Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS)

Thaci D, Pinter A, Sebastian M, Termeer C, Sticherling M, Gerdes S, Wegner S, Krampe S, Bartz H, Rausch C, Mensch A, Eyerich K (2020)

Publication Type: Journal article

Publication year: 2020

Journal

British Journal of Dermatology Wiley-Blackwell

DOI: 10.1111/bjd.18696

Abstract

Background Guselkumab, a fully human interleukin-23 antibody, is approved for systemic treatment of patients with moderate-to-severe plaque psoriasis. Objectives To compare the efficacy and safety of guselkumab with those of fumaric acid esters (FAE) in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment. Methods Eligible patients were randomized to this multicentre, randomized, open-label, assessor-blinded, active-comparator-controlled phase IIIb study to receive guselkumab 100 mg by subcutaneous injection or oral FAE according to local label guidelines. Results Through week 24, 56 of 60 patients completed guselkumab treatment and 36 of 59 completed FAE treatment. The primary endpoint (proportion of patients with >= 90% improvement from their baseline Psoriasis Area and Severity Index; PASI 90 response) was achieved by significantly more patients receiving guselkumab than FAE at week 24 (82% vs. 14%, P < 0 center dot 001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0 center dot 001) and Dermatology Life Quality Index score of 0 or 1 (no effect at all on the patient's quality of life; 62% vs. 17%, P < 0 center dot 001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0 center dot 001). The incidence of adverse events was lower with guselkumab than with FAE (73% vs. 98%). Overall, 28% of patients on FAE discontinued due to an adverse event, compared with none receiving guselkumab. No new safety findings were observed for guselkumab. Conclusions Guselkumab demonstrated superiority over FAE in systemic-treatment-naive patients with moderate-to-severe plaque psoriasis through 24 weeks. What's already known about this topic?

Authors with CRIS profile

Michael Sticherling Professur für Dermatologie

Involved external institutions

Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Janssen-Cilag GmbH DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Universität zu Lübeck DE Germany (DE) Technische Universität München (TUM) DE Germany (DE)

How to cite

APA:

Thaci, D., Pinter, A., Sebastian, M., Termeer, C., Sticherling, M., Gerdes, S.,... Eyerich, K. (2020). Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS). British Journal of Dermatology. https://doi.org/10.1111/bjd.18696

MLA:

Thaci, D., et al. "Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS)." British Journal of Dermatology (2020).

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