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. 2022 Feb 7;74(3):475–485. doi: 10.1002/art.42010

Table 2.

AEs through week 112 of the DISCOVER‐2 study*

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.