Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial - 18/12/24
Abstract |
Background |
Vunakizumab, a novel anti-interleukin-17A antibody, has shown promising efficacy for moderate-to-severe plaque psoriasis in a phase 2 trial.
Objective |
We conducted a double-blind, randomized phase 3 trial (NCT04839016) to further evaluate vunakizumab in this population.
Methods |
Six hundred ninety subjects were randomized (2:1) to receive vunakizumab 240 mg or placebo at weeks 0, 2, 4, and 8. At week 12, subjects on placebo were switched to vunakizumab 240 mg (weeks 12, 14, 16, and every 4 weeks thereafter). The co-primary endpoints were ≥90% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 90) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.
Results |
At week 12, the vunakizumab group showed higher PASI 90 (76.8% vs 0.9%) and sPGA 0/1 (71.8% vs 0.4%) response rates, as well as higher PASI 75 (93.6% vs 4.0%), PASI 100 (36.6% vs 0.0%), and sPGA 0 (38.2% vs 0.0%) response rates (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 with continuous vunakizumab. Possible treatment-related serious adverse events occurred in 0.9% of vunakizumab-treated subjects.
Limitations |
Chinese subjects only; no active comparator.
Conclusion |
Vunakizumab demonstrated robust clinical response at week 12 and through week 52, with good tolerability in moderate-to-severe plaque psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : anti-IL-17A, biologics, clinical trial, plaque psoriasis, Psoriasis Area and Severity Index, quality of life
Abbreviations used : AE, DLQI, DLQI 0/1, IL-17, IL-23, PASI, PASI 75, PASI 90, PASI 100, sPGA, sPGA 0/1
Plan
Drs Yan and Li, and Author Bi contributed equally to this article. |
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Funding sources: This study was funded by Jiangsu Hengrui Pharmaceuticals Co, Ltd. |
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The study has been presented in part at the European Academy of Dermatology and Venereology Congress in Berlin in 2023. |
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Patient consent: Not applicable. |
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IRB approval status: The study protocol was reviewed and approved by all trial centers. |
Vol 92 - N° 1
P. 92-99 - janvier 2025 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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