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Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial - 18/12/24

Doi : 10.1016/j.jaad.2024.09.031 
Kexiang Yan, MD, PhD a, Fuqiu Li, PhD b, Xiaodong Bi, MM c, Ling Han, MD, PhD a, Zhenghua Zhang, MD, PhD a, Rixin Chen, MM c, Yuye Li, PhD d, Litao Zhang, PhD e, Xiaohua Wang, MM f, Linfeng Li, PhD g, Jianyun Lu, PhD h, Ai'e Xu, MB i, Sen Yang, PhD j, Yan Lu, MD k, Jianfang Sun, PhD l, Zhiming Li, MD m, Xiaohong Zhu, MB n, Meiying Jiang, MB o, Siping Zhang, MM p, Wenqing Wang, MD q, Yanling Li, MD r, Zudong Meng, MD s, Hongyi Li, MD t, Kuanhou Mou, MD u, Xiuping Han, PhD v, Shanshan Li, MD w, Aijun Chen, MD x, Xin Li, MD, PhD y, Donghua Liu, PhD z, Chunlei Zhang, MD, PhD aa, Chao Ji, PhD bb, Yu Wang, PhD cc, Hao Cheng, PhD dd, Xiaojing Cui, PhD ee, Xiaoyan Yao, MD ee, Xiaoyan Bai, MD ee, Guangchao Dong, MD ee, Jinhua Xu, MD a,
a Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, China 
b Department of Dermatology, The Second Hospital of Jilin University, Changchun, China 
c Department of Dermatology, Nanyang First People's Hospital, Nanyang, China 
d Department of Dermatoloogy, The First Affiliated Hospital of Kunming Medical University, Kunming, China 
e Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China 
f Department of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou, China 
g Department of Dermatology, Beijing Friendship Hospital, Beijing, China 
h Department of Dermatology, Third Xiangya Hospital, Central South University, Changsha, China 
i Department of Dermatology, Hangzhou Third Hospital, Hangzhou, China 
j Institute of Dermatology/Department of Dermatology, Anhui Medical University First Affiliated Hospital, Hefei, China 
k Department of Dermatology, Jiangsu Province Hospital, Nanjing, China 
l Department of Pathology, Dermatology Hospital, Chinese Academy of Medical Sciences, Nanjing, China 
m Department of Dermatology and Venereology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China 
n Department of Dermatology, Wuxi Second People's Hospital, Wuxi, China 
o Department of Dermatology, The Second Affiliated Hospital of Nanchang University, Nanchang, China 
p Department of Dermatology, Anhui Provincial Hospital, Hefei, China 
q Department of Dermatology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China 
r Department of Dermatology, The Second Hospital of Hebei Medical University, Shijiazhuang, China 
s Department of Dermatology, Shiyan Renmin Hospital, Shiyan, China 
t Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China 
u Department of Dermatology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China 
v Department of Dermatology, Shengjing Hospital, China Medical University, Shenyang, China 
w Department of Dermatology, The First Hospital of Jilin University, Changchun, China 
x Department of Dermatology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China 
y Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China 
z Department of Dermatology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China 
aa Department of Dermatology, Peking University Third Hospital, Beijing, China 
bb Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China 
cc Department of Dermatology, The Affiliated Hospital of Guizhou Medical University, Guizhou, China 
dd Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China 
ee Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China 

Correspondence to: Jinhua Xu, MD, Department of Dermatology, Huashan Hospital Affiliated to Fudan University, No. 12 Middle Wulumuqi Rd, Shanghai, Shanghai 200040, China.Department of DermatologyHuashan Hospital Affiliated to Fudan UniversityNo. 12 Middle Wulumuqi RdShanghaiShanghai200040China

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.
 Funding sources: This study was funded by Jiangsu Hengrui Pharmaceuticals Co, Ltd.
 The study has been presented in part at the European Academy of Dermatology and Venereology Congress in Berlin in 2023.
 Patient consent: Not applicable.
 IRB approval status: The study protocol was reviewed and approved by all trial centers.


© 2024  Publié par Elsevier Masson SAS.
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