Demographic and clinical characteristics at baseline in the primary studies*
| Placebo → 50 mg q4w | Placebo → 100 mg q2w | 50 mg q4w Start | 100 mg q2w Start | 50 mg q4w Combined | 100 mg q2w Combined | Combined | |
| Enrolled patients, n | 305 | 291 | 605 | 619 | 910 | 910 | 1820 |
| Age, mean (SD), years | 54.0 (11.92) | 53.1 (11.75) | 53.1 (11.43) | 53.4 (11.29) | 53.4 (11.59) | 53.3 (11.43) | 53.4 (11.51) |
| Sex, female, n (%) | 241 (79.0) | 231 (79.4) | 479 (79.1) | 503 (81.3) | 720 (79.1) | 734 (80.7) | 1454 (79.9) |
| Race, n (%) | |||||||
| White | 231 (75.7) | 211 (72.5) | 433 (71.6) | 443 (71.6) | 664 (73.0) | 654 (71.9) | 1318 (72.4) |
| Asian | 50 (16.4) | 47 (16.2) | 102 (16.9) | 110 (17.8) | 152 (16.7) | 157 (17.3) | 309 (17.0) |
| Black | 10 (3.3) | 15 (5.2) | 21 (3.5) | 23 (3.7) | 31 (3.4) | 38 (4.2) | 69 (3.8) |
| Other* | 14 (4.6) | 18 (6.2) | 49 (8.1) | 43 (6.9) | 63 (6.9) | 61 (6.7) | 124 (6.8) |
| Weight, mean (SD), kg | 75.0 (19.4) | 72.9 (18.3) | 73.7 (20.0) | 72.5 (18.4) | 74.1 (19.8) | 72.6 (18.4) | 73.4 (19.1) |
| BMI, mean (SD), kg/m2 | 28.1 (6.5) | 27.3 (6.3) | 27.8 (6.9) | 27.4 (6.5) | 27.9 (6.8) | 27.4 (6.4) | 27.6 (6.7) |
| DAS28-CRP mean (SD) | 5.9 (0.9) | 5.9 (1.0) | 5.9 (0.9) | 5.8 (0.9) | 5.9 (0.9) | 5.8 (0.9) | 5.9 (0.9) |
| CDAI, mean (SD) | 13.4 (11.0) | 13.0 (10.8) | 14.1 (12.0) | 13.3 (11.6) | 13.8 (11.7) | 13.2 (11.3) | 13.5 (11.5) |
| SDAI, mean (SD) | 13.5 (11.1) | 13.1 (10.9) | 14.1 (12.1) | 13.3 (11.6) | 13.9 (11.8) | 13.2 (11.3) | 13.6 (11.6) |
| CRP, mean (SD), mg/dL | 2.6 (4.1) | 2.4 (2.5) | 2.3 (2.4) | 2.2 (2.5) | 2.4 (3.1) | 2.3 (2.5) | 2.3 (2.8) |
| Tender joints (68-joint count), mean (SD) | 26.0 (14.3) | 25.1 (13.5) | 25.7 (14.8) | 25.3 (14.6) | 25.8 (14.6) | 25.2 (14.2) | 25.5 (14.4) |
| Swollen joints (66-joint count), mean (SD) | 15.7 (8.8) | 14.7 (8.0) | 15.3 (9.1) | 15.7 (9.2) | 15.5 (9.0) | 15.4 (8.8) | 15.4 (8.9) |
| Physician’s global assessment of disease activity, mean (SD) | 26.0 (14.3) | 25.1 (13.5) | 25.7 (14.8) | 25.3 (14.6) | 25.8 (14.6) | 25.2 (14.2) | 25.5 (14.4) |
| Patient’s global assessment of disease activity, mean (SD) | 6.2 (1.7) | 6.2 (1.7) | 6.2 (1.7) | 6.3 (1.6) | 6.2 (1.7) | 6.3 (1.7) | 6.2 (1.7) |
| Patient’s global assessment of pain activity, mean (SD) | 6.3 (2.1) | 6.4 (2.2) | 6.4 (2.1) | 6.5 (2.1) | 6.4 (2.1) | 6.4 (2.1) | 6.4 (2.1) |
| HAQ-DI, mean (SD) | 1.5 (0.7) | 1.5 (0.6) | 1.5 (0.6) | 1.6 (0.6) | 1.5 (0.6) | 1.5 (0.6) | 1.5 (0.6) |
| Duration of exposure during the LTE study, mean, weeks | 115.87 | 113.97 | 116.04 | 116.99 | 115.98 | 116.02 | 116.00 |
*Includes multiple, not reported, other and unknown.
BMI, body mass index; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Index Score 28; HAQ-DI, Health Assessment Questionnaire-Disability Index; LTE, long-term extension; q2w, every 2 weeks; q4w, every 4 weeks; SDAI, Simplified Disease Activity Index.