A review of available Phase 2 and 3 trial data shows that guselkumab appears to be a safe and effective treatment option for moderate-to-severe plaque psoriasis. Findings from the study were published in Annals of Pharmacotherapy.

Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets interleukin (IL)-23. For this review, researchers assessed a total of 4 trials, one Phase 2 and three Phase 3 trials. In the Phase 2 trial and two of the Phase 3 trials, guselkumab was found to be more effective in reducing Physician’s Global Assessment and Investigator Global Assessment (IGA) scores compared to adalimumab and placebo.  

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In the other Phase 3 trial, transitioning to guselkumab treatment was more effective than continuing ustekinumab in reducing IGA scores in those patients who were minimally responsive to ustekinumab (P=0.001). 

Nasopharyngitis, headache, and upper respiratory tract infections were found to be the most commonly reported adverse events; no specific patterns in adverse events were noted in these trials.

The authors acknowledged that their analysis is missing long-term safety data. However, from the 4 studies examined, they concluded that “Guselkumab appears to be a safe and effective option for the treatment of moderate-to-severe plaque psoriasis in patients who have been screened for susceptibility to infection and are candidates for systemic treatment or phototherapy.”

In July, the Food and Drug Administration approved guselkumab (Tremfya; Janssen Biotech) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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