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Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study

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机构： [1]Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China. [2]Pfizer Inc, Beijing, China. [3]Pfizer Inc, Shanghai, China. [4]Pfizer Inc, Groton, Connecticut, USA. [5]Huashan Hospital, Fudan University, Shanghai, China. [6]First Affiliated Hospital of Jilin University, Changchun, China. [7]Sichuan Huaxi Hospital, Sichuan, China. [8]First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [9]Peking University First Hospital, Beijing, China. [10]First Affiliated Hospital of Harbin Medical University, Harbin, China. [11]First Affiliated Hospital of Kunming Medical University, Kunming, China. [12]Jiangsu Province Hospital, Nanjing, China. [13]Pingxiang People's Hospital, Pingxiang, China. [14]Zhuzhou Central Hospital, Zhuzhou, China. [15]Jiujiang No. 1 People's Hospital, Jiujiang, China. [16]Pfizer Inc, Istanbul, Turkey. [17]Pfizer Inc, New York, New York, USA. [18]Pfizer Canada ULC, Kirkland, Quebec, Canada.

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Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, were evaluated in a 6-month, double-blind, phase 3 study in Chinese patients with active (polyarthritic) psoriatic arthritis (PsA) and inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug.Patients were randomised (2:1) to tofacitinib 5 mg twice daily (N=136) or placebo (N=68); switched to tofacitinib 5 mg twice daily after month (M)3 (blinded).American College of Rheumatology (ACR50) response at M3. Secondary endpoints (through M6) included: ACR20/50/70 response; change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI); ≥75% improvement in Psoriasis Area and Severity Index (PASI75) response, and enthesitis and dactylitis resolution. Safety was assessed throughout.The primary endpoint was met (tofacitinib 5 mg twice daily, 38.2%; placebo, 5.9%; p<0.0001). M3 ACR20/ACR70/PASI75 responses, and enthesitis and dactylitis resolution rates, were higher and HAQ-DI reduction was greater for tofacitinib 5 mg twice daily versus placebo. Incidence of adverse events (AEs)/serious AEs (M0-3): 68.4%/0%, tofacitinib 5 mg twice daily; 75.0%/4.4%, placebo. One death was reported with placebo→tofacitinib 5 mg twice daily (due to accident). One serious infection, non-serious herpes zoster, and lung cancer case each were reported with tofacitinib 5 mg twice daily; four serious infections and one non-serious herpes zoster case were reported with placebo→tofacitinib 5 mg twice daily (M0-6). No non-melanoma skin cancer, major adverse cardiovascular or thromboembolism events were reported.In Chinese patients with PsA, tofacitinib efficacy was greater than placebo (primary and secondary endpoints). Tofacitinib was well tolerated; safety outcomes were consistent with the established safety profile in PsA and other indications.NCT03486457.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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大类 | 2 区医学

小类 | 2 区风湿病学

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出版当年[2023]版：

Q1 RHEUMATOLOGY

最新[2023]版：

Q1 RHEUMATOLOGY

影响因子： 5.1 最新[2023版] 5 最新五年平均 5.1 出版当年[2023版] 5 出版当年五年平均 6.2 出版前一年[2022版]

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第一作者机构： [1]Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.

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