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 Xiaomei Leng
A1 Wei Lin
A1 Shixue Liu
A1 Keith Kanik
A1 Cunshan Wang
A1 Weiguo Wan
A1 Zhenyu Jiang
A1 Yi Liu
A1 Shengyun Liu
A1 Zhuoli Zhang
A1 Zhiyi Zhang
A1 Jian Xu
A1 Wenfeng Tan
A1 Jiankang Hu
A1 Jingyang Li
A1 Ju Liu
A1 Levent M. Gunay
A1 Oluwaseyi Dina
A1 Cassandra Kinch
A1 Xiaofeng Zeng
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.