E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis

Abstract

Background/Aims Guselkumab is a monoclonal antibody approved to treat moderate‐tosevere plaque psoriasis and active psoriatic arthritis (PsA). In this analysis, safety data from 11 Phase 2/3 studies of guselkumab were pooled to evaluate guselkumab safety in a large population of patients with psoriatic disease. Methods Guselkumab was generally administered as 100‐mg injections at Week (W)0, W4, then Q8W in 7 psoriasis studies and at W0, W4, then Q4W or Q8W in 4 PsA studies. Patients randomized to placebo crossed over to guselkumab Q8W at W16 in 5 PsO studies and to guselkumab Q4W or Q8W at W24 in all PsA studies. Safety data were summarized for the placebo‐controlled period (W0‐W16 in PsO; W0‐W24 in PsA) and through the end of the reporting period (up to 5 years in PsO; up to 2 years in PsA). Incidence rates of key safety events were integrated post‐hoc, adjusted for duration of follow‐up, and reported per 100 patient‐years (PY). Results During the placebo‐controlled periods, 1061 patients received placebo (395 PY) and 2257 received guselkumab (856 PY). Through the longterm reporting periods, 4399 guselkumab‐treated patients (PsO: 2891; PsA: 1508) contributed 10787 PY of follow‐up (PsO: 8662 PY; PsA: 2125 PY). In PsO and PsA studies, pooled incidence rates of overall adverse events (AEs) were similar between guselkumab‐ and placebotreated patients. Rates of serious AEs, AEs leading to discontinuation, serious infections, malignancy, and major adverse cardiovascular events were low and generally similar between guselkumab‐ and placebo‐treated patients. Rates of safety events remained consistent through the long‐term reporting period for guselkumab‐treated patients (Table). No cases of Crohn's disease or ulcerative colitis were reported in guselkumab‐treated patients. No serum sickness‐like or anaphylactic reactions related to guselkumab were reported. No opportunistic infections were reported in any guselkumab‐treated PsO patient. Three cases of opportunistic infection were reported in pooled PsA studies (0.14/100 PY; all post‐W52 in DISCOVER‐2). No cases of active tuberculosis were reported across all studies. Conclusion In the most comprehensive analysis of guselkumab safety to date, AE rates in guselkumab‐treated patients were similar to those observed with placebo and were stable throughout long‐term follow‐up. (Table Presented).