| Autor: |
Xiaomei Leng, Wei Lin, Shixue Liu, Keith Kanik, Cunshan Wang, Weiguo Wan, Zhenyu Jiang, Yi Liu, Shengyun Liu, Zhuoli Zhang, Zhiyi Zhang, Jian Xu, Wenfeng Tan, Jiankang Hu, Jingyang Li, Ju Liu, Levent M. Gunay, Oluwaseyi Dina, Cassandra Kinch, Xiaofeng Zeng |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
RMD Open. 9:e002559 |
| ISSN: |
2056-5933 |
| Popis: |
ObjectivesEfficacy 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.MethodsPatients 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.ResultsThe primary endpoint was met (tofacitinib 5 mg twice daily, 38.2%; placebo, 5.9%; pConclusionIn 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 numberNCT03486457. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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