Placebo→guselkumab 100 mg Q4W | Guselkumab 100 mg (Week0–60) | All guselkumab | |||
Placebo (Week0–24) | Q4W (Week24–60) | Q4W (Week0–60) | Q8W (Week0–60) | ||
Treated patients, N | 126 | 114* | 128 | 127 | 369 |
Weeks of follow-up, mean | 24.0 | 35.3 | 59.5 | 58.3 | 51.6 |
Overall PY | 58 | 77 | 146 | 142 | 365 |
All AEs | |||||
Total PY | 38 | 53 | 69 | 71 | 193 |
Number (%) of patients | 76 (60.3) | 55 (48.2) | 89 (69.5)† | 87 (68.5)† | 231 (62.6) |
Incidence/100PY | 201.4 | 104.3 | 129.0 | 121.9 | 119.6 |
95% CI | 158.7 to 252.1 | 78.6 to 135.7 | 103.6 to 158.8 | 97.6 to 150.4 | 104.7 to 136.1 |
SAEs | |||||
Total PY | 57 | 75 | 144 | 136 | 356 |
Number (%) of patients | 5 (4.0) | 4 (3.5) | 4 (3.1)‡ | 8 (6.3)‡ | 16 (4.3) |
Incidence/100PY | 8.8 | 5.3 | 2.8 | 5.9 | 4.5 |
95% CI | 2.8 to 20.5 | 1.4 to 13.6 | 0.8 to 7.1 | 2.5 to 11.6 | 2.6 to 7.3 |
AEs leading to study agent D/C | |||||
Total PY | 57 | 76 | 146 | 141 | 363 |
Number (%) of patients | 3 (2.4) | 3 (2.6) | 1 (0.8)§ | 5 (3.9)§ | 9 (2.4) |
Incidence/100PY | 5.2 | 3.9 | 0.7 | 3.6 | 2.5 |
95% CI | 1.1 to 15.3 | 0.8 to 11.5 | 0.0 to 3.8 | 1.2 to 8.3 | 1.1 to 4.7 |
Infections | |||||
Total PY | 50 | 66 | 110 | 104 | 280 |
Number (%) of patients | 32 (25.4) | 30 (26.3) | 49 (38.3)¶ | 54 (42.5)¶ | 133 (36.0) |
Incidence/100PY | 63.6 | 45.4 | 44.6 | 51.7 | 47.4 |
95% CI | 43.5 to 89.8 | 30.6 to 64.8 | 33.0 to 59.0 | 38.8 to 67.4 | 39.7 to 56.2 |
Serious infections | |||||
Total PY | 58 | 76 | 146 | 141 | 363 |
Number (%) of patients | 2 (1.6)** | 2 (1.8)†† | 0 | 2 (1.6)‡‡ | 4 (1.1) |
Incidence/100PY | 3.5 | 2.6 | 0.0 | 1.4 | 1.1 |
95% CI | 0.4 to 12.6 | 0.3 to 9.5 | 0.0 to 2.0 | 0.2 to 5.1 | 0.3 to 2.8 |
All number-needed-to-harm statistics for guselkumab versus placebo were negative.
*These 114 patients were randomised to placebo followed by guselkumab 100mg Q4W; only AEs reported during or after the first dose of guselkumab are summarised.
†During Week0–24, 71 (55.5%) and 68 (53.5%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients reported AEs.14
‡During Week0–24, 0 and 4 (3.1%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients had SAEs.14
§During Week0–24, 1 (0.8%) and 3 (2.4%), respectively, guselkumab 100mg Q4W-randomised and Q8W-randomised patients had AEs leading to discontinuation of study agent.14
¶During Week0–24, 31 (24.2%) and 33 (26.0%), respectively, guselkumab 100 mg Q4W-randomised and Q8W-randomised patients had infections reported as AEs.14
**One patient each with pneumonia/upper respiratory infection and limb abscess/pustular psoriasis during Week0–24.14
††One patient each with pyelonephritis and urosepsis during Week24–60.
‡‡One patient each with bronchitis and cellulitis during Week24–60.
AE, adverse event; D/C, discontinuation; PY, patient-years of follow-up; Q4/8W, every 4/8 weeks; SAE, serious adverse event.