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

7 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)1-9
Number of pages9
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2017 Nov 10

Fingerprint

Rheumatoid Arthritis
Safety
Antirheumatic Agents
Methotrexate
baricitinib
Placebos
Population
Herpes Zoster
Randomized Controlled Trials
Tumor Necrosis Factor-alpha
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Rheumatology

Cite this

Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis : Subgroup analyses of four multinational phase 3 randomized trials. / Tanaka, Yoshiya; Atsumi, Tatsuya; Amano, Koichi; Harigai, Masayoshi; Ishii, Taeko; Kawaguchi, Osamu; Rooney, Terence P.; Akashi, Naotsugu; Takeuchi, Tsutomu.

In: Modern Rheumatology, 10.11.2017, p. 1-9.

Research output: Contribution to journalArticle

Tanaka, Yoshiya ; Atsumi, Tatsuya ; Amano, Koichi ; Harigai, Masayoshi ; Ishii, Taeko ; Kawaguchi, Osamu ; Rooney, Terence P. ; Akashi, Naotsugu ; Takeuchi, Tsutomu. / Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis : Subgroup analyses of four multinational phase 3 randomized trials. In: Modern Rheumatology. 2017 ; pp. 1-9.
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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.",
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