Table 2.
Rates of clinical remission and corticosteroid reduction (per-protocol set)
| Endpoint | cDMARD+anti-TNF (n=45) |
Multiple cDMARDs (n=91) |
Between-group difference* | |||||
|---|---|---|---|---|---|---|---|---|
| PPS, n | Achieved outcome, n (%) | PPS, n | Achieved outcome, n (%) | Achieved outcome, % | p-value† | |||
| Clinical remission (defined as DAS28-ESR score of ≤2.6) | ||||||||
| Primary outcome | ||||||||
| Clinical remission at month 6 | 45 | 16 (35.6) | 91 | 43 (47.3) | −11.7 | 0.1953 | ||
| Secondary outcome | ||||||||
| Clinical remission at month 3 | 45 | 12 (26.7) | 84 | 32 (38.1) | −11.4 | 0.1919 | ||
| Clinical remission at month 12 | 44 | 13 (29.6) | 82 | 37 (45.1) | −15.8 | 0.0884 | ||
| Corticosteroid reduction during study | ||||||||
| Corticosteroid reduction (≥50% reduction from baseline in dose) | 42 | 15 (35.7) | 82 | 12 (14.6) | 21.1 | 0.0071 | ||
cDMARD: conventional disease-modifying anti-rheumatic drug, anti-TNF: anti-tumor necrosis factor agent, PPS: per-protocol set, DAS28-ESR: disease activity score 28-joint count with erythrocyte sedimentation rate. *cDMARD+anti-TNF minus multiple cDMARDs. †Pearson’s chi-square test or Fisher’s exact test.