A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis - 14/06/22
Abstract |
Background |
Vunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.
Objective |
To evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.
Methods |
In this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.
Results |
At week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.
Limitations |
The study was relatively short in duration and included no active control.
Conclusion |
Vunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.
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 : ADA, AE, BSA, DLQI, IL, NAB, PASI, PGA
Plan
| Drs Zhang, Yan, and Diao contributed equally to this article. |
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| Funding sources: Supported by Jiangsu Hengrui Pharmaceuticals Co, Ltd (formerly Jiangsu Hengrui Medicine Co, Ltd). |
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| IRB approval status: Reviewed and approved by all trial centers (Huashan Hospital Affiliated to Fudan University, Shanghai, China; Peking University Third Hospital, Beijing, China; Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; The First Affiliated Hospital of Anhui Medical University, Hefei, China; Xiangya Hospital, Central South University, Changsha, China; Renmin Hospital of Wuhan University, Hubei General Hospital, Wuhan, China; Changhai Hospital of Shanghai, Shanghai, China; Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China; The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; The 1st Hospital of China Medical University, Shenyang, China; Sinclair Dermatology, East Melbourne, Australia; Veracity Clinical Research Pty Ltd, Woolloongabba, Australia; Westmead Hospital, Westmead, Australia; St George Dermatology and Skin Cancer Centre, Kogarah, Australia; Revival Research, Doral, Florida; Elite Clinical Studies, LLC, Phoenix, Arizona; Anaheim Clinical Trials, Anaheim, California; Indago Research and Health Center-Emergency Medicine, Hialeah, Florida; Great Lakes Clinical Trials LLC, Chicago, Illinois; Clinical Partners, LLC, Johnston, Rhode Island; Center for Clinical Studies, Houston, Texas; Center for Clinical Studies, Webster, Texas). |
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| Reprints not available from the authors. |
Vol 87 - N° 1
P. 95-102 - juillet 2022 Retour au numéro
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