Table 2.
Placebo (weeks 0–24) (n = 246) | Placebo–guselkumab Q4W crossover(weeks 24–112)(n = 238) | Guselkumab Q4W (weeks 0–112) (n = 245) | Guselkumab Q8W (weeks 0–112) (n = 248) | All guselkumab (n = 731)† | |
---|---|---|---|---|---|
Duration of follow‐up, weeks |
24.4 | 84.2 | 106.4 | 107.1 | 99.4 |
Patient‐years of follow‐up |
115 | 384 | 499 | 509 | 1,392 |
AEs | |||||
No. patient‐years | 85 | 240 | 225 | 224 | 690 |
Patients | 101 (41) | 126 (53) | 172 (70) | 178 (72) | 476 (65) |
No. events per 100 patient‐ years (95% CI) |
188.9 (164.6, 215.8) | 110.7 (100.5, 121.8) | 121.2 (111.7, 131.2) | 158.0 (147.3, 169.3) | 131.7 (125.8, 137.9) |
Serious AEs | |||||
No. patient‐years | 113 | 368 | 476 | 487 | 1,330 |
Patients | 7 (3) | 16 (7) | 22 (9) | 22 (9) | 60 (8) |
No. events per 100 patient‐ years (95% CI) |
6.1 (2.5, 12.6) | 6.0 (3.8, 9.0) | 5.2 (3.4, 7.6) | 6.1 (4.1, 8.7) | 5.8 (4.6, 7.2) |
AEs leading to study discontinuation |
|||||
No. patient‐years | 114 | 381 | 496 | 507 | 1,383 |
Patients | 4 (2) | 10 (4) | 13 (5) | 8 (3) | 31 (4) |
No. events per 100 patient‐ years (95% CI) |
3.5 (1.0, 8.9) | 2.9 (1.4, 5.1) | 3.2 (1.8, 5.2) | 1.6 (0.7, 3.1) | 2.5 (1.8, 3.5) |
Infections | |||||
No. patient‐years | 104 | 315 | 378 | 381 | 1,075 |
Patients | 45 (18) | 61 (26) | 82 (34) | 94 (38) | 237 (32) |
No. events per 100 patient years (95% CI) |
50.5 (38.3, 65.3) | 34.9 (29.3, 41.4) | 35.8 (30.8, 41.5) | 40.5 (35.1, 46.4) | 37.3 (34.1, 40.6) |
Serious infections | |||||
No. patient‐years | 115 | 378 | 496 | 504 | 1,378 |
Patients | 1 (0.4) | 8 (3) | 5 (2) | 8 (3) | 21 (3) |
No. events per 100 patient‐ years (95% CI) |
0.9 (0.02, 4.9) | 2.6 (1.3, 4.8) | 1.0 (0.3, 2.3) | 2.2 (1.1, 3.9) | 1.9 (1.2, 2.7) |
Except where indicated otherwise, values are the number (%) of patients. AEs = adverse events; 95% CI = 95% confidence interval; Q4W = every 4 weeks; Q8W = every 8 weeks.
Includes all patients who received ≥1 administration of guselkumab, including patients who crossed over from placebo at week 24.