Treating Moderate-to-Severe Plaque Psoriasis With Guselkumab: A Review of Phase II and Phase III Trials.

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.