Abstract:

Li Chengrang*, Yang Xueyuan, Gu Jun, Hao Fei, Zheng Min, Guo Zaipei, Zheng Qingshan. *Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China Corresponding author: Yang Xueyuan, Email: yangxueyuan@medmail.com.cn 【Abstract】 Objective To evaluate the safety and efficacy of a domestic recombinant human tumor necrosis factor receptor type Ⅱ- IgG Fc fusion protein （rhTNFR-Fc） for the treatment of moderate to severe psoriasis vulgaris. Methods A multicenter, randomized, double blind, parallel-group, positive drug-controlled clinical trial was conducted. According to random numbers generated by a hierarchical segmentation method using the SAS 9.2 software, patients with moderate to severe psoriasis vulgaris were randomly divided into two groups to be injected with two kinds of domestic rhTNFR-Fc under the trade names of Anbainuo （test group） and Yisaipu （control group） respectively at a dose of 25 mg twice a week for 12 consecutive weeks. The primary endpoint was the proportion of patients achieving a 50%, 75% and 90% reduction in psoriasis area and severity index （PASI50, PASI75 and PASI90） at week 2, 6 and 12 after initiation of the treatment. Adverse reactions were also recorded. Statistical analysis was carried out by using the chi-square test, Fisher′s exact test, two-sample t-test, and noninferiority trials with the software SAS 9.2. Results A total of 180 patients were enrolled in this study from 5 centers, and 174 completed this trial, of whom, 88 were assigned to the test group and 86 to the control group. Analysis of the full analysis set （FAS） revealed no significant differences in PASI50 （75.6% （68/90） vs. 82.2% （74/90）, P > 0.05） or PASI75 （51.1% （46/90） vs. 50.0% （45/90）, P > 0.05） between the test group and control group, but a significant increase in PASI90 in the test group compared with the control group （30.0% （27/90） vs.16.7% （15/90）, χ2 = 4.472, P < 0.05） at week 12. Drug-related adverse reactions included elevation of transaminases, leukopenia, upper respiratory infections, injection-site reactions, abnormalities in urine routine test and purified protein derivative （PPD） skin test results, etc. There was no significant difference between the two groups in the incidence rate of adverse reactions （χ2 = 0.188, P > 0.05）, most of which were mild, and subsided spontaneously or after appropriate treatment. Conclusion The domestic rhTNFR-Fc （trade name: Anbainuo） 25 mg twice a week for 12 weeks is effective and safe for the treatment of moderate to severe psoriasis vulgaris.