%0 Journal Article %A Tanaka, Yoshiya %A Atsumi, Tatsuya %A Amano, Koichi %A Harigai, Masayoshi %A Ishii, Taeko %A Kawaguchi, Osamu %A Rooney, Terence P. %A Akashi, Naotsugu %A Takeuchi, Tsutomu %D 2017 %T Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials %U https://tandf.figshare.com/articles/journal_contribution/Efficacy_and_safety_of_baricitinib_in_Japanese_patients_with_rheumatoid_arthritis_Subgroup_analyses_of_four_multinational_phase_3_randomized_trials/5598076 %R 10.6084/m9.figshare.5598076.v1 %2 https://ndownloader.figshare.com/files/9741688 %K Baricitinib %K Janus kinase (JAK) %K Japanese %K phase 3 clinical trials %K rheumatoid arthritis %X

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.

%I Taylor & Francis