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  3. 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

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

  • J Am Acad Dermatol. 2022 Jul;87(1):95-102. doi: 10.1016/j.jaad.2022.01.005.
Chunlei Zhang 1,  Kexiang Yan 2,  Qingchun Diao 3,  Qing Guo 4,  Hongzhong Jin 5,  Sen Yang 6,  Xiang Chen 7,  Tiechi Lei 8,  Jianhua Wu 9,  Hong Yu 10,  Min Zheng 11,  Xinghua Gao 12,  Rodney Sinclair 13,  Yi Zhu 14,  Qian Xu 14,  Jinhua Xu 15
Affiliations

Affiliations

  • 1 Department of Dermatology, Peking University Third Hospital, Beijing, People's Republic of China.
  • 2 Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China.
  • 3 Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, People's Republic of China.
  • 4 Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.
  • 5 Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
  • 6 Institute of Dermatology and Department of Dermatology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
  • 7 Department of Dermatology, Xiangya Hospital, Central South University, Changsha, People's Republic of China.
  • 8 Department of Dermatology, Renmin Hospital of Wuhan University/Hubei General Hospital, Wuhan, People's Republic of China.
  • 9 Department of Dermatology, Changhai Hospital of Shanghai, Shanghai, People's Republic of China.
  • 10 Department of Dermatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, People's Republic of China.
  • 11 Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, People's Republic of China.
  • 12 Department of Dermatology, The 1st Hospital of China Medical University, Shenyang, People's Republic of China.
  • 13 Sinclair Dermatology, East Melbourne, Australia.
  • 14 Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, People's Republic of China.
  • 15 Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China. Electronic address: [email protected].
PMID: 35026342 DOI: 10.1016/j.jaad.2022.01.005
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.

Keywords

anti–IL-17A; biologics; clinical trial; plaque psoriasis; psoriasis area and severity index; quality of life.

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