Guselkumab for Psoriasis: A Critical Appraisal of Phase III Studies

Abstract

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.

Generalized pustular psoriasis—Dawn of a new era in targeted immunotherapy

“…In 2017, guselkumab, an IL23-p19 antibody, was approved for the treatment of PsO. 38 One multicentre, open-label, phase-3 study reports on 10 Japanese GPP patients treated with this monoclonal IL-23 antibody at week 0, 4 and then every 8 weeks. Five out of 10 patients showed successful treatment, defined as improvement of the Global Impression Score within the first week, consecutively leading to a 100% success rate in the patients who completed the study (8/10) at week 52, demonstrating efficacy without safety concerns.…”

“…In 2017, guselkumab, an IL23‐p19 antibody, was approved for the treatment of PsO 38 . One multicentre, open‐label, phase‐3 study reports on 10 Japanese GPP patients treated with this monoclonal IL‐23 antibody at week 0, 4 and then every 8 weeks.…”

Resposta terapêutica e tempo de sobrevida dos imunobiológicos em pacientes com psoríase moderada a grave

“…No estudo VOYAGE 1, ao comparar guselcumabe, adalimumabe e placebo na semana 16, obteve-se resposta PASI 90, respectivamente, em 73,3%, 49,7% e 2,9% dos pacientes Warren, 2018). Os efeitos colaterais incluem infecções do trato respiratório superior, cefaléia, reações no local da injeção e artralgia (Markham, 2017;Amin et al, 2017).…”