Patient enrollment and discontinuations.
| Disposition | MTX → OL ADA ± MTX, n (%) | ADA → OL ADA ± MTX, n (%) | ADA + MTX → OL ADA ± MTX, n (%) |
|---|---|---|---|
| Patients randomized | 257 | 274 | 268 |
| Completed 10-year study | 79 (30.7) | 85 (31.0) | 86 (32.1) |
| Completed DB phase but did not enter into OLE | 9 (3.5) | 7 (2.6) | 13 (4.9) |
| Early discontinuation | 169 (65.8) | 182 (66.4) | 169 (63.1) |
| Primary reason for discontinuation | |||
| Planned selection criterion | 0 | 1 (0.4) | 0 |
| Adverse event | 42 (16.3) | 59 (21.5) | 68 (25.4) |
| Lost to followup | 9 (3.5) | 2 (0.7) | 7 (2.6) |
| Recovery | 1 (0.4) | 2 (0.7) | 3 (1.1) |
| Protocol violation | 9 (3.5) | 10 (3.6) | 8 (3.0) |
| Death | 2 (0.8) | 4 (1.5) | 2 (0.7) |
| Withdrawal of consent | 31 (12.1) | 33 (12.0) | 34 (12.7) |
| Lack of efficacy/progression of disease | 61 (23.7) | 58 (21.2) | 25 (9.3) |
| Administrative reasons | 14 (5.4) | 13 (4.7) | 22 (8.2) |
MTX: methotrexate; OL: open-label; ADA: adalimumab; DB: double-blind; OLE: open-label extension.