| 1-TNFi Inadequate Responder n/N (%) | 2-TNFi Inadequate Responder n/N (%) | |||||
|---|---|---|---|---|---|---|
| PBO | Q4W | Q2W | PBO | Q4W | Q2W | |
| ACR50 | ||||||
| Week 24 | 2/68 (2.9%) | 24/71 (33.8%)** | 19/65 (29.2%)** | 3/41 (7.3%) | 15/41 (36.6%)* | 16/46 (34.8%)* |
| Week 52 | -- | 29/71 (40.8%) | 20/65 (30.8%) | -- | 18/41(43.9%) | 13/46 (28.3%) |
| Improvement in HAQ-DI ≥0.35a | ||||||
| Week 24 | 9/61 (14.8%) | 28/61 (45.9%)** | 19/58 (32.8%)* | 7/38 (18.4%) | 16/36 (44.4%)* | 20/41 (48.8%)* |
| Week 52 | -- | 32/61 (52.5%) | 18/58 (31.0%) | -- | 14/36(38.9%) | 13/41 (31.7%) |
| MDA | ||||||
| Week 24 | 3/68 (4.4%) | 22/71 (31.0%)** | 14/65 (21.5%)* | 1/41 (2.4%) | 8/41(19.5%)* | 13/46 (28.3%)** |
| Week 52 | -- | 26/71 (36.6%) | 17/65 (26.2%) | -- | 11/41(26.8%) | 7/46 (15.2%) |
| DAPSA ≤14 | ||||||
| Week 24 | 11/68 (16.2%) | 30/71 (42.3%)** | 24/65 (36.9%)* | 2/41 (4.9%) | 14/41 (34.1%)* | 12/46 (26.1%)* |
| Week 52 | -- | 41/71 (57.7%) | 26/65 (40.0%) | -- | 18/41(43.9%) | 14/46 (30.4%) |
| DAS28-CRP Good Response Criteriab | ||||||
| Week 24 | 7/68 (10.3%) | 33/71 (46.5%)** | 24/65 (36.9%)** | 2/41 (4.9%) | 17/41 (41.5%)** | 16/46 (34.8%)** |
| Week 52 | -- | 38/71 (53.5%) | 27/65 (41.5%) | -- | 19/41(46.3%) | 15/46 (32.6%) |
*P<0.05 vs. PBO, **P<0.001 vs. PBO, Fisher’s exact test. Missing values imputed using nonresponder imputation.
aPatients with ≥0.35 HAQ-DI at baseline.
bGood response criteria defined as >1.2 improvement and ≤3.2 present DAS28-CRP.