Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: An open-label, long-term extension study

Hisashi Yamanaka, Yoshiya Tanaka, Tsutomu Takeuchi, Naonobu Sugiyama, Hirotoshi Yuasa, Shigeyuki Toyoizumi, Yosuke Morishima, Tomohiro Hirose, Samuel Zwillich

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Here, tofacitinib safety and efficacy data from a long-term extension study in Japanese patients are presented. Methods: Study A3921041 was a multi-centre, open-label, long-term extension study that included Japanese patients who had participated in a prior Phase 2 or Phase 3 study of tofacitinib as monotherapy or with background methotrexate. Patients received tofacitinib 5 mg twice daily (BID) or tofacitinib 10 mg BID. Dose adjustment of tofacitinib during treatment period, and concomitant usage of disease-modifying antirheumatic drugs including methotrexate after week 12 were permitted. Primary endpoints were adverse events, laboratory parameters and vital signs. Secondary efficacy endpoints included American College of Rheumatology (ACR)20/50/70 response rates, Disease Activity Score (DAS)28-4(erythrocyte sedimentation rate (ESR))

Original languageEnglish
JournalArthritis Research and Therapy
DOIs
Publication statusAccepted/In press - 2016 Jan 28

Keywords

  • Japanese
  • Long-term extension
  • Rheumatoid arthritis
  • Tofacitinib

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

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