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Abstract Number: 2606

Patient Reported Outcomes in Early Arthritis Patients

L. Heimans1, K.V.C. Wevers-de Boer1, K. Visser1, R. Goekoop2, T.H.E. Molenaar3, B.A. Grillet4, Tom Huizinga1 and C.F. Allaart1, 1Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Haga Hospital, The Hague, Netherlands, 3Dept of Rheumatology, Groene Hart Hospital, Gouda, Netherlands, 4Department of Rheumatology, Zorgsaam Hospital, Terneuzen, Netherlands

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Patient questionnaires, remission and rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects VI: Remission and Flare in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

To investigate patient reported outcomes (PROs) of functioning and health related quality of life (HRQOL) after 1 year remission (DAS<1.6)-steered treatment in early arthritis patients.

Methods:

In the IMPROVED-study 610 patients with early rheumatoid and undifferentiated arthritis were treated with methotrexate (MTX) 25mg/week and 60mg/day of prednisone, tapered to 7.5mg/day in 7 weeks. Patients who did not achieve early remission after 4 months were randomized either to hydroxychloroquine 400mg/day, sulphasalazine 2000mg/day, MTX 25mg/week plus prednisone 7.5mg/day (arm 1) or to adalimumab (ADA) 40mg/2weeks plus MTX 25mg/week (arm 2). Every 4 months, patients filled out the Health Assessment Questionnaire (HAQ) to measure functional ability, the Short Form 36 (SF-36) and visual analogue scales (VAS) for global health (VASgh), pain (VASp), disability (VASdis) and morning stiffness (VASms). Mean scores of HAQ, SF-36 and VAS over 1 year were compared between patients in the randomization arms using linear mixed models. HAQ- and VAS scores and changes over 1 year were compared between the treatment groups (early remission, arm 1, arm 2 and ‘outside protocol treatment’). SF-36 scores (higher=better HRQOL) were compared with the Dutch population norm matched for age and sex. Predictors of significant change in PCS and MCS over 1 year were identified using linear regression analyses.

Results:

After 4 months 375/610 patients achieved early remission, 83 patients were randomized to arm 1 and 78 to arm 2, and 62 did not follow the protocol; 12 were lost to follow up. Mean (sd) HAQ after 1 year was 0.4 (0.5) in the early remission group, 0.9 (0.7) and 0.8 (0.7) in arm 1 and 2, respectively, and 0.7 (0.6) in the ‘outside protocol’ group (p<0.001; early remission group vs either arm 1 or 2: p<0.001, early remission vs ‘outside protocol’: p=0.001, arm 1 vs arm 2 and ‘outside protocol’ vs both arms: p=1.0). Mean HAQ reduction in year 1 was 0.6 in all groups (p=0.7). Mean HAQ, PCS, MCS and VAS-scores over 1 year treatment were better in the early remission group. There was no significant difference between randomization arms 1 and 2. VAS improvements over 1 year were similar in all groups except VASdis, which improved significantly more in arm 2 than in arm 1 (36 versus 24 points; p=0.02). At baseline and after 1 year, all groups scored below the Dutch population average in PCS, MCS and all subscales (all p<0.001). Early remission was a predictor for significant improvement in PCS but not MCS after 1 year. For the MCS only baseline MCS was a predictor.

Conclusion:

In patients with early arthritis, functional ability and patient reported outcomes after 1 year are significantly better in patients who achieved early remission. In patients who did not achieve early remission, treatment with polyDMARD+prednisone or adalimumab+MTX results in comparable improvements. All patients with early arthritis have significantly lower HRQOL than the Dutch general population, both at baseline and after 1 year of remission steered treatment.


Disclosure:

L. Heimans,
None;

K. V. C. Wevers-de Boer,
None;

K. Visser,
None;

R. Goekoop,
None;

T. H. E. Molenaar,
None;

B. A. Grillet,
None;

T. Huizinga,
None;

C. F. Allaart,
None.

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