Safety of guselkumab in patients with psoriasis treated through 100 weeks

Abstract

Psoriasis is a long‐term skin condition that causes extra skin cells to form scaly red plaques that can be itchy and painful. Guselkumab is a biologic drug that blocks a molecule linked to psoriasis, interleukin‐23, and is approved for the treatment of psoriasis. Two large clinical trials (called VOYAGE 1 and VOYAGE 2) showed that guselkumab was more effective than adalimumab (another biologic treatment for psoriasis) and was safe to use for a year. Because psoriasis is a disease which reoccurs, understanding the safety of newer treatments over long periods of time is important. Therefore, VOYAGE 1 and VOYAGE 2 were extended to five years. The study designs were the same, with three treatment groups, guselkumab, placebo followed by guselkumab, or adalimumab, for the first six months. Then, depending on the study, patients were switched from one treatment to the other at different times during the next year and/or remained on the same treatment through two years. Rates of safety events, including common adverse events (unwanted side effects), serious adverse events, serious infections, malignancies (cancers), and major adverse cardiovascular events were calculated across studies to assess the safety of each treatment. Because of the complicated study design, data were compared in different ways: (1) one year versus two years of guselkumab treatment, and (2) before versus after transition from adalimumab to guselkumab. Results showed that cumulative safety event rates after two years of guselkumab treatment were generally consistent with those after one year. No safety concerns were found for adalimumab‐treated patients after they switched to guselkumab. In summary, guselkumab is safe for both longer‐term treatment for up to two years and after transition from adalimumab in patients with psoriasis.