Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials

Yoshiya Tanaka, Tatsuya Atsumi, Koichi Amano, Masayoshi Harigai, Taeko Ishii, Osamu Kawaguchi, Terence P. Rooney, Naotsugu Akashi, Tsutomu Takeuchi

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objectives: To evaluate efficacy/safety of baricitinib for rheumatoid arthritis (RA) in Japanese subpopulations from four phase 3 studies, and assess whether results in these subpopulations are consistent with the overall study populations. Methods: Subgroup analyses (394 patients) of four phase 3 randomized controlled trials: RA-BEGIN [no or limited treatment with disease-modifying antirheumatic drugs (DMARDs)], RA-BEAM [inadequate response (IR) to methotrexate], RA-BUILD [IR to conventional synthetic DMARDs (csDMARDs)], and RA-BEACON (IR to tumor necrosis factor inhibitors receiving csDMARDs). Results: For American College of Rheumatology 20% improvement (ACR20) response rate, Japanese patients receiving baricitinib 4-mg showed similar improvement compared to methotrexate at Week 24 (72 versus 69%; RA-BEGIN), and greater improvement compared with placebo at Week 12 (67 versus 34%; RA-BEAM). Japanese patients receiving baricitinib 4-mg also showed greater improvement compared with placebo at Week 12 in RA-BUILD and RA-BEACON. Across all studies, baricitinib was well-tolerated, with no deaths and one malignancy. In RA-BEGIN and RA-BEAM, herpes zoster rates were higher for Japanese patients than for overall populations; all events were mild/moderate. Conclusion: Data for baricitinib, with/without methotrexate, in Japanese subpopulations across all stages of the RA treatment continuum accord with the efficacy/safety profile in overall study populations. Baricitinib appears to be similarly effective in Japanese patients.

Original languageEnglish
Pages (from-to)583-591
Number of pages9
JournalModern rheumatology
Volume28
Issue number4
DOIs
Publication statusPublished - 2018 Jul 4

Keywords

  • Baricitinib
  • Janus kinase (JAK)
  • Japanese
  • phase 3 clinical trials
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

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