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).

Thaҫi, D; Pinter, A; Sebastian, M; Termeer, C; Sticherling, M; Gerdes, S; Wegner, S; Krampe, S; Bartz, H; Rausch, C; Mensch, A; Eyerich, K

doi:10.1111/bjd.18696

Benutzer: Gast

journal article

Titel:: 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).
Dokumenttyp:: Journal Article
Autor(en):: Thaҫi, D; Pinter, A; Sebastian, M; Termeer, C; Sticherling, M; Gerdes, S; Wegner, S; Krampe, S; Bartz, H; Rausch, C; Mensch, A; Eyerich, K
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 < 0·001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0·001) 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 < 0·001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0·001). 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.
Zeitschriftentitel:: Br J Dermatol
Jahr:: 2020
Band / Volume:: 183
Heft / Issue:: 2
Seitenangaben Beitrag:: 265-275
Volltext / DOI:: doi:10.1111/bjd.18696
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/31705526
Print-ISSN:: 0007-0963
TUM Einrichtung:: Professur für Experimentelle Dermato-Immunologie (Prof. Eyerich)
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