Session Type: Abstract Submissions (ACR)
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.
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.
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.
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.
K. V. C. Wevers-de Boer,
T. H. E. Molenaar,
B. A. Grillet,
C. F. Allaart,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-in-early-arthritis-patients/