Table 1.
Patient demographics and disease characteristics at baseline in the OL-LI treated population and at DB baseline in the DB population
| OL-LI treated population (n=146) | DB population | |||
| Taper arm (n=102) | Withdrawal arm (n=20) | Randomised (n=122) | ||
| Women, n (%)* | 109 (75) | 79 (77) | 12 (60) | 91 (75) |
| Race, white, n (%)* | 139 (97), n=143 | 97 (97), n=100 | 20 (100) | 117 (98), n=120 |
| Age, years* | 59.6 (10.3) | 59.2 (10.4) | 62.7 (9.2) | 59.7 (10.3) |
| Prior or concomitant NSAIDs, n (%)† | 65 (45) | 42 (41) | 12 (60) | 54 (44) |
| Prior or concomitant steroids, n (%)† | 46 (32) | 30 (29) | 9 (45) | 39 (32) |
| Concomitant steroids, n (%)† | – | 14 (14) | 4 (20) | 18 (15) |
| Prior or concomitant DMARDs, n (%)† | 146 (100)‡ | 102 (100) | 20 (100) | 122 (100) |
| Methotrexate dose, mg/week§ | 13.6 (5.7), n=122 | 13.6 (5.6), n=85 | 11.7 (5.4), n=18 | 13.3 (5.6), n=103 |
| DAS28(ESR) | 1.8 (0.7) | 1.7 (0.6) | 1.6 (0.7) | 1.7 (0.6) |
| DAS28(ESR) <2.6, n (%) | 141 (97) | 102 (100) | 20 (100) | 122 (100) |
| CDAI ≤2.8, n (%) | 116 (79) | 85 (83) | 19 (95) | 104 (85) |
| SDAI ≤3.3, n (%) | 119 (82) | 89 (87) | 19 (95) | 108 (89) |
| PtGA | 8.7 (11.8) | 6.8 (9.3) | 4.3 (6.7) | 6.4 (8.9) |
| PGA | 3.3 (6.2) | 3.8 (5.1) | 2.6 (4.4) | 3.6 (5.0) |
| PtGA pain | 9.7 (11.0) | 8.9 (11.9) | 6.0 (8.8) | 8.4 (11.5) |
| Synovitis RAMRIS¶ | – | 2.3 (2.2) | 2.1 (1.6), n=19 | 2.3 (2.1), n=121 |
| BME RAMRIS¶ | – | 1.6 (2.8) | 2.1 (2.1) | 1.7 (2.7) |
| Synovitis and BME composite RAMRIS¶ | – | 3.9 (4.1) | 4.3 (3.3), n=19 | 4.0 (4.0), n=121 |
| HAQ-DI | 0.4 (0.5) | 0.4 (0.5) | 0.2 (0.3) | 0.4 (0.5) |
| RAPID-3 | 3.3 (3.0), n=145 | 3.5 (3.3) | 2.0 (2.4) | 3.3 (3.2) |
| SF-36 PCS** | – | 49.8 (7.9), n=99 | 52.1 (6.7) | 50.1 (7.8), n=119 |
| SF-36 MCS** | 54.0 (8.1), n=99 | 56.4 (5.0) | 54.4 (7.7), n=119 | |
| FACIT-fatigue** | 43.8 (6.1), n=100 | 47.6 (3.6) | 44.4 (6.0), n=120 | |
Data are mean (SD) unless otherwise noted.
*At baseline for all populations.
†Prior or concomitant DMARDs, NSAIDs and steroids are taken before or at baseline for the OL-LI population and before or at DB baseline for the DB population. Concomitant steroids include all medications that started prior to the first dose of study drug and continued to be taken after the first dose of study drug.
‡Overall, 145 patients had received prior conventional synthetic DMARDs (including methotrexate, chloroquine, hydroxychloroquine, sulfasalazine, gold formulations and/or leflunomide) and 38 patients had received prior biologic DMARDs (excluding adalimumab).
§Methotrexate taken at baseline for the OL-LI population and at DB baseline for the DB population.
¶MRI assessments were done during the OL-LI period and not at the OL-LI baseline.
**Not collected at OL-LI baseline.
BME, bone marrow oedema; CDAI, Clinical Disease Activity Index; DAS28(ESR), 28-joint Disease Activity Score based on erythrocyte sedimentation rate; DB, double-blind; DMARD, disease-modifying antirheumatic drug; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, mental component summary; NSAID, non-steroidal anti-inflammatory drug; OL-LI, open-label lead-in; PCS, physical component summary; PGA, Physician Global Assessment of disease activity; PtGA, Patient Global Assessment of disease activity; RAMRIS, Rheumatoid Arthritis Magnetic Resonance Imaging Score; RAPID-3, Routine Assessment of Patient Index Data; SDAI, Simplified Disease Activity Index; SF-36, Short Form 36 Health Survey Questionnaire.