• Chinese medical journal · Nov 2020

    Randomized Controlled Trial

    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, and Jian-Zhong Zhang.
    • Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.
    • Chin. Med. J. 2020 Nov 9; 133 (24): 2905-2909.

    BackgroundBenvitimod 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.MethodsWe 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.ResultsThe 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.ConclusionDuring this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.Trial RegistrationChinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.Copyright © 2020 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

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