A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis.

Lin Cai; Gen-hui Chen; Qian-jin LU; Min Zheng; Yu-zhen LI; Jin Chen; Jie Zheng; Fu-ren Zhang; Jian-bin YU; Sen Yang; Fu-qiu LI; Sheng-xiang Xiao; Qiu-ning Sun; Jin-hua XU; Xing-hua Gao; Hong Fang; Tian-wen Gao; Fei Hao; Quan-zhong Liu; Ya-ting TU; Ruo-yu LI; Bao-xi Wang; Dan-qi Deng; Qing-shan Zheng; Hong-xia Liu; Jian-zhong Zhang

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A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis.

Author: Lin CAI ¹ ; Gen-Hui CHEN ² ; Qian-Jin LU ³ ; Min ZHENG ⁴ ; Yu-Zhen LI ⁵ ; Jin CHEN ⁶ ; Jie ZHENG ⁷ ; Fu-Ren ZHANG ⁸ ; Jian-Bin YU ⁹ ; Sen YANG ¹⁰ ; Fu-Qiu LI ¹¹ ; Sheng-Xiang XIAO ¹² ; Qiu-Ning SUN ¹³ ; Jin-Hua XU ¹⁴ ; Xing-Hua GAO ¹⁵ ; Hong FANG ¹⁶ ; Tian-Wen GAO ¹⁷ ; Fei HAO ¹⁸ ; Quan-Zhong LIU ¹⁹ ; Ya-Ting TU ²⁰ ; Ruo-Yu LI ²¹ ; Bao-Xi WANG ²² ; Dan-Qi DENG ²³ ; Qing-Shan ZHENG ²⁴ ; Hong-Xia LIU ²⁴ ; Jian-Zhong ZHANG ¹
Author Information

1. Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.
2. Beijing Wenfeng Tianji Pharma Ltd., Beijing 100044, China.
3. Department of Dermatology, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China.
4. Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
5. Department of Dermatology, Harbin Medical University Second Hospital, Harbin, Heilongjiang 150001, China.
6. Department of Dermatology, Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072, China.
7. Department of Dermatology, Shanghai JiaoTong University School of Medicine Ruijin Hospital, Shanghai 213002, China.
8. Shandong Provinical Institute of Dermatology and Venereology, Jinan, Shandong 250022, China.
9. Department of Dermatology, The First Affiliated Hospital, Zhengzhou University, Zhengzhou, Henan 450052, China.
10. Department of Dermatology, The First Affiliated Hospital, Anhui Medical University, Hefei, Anhui 230022, China.
11. Department of Dermatology, The Second Hospital of Jilin University, Changchun, Jilin 130041, China.
12. Department of Dermatology, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China.
13. Department of Dermatology, Peking Union Medical College Hospital, Beijing 100730, China.
14. Department of Dermatology, Fudan University Huashan Hospital, Shanghai 200041, China.
15. Department of Dermatology, The First Hospital of China Medical University, Shenyang, Liaoning 110001, China.
16. Department of Dermatology, The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang 310006, China.
17. Department of Dermatology, Xijing Hospital, Air Force Medical University of People's Liberation Army, Xi'an, Shaanxi 710032, China.
18. Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing 400038, China.
19. Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China.
20. Department of Dermatology, Wuhan Union Hospital, Wuhan, Hubei 430022, China.
21. Department of Dermatology, Peking University First Hospital, Beijing 100034, China.
22. Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, Jiangsu 210042, China.
23. Department of Dermatology, The Second Affiliated Hospital, Kunming Medical University, Kunming, Yunnan 650101, China.
24. Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Publication Type:Randomized Controlled Trial
MeSH: Double-Blind Method; Follow-Up Studies; Humans; Ointments; Psoriasis/drug therapy*; Resorcinols; Severity of Illness Index; Stilbenes; Treatment Outcome
From: Chinese Medical Journal 2020;133(24):2905-2909
CountryChina
Language:English
Abstract: BACKGROUND:Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.
METHODS:We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.
RESULTS:The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.
CONCLUSION:During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.
TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.