Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment
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Le résumé fourni par la source
BACKGROUND: Monoclonal antibodies to interleukin (IL)-17 have shown strong efficacy in patients with psoriasis. Izokibep is a unique IL-17A inhibitor with a small molecular size and favourable distribution to sites of inflammation. OBJECTIVES: To evaluate the dose response, efficacy and safety of izokibep in patients with plaque psoriasis. METHODS: In this double-blind, randomized, phase II dose-finding study (AFFIRM-35) in adults with moderate-to-severe plaque psoriasis and inadequate response to two or more standard therapies, patients were randomized (1:1:1:1:1) to placebo or izokibep 2, 20, 80 or 160 mg every 2 weeks for 12 weeks. During the remainder of the 52-week core study, patients given placebo were switched to izokibep 80 mg, and dosing intervals were adapted based on Psoriasis Area and Severity Index (PASI) scores for all patients. The core study was followed by two optional consecutive 1-year extension periods for a total duration of 3 years. The primary endpoint was a 90% reduction in PASI score (PASI 90) at week 12. Additional efficacy outcomes and adverse event (AE) rates were evaluated. RESULTS: In total, 109 patients were randomized [safety set, n = 108 (one exclusion criteria failure); full analysis set, n = 106]. At week 12, PASI 90 response rates were 0%, 5%, 19%, 71% and 59% for the placebo, 2-, 20-, 80- and 160-mg izokibep groups, respectively. Rapid dose-dependent improvements were also observed across other efficacy outcomes. During the placebo-controlled period, AEs in the izokibep groups were similar to placebo except for mild injection site reactions. AEs were generally mild to moderate and the drug was well tolerated. Izokibep maintained efficacy at the higher dosage groups for up to 3 years, with no new safety signals. CONCLUSIONS: Data from this phase II study indicate that izokibep is well tolerated and efficacious in the treatment of plaque psoriasis. Higher doses or more frequent dosing could be explored to further enhance response rates.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment
- Date Crossref
- 12/09/2023
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University Hospital Schleswig-Holstein Department of Dermatology pays non établi dans la noticeÉtablissement de santé
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University of Lübeck pays non établi dans la noticeUniversité ou école supérieure
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Johannes Gutenberg University Mainz pays non établi dans la noticeUniversité ou école supérieure
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University Medical Center of the Johannes Gutenberg University Mainz pays non établi dans la noticeÉtablissement de santé
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Rosenpark Klinik pays non établi dans la noticeÉtablissement de santé
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Zahnklinik Bochum pays non établi dans la noticeÉtablissement de santé
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Roth and Rau (Germany) pays non établi dans la noticeEntreprise
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Affibody (Sweden) pays non établi dans la noticeEntreprise
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Uppsala University Department of Immunology pays non établi dans la noticeUniversité ou école supérieure
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Medical University Center Department of Dermatology pays non établi dans la noticeUniversité ou école supérieure
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Germany Private Practice for Dermatology pays non établi dans la noticeInstitution
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toclinco GmbH pays non établi dans la noticeEntreprise
Department of Dermatology — University Hospital Schleswig-Holstein, University of Lübeck et Johannes Gutenberg University Mainz, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.