Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf. 2023 doi:10.1007/s40264-023-01361-w. Epub ahead of print

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

Psoriatic disease impacts the physical, emotional, and social well-being of patients and often requires long-term treatment­­. As such patients will weigh the efficacy of treatment they take against potential adverse effects. Comorbidities, demographic characteristics, concomitant medications, and prior treatment history are all factors that will influence this balance. Data from the studies analysed showed a consistent, favourable safety profile for guselkumab in treating patients with psoriasis or psoriatic arthritis in long-term follow ups for up to five years.