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Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials.
Mod Rheumatol. 2018 Jul; 28(4):583-591.MR

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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Authors+Show Affiliations

Tanaka Y
a First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Japan.
Atsumi T
b Division of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine , Hokkaido University , Hokkaido , Japan.
Amano K
c Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe , Japan.
Harigai M
d Department of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology , Tokyo Women's Medical University , Tokyo , Japan.
Ishii T
e Eli Lilly Japan K.K. , Kobe , Japan.
Kawaguchi O
e Eli Lilly Japan K.K. , Kobe , Japan.
Rooney TP
f Eli Lilly and Company , Indianapolis , IN , USA.
Akashi N
e Eli Lilly Japan K.K. , Kobe , Japan.
Takeuchi T
g Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.

MeSH

AdultAgedAntirheumatic AgentsArthritis, RheumatoidAzetidinesFemaleHumansJapanMaleMiddle AgedSulfonamides

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29134891

Citation

Tanaka, Yoshiya, et al. "Efficacy and Safety of Baricitinib in Japanese Patients With Rheumatoid Arthritis: Subgroup Analyses of Four Multinational Phase 3 Randomized Trials." Modern Rheumatology, vol. 28, no. 4, 2018, pp. 583-591.
Tanaka Y, Atsumi T, Amano K, et al. Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials. Mod Rheumatol. 2018;28(4):583-591.
Tanaka, Y., Atsumi, T., Amano, K., Harigai, M., Ishii, T., Kawaguchi, O., Rooney, T. P., Akashi, N., & Takeuchi, T. (2018). Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials. Modern Rheumatology, 28(4), 583-591. https://doi.org/10.1080/14397595.2017.1392057
Tanaka Y, et al. Efficacy and Safety of Baricitinib in Japanese Patients With Rheumatoid Arthritis: Subgroup Analyses of Four Multinational Phase 3 Randomized Trials. Mod Rheumatol. 2018;28(4):583-591. PubMed PMID: 29134891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials. AU - Tanaka,Yoshiya, AU - Atsumi,Tatsuya, AU - Amano,Koichi, AU - Harigai,Masayoshi, AU - Ishii,Taeko, AU - Kawaguchi,Osamu, AU - Rooney,Terence P, AU - Akashi,Naotsugu, AU - Takeuchi,Tsutomu, Y1 - 2017/11/14/ PY - 2017/11/15/pubmed PY - 2018/10/12/medline PY - 2017/11/15/entrez KW - Baricitinib KW - Janus kinase (JAK) KW - Japanese KW - phase 3 clinical trials KW - rheumatoid arthritis SP - 583 EP - 591 JF - Modern rheumatology JO - Mod Rheumatol VL - 28 IS - 4 N2 - 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. SN - 1439-7609 UR - https://www.unboundmedicine.com/medline/citation/29134891/Efficacy_and_safety_of_baricitinib_in_Japanese_patients_with_rheumatoid_arthritis:_Subgroup_analyses_of_four_multinational_phase_3_randomized_trials_ L2 - https://www.tandfonline.com/doi/full/10.1080/14397595.2017.1392057 DB - PRIME DP - Unbound Medicine ER -