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.

• Authors: Yoshiya Tanaka, Tatsuya Atsumi, Koichi Amano, Masayoshi Harigai, Taeko Ishii, Osamu Kawaguchi, Terence P Rooney, Naotsugu Akashi, Tsutomu Takeuchi
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 28 Issue 4 Pg. 583-591 (Jul 2018) ISSN: 1439-7609 [Electronic] England
• PMID: 29134891 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antirheumatic Agents
• Azetidines
• Purines
• Pyrazoles
• Sulfonamides
• baricitinib

Topics

• Adult
• Aged
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Azetidines (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Japan
• Male
• Middle Aged
• Purines
• Pyrazoles
• Sulfonamides (administration & dosage, adverse effects, therapeutic use)