31256 Malignancy rates through 5 years of follow-up in guselkumab-treated patients with moderate to severe psoriasis: Results from the VOYAGE 1 and 2 trials and comparisons to general populations

Abstract

Introduction: Surveillance of malignancy risk among patients receiving long-term immunomodulatory treatment remains an important safety objective. Here we report malignancy rates in patients with moderate-to-severe psoriasis treated with guselkumab for up to 5 years versus a representative psoriasis registry population and the general US population. Methods: Cumulative rates of malignancies/100 patient-years (PY) were evaluated in 1721 guselkumab-treated patients from VOYAGE-1&2. Overall rates of malignancies excluding NMSC were compared with rates among patients eligible for systemic therapy from the Psoriasis Longitudinal Assessment and Registry (PSOLAR; 2007-2014; N = 12,093; >40,000 PY). Standardized incidence ratios (SIRs; 95%CI) comparing rates of malignancies excluding NMSC and cervical cancer in situ between guselkumab-treated psoriasis patients and the general US population using Surveillance, Epidemiology, and End Results data (2000-2017) were calculated, adjusting for age, sex, and race. Results: Of 1721 guselkumab-treated patients included in VOYAGE-1&2 (7166PY of follow-up), 24 had NMSC (0.34/100PY) and 32 had malignancies excluding NMSC (0.45/100PY). For comparison, the rate of malignancies excluding NMSC was 0.68/100PY in PSOLAR. The rate of malignancies (excluding NMSC/cervical cancer in situ) in guselkumab-treated patients was generally consistent with that expected in the general US population [SIR (95% CI) = 0.93 (0.64-1.31)]; the most commonly reported malignancies in guselkumab-treated patients were breast [n = 6; SIR = 1.47 (0.54-3.20)], colorectal [n = 5; SIR = 1.54 (0.50-3.59)], melanoma [n = 4; SIR = 1.32 (0.36-3.39)], and prostate [n = 4; SIR = 0.59 (0.16-1.50)]. Conclusions: Through 5 years of treatment of psoriasis patients with guselkumab in VOYAGE-1&2, NMSC and other malignancy rates were low. Malignancy rates (excluding NMSC) were generally consistent with rates expected in the general US population and observed in the PSOLAR registry.