Yoshiya Tanaka1, Tatsuya Atsumi2, Koichi Amano3, Masayoshi Harigai4, Taeko Ishii5, Osamu Kawaguchi5, Terence P Rooney6, Naotsugu Akashi5, Tsutomu Takeuchi7. 1. a First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Japan. 2. b Division of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine , Hokkaido University , Hokkaido , Japan. 3. c Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe , Japan. 4. d Department of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology , Tokyo Women's Medical University , Tokyo , Japan. 5. e Eli Lilly Japan K.K. , Kobe , Japan. 6. f Eli Lilly and Company , Indianapolis , IN , USA. 7. g Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
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 receivingbaricitinib 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 receivingbaricitinib 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.
RCT Entities:
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.
Authors: Kevin L Winthrop; Peter Nash; Kunihiro Yamaoka; Eduardo Mysler; Nasser Khan; Heidi S Camp; Yanna Song; Jessica L Suboticki; Jeffrey R Curtis Journal: Ann Rheum Dis Date: 2021-10-06 Impact factor: 19.103