Guselkumab for the Treatment of Psoriasis: A Review of Phase III Trials

Introduction: Interleukin (IL)-23 inhibitors are a new class of biologics currently undergoing clinical trials for the treatment of moderate-to-severe psoriasis. Phase III studies of guselkumab, an IL-23 receptor monoclonal antibody, are currently underway.

Methods: We summarize the available phase III results to date, establishing the efficacy and safety of guselkumab in patients with moderate-to-severe plaque psoriasis.

Results: Currently, there are available data of up to 48 weeks from two Phase III, multicenter, randomized, double-blind, placebo- and comparator-controlled clinical trials, VOYAGE 1 and VOYAGE 2. At week 16, the proportion of patients attaining at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) was 73.3% in VOYAGE 1 and 70.0% in VOYAGE 2. Guselkumab remained efficacious through 48 weeks of treatment. Guselkumab maintained a satisfactory safety profile with the most frequently reported adverse events being nasopharyngitis, headache, and upper respiratory tract infection.

Conclusion: Phase III trials of Guselkumab suggest a favorable efficacy and safety profile of this novel drug. Although further studies are needed to assess long-term safety and efficacy, based on the results to date, guselkumab appears to be a promising therapeutic option for moderate-to-severe plaque-type psoriasis.