Summary of demographics and baseline characteristics: safety analysis set
| Period 1 | Period 2 | Period 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| FKB327 N=366 | RP N=362 | Total N=728 | FKB327 N=324 | RP N=321 | Total N=645 | F-F-F N=216 | F-RP-F N=108 | RP-F-F N=108 | RP-RP-F N=213 | Total N=645 | |
| Mean age (SD), years | 53.0 (12.04) | 53.6 (12.32) | 53.3 (12.18) | 52.5 (12.19) | 53.4 (12.20) | 52.9 (12.20) | 52.7 (12.35) | 52.1 (11.35) | 52.3 (11.93) | 54.0 (12.60) | 52.9 (12.20) |
| Gender, n (%) | |||||||||||
| Male | 85 (23.2) | 78 (21.5) | 163 (22.4) | 79 (24.4) | 65 (20.2) | 144 (22.3) | 54 (25.0) | 23 (21.3) | 25 (23.1) | 42 (19.7) | 144 (22.3) |
| Female | 281 (76.8) | 284 (78.5) | 565 (77.6) | 245 (75.6) | 256 (79.8) | 501 (77.7) | 162 (75.0) | 85 (78.7) | 83 (76.9) | 171 (80.3) | 501 (77.7) |
| Race, n (%) | |||||||||||
| American Indian or Alaska Native | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1 (0.5) | 0 | 0 | 1 (0.5) | 2 (0.3) |
| Asian | 1 (0.3) | 1 (0.3) | 2 (0.3) | 2 (0.6) | 0 | 2 (0.3) | 1 (0.5) | 0 | 1 (0.9) | 0 | 2 (0.3) |
| Black or African American | 2 (0.5) | 4 (1.1) | 6 (0.8) | 3 (0.9) | 3 (0.9) | 6 (0.9) | 1 (0.5) | 1 (0.9) | 2 (1.9) | 2 (0.9) | 6 (0.9) |
| White | 311 (85.0) | 308 (85.1) | 619 (85.0) | 277 (85.5) | 275 (85.7) | 552 (85.6) | 187 (86.6) | 90 (83.3) | 90 (83.3) | 185 (86.9) | 552 (85.6) |
| Other | 51 (13.9) | 48 (13.3) | 99 (13.6) | 41 (12.7) | 42 (13.1) | 83 (12.9) | 26 (12.0) | 17 (15.7) | 15 (13.9) | 25 (11.7) | 83 (12.9) |
| Mean DAS28-CRP (SD) | 6.1 (0.91) | 6.1 (0.85) | 6.1 (0.88) | 3.5* (1.31) | 3.4* (1.31) | 3.5* (1.31) | 3.5 (1.29) | 3.5 (1.31) | 3.7 (1.35) | 3.4 (1.32) | 3.5 (1.31) |
| No prior biological treatment, n (%) | 302 (82.3) | 296 (81.5) | 598 (81.9) | 268 (82.7) | 261 (81.3) | 529 (82.0) | 182 (84.3) | 87 (80.6) | 86 (79.6) | 174 (81.7) | 529 (82.0) |
| Mean MTX dose, mg/week (SD) | 15.8 (5.01) | 15.8 (4.64) | 15.8 (4.82) | 16.2 (4.97) | 15.7 (4.71) | 15.9 (4.85) | 16.2 (5.15 | 15.5 (4.93 | 16.2 (4.62) | 15.7 (4.61) | 15.9 (4.85) |
| Number of patients with ≥1 prior anti-TNF treatments for RA, n (%) | 22 (6.0) | 27 (7.5) | 49 (6.7) | 21 (6.5) | 20 (6.2) | 41 (6.4) | 14 (6.5) | 4 (3.7) | 7 (6.5) | 16 (7.5) | 41 (6.4) |
| Number of patients with ≥1 concomitant oral steroids for RA, n (%) | 219 (59.8) | 223 (61.6) | 442 (60.7) | 196 (60.5) | 207 (64.5) | 403 (62.5) | 127 (58.8) | 70 (64.8) | 69 (63.9) | 137 (64.3) | 403 (62.5) |
| Number of patients with ≥1 NSAIDs for RA, n (%) | 212 (57.9) | 212 (58.6) | 424 (58.2) | 196 (60.5) | 198 (61.7) | 394 (61.1) | 128 (59.3) | 72 (66.7) | 68 (63.0) | 126 (59.2) | 394 (61.1) |
*Baseline value of the OLE.
DAS28-CRP, Disease Activity Score in 28 joints using C-reactive protein; DB, double-blind; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; OLE, open-label extension; RA, rheumatoid arthritis; RP, reference product; TNF, tumour necrosis factor.