This article will review the available phase II and phase III guselkumab clinical trial data.
Book Title: Treating Moderate-to-Severe Plaque Psoriasis With Guselkumab: A Review of Phase II and Phase III Trials
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Objective: Guselkumab, an anti-interleukin-23 monoclonal antibody was recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. This article will review the available phase II and phase III guselkumab clinical trial data. Data Sources: A PubMed search was conducted using the terms guselkumab, interleukin-23, psoriasis, adalimumab, and ustekinumab (January 2014 to August 2017). Study Selection and Data Extraction: Articles detailing the results of phase II and phase III clinical trials were selected for review. Data Synthesis: In 1 phase II and 2 phase III clinical trials, guselkumab was more effective than adalimumab and placebo in reducing Physician’s Global Assessment and Investigator Global Assessment (IGA) scores in those with moderate-to-severe plaque psoriasis. In a separate phase III trial, transitioning to guselkumab treatment was more effective than continued ustekinumab use in reducing IGA scores in those who were minimally responsive to ustekinumab (P = 0.001). Trial results did not reveal specific patterns in adverse event (AE) incidence; the most commonly reported AEs were nasopharyngitis, headache, and upper-respiratory-tract infections. No increased incidence of malignancy, tuberculosis, or serious infections were observed with the use of guselkumab. Conclusions: 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. However, long-term safety data are lacking.
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