Guselkumab for psoriasis: a critical appraisal of Phase III studies

Biologic therapies have raised the frontiers of accepted treatment efficacy for severe psoriasis. Guselkumab is an IgG1 monoclonal antibody that binds to the p19 subunit and inhibits IL-23. In three Phase III randomized, active comparator and placebo controlled trials, guselkumab demonstrated superior efficacy and a comparable safety profile when assessed against adalimumab and ustekinumab. Critical appraisal highlighted uncertainties over risk of bias from missing details in the trial publications that would be overcome with the provision of accompanying trial protocols, as well as the need for a head-to-head trial against an IL-17 inhibitor. Overall, guselkumab is a promising addition to the biologic options for psoriasis due to its high efficacy, safe profile, low immunogenicity and efficacy in ustekinumab and adalimumab nonresponders.