ACR 2017 Review

Enhancing knowledge of the clinical importance of cytokine signalling
The Cytokine Signalling Forum
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ACR 2017
Conference Highlights

ACR 2017
Conference Highlights
Chairman’s Welcome
Dear CSF Member,
It is my pleasure to once again bring to you our review of the ACR 2017 highlights, including a review of my ‘Chairman’s picks’ – those
abstracts, which I feel were the most significant at this year’s congress.
New molecules of interest continue to be developed, and this year sees the release of Phase 3 data from upadacitinib (previously
known as ABT-494), a selective JAK-1 inhibitor – Burmester, et al. share the results of this study in 661 patients with RA with an
inadequate response to csDMARDs [#1904].
Long-term data for tofacitinib out to 9 years are presented [#522] along with the effect of dose escalation or de-escalation on efficacy
and safety in these long-term extension studies [#535]. Results from the Phase 3b/4 ORAL Strategy trial compare patient-reported
outcomes (PROs) in 1146 patients with RA receiving tofacitinib ± methotrexate versus adalimumab ± methotrexate [#1906]. Specific
considerations with tofacitinib treatment include look at the effectiveness of live zoster vaccine in patients with RA subsequently initiated
on tofacitinib 2–3 weeks later [#1440].
Tofacitinib is also examined in non-RA indications, with a pooled analysis of PROs in 430 patients with psoriasis and psoriatic arthritis
(PsA) from the OPT Pivotal studies [#613], as well as an integrated safety analysis [#616] and efficacy analysis [#619] from the OPAL
trials in PsA.
Baricitinib continues to publish extensive data, with an update to the integrated safety analysis out to 5.5 years in RA [#511] and results
from a prospective study suggesting that dose reduction is possible in patients achieving sustained disease control [#1821]. Vaccine
response is also examined by Winthrop, et al., with an evaluation of pneumococcal and tetanus vaccination in 106 patients with RA
receiving baricitinib in RA-BEYOND [#1824].
In the IL-6 field, abstracts on tocilizumab focus on long-term safety in post-marketing studies [#550] and sustained response following a
switch from methotrexate + tocilizumab [#1905]. PROs following withdrawal of methotrexate are also investigated [#2460].
The following pages provide a review of the highlights from ACR 2017, including my ‘Chairman’s picks’. Once again, thank you for your
support, and we hope you enjoyed your time at ACR 2017.
Yours,
Prof. Iain McInnes

Highlights from ACR 2017
.
During the ACR 2017 annual meeting, many presentations and posters reported on
cytokine signalling and related drugs. This document reviews the highlights.
ACR poster session A
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I:
Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules
Upadacitinib patient-reported outcomes; and long-term data
Strand, et al. presented patient-reported outcomes (PROs) with upadacitinib (previously
known as ABT-494), a selective JAK inhibitor. In this Phase 2 open-label extension study,
493 patients received upadacitinib. At Week 48, patients in all cohorts reported
improvements across all PROs, including disease activity, pain, physical functioning,
fatigue, work functioning, and overall health status. The largest improvements were seen
in patients who did not titrate their dose either up or down during the trial [#501].
Long-term safety and efficacy of upadacitinib in BALANCE-EXTEND, an ongoing,
combined open-label extension (OLE) of the Phase 2 trials was reported in a poster from
Genovese, et al. The event rate for AEs seen in the OLE was lower than in the Phase 2
trials, and overall events per 100 patient-years were 2.3 for serious infection, 3.7 for
herpes zoster, 0.8 for malignancies excluding non-melanoma skin cancer, and 1.0 for
adjudicated cardiovascular (CV) events. There were 2 deaths. At Week 72, efficacy was
maintained in patients on upadacitinib 6 mg BID; 55% of patients achieved ACR70 and
83% were in low disease activity at the end of the observation period [#509].
Filgotinib monotherapy; and the effect of MTX dose when used as combination therapy
Taylor, et al. showed that filgotinib monotherapy was associated with significant reductions
in a broad panel of immune- and tissue-related biomarkers relevant to RA, compared with
placebo (27/35 markers). The largest reductions were in the pro-inflammatory markers IL-
6, SAA, and CRP (58–68% median reduction from baseline to Week 12, P12.5 to

Baricitinib achievement of low disease activity; and patient-reported outcomes
Baricitinib Phase 3 data from RA-BEAM was presented by Nash, et al. Treatment with
baricitinib resulted in significantly lower mean disease activity at Weeks 12 and 24 than
placebo (P

functional assessment of chronic illness therapy - fatigue (FACIT-F), SF-36 physical
component score (PCS), and duration of morning joint stiffness at 4 weeks after rescue,
and these improvements were sustained through 12 weeks [#508].
Results of a systematic review and network meta-analysis, inferring from both direct and
indirect evidence comparing baricitinib and tofacitinib, were presented by Zamora, et al.
When comparing indirectly, the only differences were observed in favour of baricitinib +
MTX compared with tofacitinib alone. All drug combinations were effective compared with
placebo in reducing at least 50% of symptoms or achieving remission at 12 weeks.
Tofacitinib 10 mg and baricitinib 8 mg combined with MTX were among the most
efficacious options. SAEs were less likely with the tofacitinib groups, although the withinclass
differences were small and may not be clinically meaningful [#531].
Baricitinib and tofacitinib long-term safety
Genovese, et al. presented the 5.5-year safety profile for baricitinib from an ongoing longterm
extension (LTE). This included 3492 patients, with a total of 6637 patient-years of
exposure. No differences were seen for baricitinib 4 mg versus placebo in AEs leading to
permanent study drug discontinuation, death, malignancy, serious infection, or major
adverse cardiovascular events (MACE). The incidence of herpes zoster (HZ) was
significantly higher for baricitinib 4 mg versus placebo (4.3 versus 1.0, respectively).
Malignancy (excluding non-melanoma skin cancer [NMSC]) incidence rates were 0.5 and
1.3 for 2 mg and 4 mg, respectively, which are similar to those previously reported. The
incidence of lymphoma (0.09), gastrointestinal perforation (0.05), and tuberculosis (0.15,
all in endemic areas) were also similar to those previously reported. Fewer than 1% of
patients discontinued due to abnormal laboratory results [#511].
Wollenhaupt et al. presented the 9-year safety and efficacy data for tofacitinib. Data were
taken from two ongoing OLEs in 4967 patients, with total tofacitinib exposure of 17,738.5
patient-years. In total, 50.7% of patients discontinued; 23.9% due to AEs, and 3.6% due
to insufficient clinical response (3.6%). The most common AE classes were infections and
infestations (69.6%) and musculoskeletal/connective tissue disorders (40.3%). SAEs
occurred in 29.4% of patients, and serious infection events (SIEs) in 8.9%. Malignancies,
excluding NMSC, were reported in 3.0%. No new safety risks were identified, and clinical
responses were sustained from Month 1 to Month 96 [#522].
Clinical and structural responses of tofacitinib
The efficacy of tofacitinib and predictive value of baseline markers of inflammation in
patients with moderate to severe RA by baseline CRP and ESR was presented by
Schwartzman, et al. using data from 4 Phase 2 trials. The pooled population included 2161
patients in the csDMARD-IR group, and 512 patients in the bDMARD-IR group. In both
dose groups, ACR response rates at Month 6 were generally numerically higher with
higher baseline CRP for both csDMARD-IR and bDMARD-IR patients. A trend for greater
improvement in disease activity was observed with higher baseline CRP but not with
higher baseline ESR. The proportions with AEs, SAEs, serious infections, and
discontinuations due to AEs were generally similar regardless of baseline CRP or ESR
[#495].
van der Heijde, et al presented 3-year radiographic data from an OLE in 1156 patients with
RA. Mean change in mTSS was 0.25 at Month 12, and 1.17 at Month 36. Mean change in
erosion score and joint space narrowing (JSN) were 0.21 and 0.24 at Month 12, and 0.68

and 0.78 at Month 36, respectively. The percentage of all tofacitinib-treated patients with
radiographic non-progression decreased from 91.2% at Month 6, to 84.5% and 72.2% at
Months 12 and 36, respectively. The percentage of patients with no new erosions
decreased from 96.0% at Month 6, to 92.3% and 85.3% at Months 12 and 36, respectively.
Similar trends were observed for all endpoints in the tofacitinib monotherapy and
csDMARD treatment groups [#533].
Gaylis, et al. discussed clinical and structural responses using step-up dosing of tofacitinib
in a treat-to-target approach in 20 patients with active RA. Over a 12-week period,
6 patients remained on 5 mg BID, and 14 dose-escalated to 10 mg BID. In the 5 mg group,
3 patients completed the trial at target and 3 discontinued due to lack of efficacy,
relocation and AE. Structurally, there was no change in erosions in this group. Of the 14
dose-escalation patients, 11 completed the trial, with 7 remissions, 2 at LDA, and 1 at
MDA; 3 patients discontinued due to lack of efficacy. In the 10 mg group, 9 patients
showed no change in erosions, 1 regression and 1 progression. 5 patients showed no
change in synovitis and 6 showed regression, and 7 showed no change in osteitis, 3
showed regression and 1 showed progression. CRP values correlated with improvement
of the clinical and structural results; the levels improved after the dose was increased to 10
mg bid. Overall, the findings suggest that a significant number of patients treated with the
standard dose of 5 mg bid may potentially have improved outcomes including LDA or
remission when treated at a higher dose (10 mg bid) [#520].
In a retrospective analysis of real-world data, Mueller, et al. showed that tofacitinib may
induce high rates of LDA and remission in patients with active RA, even after use of one or
more bDMARDs, over prolonged periods of time. In 58 patients treated with tofacitinib,
86% had been pre-exposed to at least one bDMARD. Thirty-seven (63.8%) and 31(53.4%)
patients achieved LDA or remission after 62.0 and 65.3 days, respectively [#536].
Tocilizumab long-term data from large clinical trial and post-marketing populations
Long-term data were presented for tocilizumab to provide an updated report on safety in
patients with RA using data from multiple completed clinical trials and LTEs, as well as an
from the global post-marketing safety database. The clinical trial all-exposure
population included 7647 patients, constituting 22,394 patient-years of exposure. The
overall rate of SAEs in the clinical trial population was 14.16 per 100 patient-years. Overall
incidence rates for individual events for the clinical trial population were consistent in each
6-month period over the 5-year duration. The global post-marketing population included
606,937 patients. The overall spontaneous reporting rate of AEs of special interest in the
post-marketing population was 9.37 per 100 patients. Reporting rates of individual safety
events of interest were consistent in each 6-month period over the 7-year duration [#550].

Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy II: Trials Therapy
Updadacitinib Phase 3 results
A poster from Burmester, et al. showcased Phase 3 results for upadacitinib in 661 patients
with RA and inadequate response to csDMARDs. At Week 12, significantly more patients
receiving upadacitinib 15 mg and 30 mg QD achieved an ACR20 response compared with
placebo (63.8% and 66.2% vs 35.7%, P

Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I
Tofacitinib efficacy and safety in psoriatic arthritis
Nash, et al. presented an integrated efficacy analysis from the Phase 3 studies OPAL
Broaden and OPAL Beyond in 238, 236 and 236 PsA patients receiving tofacitinib 5 mg
BID, 10 mg BID, or placebo, respectively. Significant improvements versus placebo at
Month 3 were seen for peripheral arthritis and physical function endpoints for tofacitinib 5
mg and 10 mg BID. Significant improvements in psoriasis, enthesitis, and dactylitis
endpoints versus placebo were seen for tofacitinib 5 mg and 10 mg BID at Month 3, and
efficacy was maintained or further improved at Month 6 [#619].
Kivitz, et al. investigated pooled data from OPAL Broaden and OPAL Beyond, looking at
the efficacy of tofacitinib by background MTX dose in patients with PsA. In total, data from
556 patients who received tofacitinib plus MTX or placebo plus MTX (tofacitinib 5 mg BID,
n=186; tofacitinib 10 mg BID, n=178; placebo, n=192) were included in this analysis. Most
patients were treated with background MTX at doses ≤15 mg/week (66.7%; mean dose
12.6 mg/week) compared with >15 mg/week (33.3%; mean dose 19.8 mg/week). At Month
3, tofacitinib 5 and 10 mg BID were generally associated with numerically greater ACR and
HAQ-DI response rates and greater changes from baseline in HAQ-DI score compared
with placebo. The magnitude of tofacitinib effects on efficacy outcomes appeared broadly
similar between background MTX dose groups [#615].
Tofacitinib improvement of composite endpoint measures in PsA from OPAL Broaden and
OPAL Beyond were presented by Helliwell, et al. The composite endpoints assessed were
Psoriatic Arthritis Disease Activity Score (PASDAS), DAS28[CRP], Disease Activity Index
for Reactive Arthritis/Psoriatic Arthritis (DAREA/DAPSA), and Composite Psoriatic Disease
Activity Index score. Both doses of tofacitinib showed improvements in composite
endpoints versus placebo at Month 3 in both studies. In OPAL Broaden, the effects of
adalimumab were similar to both doses of tofacitinib across composite endpoints. The
largest effect size and standardised response means were observed for PASDAS. Effect
sizes and standardised response means varied across endpoints but were consistent
across studies [#623].
Data from the second interim analysis of OPAL Balance, an open-label LTE in 686
patients with PsA was presented by Nash, et al. Mean duration of tofacitinib exposure in
the LTE was 448 days. On Day 1, 98.5% of patients received a csDMARD, which was
later discontinued by 8.3% of patients. To Month 36, 1685 AEs were reported in 502
patients; 10.5% of patients had SAEs, and 7.6% discontinued due to AEs. AEs of special
interest included 11 serious infections (1.6%), 19 HZ events (2.8%) including 1 serious
event of facial HZ, 2 MACE (0.3%), and 13 (1.9%) malignancies. No AEs of
gastrointestinal perforation or inflammatory bowel disease were reported. One AE of
uveitis was reported. There were 4 deaths, but they were not attributed to treatment.
Latent tuberculosis was reported in 4 patients whose previously negative QuantiFERON
response became positive. Few patients experienced elevated liver enzyme levels.
Overall, the safety profile of tofacitinib in active PsA was similar to that of the pivotal Phase
3 studies. No new safety signals were identified, and efficacy across various disease
domains was maintained over time [#620].
In the same poster session, Burmester, et al. gave an integrated safety summary of
tofacitinib in the Phase 3 studies OPAL Broaden and OPAL Beyond, and in 1 LTE study
(OPAL Balance). Overall, tofacitinib in active PsA demonstrated a safety profile consistent

with that seen with tofacitinib in RA, and no new risks were identified. Nasopharyngitis
(5.9%) and headache (8.5%) were the most commonly reported AEs at Month 3 in patients
receiving tofacitinib 5 and 10 mg BID, respectively. Discontinuation due to AEs occurred in
4.6% and 4.7% of patients, respectively. Across all tofacitinib-treated patients in the
Phase 3 and LTE studies, serious infections occurred in 1.4%, and HZ was reported in
2.0%. There were 2 deaths, both considered unrelated to the study drug. MACE was
reported in 0.4%, malignancies (excluding NMSC) in 0.6%, and NMSC in 0.5% [#616].
Effect of tofacitinib on patient-reported outcomes in psoriatic arthritis
Strand, et al. presented the effect of tofacitinib on PROs in patients with active PsA in
OPAL Beyond and OPAL Broaden. Improvements in PtGA and pain were observed as
early as Week 2 and exceeded placebo at Month 3 with both tofacitinib doses (P≤0.05). At
Month 3, SF-36v2 and FACIT-F scores exceeded placebo with both doses (P≤0.05), and
improvements in PCS, physical functioning, bodily pain and FACIT-F exceeded minimal
clinically important difference (MCID). PRO improvements reported in OPAL Broaden with
tofacitinib were similar to adalimumab [#596].
In an analysis reported by Bachelez, et al. 52-week data were pooled from the two OPT
Pivotal studies of tofacitinib in patients with psoriasis and concomitant PsA. At Week 16 a
greater proportion of patients achieved PASI75, PGA, and PtGA responses with tofacitinib
5 and 10 mg BID versus placebo (all P

ACR Poster Session B
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II:
Prognostic Factors, Imaging and Miscellaneous Reports
Effects of tofacitinib on zoster vaccine; and the effect of tofacitinib monotherapy on
arterial stiffness
Winthrop, et al. evaluated the long-term effectiveness of live zoster vaccine (LZV) in
patients with RA by looking at the incidence of HZ after treatment with tofacitinib for up to
27 months. In total, 112 patients received LZV and were randomised 2–3 weeks later to
tofacitinib 5 mg BID or placebo for 12 weeks. HZ occurred in 5 cases, with an incidence
rate per 100 patient-years of 3.60. Four cases were monodermatomal, and 1 case
involved 5 dermatomes. All cases resolved with treatment. ELISPOT measures were
undetectable at baseline and at Week 6 post-vaccination in three patients, indicating a lack
of VZV-specific immunity. The authors concluded that LZV prior to treatment with
tofacitinib is effective at boosting IgG levels and cell-mediated immunity towards VZV
[#1440].
In a cohort study, Kume, et al. showed that tofacitinib monotherapy improved arterial
stiffness in 16 patients with active RA despite treatment with csDMARDs. Tofacitinib
significantly attenuated arterial stiffness as measured with the cardio-ankle vascular index
from baseline to 24 weeks, although fasting serum total cholesterol (TC) was significantly
increased. These findings suggest that tofacitinib monotherapy not only reduces RA
disease activity but also limits vascular damage, despite up-regulating cholesterol [#1421].
Factors affecting prescription of tocilizumab; and the effect of treat-to-target in ‘early RA’
Saraux, et al. presented a pooled analysis of two observational studies in 884 patients.
Past RA treatment included csDMARDs in 98.2% of patients and bDMARDs in 73.8%.
Tocilizumab was initiated as monotherapy in 39% of patients and as combination in 61%,
with MTX in 78.5% of combination patients (mean dose 16.1 ± 4.5 mg). Steroids were
used in 78.5% (mean dose 11 ± 6.8 mg). In the multivariate analysis, variables associated
with a prescription for tocilizumab monotherapy were: number of previous bDMARDs, high
blood pressure, osteoporosis, and CRP ≥10 mg/L. At 12 months, mean DAS28-ESR for
monotherapy and combination therapy groups was 2.41 and 2.29 with 74.7% and 77% of
patients in DAS28 LDA, respectively. No differences were observed between groups on
other efficacy data; this remained true when weighting by the propensity score [#1439].
Teitsma, et al. looked at the effect of treat-to-target tocilizumab- and MTX-based strategies
on health-related quality of life in the U-Act-Early Trial in newly diagnosed RA. A total of
317 ‘early RA’ patients were randomised 1:1:1 to initiate MTX, tocilizumab or tocilizumab +
MTX, and were treated to target until sustained remission was achieved (defined as
DAS28

ACR Poster Session C
Rheumatoid Arthritis – Clinical Aspects Poster III: Comorbidities
Tofacitinib and the effect of live zoster vaccine on herpes zoster events
Calabrese, et al. presented an evaluation of LZV in a subset of 1146 patients with RA
treated with tofacitinib with or without MTX, and adalimumab + MTX in ORAL Strategy. A
total of 216 patients received vaccination with LZV. No patients had zoster-like lesions
within 42 days of vaccination; 1 had vaccination-site erythema. In the overall study
population, the incidence rate of HZ was similar between tofacitinib monotherapy and
adalimumab + MTX, and numerically higher with tofacitinib + MTX. Overall, 18 patients
had HZ; only 3 vaccinated patients had HZ. No events were serious, and only 1 case was
multidermatomal. Among the 15 patients with HZ, there were 2 serious events and
3 multidermatomal events [#2393].
Baricitinib and the effects on cardiovascular safety
A poster on CV safety during treatment with baricitinib in patients with RA was shared by
Weinblatt, et al. Data were pooled from 8 completed studies. Overall, 3492 patients were
exposed to baricitinib – a total exposure of 6637 patient-years. Of these, 78.0% were
exposed for >1 year and 53.5% for >2 years. Weinblatt, et al. presented their data in this
area that requires further detailed examination [#2352].
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III:
Efficacy and Safety of Originator Biologics and Biosimilars
Efficacy and safety of switching from adalimumab to sarilumab
Burmester GR, et al. examined disease activity, physical function and safety in patients
receiving sarilumab 200 mg Q2W monotherapy in the OLE following the double-blind
phase of the MONARCH study. Of the 320 patients who completed MONARCH, 320
entered the OLE; 155 switched from adalimumab 40 mg to sarilumab 200 mg Q2W (switch
group), and 165 remained on sarilumab (continuation group). DAS28-ESR ≤3.2 at OLE
entry was 16.1% in the switch group and 47.9% in the continuation group (P

patients achieving efficacy outcomes versus MTX-IR and bDMARD-IR groups. TEAEs,
SAEs, and discontinuations due to AEs were numerically lower in the non-MTX
csDMARD-IR group versus MTX-IR, and both groups had lower rates compared to the
bDMARD-IR population. The results suggest that tofacitinib may be more efficacious when
used in earlier lines of therapy [#2493].
The effect of tocilizumab on joint damage; and on patient-reported outcomes after
discontinuation of MTX
Teitsma, et al. used data from U-Act-Early to show that tocilizumab inhibits progression of
erosive joint damage in early RA more effectively than step-up MTX therapy. A total of 317
DMARD-naïve patients with early RA were randomised to tocilizumab + MTX, tocilizumab
alone or MTX alone. For changes from baseline in the Sharp-van der Heijde score,
significantly lower scores were found for tocilizumab + MTX after 52 weeks when
compared with the MTX arm (P=0.02); after 104 weeks, the difference compared with the
MTX arm was significant for both tocilizumab strategies. For erosions, significant betweengroup
differences were noted after 104 weeks in favour of the tocilizumab strategies.
However, for JSN, no significant differences were found between the strategies during
follow-up (P≥0.20), which was in accordance with the findings of the computerised method
(P≥0.20) and data from literature [#2458].
Results from the COMP-ACT trial in 296 MTX-IR patients with RA were shared by Kremer,
et al. Initial combination therapy included MTX + subcutaneous tocilizumab QW or Q2W.
Patients who achieved DAS28-ESR ≤3.2 at Week 24 were randomised 1:1 to receive
tocilizumab monotherapy or continue tocilizumab + MTX until Week 52 in a double-blind
extension. At the Week 24 randomisation, PRO scores were similar between treatment
groups. The mean changes in PtGA, pain, HAQ-DI and FACIT-fatigue scores from Week
24 to Weeks 40 were similar between the tocilizumab + MTX and tocilizumab monotherapy
groups. The proportion of patients with HAQ-DI

improvements in DAS28-CRP, CDAI, and CRP at Week 24. Placebo-adjusted treatment
effect with sarilumab was more pronounced in patients with higher baseline disease
activity, with lower responses seen with placebo in these patients. The odds ratio versus
placebo for achieving an ACR20/50/70 response at Week 24 was greater in
sarilumab-treated patients with higher baseline disease activity than in those with lower
baseline disease activity for each definition assessed. Likewise, changes from baseline in
DAS28-CRP, CDAI, and CRP at Week 24 were greater in sarilumab-treated patients with
higher baseline disease activity for each definition assessed [#2470].
Fleischmann was also the lead author on a second poster from TARGET. Overall, a
significantly higher percentage of patients treated with sarilumab (both 150 and 200 mg
doses) + csDMARDs achieved ACR20/50/70 response and HAQ-DI ≥0.22 units of
improvement from baseline (200 mg Q2W dose only) at Week 12 versus those treated
with placebo + csDMARDs. This response was sustained in most patients until the end of
the study. In contrast, there were fewer patients in the placebo + csDMARD group who
achieved and sustained a response from Week 12 to the end of the study. A similar trend
was also observed for CDAI and SDAI remission and LDA, and DAS28-CRP

ACR Concurrent Abstract Session
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy I: Outcomes Therapy
Baricitinib dose reduction in a long-term extension study
Takeuchi, et al. presented the results of a LTE including patients with RA who completed a
baricitinib Phase 3 study. In the LTE, patients who received baricitinib 4 mg for ≥15
months and who achieved sustained LDA or remission at 2 consecutive visits ≥3 months
apart were re-randomised in a blinded manner to either continue baricitinib 4 mg or step
down to 2 mg. Most patients in both groups maintained the state of LDA or remission over
the 48-week period. However, dose reduction to 2 mg resulted in significant increases in
disease activity at 12, 24, and 48 weeks. Dose reduction also resulted in a more rapid time
to relapse, with significantly more patients relapsing over 48 weeks compared with the
4 mg group. Rescue rates were 9.6% for baricitinib 4 mg, and 18.3% for baricitinib 2 mg.
Most rescued patients could regain LDA or remission with the 4 mg dose. Dose reduction
was associated with a numerically lower rate of non-serious infections; rates of SAEs and
AEs leading to discontinuation were similar across groups [#1821].
Baricitinib effect on pneumococcal conjugate and tetanus toxoid vaccine responses
An evaluation of pneumococcal and tetanus vaccine responses in 106 patients with RA
receiving baricitinib from a LTE sub-study were shown by Winthrop, et al. A positive
response was achieved in 68% of patients in ≥6/13 PCV13 serotypes; 43% of patients
achieved a ≥4-fold increase in anti-tetanus titres; 73.5% achieved a ≥2-fold increase.
Through 12 weeks post-vaccination, 6.6% of patients reported injection-site events
possibly related to vaccination. Two patients reported moderate pain. There were no SAEs
related to the vaccine [#1824].
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy II: Trials Therapy
The effect of tofacitinib on patient-reported outcomes
PROs from ORAL Strategy were reported by Strand, et al. A total of 1146 patients with RA
were randomised 1:1:1 to receive tofacitinib 5 mg BID alone, tofacitinib 5 mg BID + MTX or
adalimumab 40 mg Q2W + MTX. At Months 6 and 12, improvements in all PROs were
similar for tofacitinib + MTX and adalimumab + MTX, and numerically greater than with
tofacitinib monotherapy. Mean changes from baseline in HAQ-DI scores were similar in
each treatment group at Months 6 and 12, and similar proportions reported improvements
greater than the MCID [#1906].
Filgotinib 84-week safety data
Genovese, et al. reported Week 84 safety data from DARWIN-3, a Phase 2b OLE of
filgotinib in RA. When the last patient completed 84 weeks in DARWIN-3, 70.4% of
patients remained on study; 29.6% had discontinued. Most frequent reasons for
discontinuation were positive/indeterminate QuantiFERON (10.3%; no active tuberculosis),
protocol specified AE stopping rules (6.8%) and withdrawal of consent (5.8%). Cumulative
patient-years of exposure were 1708, with a median time on study drug of 917 days.
Based on ‘observed case’ analysis, 86%, 69%, and 47% of patients achieved
ACR20/50/70, respectively, and 71% achieved DAS28-CRP ≤3.2 [#1909].

Response with tocilizumab following MTX discontinuation
Results from the COMP-ACT trial were presented by Kremer, et al., showcasing the
sustained response following discontinuation of MTX in 718 US patients with RA. These
patients who were inadequate responders to MTX initially received MTX + subcutaneous
tocilizumab either QW or Q2W. Patients who achieved DAS28-ESR ≤3.2 at Week 24 were
randomised 1:1 to receive tocilizumab monotherapy or tocilizumab + MTX until Week 52.
Early discontinuation in the randomised cohort occurred in 12.2% of patients in the
tocilizumab monotherapy group and 10.2% in the tocilizumab + MTX group. At Week 24,
DAS28 scores were similar in both groups, but ACR responses were around 8–11% lower
in the tocilizumab monotherapy group prior to MTX withdrawal (randomisation). The mean
change in DAS28 was similar between the randomised treatment groups. This study
demonstrated that discontinuing MTX in tocilizumab responders was noninferior to
continuing MTX. The safety of subcutaneous tocilizumab was consistent with the known
safety profile, with no new safety signals observed. The most common SAE was infection,
occurring in 4.1% of patients. Patients treated with tocilizumab + MTX had a greater
frequency of AEs, SAEs and serious infections than those receiving tocilizumab alone
[#1905].
Rheumatoid Arthritis – Clinical Aspects IV: Medications and Risk
Infections associated with tofacitinib and baricitinib treatment
Amaral de Avila Machado, et al. reported serious infections associated with tofacitinib in
patients with RA previously treated with MTX, using retrospective cohort data from 2010–
2014. Of the 21,832 patients identified, 0.8% received tofacitinib, 24.7% received other
DMARDs, 61.2% TNFi, and 13.3% received non-TNF biologics. The incidence of serious
infection with tofacitinib was 3.7 per 100 patient-years. The adjusted hazard ratio for
hospitalised infection was 1.81 for tofacitinib compared with the reference group [#2785].
In the same session, Winthrop, et al. presented on tuberculosis and other infections of
interest in patients with RA in the baricitinib programme in patients exposed to any
baricitinib dose, with exposure up to 5.5 years. Overall, 45 events were identified. There
were 10 reported cases of tuberculosis (incidence rate 0.15 per 100 patient-years); all
occurred in endemic regions and 6 were associated with extra-pulmonary involvement.
Baricitinib was associated with an increased risk of treatment-emergent HZ compared with
placebo (incidence 1.0 per 100 patient-years versus 4.3). There were 194 cases of herpes
zoster (overall incidence 3.2 per 100 patient-years); 18 cases had distribution beyond the
primary or adjacent dermatomes (considered a potential opportunistic infection). A single
case each of cytomegalovirus and Epstein-Barr virus infection were reported. Fungal
events of candidiasis involving the esophagus (6), lung (1), and soft tissue
(1), Pneumocystis jirovecii pneumonia (3, all in Japan) and single cases of histoplasmosis,
paracoccidioidomycosis, and cryptococcal lung infections, and aspergillosis skin infection
were reported [#2787].

Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy V:
Imaging and Cardiovascular Outcomes Therapy
The impact of tofacitinib on cardiovascular risk scores
Nurmohamed, et al. shared data on the impact of tofacitinib treatment compared with
placebo or MTX on CV risk scores in the Phase 3 ORAL trials. In 2 of 5 trials in DMARD-IR
patients there was a significantly higher change from baseline to Month 3 in Framinghan
risk score with tofacitinib versus placebo. Reynolds risk scores were significantly reduced
from baseline to Month 3 with both doses of tofacitinib versus placebo – except in ORAL
Step, in which there was no significant change. Change from baseline to Month 3 in
Framingham risk score was significantly higher with tofacitinib 5 mg and 10 mg versus
MTX in ORAL Start; however, for Reynolds risk score there was no significant difference
between either dose of tofacitinib and MTX [#2966].
Effect of MTX discontinuation on MRI results with tocilizumab treatment
MRI results following discontinuation of MTX in patients with RA treated with
subcutaneous tocilizumab in COMP-ACT were presented by Peterfy, et al. A subset of 79
patients had MRI images of bilateral hands and wrists at Weeks 24 and 40. Mean changes
in bone erosion, synovitis, osteitis and cartilage loss scores were not significantly different
between the tocilizumab + MTX and tocilizumab alone groups for both bilateral hands and
the dominant hand. There were no significant differences between the groups in the
proportion of patients with no progression in each outcome measure [#2962].
Health Services Research I: Cost Drivers in Rheumatic Disease
Patient characteristics, treatment patterns, and costs in patients initiating tofacitinib
In a retrospective cohort study, Smith, et al. found that among bDMARD-naïve patients
with RA and prior MTX, there was higher baseline monotherapy use among those
receiving tofacitinib versus adalimumab and etanercept. Persistence and adherence were
similar for tofacitinib, and total RA-related costs were lower versus adalimumab and
etanercept, despite tofacitinib patients having higher pre-baseline costs [#2831].
Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment I
An evaluation of radiographic progression with tofacitinib treatment
van der Heijde, et al. evaluated radiographic progression in patients with PsA treated with
tofacitinib, using data from OPAL Broaden. Patients in all groups demonstrated minimal
changes from baseline in mTSS, erosion, and JSN at Month 12. Change from baseline
was similar in patients with CRP >2.87 mg/L or ≤2.87 mg/L. Radiographic non-progression
at Month 12 using any threshold was observed in >90% of patients in all groups. At Month
12, 95.9%, 94.9%, and 97.9% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg
BID, and adalimumab, respectively, were non-progressors based on radiographic changes
less than the smallest detectable change in mTSS [#880]

Lipid levels and cardiovascular events following tofacitinib treatment
An integrated analysis across Phase 3 studies and LTEs looked at changes in lipid levels
and CV events following tofacitinib treatment in 783 patients with PsA. Gladman, et al.
showed that after 3 months of tofacitinib treatment, dose-dependent increases in lipid
levels were observed. There were minimal changes observed with placebo, with the
exception of triglycerides. Concurrent increases in HDL and LDL and no change in the
total cholesterol/HDL ratio were shown. Across Phase 3 and LTE studies, no clinically
significant changes in systolic or diastolic blood pressure were seen. Hypertension events
were reported in 4.9% of patients; of these events, 4 led to discontinuation, and 2 were
classed as SAEs. MACE were reported for 0.4% of patients breceiving tofacitinib, which is
within the range reported in tofacitinib studies in psoriasis and RA. No dose-dependent
effects on blood pressure, hypertension, or MACE were apparent [#884].

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