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ii<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

Published by:<br />

Na onal Infl ammatory Arthri s Registry (NIAR)<br />

Clinical Research Centre, 4th fl oor Specialist offi ce<br />

Selayang Hospital, Selayang-Kepong Highway<br />

68100 Batu Caves, Selangor<br />

Malaysia<br />

Direct line : (603) 6120233 ext 9111/4169<br />

Fax : (603) 61202761<br />

Website : h ps://app.acrm.org.my/NIAR<br />

Disclaimer : Data reported here are supplied by the NIAR. Interpreta on and<br />

repor ng of these data are the responsibility of the editors and in<br />

no way should be seen as an offi cial policy or interpreta on of the<br />

NIAR. This report is copyright. However it can be freely reproduced<br />

without the permission of the NIAR. However, acknowledgement<br />

would be appreciated.<br />

Suggested cita on : The suggested cita on for this report is as follows:<br />

Dr Azmillah Rosman, Dr Hasselynn Hussein,<br />

Dr Gun Suk Chyn, Dr Lau Ing Soo,<br />

Dr Mollyza Mohd. Zain, Dr Habiba @ Habibah Mohd Yusoof<br />

Dr Asmahan Mohamed Ismail, Dr Liza Mohd.Isa,<br />

Dr Nor Shuhaila Shahril, Dr Ramani Arumugam,<br />

Dr Ong Yew Chong<br />

ISSN No :


CONTENTS<br />

ACKNOWLEDGEMENTS<br />

STEERING COMMITTEE MEMBERS<br />

MEMBERS OF THE ADVISORY BOARD<br />

LIST OF CONTRIBUTORS<br />

ABOUT NIAR<br />

Objec ve<br />

Inclusion Criteria<br />

Instrument<br />

Data Flow Process<br />

Progress<br />

1. DISTRIBUTION OF CASES ACCORDING TO HOSPITAL<br />

2. DEMOGRAPHICS<br />

2.1 GENDER DISTRIBUTION<br />

2.2 AGE DISTRIBUTION<br />

2.3 ETHNIC GROUP<br />

2.4 SOCIOECONOMIC STATUS<br />

2.4.1 PROFESSIONAL VS NON-PROFESSIONAL<br />

2.4.2 INCOME GROUP<br />

2.4.3 PERSONAL MEDICAL INSURANCE<br />

3. CHARACTERISTICS OF PATIENTS<br />

3.1 NUMBER OF PATIENTS FULFILLING ACR CRITERIA<br />

3.2 DURATION OF DISEASE BEFORE DIAGNOSIS<br />

3.3 ASSOCIATED MEDICAL PROBLEMS<br />

3.3.1 MEDICAL CO-MORBIDITIES<br />

3.3.2 MALIGNANCIES<br />

3.4 EXTRAARTICULAR MANIFESTATIONS<br />

3.5 DISEASE STATUS AT 1ST NOTIFICATION<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

4. DISEASE BURDEN<br />

4.1 WORK STATUS<br />

4.2 DAYS OF SICK LEAVE TAKEN DUE TO ARTHRITIS IN THE PAST 3<br />

MONTHS<br />

5. STANDARD OF CARE<br />

5.1 TIME TO INITIATION OF DMARDS AFTER DIAGNOSIS<br />

5.2 TYPES OF DMARDS USED<br />

1<br />

2<br />

2<br />

3<br />

5<br />

6<br />

6<br />

6<br />

6<br />

7<br />

9<br />

11<br />

12<br />

12<br />

13<br />

14<br />

14<br />

15<br />

15<br />

17<br />

18<br />

19<br />

20<br />

20<br />

21<br />

21<br />

22<br />

25<br />

26<br />

26<br />

27<br />

28<br />

29<br />

iii


iv<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

5.3 USE OF COMBINATION DMARDS<br />

5.4 USE OF BIOLOGICS<br />

5.5 USE OF ORAL STEROIDS<br />

5.6 USE OF NSAIDS/COX2 INHIBITORS<br />

5.7 SURGERY<br />

DISCUSSION<br />

CONCLUSIONS AND RECOMMENDATIONS<br />

REFERENCES<br />

APPENDIX I : CASE REPORT FORM<br />

APPENDIX II : INFORMATION ON PATIENT CONFIDENTIALITY<br />

29<br />

30<br />

30<br />

30<br />

30<br />

31<br />

33<br />

35


ACKNOWLEDGMENTS<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

The Na onal Infl ammatory Arthri s Registry would like to express its sincere thanks and<br />

apprecia on to all who have supported and contributed to this report.<br />

We thanks the following for their support:<br />

• The Ministry of Health, Malaysia<br />

• Y.B. Tan Sri Dato’ Seri Dr Hj Mohd Ismail Merican, Director General of Health,<br />

Malaysia<br />

• Dr Lim Teck Onn, Director, Network of Clinical Research Centre<br />

• Dr Goh Pik Pin, Co-Director, Network of Clinical Research Centre<br />

• Dr Jamaiyah Haniff , Head of Clinical Epidemiology Unit of <strong>CRC</strong><br />

• Informa on technology personnelnamely MS Lim Jie Ying, database administrator,<br />

Ms Teo Jau Shya, clinical data manager<br />

• Members of the “Steering Commi ee” for their contribu ons to the registry<br />

• Clinical Research Centre, Ministry of Health, Malaysia<br />

• Other sponsors and supporters from the professional bodies, industries and<br />

ins tua ons as listed below:<br />

Ka Consul ng Sdn. Bhd<br />

Schering Plough<br />

Staff from Hospital Selayang, Hospital Tuanku Jaafar, Seremban and<br />

Hospital Putrajaya<br />

1


2<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

STEERING COMMITTEE MEMBERS<br />

Dr Azmillah Rosman (Principal Inves gator)<br />

Department of Medicine, Hospital Selayang<br />

Dr Chow Sook Khuan<br />

Sunway Medical Centre<br />

Dr Amir Azlan Zain<br />

Sunway Medical Centre<br />

Dr Heselynn Hussein<br />

Department of Medicine, Hospital Putrajaya<br />

Dr Gun Suk Chyn<br />

Department of Medicine, Hospital Tuanku Abdul Jaafar, Seremban<br />

Dr Lau Ing Soo<br />

Department of Medicine, Hospital Selayang<br />

Dr Mollyza Mohd Zain<br />

Department of Medicine, Hospital Selayang<br />

MEMBERS OF THE ADVISORY BOARD<br />

Dr Lim Teck Onn (Chairman)<br />

Clinical Research Centre, Ministry of Health Malaysia<br />

Tan Sri Hari Narayanan (Co-chairman)<br />

Arthri s Founda on Malaysia<br />

Ms Ding Mee Hong<br />

Arthri s Founda on Malaysia<br />

Professor Florence Wang<br />

University Malaya Medical Centre


LIST OF CONTRIBUTORS<br />

Hospital Selayang<br />

Dr Azmillah Rosman<br />

Dr Lau Ing Soo<br />

Dr Mollyza Mohd Zain<br />

Dr Habibah Mohd Yusoof<br />

Dr Asmahan Mohamed Ismail<br />

Dr Chong Hwee Cheng<br />

Dr Kuan Woon Pang<br />

Dr Ramani Arumugam<br />

Dr Shereen Ch’ng Suyin<br />

Dr Hilmi Abdullah<br />

Dr Ong Yew Chong<br />

Mdm Ramlah Shukor<br />

Mdm Norlela Mohd Salleh<br />

Hospital Tuanku Jaafar, Seremban<br />

Dr Gun Suk Chyn<br />

Dr Beryl D’Sauza<br />

Dr C Gandhi<br />

Dr Lim Ai Lee<br />

Dr Nadia Mohd Noor<br />

Mdm Ho Ah May<br />

Hospital Putrajaya<br />

Dr Heselynn Hussein<br />

Dr Eashwary Mageswaren<br />

Dr Liza Mohd Isa<br />

Dr Nor Shuhaila Shahril<br />

Dr Shamala Rajalingam<br />

Mdm Amnahliza Abu Rahman<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

3


ABOUT THE NATIONAL<br />

INFLAMMATORY ARTHRITIS<br />

REGISTRY (NIAR)


6<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

ABOUT THE NATIONAL INFLAMMATORY ARTHRITIS REGISTRY (NIAR)<br />

Introduc on<br />

Rheumatoid Arthri s (RA), the most common form of infl ammatory arthri s is es mated<br />

to aff ect about 1% of the popula on. Of unknown ae ology, it typically aff ects many joints,<br />

causing acute infl amma on, in most cases leading to joint erosions and joint damage (1).<br />

The NIAR, ini ated in 2008, was set up with the aim of obtaining informa on about pa ents<br />

with Rheumatoid Arthri s. Informa on about pa ents with the other infl ammatory<br />

arthri des will be collected in the future.<br />

Objec ves<br />

1. To determine the incidence and prevalence of RA in Malaysia.<br />

2. To obtain demographic data.<br />

3. To determine the disease expression in terms of clinical manifesta ons.<br />

4. To study the management of pa ents.<br />

5. To assess pa ents’ outcome, studying pa ents’ disease ac vity, extent of disability,<br />

economic impact and mortality rate.<br />

Inclusion Criteria<br />

Patients enrolled into the registry are patients with established Rheumatoid Arthritis,<br />

diagnosed by a rheumatologist.<br />

Instrument<br />

A structured Case Report Form (CRF) [Appendix I] is used for data collection. The CRF<br />

was designed and reviewed by a technical committee. Prior to the launch of the registry,<br />

copies of the CRFs were distributed to doctors from the various <strong>hospital</strong>s involved. A trial<br />

run was done and feedback given to the committee before the fi nal CRF was used for data<br />

collection. Training sessions were also conducted at the <strong>hospital</strong>s involved.<br />

Patients’ outcome is assessed three times - at months 0, 6 and 12.<br />

Data Flow Process<br />

The registry is coordinated centrally at the Clinical Research Centre (<strong>CRC</strong>) based at<br />

Hospital Selayang. Each <strong>hospital</strong> has an appointed clinic and registry nurse. The database<br />

is available online via password access.<br />

Patients attending their regular clinic appointments were identifi ed. Verbal consent was<br />

obtained from patients using the Patient Confi dentiality Information form [Appendix II].<br />

Demographic information was obtained from the patient or carer. Joint count assessments


PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

were then performed by the assessing doctor while other information necessary to fi ll into<br />

the CRF was obtained from patients’ medical records. The registry nurse then entered the<br />

information into the online database. The next outcome date was then determined and this<br />

was coordinated with patients’ scheduled clinic visit.<br />

Patient identifi ed by<br />

Appointed clinic<br />

Nurse / Dr<br />

Progress<br />

Nurse / Dr obtains<br />

basic demographic<br />

information<br />

Registry nurse<br />

determines next visit<br />

date, informs clinic<br />

nurse<br />

Figure 1: Data Flow Process<br />

Doctor performs joint<br />

count and fi lls in<br />

relevant information<br />

manually<br />

Registry nurse enters<br />

data online<br />

The NIAR was launched offi cially on 18th December 2008. A er a trial run, the fi rst pa ent<br />

was enrolled into the registry on 21st April 2009. The online database was started on 22nd<br />

May 2009. As of 31st August 2010, 1000 pa ents have been enrolled into the registry.<br />

7


DISTRIBUTION OF CASES<br />

ACCORDING TO HOSPITAL


10<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

1. DISTRIBUTION OF CASES ACCORDING TO HOSPITAL<br />

Three <strong>hospital</strong>s were chosen for the pilot project, namely Hospital Selayang, Hospital<br />

Tuanku Jaafar, Seremban and Hospital Putrajaya. These <strong>hospital</strong>s were selected as<br />

they are the largest rheumatology centres in the MOH. The distribu on of cases are<br />

as follows:<br />

Hospital Tuanku<br />

Jaafar, Seremban<br />

364 (36.4%)<br />

Hospital Putrajaya<br />

202 (20.2%)<br />

Figure 2: Distribu on of cases according to <strong>hospital</strong><br />

Hospital Selayang<br />

434 (43.4%)<br />

N = 1000 pa ents


DEMOGRAPHICS


12<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

2. DEMOGRAPHICS<br />

2.1 GENDER DISTRIBUTION<br />

87.4%<br />

12.6%<br />

Figure 3: Gender distribu on<br />

Male<br />

Female<br />

The gender distribu on showed a female preponderance at 87.4% (n=874)<br />

compared to males 12.6% males (n=126). The male to female ra o was<br />

approximately 7:1.<br />

2.2 AGE DISTRIBUTION<br />

40<br />

35<br />

30<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

0.6<br />

12 to 20<br />

4.3<br />

10.3<br />

23.3<br />

37.5<br />

17.2<br />

6.9<br />

21 to 30 31 to 40 41 to 50 51 to 60 61 to 70 > 71<br />

Figure 4: Age Distribu on


PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

Currently, data has only been collected for adult pa ents with Rheumatoid<br />

Arthri s, defi ned as those above 12 years old.<br />

The mean age was 52.57 years with the youngest pa ent being 18 years and<br />

the oldest 87 years.<br />

More than half of the pa ents were in the 41-60 age group categories.<br />

2.3 ETHNIC GROUP<br />

The Malays being the largest ethnic group in Malaysia made up 43.2% of the<br />

pa ents in the registry. The Indians who are the smallest of the 3 major ethnic<br />

groups in Malaysia made up 30.4% followed by the Chinese at 24.1%. The other<br />

ethnic groups and foreigners comprised 2.3% of the pa ents.<br />

30.4%<br />

24.1%<br />

2.3%<br />

43.2%<br />

Figure 5: Distribu on of ethnic groups<br />

Malay<br />

Chinese<br />

Indian<br />

Other<br />

Comparing these fi gures with the 2004 Malaysian Census, the Indians are overrepresented<br />

since they cons tute only 7.1% of the Malaysian popula on (2).<br />

The under-representa on of the other ethnic groups in the registry may be<br />

explained by the fact that none of the <strong>hospital</strong>s in Sabah or Sarawak were<br />

included in this pilot project.<br />

13


14<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

Malaysian Census 2004 NIAR<br />

Malay 50.4% 43.2%<br />

Chinese 23.7% 24.1%<br />

Indian 7.1% 30.4%<br />

Other 18.8% 2.3%<br />

Table 1: Comparison of ethnic groups with Malaysian Census 2004<br />

2.4 SOCIO-ECONOMIC STATUS<br />

2.4.1 PROFESSIONAL VS NON-PROFESSIONAL<br />

The majority of pa ents were from the lower socio-economic group.<br />

Nearly 90% were non-professionals.<br />

89.8%<br />

10.2%<br />

Prfessional<br />

Non-professional<br />

Figure 6: Distribu on of professional and non-professional groups


2.4.2 INCOME GROUP<br />

Monthly Income (RM)<br />

Unknown 9.3<br />

>7000<br />

5001-7000<br />

3001-5000<br />

1001-3000<br />


CHARACTERISTICS<br />

OF PATIENTS


18<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

3. CHARACTERISTICS OF PATIENTS<br />

3.1 NUMBER OF PATIENTS FULFILLING AMERICAN COLLEGE OF RHEUMATOLOGY<br />

(ACR) CRITERIA<br />

The tradi onal defi ni on for Rheumatoid Arthri s has been defi ned as pa ents<br />

fulfi lling 4 or more of the 7 criteria listed in the 1987 ACR criteria (Table 2) (3).<br />

This criteria has been revised in the new ACR-EULAR criteria published in 2010<br />

(4).<br />

Morning s ff ness > 1 hour<br />

≥ 3 joints arthri s<br />

Arthri s in a wrist, MCP or PIP joint<br />

Symmetrical arthri s<br />

Factor<br />

Posi ve rheumatoid factor<br />

Erosions or osteopenia on hand or wrist radiograph<br />

* symptoms present for at least 6 weeks<br />

Table 2: 1987 ACR criteria for Rheumatoid Arthri s<br />

The propor on of pa ents fulfi lling each criterion is shown in Table 3.<br />

ACR criteria % of pa ents fulfi lling criteria<br />

≥ 3 joints arthri s 94.4<br />

Symmetrical arthri s 92.8<br />

Arthri s in a wrist, MCP or PIP joint 70.5<br />

Morning s ff ness > 1 hour 70.5<br />

Posi ve rheumatoid factor 68.5<br />

Erosions or osteopaenia on hand or<br />

wrist radiograph<br />

41.0<br />

Rheumatoid factor 6.1<br />

Table 3: Percentage of pa ents fulfi lling each ACR criteria


PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

The percentage of pa ents fulfi lling the 1987 ACR criteria is shown in Figure<br />

9. 78.3% fulfi ll the ACR criteria defi ni on for Rheumatoid Arthri s however a<br />

signifi cant propor on fulfi ll less than 4 of the criteria.<br />

21.7%<br />

≥ 4 ≥ 4<br />

78.3%<br />

% of pa ents<br />

35<br />

30<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

22.5<br />

4<br />

34<br />

20<br />

1.8<br />

5 6 7<br />

Figure 9: Percentage of pa ents fulfi lling ACR criteria<br />

3.2 DURATION OF DISEASE BEFORE DIAGNOSIS<br />

Number of ACR<br />

Criteria fulfi lled<br />

Almost half of the pa ents were diagnosed late, that is more than a year a er<br />

the onset of symptoms. However, a signifi cant propor on of pa ents were<br />

diagnosed between 1 to 6 months from symptom onset.<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

37.3<br />

14<br />

48.7<br />

< 6 months < 6 months < 12 months<br />

Number of months from symptom onset to diagnosis<br />

Figure 10: Distribu on of pa ents according to dura on of disease<br />

before diagnosis<br />

19


20<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

Comparing professionals and non-professionals, it would appear that more<br />

professionals are diagnosed earlier, that is less than 6 months from disease<br />

onset. However, even amongst the professionals, about 40% were diagnosed<br />

more than a year from the onset of symptoms.<br />

120<br />

100<br />

80<br />

60<br />

40<br />

20<br />

0<br />

N=102<br />

40.2<br />

15.59<br />

44.11<br />

N=898<br />

49.67<br />

13.81<br />

36.52<br />

Professional Non-Professional<br />

Figure 11: Dura on of disease before diagnosis comparing<br />

professionals and non-professionals<br />

3.3 ASSOCIATED MEDICAL PROBLEMS<br />

3.3.1 MEDICAL CO-MORBIDITIES<br />

> 12 months<br />

6 to 12 months<br />

< 6 months<br />

Among the medical condi ons, hypertension was the commonest comorbidity<br />

with a prevalence of 36.2%. This is slightly lower than the<br />

na onal prevalence of 42.6% of hypertension in adults above 30 years<br />

of age (5). Next was hyperlipidaemia at 25.5% followed by diabetes at<br />

16.1%. The Na onal Health and Morbidity Survey in 2006 found that the<br />

prevalence of diabetes is 12% (6). 6.1% of pa ents had been diagnosed<br />

to have osteoporosis. Pep c ulcer disease and ischaemic heart disease<br />

were each reported in 3.9% of the pa ents.<br />

The other medical condi ons with the reported fi gures are listed in<br />

Table 4.


IHD<br />

PUD<br />

Osteoporosis<br />

DM<br />

Hyperlipidaemia<br />

Hypertension<br />

3.3.2 MALIGNANCIES<br />

3.9<br />

3.9<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

6.7<br />

16.1<br />

25.5<br />

36.2<br />

0 5 10 15 20 25 30 35 40<br />

Figure 12: Associated co-morbidi es<br />

Disease % of pa ents<br />

Fa y liver 2.3%<br />

Tuberculosis 1.2%<br />

Hepa s B 1.0%<br />

Stroke 0.6%<br />

Renal impairment 0.5%<br />

Hepa s C 0.2%<br />

Others 20.4%<br />

Table 4: Associated co-morbidi es<br />

16 cases of malignancies were reported. The highest malignancy<br />

reported was breast cancer. The other malignancies to fi nd out what<br />

the other malignancies are 4 other malignancies includes - kidney,<br />

brain, thyroid & colon cancer<br />

3.4 EXTRAARTICULAR MANIFESTATIONS<br />

There are a number of extraar cular manifesta ons associated with Rheumatoid<br />

Arthri s. The commonest one seen in this pa ent cohort was keratoconjunc vi s<br />

sicca followed by lung fi brosis and anaemia due to rheumatoid arthri s. 35<br />

21


22<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

pa ents had rheumatoid nodules. The percentages of pa ents with each<br />

extraar cular manifesta ons are listed below.<br />

Manifesta on Numbers Percentage %<br />

Keratoconjunc vi s sicca 226 22.6<br />

Inters al lung disease 61 6.1<br />

Anaemia (due to RA disease ac vity) 37 3.7<br />

Rheumatoid nodules 61 6.1<br />

Eye infl amma on 8 0.8<br />

Fever 5 0.5<br />

Raynaud’s 4 0.4<br />

Entrapment neuropathy 4 0.4<br />

Atlanto-axial subluxa on 4 0.4<br />

Cutaneous vasculi s 3 0.3<br />

Mononeuropathy 2 0.2<br />

Polyneuropathy 1 0.1<br />

Felty’s syndrome 1 0.1<br />

Cervical myelopathy 1 0.1<br />

Pleural eff usion 0 0<br />

Pericardi s/eff usion 0 0<br />

Amyloidosis 0 0<br />

Lymphadenopathy 0 0<br />

Others 9 0.9<br />

3.5 DISEASE STATUS AT 1ST NOTIFICATION<br />

Table 5: Extraar cular manifesta ons<br />

The DAS28 score is used to assess pa ent’s disease ac vity. The DAS28 score<br />

is calculated based on the number of swollen and tender joints (only 28 joints<br />

are assessed), general health assessment using a pa ent visual analogue scale<br />

and either ESR or CRP. Pa ents are then categorized into either having low<br />

(DAS28 2.6 to 3.2), moderate (DAS28 >3.2 to 5.1) or high (DAS28 >5.1) disease<br />

ac vity states or in remission (DAS29


35<br />

30<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

13.9<br />

Remission<br />

16.5<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

31.5<br />

Disease ac vity based on<br />

DAS28 ESR/CRP score<br />

16<br />

Figure 13: Disease status at 1st no fi ca on<br />

22.1<br />

Unknown<br />

23


DISEASE BURDEN


26<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

4. DISEASE BURDEN<br />

4.1 WORK STATUS<br />

2%<br />

26%<br />

32%<br />

32%<br />

8% unempliyed<br />

51.8%<br />

due to disease<br />

Full me<br />

Re red<br />

Part- me<br />

Home-maker<br />

Unemployed due to disease<br />

Unemployed due to family<br />

Unemployed others<br />

Figure 14: Work status and reasons for unemployment<br />

8% of pa ents were unemployed but signifi cantly, nearly 52% of those<br />

who were unemployed a ributed this to their disease. 32% of pa ents<br />

were home-makers.<br />

4.2 DAYS OF SICK LEAVE TAKEN DUE TO ARTHRITIS IN THE PAST 3 MONTHS<br />

10<br />

8<br />

6<br />

4<br />

2<br />

0<br />

% of pa ents<br />

1 to 14<br />

8.1<br />

0.3<br />

15 to 30<br />

0<br />

31 to 45<br />

0.1<br />

46 to 60<br />

Number of days<br />

0<br />

61 to 75<br />

0<br />

76 to 90<br />

Figure 15: Days of sick leave taken due to arthri s in the past 3 months<br />

Out of the 338 pa ents who were employed, 81 pa ents took between 1 to 14<br />

days of sick leave due to arthri s. 3 pa ents took between 15 to 30 days of sick<br />

leave and 1 pa ent took sick between 46 to 60 days. None took more than 60<br />

days of sick leave.


STANDARD OF CARE


28<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

5. STANDARD OF CARE<br />

5.1 TIME TO INITIATION OF DMARDS AFTER DIAGNOSIS<br />

A large propor on of pa ents were started on Disease Modifying An -Rheuma c<br />

Drugs (DMARDS) soon a er the diagnosis was made. This is in accordance with<br />

current treatment recommenda ons.<br />

80<br />

60<br />

40<br />

20<br />

0<br />

69.7<br />

< 1months<br />

11.6<br />

1-6 months<br />

3.3<br />

6-12 months<br />

11.6<br />

>12 months<br />

Figure 16: Time to ini a on of DMARDS a er diagnosis<br />

11.6<br />

Unknown<br />

Comparing professionals and non-professionals, there does not appear to be<br />

much diff erence in terms of when treatment was started.<br />

100%<br />

90%<br />

80%<br />

70%<br />

60%<br />

50%<br />

40%<br />

30%<br />

20%<br />

10%<br />

0%<br />

5<br />

5<br />

15<br />

75<br />

Professional<br />

N=100<br />

12.88<br />

3.25<br />

11.72<br />

72.12<br />

Non-Professional<br />

N=862<br />

> 12 months<br />

6-12 months<br />

1-6 months<br />

< 1 months<br />

Figure 17: Time to ini a on of DMARDS a er diagnosis comparing<br />

professionals and non-professionals


5.2 TYPES OF DMARDS USED<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

Methotrexate (MTX) being the anchor drug in the treatment of Rheumatoid<br />

Arthri s was used in 86.6% of pa ents. This was followed by sulphasalazine<br />

(SSZ) at 69.5% and hydroxychloroquine (HCQ) at 34.6%. The use of Lefl unomide<br />

was 24.1%. The other less commonly used drugs for example cyclosporine,<br />

penicillamine, azathioprine and cyclophosphamide were used in 2.7% of the<br />

pa ents.<br />

100%<br />

90%<br />

80%<br />

70%<br />

60%<br />

50%<br />

40%<br />

30%<br />

20%<br />

10%<br />

0%<br />

86.6<br />

69.5<br />

5.3 USE OF COMBINATION DMARDS<br />

24.1<br />

34.6<br />

2.7<br />

MTX SSZ HCQ Others<br />

Figure 18: Types of DMARDS used<br />

697 of pa ents were on combina on DMARDS. The distribu on of pa ents<br />

using the various combina on DMARDS are shown in the fi gure below.<br />

20.44%<br />

24.6%<br />

35.45%<br />

Figure 19: Combina on DMARDS used<br />

MTX + SSZ<br />

MTX + Lefl unomide<br />

MTX + SSZ + HCQ<br />

29


30<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

5.4 USE OF BIOLOGICS<br />

The use of the TNF inhibitors comprising Infl iximab, Etanercept and Adalimumab<br />

was 3.9% in this pa ent cohort.<br />

5.5 USE OF ORAL STEROIDS<br />

Short courses of oral steroids is some mes used as bridging therapy. The use of<br />

steroids in this pa ent popula on was 38.2%.<br />

5.6 USE OF NSAIDS/COX2 INHIBITORS<br />

Non steroidal an -infl ammatory drugs (NSAIDS) is used as analgesic therapy.<br />

If NSAIDS are contraindicated, pa ents can be prescribed cyclo-oxygenase 2<br />

inhibitors (COX2 INHIBITORS). About 62% of pa ents had been on NSAIDS/<br />

COX2 INHIBITORS.<br />

5.7 SURGERY<br />

4% of pa ents have undergone arthroplasty. Surgical interven ons such as<br />

arthrodesis, spinal surgery and synovectomy are not commonly performed.<br />

Surgeries not directly related to rheumatoid arthri s for example appendicectomy<br />

or caesearean sec ons are categorized into other.<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

4<br />

0.4 0.4 0.8<br />

Arthroplasty Arthrodesis Spinal<br />

surgery<br />

Figure 20: Surgical interven ons<br />

23.3<br />

Synovectomy Other


DISCUSSION


32<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

DISCUSSION<br />

This is a pilot project involving only three <strong>hospital</strong>s from the Ministry of Health. In order<br />

to be er refl ect the demographics, characteris cs, standard of care and pa ent outcomes<br />

in the general popula on, there is a need to recruit pa ents from more centres including<br />

those from private and university <strong>hospital</strong>s.<br />

There is over-representa on of Indians in this registry perhaps due to sampling bias<br />

because of the areas covered by the three <strong>hospital</strong>s. Not surprisingly, many of the pa ents<br />

are non-professionals and from the lower socio-economic group since the three <strong>hospital</strong>s<br />

are public <strong>hospital</strong>s. These pa ents do not have medical insurance cover and need fi nancial<br />

aid from the government.<br />

A signifi cant propor on of pa ents do not fulfi ll the ACR criteria for rheumatoid arthri s.<br />

This confi rms the fact that the criteria should not be used as the sole criterion for diagnosis<br />

since many pa ents do not fulfi ll the criteria at disease onset especially those who present<br />

early in the course of the disease.<br />

Alarmingly, many pa ents are s ll diagnosed late. This may result in increased disease<br />

burden. Nevertheless, the results from the registry show that there are a signifi cant<br />

propor on who are diagnosed less than six months from disease onset. It may be that<br />

pa ents who were diagnosed late were those who were diagnosed in the earlier years<br />

whereas there may be a trend now towards earlier diagnosis. However, this would require<br />

further study.<br />

A signifi cant number of pa ents have medical co-morbidi es. The prevalence of the<br />

various diseases in this pa ent cohort are similar to the prevalence rates of the Malaysian<br />

adult popula on. Pa ents with rheumatoid arthri s are at risk of osteoporosis due to the<br />

disease itself as well as due to steroid use. The prevalence of osteoporosis in this cohort was<br />

reported as 6.7%. This is markedly below the reported prevalence of 22% (7). This might<br />

be due to under-repor ng or that pa ents have been not adequately screened. Pa ents<br />

with rheumatoid arthri s are also at increased risk of malignancies. Of the malignancies,<br />

the incidence of lymphoma has been reported to be two-fold higher than expected (8).<br />

However, there were no cases of lymphoma in this pa ent cohort.<br />

In terms of pa ent outcome, many pa ents are s ll in the moderate to high disease ac vity<br />

categories. The reasons for this need to be ascertained. It may be that more aggressive<br />

treatment strategies need to be ins tuted. The cost-eff ec veness of biologics also need to<br />

be determined in rela on to this.<br />

Among the unemployed pa ents, more than half of the pa ents claim that this is due to<br />

their disease. Of note, 32% of pa ents are home-makers. It would be interes ng to fi nd<br />

out whether the decision to be a home-maker was infl uenced by their disease.<br />

The majority of pa ents were started on treatment soon a er the diagnosis was made.<br />

This is in accordance with current treatment guidelines (9).


CONCLUSIONS AND<br />

RECOMMENDATIONS


34<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

CONCLUSIONS AND RECOMMENDATIONS<br />

Thus far, several interes ng results have been obtained from the registry. The data confi rm<br />

that rheumatoid arthri s has signifi cant socio-economic impact to the society. Therefore,<br />

policies need to be implemented to reduce the fi nancial burden to pa ents and to society<br />

as a whole. There is also a need to raise awareness among the general public regarding<br />

the disease and primary care physicians need to refer early so that pa ents can be treated<br />

appropriately. Clinicians also need to be aware that pa ents with rheumatoid arthri s<br />

have co-morbidi es and need to be treated holis cally.<br />

The NIAR data off ers much poten al for research and hopefully, this will serve as an<br />

impetus for research and the implementa on of policies for the benefi t of pa ents.


REFERENCES


36<br />

PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

REFERENCES<br />

(1) Kasper D. Braunwald E. et al. Harrisons’s Principles of Internal Medicine, 17th edi on.<br />

Chapter 14: Sec on 2.<br />

(2) Malaysian census 2004<br />

(3) Arne FC, Edworthy SM et al. The American Rheuma sm Associa on 1987<br />

revised criteria for the classifi ca on of rheumatoid arthri s. Arthri s Rheum. 1988<br />

Mar;31(3):315-24<br />

(4) Aletaha D, Neogi T et al. 2010 Rheumatoid arthri s classifi ca on criteria: an American<br />

College of Rheumatology/European League Against Rheuma sm collabora ve<br />

ini a ve. Ann Rheum Dis 2010;69:1580-1588.<br />

(5) The Third Na onal Health Morbidity Survey (NHMS III). Diabetes Group. Ministry of<br />

Health Malaysia, 2006.<br />

(6) The Third Na onal Health Morbidity Survey (NHMS III). Hypertension Group. Ministry<br />

of Health Malaysia, 2006.<br />

(7) Haugeberg G et al. Clinical decision rules in rheumatoid arthri s: do they iden fy<br />

pa ents at high risk for osteoporosis? Tes ng clinical criteria in a popula on based<br />

cohort of pa ents with rheumatoid arthri s recruited from the Oslo Rheumatoid<br />

Arthri s Register. Ann Rheum Dis 2002 Dec;61(12):1085-9)<br />

(8) Franklin J, Lunt M et al. Incidence of lymphoma in a large primary care derived cohort<br />

of cases of infl ammatory polyarthri s. Ann Rheum Dis. 2006 May;65(5):617-22.<br />

(9) Saag KG, Teng GG, Patkar NM et al. American College of Rheumatology 2008<br />

recommenda ons for the use of nonbiologic and biologic disease-modifi ying<br />

an rheuma c drugs in rheumatoid arthri s. Arthri s Rheum 2008;59:762.


PRELIMINARY REPORT: APRIL 2009 - AUGUST 2010<br />

National Infl ammatory Arthritis Registry (NIAR)<br />

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