RT Journal Article
SR Electronic
T1 Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study
JF RMD Open
JO RMD Open
FD EULAR
SP e002559
DO 10.1136/rmdopen-2022-002559
VO 9
IS 1
A1 Leng, Xiaomei
A1 Lin, Wei
A1 Liu, Shixue
A1 Kanik, Keith
A1 Wang, Cunshan
A1 Wan, Weiguo
A1 Jiang, Zhenyu
A1 Liu, Yi
A1 Liu, Shengyun
A1 Zhang, Zhuoli
A1 Zhang, Zhiyi
A1 Xu, Jian
A1 Tan, Wenfeng
A1 Hu, Jiankang
A1 Li, Jingyang
A1 Liu, Ju
A1 Gunay, Levent M.
A1 Dina, Oluwaseyi
A1 Kinch, Cassandra
A1 Zeng, Xiaofeng
YR 2023
UL http://rmdopen.bmj.com/content/9/1/e002559.abstract
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.Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.