33150 Safety of guselkumab in patients with moderate-to-severe psoriasis: Pooled analyses across clinical studies

Abstract

Introduction: Studies of guselkumab in plaque psoriasis have established a favorable safety profile for the drug. To evaluate the cumulative safety experience in psoriasis, we pooled safety data from phase 2/3 studies of guselkumab (CNTO1959PSO2001, CNTO1959PSO3001/3002, CNTO1959PSO3003, CNTO1959PSO3004, CNTO1959PSO3006, and CNTO1959PSO3009). Methods: Safety data were summarized for the placebo-controlled (wk 0-16 in CNTO1959PSO2001, CNTO1959PSO3001/3002, and CNTO1959PSO3006) and end-of-reporting (wk 0-40 for CNTO1959PSO3006; wk16-44 for CNTO1959PSO3003; wk0-52 for CNTO1959PSO2001 and CNTO1959PSO3004; wk0-56 for CNTO1959PSO3009; and through wk264 for CNTO1959PSO3001/3002) periods. Pooled data were adjusted by exposure per 100 patient-years of follow-up [100PY]). Results: During the placebo-controlled period, 544 patients received placebo (165 PY) and 1220 received guselkumab (378 PY). Adverse event (AE) rates were similar for placebo (341.12/100PY) and guselkumab (345.63/100PY); corresponding serious AE (SAE) rates were 6.66/100PY and 6.34/100PY. Infection rates were 83.61/100PY (placebo) and 95.92/100PY (guselkumab). Serious infections (SIs) occurred at rates of 1.21/100PY and 1.06/100PY in the placebo and guselkumab groups, respectively. The rate was 0.26/100PY for both NMSC and malignancies other than NMSC in the guselkumab group (none in the placebo group). Through the end-of-reporting period (n = 2891 patients; 8662 PY), rates remained low for guselkumab-treated patients: 169.02/100PY (AE), 5.26/100PY (SAE), 65.92/100PY (infections), and 0.88/100PY (SIs). Other AEs of interest rates were 0.43/100PY (malignancies), 0.35/100PY (NMSC), and 0.33/100PY (MACE). In guselkumab-treated patients, there were no reported active tuberculosis or opportunistic infections; no serum sickness-like/anaphylactic reactions related to guselkumab were reported. Conclusions: Pooled analyses confirm the established safety profile of guselkumab for patients treated for up to 5 years.