Groups | Time | SF-36 PCS | SF-36 ASHI | HAQ-DI FIS | |||
---|---|---|---|---|---|---|---|
Mean (SD) | p* | Mean (SD) | p* | Mean (SD) | p* | ||
Responder | |||||||
n = 36 | Baseline | 35.1 (10.7) | – | 55.4 (29.1) | – | 1.0 (0.8) | – |
n = 36 | 3 mos | 38.6 (12.3) | 0.24 | 65.9 (31.4) | 0.18 | 0.9 (0.9) | 0.40 |
n = 36 | 6 mos | 41.6 (11.2) | 0.02 | 78.8 (28.3) | 0.002 | 0.8 (0.8) | 0.20 |
mITT Nonresponder | |||||||
n = 47 | Baseline | 35.2 (11.1) | – | 53.6 (28.3) | – | 1.2 (0.9) | – |
n = 49 | 3 mos | 36.7 (10.0) | 0.45 | 62.8 (24.9) | 0.11 | 1.1 (0.8) | 0.46 |
n = 49 | 6 mos | 39.2 (11.5) | 0.15 | 69.7 (29.1) | 0.02 | 0.9 (0.8) | 0.20 |
PP Nonresponder | |||||||
n = 22 | Baseline | 33.8 (10.8) | – | 47.4 (26.9) | – | 1.4 (0.9) | – |
n = 24 | 3 mos | 37.0 (10.2) | 0.20 | 65.0 (23.1) | 0.03 | 1.0 (0.8) | 0.17 |
n = 22 | 6 mos | 39.4 (10.1) | 0.07 | 70.3 (24.6) | 0.005 | 0.9 (0.7) | 0.04 |
Placebo | |||||||
n = 43 | Baseline | 31.0 (11.1) | – | 45.8 (27.3) | – | 1.2 (1.0) | – |
n = 42 | 3 mos | 32.4 (11.9) | 0.66 | 49.5 (30.2) | 0.78 | 1.3 (1.0) | 0.8 |
n = 38 | 6 mos | 30.2 (11.9) | 0.78 | 46.6 (29.0) | 1.0 | 1.3 (0.9) | 0.7 |
↵* Versus baseline. ASHI: arthritis-specific health index score; HAQ-DI FIS: Health Assessment Questionnaire–Disability Index Functional Index Scale; mITT: modified intent to treat; PCS: physical component summary score; PP: per protocol; SF-36: Medical Outcomes Study Short Form-36 questionnaire.