Baseline data for intention-to-treat cohorts and Week-26 and Week-104 analysis cohorts.
| MTX monotherapy | Adalimumab plus MTX | Adalimumab monotherapy | |||||||
|---|---|---|---|---|---|---|---|---|---|
| ITT, n = 257 | Week 26, n = 213 | Week 104, n = 166 | ITT, n = 268 | Week 26, n = 240 | Week 104, n = 199 | ITT, n = 274 | Week 26, n = 222 | Week 104, n = 161 | |
| Age, yrs | 52.0 (13.1) | 52.2 (13.7) | 52.6 (13.2) | 51.9 (14.0) | 51.7 (14.2) | 51.4 (14.3) | 52.1 (13.5) | 51.5 (13.3) | 52.3 (12.7) |
| Female, n (%) | 190 (73.9) | 159 (74.6) | 123 (74.1) | 193 (72.0) | 172 (71.7) | 144 (72.4) | 212 (77.4) | 170 (76.6) | 123 (76.4) |
| Disease duration since diagnosis, yrs | 0.84 (0.89) | 0.82 (0.89) | 0.83 (0.89) | 0.72 (0.79) | 0.73 (0.79) | 0.73 (0.80) | 0.73 (0.81) | 0.70 (0.78) | 0.70 (0.78) |
| Prior DMARD use, n (%) | 81 (31.5) | 64 (30.0) | 51 (30.7) | 87 (32.5) | 74 (30.8) | 62 (31.2) | 91 (33.2) | 75 (33.8) | 56 (34.8) |
| Corticosteroid use, n (%) | 91 (35.4) | 73 (34.3) | 57 (34.3) | 96 (35.8) | 86 (35.8) | 74 (37.2) | 100 (36.5) | 83 (37.4) | 60 (37.3) |
| RF-positive, n (%) | 215 (84.0) | 180 (84.9) | 140 (84.8) | 228 (85.1) | 204 (85.0) | 166 (83.4) | 227 (83.5) | 188 (84.7) | 138 (85.7) |
| SJC (0–66) | 22.1 (11.7) | 22.2 (11.9) | 23.2 (12.4) | 21.1 (11.2) | 21.2 (11.4) | 21.3 (11.3) | 21.8 (10.5) | 21.6 (10.5) | 21.2 (10.3) |
| TJC (0–68) | 32.3 (14.3) | 31.8 (14.0) | 32.0 (14.1) | 30.7 (14.2) | 30.8 (14.3) | 30.1 (14.2) | 31.8 (13.6) | 32.4 (13.8) | 32.3 (13.7) |
| HAQ | 1.5 (0.67) | 1.5 (0.68) | 1.5 (0.65) | 1.5 (0.64) | 1.5 (0.63) | 1.4 (0.63) | 1.6 (0.62) | 1.6 (0.62) | 1.6 (0.60) |
| DAS28 | 6.3 (0.9) | 6.3 (0.9) | 6.3 (0.9) | 6.3 (0.9) | 6.3 (0.9) | 6.3 (0.9) | 6.4 (0.9) | 6.3 (0.9) | 6.3 (0.9) |
| CRP, mg/dl | 4.0 (4.0) | 3.9 (4.0) | 3.9 (4.1) | 3.9 (4.2) | 3.9 (4.2) | 3.9 (4.1) | 4.1 (3.9) | 3.9 (3.7) | 3.7 (3.5) |
| TSS | 21.9 (22.2) | 21.8 (22.4) | 22.7 (23.0) | 18.1 (20.1) | 18.2 (20.3) | 18.1 (20.7) | 18.8 (19.0) | 19.1 (18.7) | 18.9 (19.4) |
| Erosion score | 13.6 (13.5) | 13.6 (13.6) | 14.1 (14.0) | 11.0 (12.3) | 11.1 (12.7) | 11.2 (13.0) | 11.3 (11.3) | 11.6 (11.5) | 11.3 (11.6) |
| JSN score | 8.2 (10.7) | 8.1 (10.7) | 8.6 (11.1) | 7.1 (9.6) | 7.1 (9.3) | 7.0 (9.4) | 7.5 (9.5) | 7.5 (8.8) | 7.6 (9.0) |
| Rate of TSS progression* | 26.1 | 27.8 | 27.9 | 29.7 | 30.4 | 30.7 | 28.8 | 28.0 | 27.4 |
↵* Median of the individual values for (baseline TSS)/(disease duration since diagnosis). Values for the intention-to-treat cohorts are as reported11. Week 26 and Week 104 represent the cohorts of patients who completed 26 or 104 weeks of treatment, respectively. Values are mean (standard deviation) unless specified as n (%) or as median. CRP: C-reactive protein; DAS28: 28-joint Disease Activity Score; DMARD: disease modifying antirheumatic drug; HAQ: Health Assessment Questionnaire; ITT: intention-to-treat; JSN: joint space narrowing; MTX: methotrexate; RF: rheumatoid factor; SJC: swollen joint count; TJC: tender joint count; TSS: total Sharp score.