged ≥ 65 years

(n = 260)

Lesion not visualized, n (%) 20 (4,3) 9 (4,3) 11(4,2) 0,959

Gastric ulcer, n (%) 77 (16,5) 27 (13) 50 (19,2) 0,070

Duodenal ulcer, n (%) 159 (34) 81 (38,9) 78 (30) 0,042

Upper GIS malignancy, n (%) 42 (9) 19 (9,1) 23 (8,8) 0,914

Mallory-Weiss syndrome, n (%) 16 (3,4) 7 (3,4) 9 (3,5) 0,955

Erosive gastritis, n (%) 53 (11,3) 21 (10,1) 32 (12,3) 0,453

Erosive duodenitis, n (%) 20 (4,3) 7 (3,4) 13 (5) 0,385

Erosive esophagitis, n (%) 17 (3,6) 8 (3,8) 9 (3,5) 0,825

Esophageal ulcer, n (%) 28 (6) 14 (6,7) 14 (5,4) 0,542

Angioectasia, n (%) 17 (3,6) 2 (1) 15 (5,8) 0,006

Cameroon lesion, n (%) 5 (1,1) 4 (1,9) 1 (0,4) 0,176

Dieulafoy lesion, n (%) 5 (1,1) 3 (1,4) 2 (0,8) 0,660

Anastomotic ulcer, n (%) 9 (1,9) 6 (2,9) 3 (1,2) 0,195

x Results are expressed as: frequency (%)


GIS: Gastrointestinal system

Table 4 Comparisons of clinical outcomes based on endoscopy timex

Very early (< 12 h) Early (12–24 h) Late (> 24 h)

< 65 years

(n = 150)

≥ 65 years

(n = 180)

P

< 65 years

(n = 41)

≥ 65 years

(n = 53)

P

< 65 years

(n = 17)

≥ 65 years

(n = 27)

Length of hospital stay, days 6 (3–9) 10 (4–20,7) 0,001 3 (0–7) 6 (3–12) 0,031 7 (3,5–9) 6 (3–13) 0,680

30-day mortality, n (%) 8 (5,3) 28 (15,6) 0,003 2 (4,9) 4 (7,5) 0,693 - 8 (29,6) 0,016

P

0,082

1

0,036

P

P

9 (6–12)

26 (5,6)

336 (71,8)

1 (0–2)

181 (38,7)

136 (29,1)

3 (1–4)

83 (17,7)

292 (62,4)

5 (3–6)

83 (17,7)

50 (10,7)

7 (5–10)

21 (10,1)

124 (59,6)

0 (0–0)

175 (84,1)

12 (5,8)

1 (0–3)

83 (39,9)

60 (28,8)

3 (1–5)

75 (36,1)

4 (1,9)

11 (8–13)

5 (1,9)

212 (81,5)

1 (1–2)

6 (2,3)

124 (47,7)

4 (3–5)

-

232 (89,2)

6 (4–7)

8 (3,1)

46 (17,7)

x Results are expressed as: median (interquartile range) or frequency (%)



x

Results are expressed as: mean ± standard deviation, median (interquartile range), or frequency (%)

* : Patients classified as low risk

** : Patients classified as high risk


CHF: Congestive heart failure, CHD: Coronary heart disease, CRF: Chronic renal failure, CVD: Cerebrovascular disease, CLD: Chronic liver disease, HT: Hypertension,

DM: Diabetes mellitus, PPI: Proton pump inhibitors, UGIB: Upper gastrointestinal bleeding, GIS: Gastrointestinal system, NSAIDs: Non-steroidal anti-inflammatory

drugs, ASA: Acetylsalicylic acid, DAPT: Dual antiplatelet therapy, DOACs: Direct oral anticoagulants, Hgb: Hemoglobin, INR: International normalized ratio, GBS:

Glasgow-Blatchford score, CCRS: Clinical Rockall score, CRS: Complete Rockall score

Table 5 Comparisons of clinical outcomes based on endoscopy time in patients aged ≥ 65 yearsx

Very early

(< 12 h)

(n = 180)

Early

(12–24 h)

(n = 53)

Late

(> 24 h)

(n = 27)

Length of hospital stay, days 10 (4–20,7) 6 (3–12) 6 (3–13) 0,197

Need for endoscopic hemostasis, n (%) 61 (33,9) 13 (24,5) 5 (18,5) 0,157

Need for surgical /radiological intervention, n (%) 3 (1,7) * 3 (5,7) 1 (3,7) * 0,016

Rebleeding, during hospital stay, n (%) 15 (8,3) 4 (7,5) 6 (22,2) 0,063

30-day mortality, n (%) 28 (15,6) 4 (7,5) * 8 (29,6) * 0,035

x

Results are expressed as: median (interquartile range) or frequency (%)

* Groups that significantly differed in subgroup analysis


P


10 11

FEATURE


Page 7 of 9

FEATURE


Table 6 Multiple variate Cox regression analysis of predictors for current patients analysis, presenting the with number UGIB. GBS of patients is recommended with high by scores the European

30-day mortality

in the Society elderly of Gastrointestinal was statistically Endoscopy higher [5], than especially in the for younger. identifying lowrisk

95% CI

patients. incidence When of UGIB the score was is ≤ reported 1, the need to for be endoscopy significantly is quite

The

HR Lower Upper P

higher low and at outpatient 425.2 per follow-up 100,000 can in be the recommended. population In over the current 75

Age, ≥ 65 years 1.041 0.355 3.055 0.942

compared study, only with 26 (5.6%) 31.7 patients per 100,000 had a GBS ≤ 65 score years of of 0 or age 1, statistically [18].

Gender, male 1.686 0.858 3.314 0.130

UGIB, less in whose the elderly. incidence GBS ≥ and 7 is used mortality as a basis increases for predicting as people high-risk

CHF, yes 0.915 0.361 2.318 0.852

get patients. older, is In the an current issue of analysis, concern the and number difficulty of patients for with physicians.

scores Previous in the elderly studies was statistically have reported higher than NVUGIB in the younger. mor-

high

Arrhythmia, yes 0.886 0.340 2.310 0.805

CHD, yes 1.142 0.555 2.347 0.719

tality as 5% in all age groups while the mortality rate in

CRF, yes 2.474 1.040 5.887 0.041

patients The incidence aged ≥ of 75 UGIB years was increased reported to to be 15% significantly [7, 14, higher 19]. In at 425.2

CVD, yes 0.834 0.285 2.436 0.740

the per present 100,000 study, in the population the 30-day over mortality 75 compared rate with was 31.7 4.8% per in 100,000

HT, yes 0.953 0.455 1.995 0.898

patients ≤ 65 years under of age 65 [18]. to 15.4%, UGIB, whose and as incidence high as and 15.4% mortality in older increases

Malignancy, yes 2.186 0.978 4.886 0.057

than as people 65 years. get older, In the is current an issue of study, concern multivariate and difficulty analysis for physicians.

PPI usage, yes 1.397 0.692 2.821 0.350

showed Previous that studies age over have reported 65 was not NVUGIB an independent mortality as 5% predictor

groups of 30-day while mortality the (HR: rate in 1.041, patients 95% aged CI: ≥ 0.355–3.055,

75 years increased

in all age

Previous history of UGIB, yes 1.537 0.291 8.118 0.613

NSAIDs usage, yes 0.891 0.335 2.370 0.818

ASA usage, yes 1.632 0.724 3.681 0.238 p: to 0.942). 15% [7, The 14, 19]. fact In that the present patients study, over the 65 30-day have mortality a mortality

4.8% rate in that patients is significantly under 65 to 15.4%, higher and than as high younger as 15.4% patients in older than

rate was

DOACs usage, yes 0.554 0.162 1.889 0.345

Hgb level 1.327 1.100 1.603 0.003 may 65 seem years. paradoxical, In the current study, however, multivariate independent analysis risk showed factors that age

Urea level 0.996 0.989 1.002 0.176 including over 65 was comorbidities not an independent and decreased predictor of 30-day serum mortality albumin (HR:

INR 0.903 0.717 1.138 0.387 and 1.041, hemoglobin 95% CI: 0.355–3.055, level in patients p: 0.942). over The 65 fact years that patients may have over 65

Serum Albumin level 0.870 0.813 0.931 < 0.001 contributed have a mortality to a rate high that mortality is significantly rate. higher Comprehensive than younger surveillance,

patients

GBS 1.165 0.998 1.359 0.053

may seem risk paradoxical, assessment, however, and successful independent endoscopic risk factors including and

AIMS65 score 1.396 0.897 2.170 0.139 medical comorbidities treatment and decreased are important serum albumin measures and for hemoglobin decreasing

level

CCRS 0.648 0.426 0.985 0.042

in bad patients clinical over outcomes 65 years may in have older contributed individuals to a who high mortality suffer

CRS 1.520 1.121 2.060 0.007 from rate. UGIB Comprehensive [10, 20]. surveillance, risk assessment, and successful


Considering endoscopic and the medical increased treatment acute are UGIB important mortality measures rates for

HR: Hazard ratio, CI: Confidence interval, CHF: Congestive heart failure, CHD: in decreasing the elderly bad patient clinical outcomes group, in the older optimal individuals endoscopy who suffer from

Coronary heart disease, CRF: Chronic renal failure, CVD: Cerebrovascular

time UGIB is [10, even 20]. more important in this patient group. Previous

studies suggest the benefits of early endoscopy

disease, HT: Hypertension, DM: Diabetes mellitus, PPI: Proton pump inhibitors,

UGIS: Upper Gastrointestinal system, NSAIDs: Non-steroidal anti-inflammatory

drugs, ASA: Acetylsalicylic acid, DOACs: Direct oral anticoagulants, Hgb:

[21, Considering 22]. Cooper the increased et al. [23] acute carried UGIB mortality out early rates endoscopy

Hemoglobin, INR: International normalized ratio, GBS: Glasgow-Blatchford

in the elderly

score, CCRS: Clinical Rockall score, CRS: Complete Rockall score

(endoscopy patient group, within the optimal 24 h) endoscopy in the majority time is even of 909 more patients. important

Endoscopy within 24 h was linked to lower rebleeding,

in this patient group. Previous studies suggest the benefits of early

surgery, and hospitalization rates. Brennan Spiegel more

endoscopy [21, 22]. Cooper et al. [23] carried out early endoscopy

had considerably higher rates of comorbidity, PPI, and clearly claimed that it was time for 24-hour endoscopy to

(endoscopy within 24 h) in the majority of 909 patients. Endoscopy

individuals antithrombotic suffering usage from acute compared UGIB should with be other advantageous, groups. At become universal [24]. In line with the studies above, in

within 24 h was linked to lower rebleeding, surgery, and hospitalization

considering admission, the hemoglobin rise comorbidities and serum associated albumin with age, values concomitant were studies based in Denmark and Korea, when endoscopy

medications, and distinct age-related illnesses that raise the risk

rates. Brennan Spiegel more clearly claimed that it was time for

statistically significantly lower, and urea and INR values performed within 24 h was compared with endoscopy

of morbidity and mortality [15–17]. Though endoscopy should be

24-hour endoscopy to become universal [24]. In line with the studies

were higher in elderly patients. Furthermore, risk scoring

systems involving GBS, AIMS65, CCRS, and CRS group was associated with reduced mortality [25, 26].

performed between 24 and 48 h, the early endoscopy

undertaken within 24 h of presentation to the emergency room at

above, in studies based in Denmark and Korea, when endoscopy

Acute UGIB, there no age-based recommendation. This study is the

performed within 24 h was compared with endoscopy performed

were statistically substantially higher in the ≥ 65 population

(p < 0.001, for each parameter). Based on the thresh-

many studies have revealed questionable results [13, 27–

Contrary to the very early endoscopy advocated above,

first in the literature to compare the timing of endoscopy in older and between 24 and 48 h, the early endoscopy group was associated

younger patients presenting with UGIB.

with reduced mortality [25, 26]. Contrary to the very early endoscopy

olds used in each risk score system, high-risk patients 29]. Very early endoscopy correlates with a higher length

advocated above, many studies have revealed questionable results

were statistically more likely to be elderly. Those over of stay, and need for surgical/radiological interventions,

In this study, the clinical outcomes were compared based on

[13, 27–29]. Very early endoscopy correlates with a higher length of

65 had significantly longer hospitalizations and a higher especially in the high-risk patient group. Elderly individuals

with acute UGIB may be classified as high-risk,

radiological intervention was statistically less in the very early high-risk patient group. Elderly individuals with acute UGIB may be

endoscopy time. In the ≥ 65 population, the need for surgical

stay, and need for surgical/radiological interventions, especially in the

30-day mortality. GBS is widely used to predict the need

for endoscopy patients presenting with UGIB. GBS is and early endoscopy in this population might be linked

endoscopy group than in the late endoscopy group. The 30-

classified as high-risk, and early endoscopy in this population might

recommended by the European Society of Gastrointestinal

Endoscopy [5], especially for identifying low-risk in the ≥ 65 age group, late endoscopy was associated

with unfavorable clinical outcomes. In the current study,

day mortality rate was considerably higher in the late-endoscopy be linked with unfavorable clinical outcomes. In the current study, in

group versus the early-endoscopy group. The ≥ 65 population had the ≥ 65 age group, late endoscopy was associated with increased

patients. When the score is ≤ 1, the need for endoscopy is with increased mortality, and was linked to an increased

considerably higher rates of comorbidity, PPI, and antithrombotic mortality, and was linked to an increased need for surgical/radiological

quite low and outpatient follow-up can be recommended. need for surgical/radiological intervention. Although

usage In the compared current with study, other only groups. 26 (5.6%) At admission, patients hemoglobin had a GBS and

serum score albumin of 0 or values 1, statistically were statistically less in significantly the elderly. lower, GBS and ≥ urea 7 is

and used INR as values a basis were for higher predicting in elderly high-risk patients. Furthermore, patients. In risk the

scoring systems involving GBS, AIMS65, CCRS, and CRS were

statistically substantially higher in the ≥ 65 population (p < 0.001, for

each parameter). Based on the thresholds used in each risk score

system, high-risk patients were statistically more likely to be elderly.

there

intervention.

was no

Although

statistical

there

difference,

was no statistical

when

difference,

the very

when

early

the

endoscopy very early endoscopy and early and endoscopy early endoscopy groups groups were were compared, compared,

the the mortality rates were were higher higher in the in very the early very group. early Endoscopy group.

Endoscopy during the during first 12 h the provided first no 12 advantage h provided over no endoscopy advantage performed

between 12 and 24 h. In the very early endoscopy group, 6 patients

experienced hypotension, 4 patients had hypoxia due to aspiration,

and one patient had cardiac arrest during the procedure, while just 1

Those over 65 had significantly longer hospitalizations and a higher 30-

day mortality. GBS is widely used to predict the need for endoscopy in

patient experienced hypoxia due to aspiration in the early endoscopy

group. The 30-day mortality between very early and early endoscopy

groups was [28 (15.6%) and 4 (7.5%), respectively, p = 0.035]. This

may be due to adverse events developing during the procedure.

No statistically significant difference was found between subgroups

regarding rebleeding in patients > 65 years and younger and also

based on endoscopy timing in patients > 65 years. This may be due

to an endoscopy nurse, two gastroenterologists (one senior), and an

anesthetist being on duty out of working hours.

Although acute UGIB decreases in the elderly population, it is

mostly self-limiting. Immediately starting high-dose PPI infusion (can

stabilize clots and accelerate ulcer healing), saline infusion, and blood

transfusion when necessary (can allow time to optimize patients’

medical conditions) allow endoscopy to be performed under safer

conditions [30, 31]. It was previously claimed to compare endoscopy

< 12 h to endoscopy < 24 h. The rationale is to allow sufficient

time for resuscitation and stabilization of medical conditions in of

further hemorrhage and death. The optimal time may be endoscopy

between 6 and 12 h [32]. For the above reasons, when determining

the timing of endoscopy, we determined it as within 12 h after

admission, 12–24 h, and afterward 24 h rather than the first 6 h. The

first 12 h may be a safe time limit for hemodynamic stabilization,

acid suppression, and reduction of endoscopic procedure-related

complications (such as aspiration pneumonia and acute coronary

syndrome). It may benefit the management of acute UGIB, especially

in the elderly population with high comorbidities and the severity

of bleeding.

The study’s limitations comprise a single-center retrospective

methodology and a possible tendency to a higher acceptance of

patients at high risk, which could have altered the outcomes. In

addition, Helicobacter Pylori (HP) status was not analyzed in all

patients. Though the prevalence of drug-related hemorrhage rises

with getting older, HP-associated peptic ulcer is still essential [33,

34]. Although we started PPI and fluid infusion as standard in all

patients, we could not define the optimal fluid and blood transfusion

protocol. The fact that the patients had different hemodynamics

made it difficult to determine the standard optimal transfusion

strategy patients with bleeding secondary to malignant lesions

were also enrolled in this study which can affect the evaluation

of the role of urgent endoscopy on the clinical outcomes since

its high mortality rates. However, there was no difference in

endoscopic findings between the groups. Patients presenting with

severe bleeding, patients had endoscopies within the first 12 h.

Endoscopy was scheduled as soon as possible after 12 h for patients

whose hemodynamically were stable. As a result, there could be

discrepancies in the results if the group that had an endoscopy within

the first 12 h had worse outcomes. The study’s strengths were a

comparative design, skilled endoscopists performing endoscopy on

all patients, and data collection by gastroenterologists.

Conclusion

An assessment approach based on age in acute UGIB may be

advantageous given the increased risk of poor outcomes. Unlike very

early or late endoscopic timing, early endoscopy (12–24 h) may benefit

the management of acute UGIB, especially in the elderly with high

comorbidities and bleeding severity.

Abbreviations

UGIB Upper gastrointestinal bleeding

ESGE European society of gastrointestinal endoscopy

NSAIDs Nonsteroidal anti-inflammatory drugs

NVUGIB Nonvariceal upper gastrointestinal bleeding

CCRS Clinical rockall score

GBS Glasgow blatchford score

CRS Complete rockall score

ES Erythrocyte suspension

OR Odds ratio

CI Confidence interval

HT Hypertension

CHD Coronary heart disease

CHF Chronic heart failure

CKD Chronic kidney failure

CVD Cerebrovascular disease

DM Diabetes mellitus

PPI Proton pumps inhibitor

DOAC Direct oral anticoagulant

HP Helicobacter pylori

Acknowledgements

None.

Author contributions

YC: Investigation, data collection, writing-original draft preparation,

reviewing and editing, visualization. MBD: Writing-original draft

preparation, statistics, reviewing and editing. IY: Conceptualization,

Methodology, Investigation, Supervision, writing- reviewing and editing.

Funding

The authors declared that this study has received no financial support.

Data availability

Data is available from corresponding author upon reasonable request.

Declarations

Ethics approval and consent to participate

The study was conducted in accordance with the ethical guidelines

of the institutional research committee, the 1964 Declaration of

Helsinki, and its subsequent amendments, or comparable ethical

standards. The Ankara Bilkent City Hospital Scientific Research and

Ethics Committee accepted the project with approval No: E1/22/2951.

Informed consent statement was waived by the committee due to the

retrospective design of the study.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Author details

1

Department of Gastroenterology, Ankara Bilkent City Hospital, Ankara

06800, Turkey

2

Department of Gastroenterology, Faculty of Medicine, Hacettepe

University, Ankara 06230, Turkey


12 13

FEATURE

FEATURE


3

Department of Gastroenterology, Faculty of Medicine, Ankara Yildirim

Beyazit University, Ankara 06800, Turkey

Received: 31 May 2024 / Accepted: 27 November 2024

Published online: 02 December 2024

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Villous tumours of the duodenum. An analysis of the literature with

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HEALTH-CARE RESOURCE USE

AND COSTS ASSOCIATED WITH

INFLAMMATORY BOWEL DISEASE IN

NORTHWEST LONDON: A RETROSPECTIVE

LINKED DATABASE STUDY

Zia UI-Haq 1 , Luiz Causin 2 , Tahereh Kamalati 1 , Durgesh Kahol 2 , Trishan Vaikunthanathan 2 , Charlotte Wong 3,4

and Naila Arebi 3,4*

UI-Haq et al. BMC Gastroenterology (2024) 24:480 https://doi.org/10.1186/s12876-024-03559-3

RESEARCH

Abstract

Background With 20–40% of patients who have inflammatory bowel

disease (IBD) not responding to therapy, resource use and costs can

be high. We performed a descriptive analysis of health-care data for

IBD management in the National Health Service to explore potential

areas for improvement.

Methods In this exploratory study, we analysed real-world data

from the Discover dataset for adults with a diagnosis of incident IBD

recorded in northwest London, UK, between 31 March, 2016, and

31 March, 2020. We compared mean visit numbers and primary and

secondary care costs per patient to examine resource use and costs

for active disease versus remission.

Results We included 7,733 patients (5,872 with ulcerative colitis [UC],

1,427 with Crohn’s disease [CD], and 434 with codes for both [termed

IBD-undefined in this study]). Remission was recorded in 19,218 (82%)

of 23,488 observations for UC, 4,686 (82%) of 5,708 for CD, and 1,122

(65%) for IBD-undefined observations. Health-care resource use was

significantly higher with active disease in all settings except primary

care for UC. Total health-care costs were greater with active disease

than remission for all diagnoses (all p < 0.0001). The main driver of

costs was inpatient hospital care among those with active disease;

elective inpatient costs were high among patients with UC and IBDundefined

in remission.

Conclusions Higher health-care resource use and costs were

observed with active disease, which underscores the importance of

early induction and maintenance of remission in UC and CD. Updated

strategies that incorporate treat to target may offer cost benefits by

the offsetting of biologic drug costs with a reduction in costly inpatient

hospital stays.

Trial registration This trial was not registered as it used

pseudonymised retrospective data.

Keywords Inflammatory bowel disease, Cost, Outcomes, Biologics,

Active disease, Remission

Background

Inflammatory bowel disease (IBD) is an umbrella term for chronic

idiopathic inflammatory diseases of the gastrointestinal system,

encompassing ulcerative colitis (UC) and Crohn’s disease (CD) [1]. Of

the various presentations, a relapsing-remitting inflammatory course

is the most common [2, 3]. Progressive disease with complications is

associated with hospitalisations, surgery, and impacts on quality of life

and work productivity, which can have further psychological, social,

and physical consequences [1, 4–6].

IBD places substantial health and economic burdens on communities

worldwide. In the USA and Europe, more than 3 million people are

estimated to have IBD, whilst in the UK, the prevalence is around

0.5‒0.8%.7–11 Owing to factors such as early onset, no cure, and low

mortality, IBD is going through a period of compounding prevalence.

Thus, in high-income countries, prevalence is estimated to reach 1%

by 2030 [12]. Furthermore, with the disease exhibiting a bimodal age

distribution and in the context of an ageing general population, older

people now represent the largest-growing population of patients

living with IBD. This will pose unique challenges and considerations

to health-care professionals in terms of diagnosis and treatment

decisions [13–15].

*Correspondence:

Naila Arebi

naila.arebi@imperial.ac.uk

1

Imperial College Health Partners, London, UK

2

Janssen-Cilag Ltd, High Wycombe, UK

3

Department of Inflammatory Bowel Disease, St Mark’s National Bowel Hospital, Central Middlesex Hospital, Acton Lane, London NW10 7NS, UK

4

Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK


FEATURE

FEATURE


Health-care use in IBD, particularly during active stages, incurs direct

and indirect costs to health-care systems, patients, their families, and

society as a whole [16, 17]. Direct health-care costs are attributed

to diagnostic delays, disease activity, drug and surgical treatments,

and monitoring for treatment response and complications, such

as infections. Furthermore, although a broad range of therapies is

available, ranging from 5-aminosalicylates (for UC), corticosteroids,

immunomodulators, small molecules, and biologic agents [18], up

to 20–40% of patients experience non-response, loss of response,

and intolerance to therapy [19, 20]. The resulting treatment dose

adjustments, drug switches, and treatment augmentation potentially

raise costs further [21–24].

The advent of monoclonal antibody biologics against tumour necrosis

factor (anti-TNF), such as infliximab and adalimumab, have improved

outcomes in IBD and helped to move treatment goals beyond symptom

resolution alone. Nevertheless, widespread uptake has been subject to

some reservations about increased risks of infections and bowel surgery,

particularly in the elderly [15], and immunogenicity [25]. Non-anti-TNF

biologics, such as vedolizumab, ustekinumab, risankizumab, and

mirikizumab, have extended treat-to-target options [26, 27] and reduced

risks of infection [28] and anti-drug antibodies [29, 30]. However,

suboptimal use of such drugs might contribute to a ‘glass ceiling’ effect

[31]. Considering different drug mechanisms of action and innovations in

treatment strategies could consolidate elusive efforts to break through

recognised therapeutic limitations [18, 23, 32, 33].

Decisions on funding of biologic drugs in the UK have considered

costs of drugs and cost-effectiveness measured in terms of qualityadjusted

life years [34]. This approach, however, may not the capture

the impact of active disease on use of health-care resources or rapid

disease control and maintenance of remission. Furthermore, anti-TNF

biosimilar alternatives have not yet been available long enough to

have been included in many health economic assessments, although

in Europe UI-Haq biosimilars et al. BMC Gastroenterology prescribed for the management (2024) 24:480 of IBD allow

savings of 15–75% compared with the original compounds [35]. We

used real-world data to examine health-care resource use and to

investigate drivers of costs during active disease versus remission. We

tested the hypothesis that active disease would be associated with use

of more health-care resources and greater costs than remission. We

also examined the impacts of age, timing of starting biologics, and the

use of non-anti-TNF biologics (ustekinumab and vedolizumab) versus

anti-TNFs as first biologic on health-care resources usage and costs.

Methods

Study design and population

This was a population-based, retrospective, linked database study

of adults (age > 18 years) with IBD in primary and secondary care

in northwest London. A pre-study protocol was approved by all

investigators for the ethics application. Anonymised data were

obtained from the start of 2015 to allow the selection and testing of

covariates and ensure patients with a pre-existing IBD diagnosis were

excluded. This approach removed uncertainty about previous biologic

treatment exposure that would not have been captured for the cohort

because the dataset was only linked to the high-cost drug database in

2016. Eligible patients were those who received a diagnosis of incident

IBD (a Read code, version 2, in primary care or an ICD 10 code in

secondary for UC or CD) between 31 March, 2016, when linkage to

the NHS High Cost Drugs Database began, and 31 March, 2020 (Fig.

1). All patients were biologic naïve at inclusion. A small population of

patients who had codes for both CD and UC were also included, for

whom we adopted the term IBD-undefined to avoid confusion with

the term IBD unclassified. The former term aims to capture changes

in coding as well as uncertainty of the diagnosis. Data on relevant

therapeutic procedures were identified with OPCS Classification of

Interventions and Procedure codes (version 4; Appendix Table A1). We

excluded patients who had had bowel resections before the recorded

use of biologics in 2016, as their treatment might not be representative

of the current standard of care. Page 3 of 13

Fig. 1 Population identification and selection procedure. Abbreviations: BMI, body-mass index; GP, general (family) practitioner; IBD, inflammatory bowel

disease

Dataset

As part of the integrated care system in northwest London, health and

social care data linked by NHS number are collected for around 2.5

million patients registered with an NHS general practice (GP). The data

come from more than 400 general practices, mental health service

providers, community trusts, and acute providers [36]. Information

recorded includes demographics, medical histories, consultation

notes, test results, prescriptions, and procedures so that primary,

secondary, and other care providers may access a summary of

relevant information to aid decision-making. Additional patient-level

information on direct commissioners’ costs is also stored.

For this study, we requested access to data via the Discover-NOW

Health Data Research Hub for Real World Evidence (Discover) linked

dataset, which is hosted by Imperial College Health Partners. All data

were deidentified to meet the minimization standards of the Information

Standards Boards of NHS Digital, and were stored on a secure server.

A governance suppression rule, in which numbers lower than five are

annotated as < 5, was applied to further protect anonymity.

Ethics approval

Ethics approval for the use of the Discover Platform for research was

secured from the NHS Health Research Authority in October 2018. The

REC reference is 18/WM/0323 and the IRAS project ID is 253,449. The

sponsor of the study did not have access to patient-level data.

Definitions

Disease activity is not recorded in the dataset. Instead, we inferred

active disease and remission throughout the study period by review

of events: active disease was defined as more than two events within

a 12-month period and remission as two or fewer events within a

12-month period. An event was considered to have occurred when one

or more of the following activities were recorded: a new prescription

of any non-biologic treatment; any dose escalation within the class of

drug; addition of another class of drug (any class); a new prescription

of any biologic treatment; or a change in biologic treatment (not

including change to a biosimilar). A cut off of two events was used to

comply with current British Society of Gastroenterology guidelines

wherein treatment escalation for disease activity is recommended

after two or more steroid courses in 1 year [18]. The first event in each

period of active disease was referred to as an index event. Disease

status was checked and recorded as changed or unchanged every

12 months.

Drugs were categorised as conventional, anti-TNF biologics, or nonanti-TNF

biologics (Appendix Table A2). Initiation of biologics (anti-TNFs

and non-anti-TNFs) was separated into early and late (delayed). Early

initiation was defined as biologic therapy administered within 3 months

of an index event whereas late initiation occurred more than 3 months

after an index event or following a second event within a 12-month

assessment period.

Terminology for IBD-related resource use is reported as captured

in the dataset. Elective inpatient visits refer to planned hospital

admissions; non-elective inpatient visits refer to unplanned hospital

care after urgent and emergency attendances; outpatient visits refer

to clinic attendances and investigations; and primary care visits are

attendances at GPs.

Cost analysis

Discover captures cost data from health-care providers on primary

and secondary care. Primary care costs are based on commissioning

pricing for different provider services, classified as general care

(national-level services), personal care (local-level services), and

alternative provider medical services (use of third-party providers),

and additional costs like local incentive schemes and out-of-hours

services. GP prescribing costs are unavailable at the individual patient

level and, therefore, we estimated these from historic data on contract

costs, budgets, and sizes and characteristics of practice patient lists.

Secondary care costs are based on specific activities (e.g., accident

and emergency visits, specific procedures, surgery, length of stay

in hospital, etc.) and are available per patient. Community costs are

based primarily on block contracts that are split across service lines/

activity groupings. Patient-level data are based on the share of a

service/activity that an individual uses.

We calculated costs per patient over the study period for direct healthcare

resource use, overall and separately, for inpatient secondary

care (elective hospital admissions, non-elective hospital admissions,

and length of stay), outpatient secondary care, primary care, and

community care. All costs were calculated in GBP.

Statistical analysis

The primary outcome was health-care resource use and per-patient

costs of care for active disease and remission. Secondary objectives

were to compare costs according to disease activity (active disease

vs. remission), timing of biologic initiation (early vs. late), and type

of biologic received first (non-anti-TNF biologics vs. anti-TNF) in all

patients and in two age groups (18–59 years or ≥ 60 years). As this

was an exploratory study, descriptive statistics were generated and

are presented as frequency distributions for categorical variables and

mean values and standard deviations (SDs) for continuous variables.

No missing data were imputed. Differences between patients with

active disease and those in remission were assessed with the Wilcoxon

test. Significance was indicated by p values less than 0.05 and no

overlap over 95% confidence intervals. All statistical analyses were

performed with R version 2022.02.0.

Results

Population demographics

Between 31 March 2016 and 31 March 2020, the number of patients

identified with an incident diagnosis of IBD within the study period

was 7,733 (Table 1). Of these, 5,872 had UC, 1,427 had CD, and

434 had IBD-undefined. Most patients were younger than 60 years

of age and around 44% had comorbidities (Table 1). Roughly half of

patients had disease durations of at least 2 years by the end of the

study. Active disease was seen mostly in patients in the 18–59-year

age group. Throughout the study, remission was recorded in 19,218

(82%) of 23,488 observations in patients with UC, 4,686 (82%) of 5,708

in patients with CD, and 1,122 (65%) of 1,736 in patients with IBDundefined.

Biologics were prescribed in 392 (5%) patients, two-thirds

of whom started them late in the treatment course (Table 1). Within the

biologically treated group (n = 392), active disease was recorded in 371

(95%) and remission in 21 (5%). The age distribution consisted of 340

(87%) in the younger 18–59-year age group and 55 (14%) in older ≥

60-year age group.


18 Dataset

the study period by review of events: active disease was

19

As part of the integrated care system in northwest London,

health and social care data linked by NHS number

defined as more than two events within a 12-month

period and remission as two or fewer events within

FEATURE

UI-Haq et al. BMC Gastroenterology (2024) 24:480

Page 5 of 13


FEATURE


Table 1 Characteristics of patients

Characteristic UC (n = 5,872) CD (n = 1,427) IBD-undefined (n = 434)

Sex

Male 3,023 (51.5%) 691 (48.0%) 229 (53.0%)

Female 2,849 (48.5%) 736 (52.0%) 205 (47.0%)

Age (years)

18‒59 years 3,613 (62%) 1,117 (78.28%) 352 (81.11%)

≥ 60 years 2,259 (39%) 310 (21.72%) 82 (18.89%)

Mean (SD) 52.83 (19.5) 44.03 (18.4) 42.99 (17.6)

Median (range) 55 (18‒103) 39 (18‒100) 39 (18‒88)

BMI (kg/m 2 )*

Mean (SD) 26.5 (5.8) 25.4 (5.4) 26.0 (5.7)

Median (range) 25.6 (9.2–58.0) 24.8 (10.1–52.5) 25.3 (12.4–45.6)

Ethnicity (%)

Asian 1,524 (26%) 299 (21%) 100 (23%)

Black 344 (6%) 63 (4%) 16 (4%)

Mixed race 131 (2%) 42 (3%) 10 (2%)

White 523 (9%) 144 (10%) 53 (12%)

Other 411 (7%) 105 (7%) 36 (8%)

Not recorded 2,939 (50%) 774 (54%) 219 (50%)

Smoking status

Smoker 1,054 (18%) 314 (22%) 92 (21%)

Ex-smoker 1,015 (17%) 173 (12%) 65 (15%)

Non-smoker 123 (2%) 29 (2%) 8 (2%)

Not recorded 3,680 (63%) 911 (64%) 269 (62%)

Time from diagnosis to study end (months)

< 24 3,000 (51%) 681 (48%) 209 (48%)

≥ 24 2,872 (49%) 746 (52%) 225 (52%)

Electronic Frailty Index score

Mild 808 (14%) 137 (10%) 47 (11%)

Moderate 547 (9%) 70 (5%) 29 (7%)

Severe 405 (7%) 55 (4%) 7 (2%)

Well 3,306 (56%) 911 (64%) 290 (67%)

Not recorded 806 (14%) 254 (18%) 61 (14%)

At least one comorbidity

Number 2,960 (50%) 586 (41%) 177 (40%)

Mean (SD) 2.0 (1.2) 1.8 (1.0) 1.8 (1.2)

Median (range) 2 (1‒7) 1 (1‒8) 1 (1‒7)

Disease activity status at baseline

Active disease 2,040 (35%) 483 (34%) 263 (60%)

18‒59 years 1,409 (69%) 393 (81%) 210 (80%)

≥ 60 years 631 (31%) 90 (19%) 53 (20%)

Remission 3,832 (65%) 944 (66%) 171 (40%)

18‒59 years 2,204 (58%) 724 (77%) 91 (83%)

≥ 60 years 1,628 (42%) 220 (23%) 29 (17%)

Biologic treatment

Yes 177 (3%) 122 (9%) 93 (21%)

Early 70 37 37

Late 107 85 56

No 5,725 (97%) 1,350 (91%) 341 (79%)

Remission achieved

Total number of observations 23,488 5,708 1,736

Observations classified as remission 19,218 (82%) 4,686 (82%) 1,122 (65%)

*Denominators 4,171, 903, and 316 for UC, CD, and IBD-undefined, respectively. Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; UC, ulcerative

colitis

Health-care resource use

Primary analysis

Mean use of all health-care resources and lengths of stay in hospital

were significantly greater for patients with active disease than those

in remission (all p < 0.0001) except for primary care visits in the UC

group, which did not differ statistically (Fig. 2). Primary care accounted

for most health-care resource use. Other than care for IBD, the

most frequent (mean number of visits > 2.00 per patient) reasons for

primary care visits among patients with active disease were mental

health, measurement of C-reactive protein, and smoking cessation,

irrespective of diagnosis; general rheumatology in patients with UC

and CD; psoriasis in patients with UC; and depression and anxiety in

those with IBD (Appendix Table A3). For patients defined as being in

remission, the commonest reasons for primary care visits were mental

health for all IBD groups, smoking cessation and depression for UC

and CD, and suicide for UC.

Subgroup analyses of health-care resource use for active

and remission states

Age In the 18–59-year age group, mean frequencies of all types of

health-care usage were significantly higher with active disease than

with remission (Fig. 3). Hospital stays (elective and non-elective) were

significantly longer in patients with active state than remission in the

UC and CD groups; the opposite was found in the IBD-undefined

group (Fig. 3).

In the 18–59 year age group, the UC group, comparative mean values

for active disease versus remission were significantly different: elective

inpatient visits 2.02 (SD 2.16) versus 1.40 (SD 0.89), non-elective

inpatient visits 1.42 (SD 0.80) versus 1.06 (SD 0.24), length of inpatient

stay 8.69 (SD 11.77) days vs. 4.74 (SD 9.27) days, outpatient visits

5.49 (SD 6.02) versus 2.37 (SD 2.22), and primary care visits 21.15 (SD

21.32) versus 20.11 (SD 23.20) (all p < 0.0001).

In the CD group, hospital care values for patients age 18–59 years

were 2.31 (SD 2.06) versus 1.86 (1.64) for elective inpatient visits, 1.42

(SD 0.95) versus 1.14 (SD 0.39) for non-elective inpatient visits, 6.53

(SD 8.33) days versus 3.76 (SD 5.87) days for length of inpatient stay,

7.23 (SD 6.68) versus 3.61 (SD 3.88) for outpatient visits, and 23.95 (SD

24.73) versus 18.86 (SD 19.67 for primary care visits (all p < 0.0001).

The mean values in the IBD-undefined 18–59-year age group were

2.27 (SD 1.87) versus 1.25 (0.50) for elective inpatient visits (p =

0.0004), 1.49 (SD 1.10) versus 1.20 (SD 0.42) for non-elective inpatient

visits (p < 0.0001), 8.67 (SD 10.61) days versus 11.43 (SD 20.00) days

for length of stay (p < 0.0001), 8.45 (SD 8.66) versus 3.55 (SD 3.15) for

outpatient visits (p < 0.0001), and 28.70 (SD 27.77) versus 18.10 (SD

18.03) for primary care visits (p < 0.0001).

In the ≥ 60-year age group, the UC group, mean per-patient values

were significantly higher for the active state than remission for elective

inpatient visits (1.61 [SD 1.66] vs. 1.00 [SD 0.00], p < 0.0001), nonelective

inpatient visits (1.30 [SD 0.76] vs. 1.05 [SD 0.25], p < 0.0001),

length of inpatient stay (11.92 [SD 15.30] days vs. 4.73 [SD 5.08] days,

p < 0.0001), and outpatient visits (4.63 [SD 5.00] vs. 2.54 [SD 2.01],

p < 0.0001), whereas for primary care visits the number was higher

with remission (39.82 [SD 35.00] vs. 43.75 [SD 35.40], p = 0.0006;

Fig. 3).

Fig. 2 Health-care resource use over the study period by care type and

disease activity status. Data are means with standard deviations. (A) Ulcerative

colitis. (B) Crohn’s disease. (C) IBD-undefined. *Elective and nonelective

hospital visits. Abbreviation: IBD-undefined, diagnosis including

codes for both ulcerative colitis and Crohn’s disease

elective inpatient visits, 1.42 (SD 0.95) versus 1.14 (SD

0.39) for non-elective inpatient visits, 6.53 (SD 8.33) days

In the CD group aged ≥ 60 years, mean values were significantly higher

versus 3.76 (SD 5.87) days for length of inpatient stay,

with active state than remission for non-elective inpatients visits (1.21

7.23 (SD 6.68) versus 3.61 (SD 3.88) for outpatient visits,

[SD 0.58] vs. 1.08 [SD 0.29], p = 0.021) and outpatient visits (6.81 [SD

and 23.95 (SD 24.73) versus 18.86 (SD 19.67 for primary

6.18] vs. 3.79 [SD 3.59], p < 0.0001), whereas they were higher with

care visits (all p < 0.0001).

remission for elective inpatient visits (1.00 [SD 0.00] vs. 2.00 [SD 0.00],

The mean values in the IBD-undefined 18–59-year age

p = 0.01) and duration of inpatient stay (15.44 [SD 15.00] days vs.

group were 2.27 (SD 1.87) versus 1.25 (0.50) for elective

15.46 [SD 20.35] days, p = 0.003). The mean numbers of primary care

inpatient visits (p = 0.0004), 1.49 (SD 1.10) versus 1.20 (SD

visits did not differ significantly (40.18 [SD 39.39] vs. 42.98 [SD 36.61],

p = 0.37; Fig. 3).

Within the ≥ 60-year IBD-undefined age group, while significantly

higher values were seen in active disease for elective inpatient visits

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20 21

FEATURE


Page 8 of 13

FEATURE

(1.17 [SD 0.41] vs. 0 [SD 0.00], p < 0.0001), duration of inpatient stay

(35.50 [SD 28.25] days vs. 11.25 [SD 6.81] days, p = 0.031), outpatient

visits (8.03 [SD 10.25] vs. 3.63 [SD 2.08], p = 0.0035), and primary care

visits (44.44 [SD 37.25] vs. 31.66 [SD 28.04], p = 0.0019), the difference

for non-elective inpatient visits was not significant (2.27 [SD 3.31] vs.

1.00 [SD 0.00], p = 0.84; Fig. 3).

(mean 6.56 [SD 7.33] vs. 9.15 [SD 7.08], p = 0.0049; Appendix Table

A4). When we compared the type of biologics used first, the only

significant difference in use for any type of healthcare resource was

for length of hospital stay (elective and non-elective) in the UC group

(mean 10.64 [SD 9.30] days vs. 16.65 [SD 18.82], p = 0.006; Appendix

Table A5).

Biologic initiation Comparison of health-care resource use between

early and delayed start of biologics showed no significant differences

in most of the cohort except for outpatient visit numbers being


significantly higher with later biologic use in the IBD-undefined group

Costs

Primary analysis

The mean total per-patient costs of health care were significantly higher

Page 7 of 13

among patients with active disease than remission for all ages and


Fig. 3 Health-care resource use over the study period by care type, disease activity status, and age group. Data are means with standard deviations. (A)

Ulcerative colitis, (B) Crohn’s disease, and (C) IBD-undefined in the 18–59-year age group. (D) Ulcerative colitis, (E) Crohn’s disease, and (F) IBD-undefined

in the ≥ 60-year age group. *Elective and non-elective hospital visits. Abbreviation: IBD-undefined: diagnosis including codes for both ulcerative colitis

and Crohn’s disease

Fig. 4 Total per-patient health-care costs over the study period by disease

and activity status. Data are means with standard deviations. (A) Whole cohort.

(B) All patients aged 18–59 years. (C) All patients aged ≥ 60 years. Abbreviation:

IBD-undefined: diagnosis including codes for both ulcerative

colitis and Crohn’s disease

Subgroup analyses of costs

by age group (all p < 0.0001 except p = 0.00026 for CD patents aged

Age For UC, in the 18–59-year age group, the mean perpatient

costs were higher with active disease state than

≥ 60 years; Fig. 4). However, when analysing the different care types

separately, variation was seen. For UC and CD, significantly higher

remission for non-elective inpatient visits (£4,583 [SD

costs for hospital care (inpatient and outpatient) were associated with

£4,489] vs. £2,582 [SD £2,141]), outpatient visits (£559

the active state while the opposite was true for inpatient care among

[SD £481] vs. £340 [SD £320]), and primary care visits

patients with IBD-undefined (Fig. 5). The mean number of primary care

(£357 [SD £558] vs. £32 [SD £599]), whereas the opposite

visits were numerically lower with active UC, although not statistically

was true for elective inpatient visits (£2,581 [SD £3,660]

significant (p = 0.67), were significantly lower with active CD (p =

0.0006), and were significantly higher with active IBD-undefined.

Biologics costs were higher with active disease than remission for all

diagnoses, but significance was reached for this difference only in the

CD group.

Fig. 5 Total per-patient health-care costs over the study period by care

type and disease activity status. Data are means with standard deviations.

(A) Ulcerative colitis. (B) Crohn’s disease. (C) IBD-undefined. Abbreviation:

IBD-undefined: diagnosis including codes for both ulcerative colitis and

Crohn’s disease

vs. £5,085 [SD £4,247]) (all, p < 0.0001, Fig. 6). The cost

of biologics did not differ significantly (mean £6,547 [SD

Subgroup analyses of costs

£6,971] vs. £6,213 [SD £5,700], p = 0.81). By contrast, the

Age For UC, in the 18–59-year age group, the mean per-patient costs

costs for CD were consistently greater with active disease

were higher with active disease state than remission for non-elective

than with remission, and all differences were significant

inpatient visits (£4,583 [SD £4,489] vs. £2,582 [SD £2,141]), outpatient

(all p < 0.0001, Fig. 6): elective inpatient visits mean £4,581

visits (£559 [SD £481] vs. £340 [SD £320]), and primary care visits

(SD £4,506) versus £443 (SD £2,759); non-elective inpatient

visits £4,183 (SD £4,169) versus £2,702 (SD £2,771);

(£357 [SD £558] vs. £32 [SD £599]), whereas the opposite was true

for elective inpatient visits (£2,581 [SD £3,660] vs. £5,085 [SD £4,247])

outpatient visits £696 (SD £591) versus £411 (SD £332);

(all, p < 0.0001, Fig. 6). The cost of biologics did not differ significantly

(mean £6,547 [SD £6,971] vs. £6,213 [SD £5,700], p = 0.81). By contrast,

the costs for CD were consistently greater with active disease than

with remission, and all differences were significant (all p < 0.0001, Fig.

6): elective inpatient visits mean £4,581 (SD £4,506) versus £443 (SD


22 23

except p = 0.00026 for CD patents aged ≥ 60 years; Fig. 4).

However, when analysing the different care types separately,

variation was seen. For UC and CD, significantly

statistically significant (p = 0.67), were significantly lower

with active CD (p = 0.0006), and were significantly higher

with active IBD-undefined. Biologics costs were higher

FEATURE


Page 9 of 13

FEATURE

inpatient visits £6,190 [SD £5,254] vs. £5,201 [SD £4,220]; outpatient

care £767 [SD £611] vs. £461 [SD £376]; and biologics £11,759 [SD

£11,162] vs. £3,517 [SD £3,750]). For IBD-undefined, significantly

higher costs were seen with active disease for elective inpatient visits

(mean £3,506 [SD £4,730] vs. £0 [SD £0], p < 0.0001), outpatient visits

(£798 [SD £784] vs. £424 [SD £339], p = 0.0038), and primary care

visits (£768 [SD £869] vs. £530 [£577], p = 0.032). Other costs were

numerically higher for patients with active disease but not statistically

(non-elective inpatient visits mean £11,989 [SD £11,710] vs. £5,175

[SD £3,825], p = 0.16 and biologics £10,409 [SD £8,187] vs. £2,060

[SD £0], p = 0.23).

Biologic initiation We found no significant differences in the costs

associated with any type of care when assessed by timing of biologic

initiation (Appendix Table A6). Costs associated with receiving non-anti-

TNFs as the first biologic therapy were significantly more expensive

than those of receiving anti-TNFs first (UC mean £11,208 [SD £8,348]

vs. £5,068 [SD £5,845], p < 0.0001; CD £10,648 [SD £8,370] vs.

£6,296 [SD £5,828], p = 0.022; IBD-undefined £13,020 [SD £7,022] vs.

£6 695 [SD £9,334], p < 0.001). However, when direct biologics costs

were removed, none of the costs associated with primary or secondary

care differed significantly other than that for non-elective inpatient visits

among patients with UC and outpatient visits for those with CD (both

favoured anti-TNFs; Appendix Table A7).

Discussion

This large 4-year real-world cohort study shows a substantial burden

on the health-care system associated with IBD, wherein more healthcare

resources are used by patients meeting pre-defined criteria for

active disease than by those considered to be in remission. A similar

pattern was seen for costs. The greatest health-care resource use is

seen for primary care, particularly in patients aged 60 years and older,

followed by outpatient care. The overarching driver for costs was

inpatient hospital care (elective and non-elective). Total health-care

costs were greater in an active state than in remission (all p < 0.0001),

with the main cost driver being inpatient hospital care visits for active

disease. Among patients with UC and IBD-undefined in remission

elective inpatient costs were higher than those with active disease.

definitions of active disease and remission. Other studies within similar

time periods showed higher biologic use. In an Israeli study 39% of

patients with CD and 15% with UC diagnosed between 2005 and

2020 received biologics [38], while, in a Danish study, among patients

diagnosed from 2000 to 2018, 27% with CD and 10% with UC received

biologics within 1 year of onset [39].

Some studies suggest that costly novel therapies failed to lower the

overall cost burden of IBD. Alulis and colleagues [40] reported higher

annual costs of treatment among patients who received biologics

than for those who did not. Nevertheless, staffing costs were reduced

driven by more patients being seen as outpatients. Similarly, Park

and colleagues [41] showed that care costs rose with increasing use

of biologics after 2014, particularly in elderly IBD patients, where

costs were 20–40% higher than those for adults aged 19–54 years.

This finding is intriguing, as people older than 60 years are less often

treated with biologics [13, 15], similar to the pattern in our cohort.

Such findings might be related to co-existing conditions associated

with ageing. Burisch and colleagues [42] assessed 5-year direct

expenditure profiles for 1,289 patients with IBD across Europe and

highlighted that biologics accounted for a significant proportion of

direct health-care costs. Concurrently, however, they reported that

overall costs decreased over the 5-year period, which they attributed

to reduced costs for procedures, hospitalisations, and surgeries

despite increased spending on biologicals.

Differing prescribing habits by age group might be driven by safety

concerns related to anti-TNF biologics [15], but it seems unlikely that

the use of biologics alone, and especially more costly non-anti-TNF

biologics, is driving higher treatment costs. Rather, we found that costs

for older patients with active disease were high for inpatient hospital

care, probably because of the length of stay required. Meanwhile,

younger patients with disease in remission accessed the most

inpatient care, especially elective hospital visits, which were probably

related to attendances for day-care infusions. This is consistent with

the reported literature, particularly for UC [43]. More-granular details

on the use of care would add value to understand further whether

different approaches can reduce the costs associated with more

urgent secondary care.


Fig. 6 Total per-patient health-care costs over the study period by care type, disease activity status, and age group. Data are means with standard deviations.

(A) Ulcerative colitis, (B) Crohn’s disease, and (C) IBD-undefined in the 18–59-year age group. (D) Ulcerative colitis, (E) Crohn’s disease, and (F) IBDundefined

in the ≥ 60-year age group. Abbreviation: IBD-undefined: diagnosis including codes for both ulcerative colitis and Crohn’s disease

primary care visits £401 (SD £509) versus £314 (SD £8,041], p < 0.0001) while outpatient and primary care visits

were significantly higher with active disease (£761 [SD

£425); and biologics £7,927 (SD £7,076) versus £3,095

£2,759); non-elective inpatient visits £4,183 (SD £4,169) versus £2,702 In the ≥ 60-year age group, mean per-patient costs associated with

(SD £2,861). For IBD-undefined, costs for elective inpatient

visits and biologics differed notably numerically but £310 [SD £374], p = 0.0001).

£599] vs. £418 [£340], p < 0.0001, and £493 [SD £627] vs.

(SD £2,771); outpatient visits £696 (SD £591) versus £411 (SD £332); all care types for UC were significantly higher with active disease than

primary care visits £401 (SD £509) versus £314 (SD £425); and biologics with remission (elective inpatient visits mean £4,873 [SD £4,421] vs.

not statistically (mean £4,863 [SD £3,934] vs. £7,759 [SD

£7,927 (SD £7,076) versus £3,095 (SD £2,861). For IBD-undefined, costs £1,646 [SD £1,081], p < 0.0001; non-elective inpatient visits £4,479

£11,948], p = 0.63, and £8,567 [SD £9,442] vs. £1,135 [SD In the ≥ 60-year age group, mean per-patient costs

for elective inpatient visits and biologics differed notably numerically [SD £3,816] vs. £2,664 [SD £1,608], p < 0.0001; outpatient care £547

£2,842], p = 0.33, respectively). Non-elective inpatient associated with all care types for UC were significantly

but not statistically (mean £4,863 [SD £3,934] vs. £7,759 [SD £11,948], [SD £463] vs. £375 [SD £270], p < 0.0001; and biologics £10,139 [SD

visits were significantly lower with active disease than higher with active disease than with remission (elective

p = 0.63, and £8,567 [SD £9,442] vs. £1,135 [SD £2,842], p = 0.33, £8,667] vs. £1,948 [SD £1,360], p = 0.018) except for primary care

with remission (mean £4,809 [SD £3,954] vs. £7,213 [SD inpatient visits mean £4,873 [SD £4,421] vs. £1,646 [SD

respectively). Non-elective inpatient visits were significantly lower with (£633 [SD £850] vs. £709 [SD £844], p = 0.003; Fig. 6). For CD, primary

active disease than with remission (mean £4,809 [SD £3,954] vs. £7,213

[SD £8,041], p < 0.0001) while outpatient and primary care visits were

significantly higher with active disease (£761 [SD £599] vs. £418 [£340],

p < 0.0001, and £493 [SD £627] vs. £310 [SD £374], p = 0.0001).

care costs did not differ significantly between disease statuses (mean

£632 [SD £691] for active disease vs. £755 [SD £887] for remission, p =

0.33) while all other costs were significantly higher with active disease

(elective inpatient visits £6,464 [SD £2,575] vs. £0 [SD £0]; non-elective

Understanding the activities driving costs in IBD is important in a two

respects: firstly, as the prevalence of the disease continues to rise in

high-income countries, anticipating the needs of the population is a

prerequisite for planning health services; secondly, as more drugs are

marketed for IBD, more-effective therapies and early recognition of

non-response facilitates a switch to the next drug to elicit a response,

thereby mitigating the likelihood of more costly hospital admissions.

The lower health-care resources cost with remission links economic

with clinical arguments for early use of effective therapies to induce and

maintain remission in IBD and minimise hospital admissions for active

disease, particularly non-elective admissions [17, 37]. In our cohort only

5% of patients (n = 392) were prescribed biologics: 144 (37%) received

them early, within 3 months of an active disease event, and 248 (63%)

received later therapy. We were unable to study the underlying reasons

behind prescribing practices due to the retrospective design of the

study. However, compared with other cohorts, these figures are low,

which suggests undertreatment even beyond the constraints of the

Much of the care burden of patients with IBD in this study fell on

primary care, particularly for patients in the 60 years and older age

group. While the costs of these visits are low, the numbers of visits

require substantial time. In a UK survey of 624 family physicians, 70%

reported that they had no formal training in IBD and more than half

(52%) expressed low confidence in knowing how to manage disease

flares [44]. This could be an important area in which to provide training

to GPs and education to patients that could reduce the need for

hospital admissions and the number of visits.

Everhov and colleagues [15] showed that increased spending on

direct health-care costs can reduce the need for societal support of

patients due to sickness absence. Burisch et al. [45] recommended

that health-care costs assessments should include indirect costs to

better reflect the results of improved disease management, and use

registries and big data to assess changes in health-care models in the

real world. While we had access to a large real-world dataset, sufficient

data on indirect costs were not available to enable such comparisons.


24 25

FEATURE

FEATURE


We did find that in patients who received biologics, non-drug costs did

not increase. We support the improved reporting and use of data on

community, social, and other indirect costs.

The Discover dataset is one of Europe’s largest linked longitudinal

costed datasets [36], and captures roughly one-third of London’s

population, representing wide diversity. It can provide longitudinal

health-care data at the patient level based on commissioner pricing

for different provider services, linked by patients’ unique NHS

identifiers. Primary care data available from birth, including diagnoses,

prescriptions, hospital activity, and events such as emergency,

outpatient, and social care visits add to the strength of this study.

Nevertheless, we caution that there may be some variability in clinical

practice between individual centres and other geographical areas that

might affect the generalisability of results.

However, this study has some limitations. First, the definitions of

active disease and remission were based on indirect assumptions,

albeit underpinned by indications for treatment escalation in prevailing

guidelines [18]. Shortcomings in the granularity of real-world data is

a well-recognised limitation [46]. This issue led to active disease and

remission having to be estimated from numbers of events in 12-month

periods and remission from the proportion of observations that did

not show more than two events in a 12-month period. This approach

precluded some analyses, such as accurate calculations of length of

remission, which might have been of interest to readers. Additionally,

it may have led to an overestimate of the remission rate. Another

study using real-world data from UK IBD BioResource calculated that

remission at 1 year was 74–76% in patients with CD, dependent on the

first-line biologic received, and at 3 years was 50–70% [47]. Norwegian

population-based cohort studies suggest clinical remission in 48% of

patients with UC and 44% with CD, 5–10 years after diagnosis [2, 3,

48]. Thus, the most appropriate way to record and measure remission

should be investigated further. Second, although the Discover dataset

includes social care records, methods to calculate societal cost factors

at the patient level are still underway. We acknowledge, however, that

these social care and wider societal costs are likely to further impact

cost-effectiveness in health care. Hansson-Hedblom and colleagues

[49] used a cost-effectiveness model to estimate direct and indirect

costs of CD in Sweden. They showed that for total costs over a 60-

year life-time horizon, indirect costs for loss of productivity accounted

for around 50% of disease-associated costs. Another Swedish study

showed that mean annual societal costs for adults were increased

around threefold with CD and doubled with UC compared with costs

for the general population, with 56% and 59%, respectively, being

due to loss in productivity [50]. Our aim was to test the hypothesis

that active disease is associated with higher use and costs of clinical

health care to support clinical practice that delivers timely and effective

therapies. We did not assess differences in health-care resource use

by subgroups of patients, for example by sex, education, employment,

etc., as it was outside the scope of the study. Such population

data are stored in the Discover database and following on from

our findings could identify subgroups who might benefit most from

tailored approaches to treatment. A previous study [51] found multiple

sociodemographic and clinical factors within patient subgroups that

were associated with high treatment costs, especially unemployment,

use of prescribed opiates, and psychiatric and cardiovascular

diseases. Of note, data on ethnicity were very poorly recorded in our

data set, with records missing for about half of patients. While this

level of missing data seems particularly high and the reasons for this

are unclear, recording of ethnicity is a known issue across England,

particularly in London [52].

Conclusions

In our cohort, only 5% of IBD patients living in northwest London were

prescribed biologic therapy. Based on our indirect definition, active

disease was associated with significantly greater costs than care of

patients in remission. Earlier use of biologics and the use of non-anti-

TNF biologics as first-line therapy did not lead to significant increases

in overall health-care resource costs, supporting a paradigm of timely

and effective therapy. Further analysis of real-world data is warranted

to explore subgroups who may benefit most from earlier initiation of

biologics, whether uptake of classes of biologics with lower infection

risks offer additional benefits for the older age groups, and whether

uptake of biologic for this age group may increase with lower nonelective

hospital resource use.

Abbreviations

Anti-TNF Monoclonal antibody against tumour necrosis factor

CD Crohn’s disease

GP General practice

IBD Inflammatory bowel disease

SD Standard deviation

UC Ulcerative colitis

Supplementary Information

The online version contains supplementary material available at

https://doi.org/10.1186/s12876-024-03559-3.

Supplementary Material 1

Acknowledgements

We thank Rachel Ashton for providing writing and editorial support,

which was paid for by the study funder. All authors approved the final

version of the article.


Zia UI-Haq: conceptualization; data curation; formal analysis;

investigation; methodology; writing – review and editing. Luiz Causin:

conceptualization, project administration; writing – review and

editing. Tahereh Kamalati: conceptualization; project administration;

supervision; formal analysis; writing – review and editing. Durgesh

Kahol: conceptualization; supervision; formal analysis; writing – review

and editing. Trishan Vaikunthanathan: formal analysis; writing – review

and editing. Charlotte Wong: conceptualization; formal analysis; writing

– review and editing. Naila Arebi: conceptualization; supervision;

formal analysis; writing – original draft preparation; writing – review

and editing.

Funding

This study was funded by Janssen-Cilag Limited. The funder had a role

in study conceptualization, design, data collection, analysis, decision

to publish, and preparation of the manuscript.

Data availability

The data that support the findings of this study are available from

Imperial College Health Partners, but restrictions apply to the

availability of these data, which were used under license for the current

study, and so are not publicly available. Data are however available

from the Imperial College Health Partners upon reasonable request

and with permission of Professor Naila Arebi.

Declarations

Ethics approval and consent to participate

Ethics approval for the use of the Discover Platform for research was

secured from the NHS Health Research Authority in October 2018.

The REC reference is 18/WM/0323 and the IRAS project ID is 253449.

Ethics approval from an institutional review board was not sought as all

data were anonymised.

Consent for publication

Not applicable.

Competing interests

DK was employed by Janssen-Cilag Ltd (a subsidiary of Johnson &

Johnson) at the time that the study was conducted and currently owns

Johnson & Johnson stock/stock options. TV is currently employed

by Janssen-Cilag Ltd (a subsidiary of Johnson & Johnson) and owns

Johnson & Johnson stock/stock options. NA has received grants and

consultancy fees from Janssen, Lilly, Ferring and Abbvie. ZU-H, TK and

CW declared no conflicts of interest. LC was employed by Janssen-

Cilag Ltd (a subsidiary of Johnson & Johnson) at the time that the study

was conducted. TK and ZU-H were employed by Imperial College

Health Partners at the time that the study was conducted.

Received: 28 September 2024 / Accepted: 10 December 2024

Published online: 30 December 2024

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Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in

published maps and institutional affiliations.

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28 29

COMPANY NEWS

COMPANY FEATURE NEWS


Tillotts Pharma AG

celebrates 15 years as an

integral part of the Japanese

Zeria Group

RHEINFELDEN, Switzerland, February

13, 2025 – Life Science Newswire –Tillotts

Pharma AG ("Tillotts") proudly marks

its 15th anniversary as a member of the

Japanese Zeria Group, celebrating a

period of exceptional growth and valuable

collaboration together. The milestone was

commemorated in December 2024 with

Tillotts’ CEO, Thomas A. Tóth von Kiskér,

and members of the leadership team

visiting Zeria. During this special occasion,

Mr. Sachiaki Ibe, Chairman of the Board of

Directors and CEO of Zeria Pharmaceutical

Co., Ltd., presented Mr. Tóth a symbolic

piece of Japanese art featuring Mount Fuji

as a gift to honor Zeria’s appreciation for

Tillotts’ remarkable accomplishments since

the acquisition.

Over the past 15 years, Tillotts has

consistently achieved strong double-digit

growth and broadened its portfolio while

leveraging the trust and support of the Zeria

Group. Tillotts’ remarkable success and

progress is largely due to the exceptional

dedication of its employees, who constantly

strive to unlock the full potential of both

in-house developments and in-licensed

products and technologies. This commitment

has also led to Tillotts in-licensing the product

Dificlir for the treatment of Clostridioides

difficile infection (CDI) in 2020, a potentially

life-threatening disease. An effective and rapid

integration of Dificlir enabled the company

to quadruple its revenue since its in-licensing.

Mr. Sachiaki Ibe, Chairman and CEO of

Zeria Pharmaceutical Co., Ltd. said:

"Tillotts has shown extraordinary performance

over these 15 years, and I sincerely appreciate

the significant contributions made to the

Zeria Group. Our partnership has been

strengthened over the years and has positively

influenced the future trajectory of both Tillotts

and Zeria. I extend my sincere gratitude to the

entire Tillotts team for their dedication and

look forward to continued growth for both

Zeria and Tillotts through our collaborative

efforts", says Mr. Sachiaki Ibe.

"The long-standing partnership with Zeria

fills us with great pride and gratitude for the

mutual trust we have built over the years.

Tillotts has evolved from a key player in IBD

to a strong specialty pharma company,

establishing ourselves as a leader in

gastroenterology and infectious diseases.

Our successes have allowed us to broaden

our network of affiliates across Europe, with

ambitions to grow beyond the continent in the

near future. I am immensely grateful to our

employees for their passion and hard work

in pursuing our goal of reaching even more

patients and improving their lives."

Pictured: Mr. Sachiaki Ibe, Chairman of

the Board of Directors and CEO of Zeria

Pharmaceutical Co., Ltd., Mr Mitsuhiro Ibe

Director of Zeria Pharmaceutical Co., and

Tillotts’ CEO, Thomas A. Tóth von Kiskér (right

to left) at the celebration ceremony at Zeria’s

headquarters in Tokio

50 Years of Trust: Advancing

Healthcare and Science

Together

Alpha Laboratories Has Been Supplying

Quality to Science Since 1975

Alpha Laboratories (Eastleigh, UK) is

celebrating its 50th anniversary this year,

marking half a century of commitment

to supporting clinicians, scientists, and

patients across the globe. Founded in 1975,

Alpha Laboratories has become a trusted

supplier of laboratory consumables, liquid

handling supplies, diagnostic solutions, and

lab equipment.

David Giles was a founding member and

Chairman, pushing the company forward with

tenacity, passion and a drive for scientific

innovation. That passion and drive has

continued, with Alpha building a reputation for

providing high-quality products that support

critical research and healthcare applications.

Five decades on and the company remains

true to its original vision and ethos: to help

science improve people’s lives. Alpha’s

values are embedded in the pillars of People,

Planet, Culture where our team’s expertise,

professionalism, and involvement in local

communities and environment make them

proud to be part of Alpha.

From routine laboratory supplies to advanced

clinical diagnostics, Alpha Laboratories’

expertise spans a wide range of scientific

fields. Notably, the company has become

a leader in Faecal Immunochemical and

Calprotectin testing, offering products

that help clinicians make timely, accurate

diagnoses and improve patient outcomes.

“Celebrating 50 years is a testament to

the hard work and dedication of our team,

and to the trust our customers place in us,”

said Rob Vint, Managing Director of Alpha

Laboratories. “As we look to the future, we

remain committed to advancing healthcare

through innovation, sustainable solutions,

and exceptional service. Our journey has

been shaped by strong partnerships with

healthcare professionals, researchers, and

suppliers, and we are proud to have played

a role in supporting scientific progress and

improving patient care. While much has

changed over the past five decades, our

core values of integrity, collaboration, and

a passion for making a difference have

remained constant. We are excited about

the opportunities ahead and look forward to

continuing to serve the scientific and medical

communities for many years to come.”

As Alpha Laboratories celebrates this

remarkable milestone, it remains focused on

its vision for the future, continuing to invest in

innovative technologies, sustainable practices,

and global healthcare solutions.

To learn more about Alpha Laboratories’ 50-

year journey, visit www.alphalabs.co.uk/50th.

BIOHIT introduces the

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16. Sivero, L. et al. Endoscopic diagnosis and treatment convenient of dropper tube, Author enabling contributions

precise Jussi Hahtela, CEO of BIOHIT OYJ,

neuroendocrine tumors of the digestive system. and Open reproducible Med. 11(1), sample Ç.E., dispensing M.Y.: conception, for design, commented: supervision, “The BIOHIT materials, FAEX data Sample collection

369–373. https://doi.org/10.1515/med-2016-0067 ELISAs, (2016). chemiluminescence and assays, processing, lateral analysis System and interpretation, exemplifies literature our commitment review, writer to

17. Witteman, B. J., Janssens, A. R., Griffi oen, G. flow & Lamers, tests and C. proprietary B. and diagnostic critical review. kits. The D.A., B.Y., providing K.K. O.C., innovative İ.T., H.T.K.: solutions materials, that address data

Villous tumours of the duodenum. An analysis precision-engineered of the literature with collection collection stick and ensures processing, real-world analysis and challenges interpretation, for patients literature and review

emphasis on malignant transformation. Neth. J. Med. 42, 5 (1993).

consistent and accurate sample and manuscript collection, supervision. laboratories. By combining precision and


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presentation and pathological features

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System, of 27 a cases. revolutionary Am. J. Gastroenterol. stool sample 90, 290–294 (1995).

Competing interests

collection 19. Noguchi, and H. handling et al. Prevalence solution of that Helicobacter

transport,

pylori infection

storage

rate

and disposal. The authors declare no competing patient experience. interests. The unique adaptability

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and laboratories.

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report and literature review. Case Rep. Gastrointest. Med. 2013,

934875 (2013).

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The 21. Modlin, BIOHIT I. FAEX M., Lye, Sample K. D. System & Kidd, combines M. A 5-decade as analysis part of a of diagnostic 13,715 kit, it is a versatile and en/products/biohit-faex-sample-system/

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jurisdictional

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claims in published

Sample

maps

System.

and institutional affi liations.

gastrointestinal endoscopy: A retrospective analysis in 19560

patients, a single-center study of a 5-year experience in Turkey. Open Access This article is licensed under a Creative Commons

N. Clin. Istanb. 8(2), 178–185. https://doi.org/10.14744/

Attribution 4.0 International License, which permits use, sharing,

nci.2020.16779 (2020).

23. Kostiainen, S., Teppo, L. & Virkkula, L. Papilloma of the

oesophagus. Report of a case. Scand. J. Thorac. Cardiovasc.

Surg. 7(1), 95–97. https://doi.org/10.3109/14017437309139176

(1973).

24. Mandard, A. M. et al. Cancer of the esophagus and associated

lesions: Detailed pathologic study of 100 esophagectomy

specimens. Hum. Pathol. 15, 660 (1984).


gland hamartomas: Clinical presentation and pathological features

of 27 cases. Am. J. Gastroenterol. 90(2), 290–294 (1995).

26. Ma, M. X. & Bourke, M. J. Management of duodenal polyps. Best

Pract. Res. Clin. Gastroenterol. 31(4), 389–399 (2017).

adaptation, distribution and reproduction in any medium or format, as

long as you give appropriate credit to the original author(s) and the source,

provide a link to the Creative Commons licence, and indicate if changes

were made. The images or other third party material in this article are

included in the article’s Creative Commons licence, unless indicated

otherwise in a credit line to the material. If material is not included in the

article’s Creative Commons licence and your intended use is not permitted

by statutory regulation or exceeds the permitted use, you will need to

obtain permission directly from the copyright holder. To view a copy of this

licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/.

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