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

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.

Keywords:

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

Acknowledgements

The authors would like to thank the patients and investigators for their participation in the study.

Conflict of interest

Y.T. has received research grants from Mitsubishi Tanabe Pharma, Takeda Pharmaceutical Company, Daiichi Sankyo Company, Chugai Pharmaceutical Company, Bristol-Myers Squibb, MSD, Astellas Pharma, Abbvie, and Eisai Company, and has received speaking fees and/or honoraria from Abbvie, Chugai Pharmaceutical Company, Daiichi Sankyo Company, Bristol-Myers Squibb, Mitsubishi Tanabe Pharma, Astellas Pharma, Takeda Pharmaceutical Company, Pfizer, Teijin Pharma, Asahi Kasei Corporation, YL Biologics, Sanofi, Janssen, Eli Lilly and Company, and GlaxoSmithKline. T.A. has participated in consultancies and advisory panels for Pfizer, UCB Japan Co, GlaxoSmithKline K.K., Integrated Development Associates, Daiichi Sankyo Company, Eli Lilly Japan K.K., and Sanofi K.K. K.A. has participated in consultancies and advisory panels for Pfizer Japan Inc., and is a member of the baricitinib advisory board for Eli Lilly Japan K.K. M.H. has participated in consultancies and advisory panels for Bristol-Myers Squibb K.K., Eisai Company, Ono Pharmaceuticals, Takeda Pharmaceutical Company, Mitsubishi Tanabe Pharma Co., and Eli Lilly and Company, and is the baricitinib advisor for Eli Lilly Japan K.K. T.I. and T.P.R. are employees of and own stock in Eli Lilly and Company. O.K. and N.A. are employees of Eli Lilly and Company. T.T. has received: grants from Astellas Pharma Inc, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Taisho Toyama Pharmaceutical Co., Ltd., Eisai Co., Ltd., AYUMI Pharmaceutical Corporation; speaking fees from AbbVie GK, Bristol–Myers K.K., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Astellas Pharma Inc., and Diaichi Sankyo Co., Ltd.; and consultant fees Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co. Ltd., Janssen Pharmaceutical K.K., Astellas Pharma Inc., and Taiho Pharmaceutical Co., Ltd.

Role of the sponsor

Eli Lilly and Company was involved in the study design, data collection, data analysis, and preparation of the article.

Additional information

Funding

The studies described in this article were sponsored by Eli Lilly and Company and Incyte Corporation. Medical writing assistance was provided by Thao Le, MD, PhD, and Serina Stretton, PhD, CMPP of ProScribe – Envision Pharma Group. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).