Table 1.
Demographics and baseline disease characteristics
| Certolizumab pegol–IR plus bimekizumab (n=52) |
Certolizumab pegol–IR plus placebo (n=27) |
Certolizumab pegol responders (n=80) |
|
| Demographics, n (%) | |||
| Age, median (range), years | 53 (26–69) | 57 (30–67) | 58 (21–69) |
| Gender | |||
| Male | 7 (13.5) | 4 (14.8) | 13 (16.3) |
| Female | 45 (86.5) | 23 (85.2) | 67 (83.8) |
| Race | |||
| Caucasian | 52 (100) | 27 (100) | 80 (100) |
| Duration of RA | |||
| <2 years | 12 (23.1) | 8 (29.6) | 17 (21.3) |
| ≥2 years | 40 (76.9) | 19 (70.4) | 63 (78.8) |
| History of extra-articular features | 7 (13.5) | 1 (3.7) | 7 (8.8) |
| Anti-CCP positive | 39 (75) | 19 (70.4) | 66 (82.5) |
| Rheumatoid factor positive | 39 (75) | 22 (81.5) | 64 (80.0) |
| Prior csDMARDs* | 49 (94.2) | 27 (100) | 79 (98.8) |
| Methotrexate | 43 (82.7) | 22 (81.5) | 76 (95) |
| Methotrexate sodium | 6 (11.5) | 4 (14.8) | 5 (6.3) |
| Concomitant csDMARDs† | 42 (80.8) | 26 (96.3) | 71 (88.8) |
| Methotrexate | 29 (55.8) | 20 (74.1) | 63 (78.8) |
| Methotrexate sodium | 6 (11.5) | 3 (11.1) | 3 (3.8) |
| Disease characteristics, mean (SD) | |||
| SJC‡ | 13.6 (6.4) | 16.2 (7.9) | 11.1 (5.4) |
| TJC‡ | 20.6 (10.5) | 26.2 (12.3) | 20.3 (9.8) |
| PtAAP | 72.9 (15.5) | 73.1 (17.8) | 63.2 (21.4) |
| PtGADA | 74 (14.2) | 77.7 (17) | 64.3 (20.9) |
| HAQ-DI | 1.7 (0.6) | 1.9 (0.4) | 1.6 (0.6) |
| DAS28(CRP) | 6.1 (0.7) | 6.2 (0.8) | 5.7 (0.8) |
All patients received certolizumab pegol during the 8-week open-label run-in period.
*Prior medications include any medications that started prior to the start date of study medication.
†Concomitant medications are medications taken at least 1 day in common with the study medication, ie, whose start date is prior to the date of last study medication administration plus 14 days, and whose stop date is either missing, or on or after the date of first study medication administration.
‡SJC and TJC were based on 66 and 68 counts, respectively.
Anti-CCP, anti-cyclic citrullinated peptide;csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28(CRP), Disease Activity Score 28-joint count (C-reactive protein);HAQ-DI, Health Assessment Questionnaire–Disability Index;PtAAP, Patient’s Assessment of Arthritis Pain;PtGADA, Patient’s Global Assessment of Disease Activity;RA, rheumatoid arthritis;SCJ, swollen joint count;TJC, tender/painful joint count.