Patient demographics and disease characteristics of the OLE patient population at entry to the DBP and disease characteristics of the OLE population at entry to the OLE (ITT population)
| Adalimumab/sarilumab (n=155) | Sarilumab/sarilumab (n=165) | All (n=320) | |
| DBP entry | |||
| Mean age, years (SD) | 53.1 (11.80) | 50.1 (12.80) | 51.6 (12.40) |
| Female, n (%) | 126 (81.30) | 142 (86.10) | 268 (83.80) |
| Caucasian/White, n (%) | 137 (88.40) | 153 (92.70) | 290 (90.60) |
| Mean weight, kg (SD) | 71.35 (17.69) | 71.90 (16.59) | 71.63 (17.11) |
| BMI ≥30 kg/m2, n (%) | 42 (27.10) | 36 (21.80) | 78 (24.40) |
| Mean time since RA diagnosis, years (SD) | 6.66 (7.68) | 8.23 (8.25) | 7.47 (8.01) |
| Mean CDAI (SD) | 42.24 (11.68) | 43.30 (11.76) | 42.79 (11.71) |
| Mean HAQ-DI (SD) | 1.62 (0.65) | 1.63 (0.53) | 1.63 (0.59) |
| Mean DAS28-CRP (SD) | 6.00 (0.88) | 5.99 (0.87) | 5.99 (0.87) |
| Mean DAS28-ESR (SD) | 6.74 (0.83) | 6.81 (0.76) | 6.78 (0.79) |
| OLE entry | |||
| Mean CDAI (SD) | 16.53 (10.45) | 13.73 (11.39) | 15.09 (11.01) |
| Mean HAQ-DI (SD) | 1.21 (0.67) | 1.01 (0.64) | 1.10 (0.66) |
| Mean DAS28-CRP (SD) | 3.92 (1.25) | 3.07 (1.21) | 3.48 (1.30) |
| Mean DAS28-ESR (SD) | 4.46 (1.29) | 3.45 (1.44) | 3.94 (1.46) |
BMI, body mass index; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28, Disease Activity Score (28 joints); DBP, double-blind phase; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intent-to-treat; OLE, open-label extension; RA, rheumatoid arthritis.