PMID- 36720560 OWN - NLM STAT- MEDLINE DCOM- 20230202 LR - 20230217 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 9 IP - 1 DP - 2023 Jan TI - Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study. LID - 10.1136/rmdopen-2022-002559 [doi] LID - e002559 AB - OBJECTIVES: 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. METHODS: 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). PRIMARY ENDPOINT: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION NUMBER: NCT03486457. CI - (c) 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. FAU - Leng, Xiaomei AU - Leng X AD - 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. FAU - Lin, Wei AU - Lin W AD - Pfizer Inc, Beijing, China. FAU - Liu, Shixue AU - Liu S AD - Pfizer Inc, Shanghai, China. FAU - Kanik, Keith AU - Kanik K AD - Pfizer Inc, Groton, Connecticut, USA. FAU - Wang, Cunshan AU - Wang C AD - Pfizer Inc, Groton, Connecticut, USA. FAU - Wan, Weiguo AU - Wan W AD - Huashan Hospital, Fudan University, Shanghai, China. FAU - Jiang, Zhenyu AU - Jiang Z AD - First Affiliated Hospital of Jilin University, Changchun, China. FAU - Liu, Yi AU - Liu Y AD - Sichuan Huaxi Hospital, Sichuan, China. FAU - Liu, Shengyun AU - Liu S AD - First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Zhang, Zhuoli AU - Zhang Z AUID- ORCID: 0000-0001-7219-9141 AD - Peking University First Hospital, Beijing, China. FAU - Zhang, Zhiyi AU - Zhang Z AUID- ORCID: 0000-0003-3951-3834 AD - First Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Xu, Jian AU - Xu J AD - First Affiliated Hospital of Kunming Medical University, Kunming, China. FAU - Tan, Wenfeng AU - Tan W AD - Jiangsu Province Hospital, Nanjing, China. FAU - Hu, Jiankang AU - Hu J AD - Pingxiang People's Hospital, Pingxiang, China. FAU - Li, Jingyang AU - Li J AD - Zhuzhou Central Hospital, Zhuzhou, China. FAU - Liu, Ju AU - Liu J AD - Jiujiang No. 1 People's Hospital, Jiujiang, China. FAU - Gunay, Levent M AU - Gunay LM AD - Pfizer Inc, Istanbul, Turkey. FAU - Dina, Oluwaseyi AU - Dina O AD - Pfizer Inc, New York, New York, USA. FAU - Kinch, Cassandra AU - Kinch C AUID- ORCID: 0000-0002-2712-1668 AD - Pfizer Canada ULC, Kirkland, Quebec, Canada. FAU - Zeng, Xiaofeng AU - Zeng X AD - 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 xiaofeng.zeng@cstar.org.cn. LA - eng SI - ClinicalTrials.gov/NCT03486457 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 87LA6FU830 (tofacitinib) RN - 0 (Piperidines) SB - IM MH - Humans MH - *Arthritis, Psoriatic/drug therapy MH - East Asian People MH - Piperidines/adverse effects MH - *Enthesopathy MH - *Herpes Zoster PMC - PMC9890804 OTO - NOTNLM OT - Arthritis OT - Arthritis, Psoriatic OT - Inflammation COIS- Competing interests: XZ, XL, WW, ZJ, YL, SL, ZhuZ, ZhiZ, JX, WT, JH, JiL and JuL declare no conflicts of interests. WL is a former employee of Pfizer Inc. SL, KK, CW, LMG, CK and OD are current employees and shareholders of Pfizer Inc. EDAT- 2023/02/01 06:00 MHDA- 2023/02/03 06:00 PMCR- 2023/01/31 CRDT- 2023/01/31 21:02 PHST- 2022/07/05 00:00 [received] PHST- 2022/10/17 00:00 [accepted] PHST- 2023/01/31 21:02 [entrez] PHST- 2023/02/01 06:00 [pubmed] PHST- 2023/02/03 06:00 [medline] PHST- 2023/01/31 00:00 [pmc-release] AID - rmdopen-2022-002559 [pii] AID - 10.1136/rmdopen-2022-002559 [doi] PST - ppublish SO - RMD Open. 2023 Jan;9(1):e002559. doi: 10.1136/rmdopen-2022-002559.