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Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals : Post Hoc Analysis of Japanese Patients (MELODY Study)

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Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/62851

Title: Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals : Post Hoc Analysis of Japanese Patients (MELODY Study)
Authors: Koike, Takao Browse this author →KAKEN DB
Harigai, Masayoshi Browse this author →KAKEN DB
Ishiguro, Naoki Browse this author →KAKEN DB
Inokuma, Shigeko Browse this author
Takei, Syuji Browse this author
Takeuchi, Tsutomu Browse this author →KAKEN DB
Yamanaka, Hisashi Browse this author →KAKEN DB
Takasaki, Yoshinari Browse this author →KAKEN DB
Mimori, Tsuneyo Browse this author →KAKEN DB
Hisamatsu, Katsutoshi Browse this author
Komatsu, Shuichi Browse this author
Tanaka, Yoshiya Browse this author →KAKEN DB
Keywords: Adalimumab
Doses
Effectiveness
Methotrexate
Rheumatoid arthritis
Safety
Issue Date: Jun-2016
Publisher: Springer Healthcare
Journal Title: Rheumatology and Therapy
Volume: 3
Issue: 1
Start Page: 129
End Page: 141
Publisher DOI: 10.1007/s40744-015-0023-x
Abstract: Introduction: There is insufficient evidence regarding the appropriate dose of methotrexate (MTX) required to achieve specific treatment goals in patients with rheumatoid arthritis (RA) receiving biologic drugs in Japan. The present study aimed to assess the dose-response effect of MTX in combination with adalimumab (ADA) to achieve low disease activity (LDA) and/or remission at 24 weeks in RA patients. Methods: This analysis used data of the ADA all-case survey in Japan (n = 7740), and 5494 patients who received ADA and MTX were classified into five groups by weighted average MTX dose (>0-<4, 4-<6, 6-<8, 8-< 10, and ≥10 mg/week). Of the 5494 patients, 3097 with baseline 28-joint disease activity score based on erythrocyte sedimentation rate >3.2 were analyzed for effectiveness by MTX dose. Results: In biologic-naive patients (n = 1996/3097), LDA/remission rates increased with MTX up to 6-<8 mg/week and then plateaued at higher doses (LDA, p = 0.0440; remission, p = 0.0422). In biologic-exposed patients (n = 1101/3097), LDA/remission rates increased with MTX dose (LDA, p = 0.0009; remission p = 0.0143). The incidences of serious adverse drug reactions (ADRs) and serious infections did not differ by MTX dose, but total ADRs and infections were significantly higher (p < 0.05) with increased MTX doses. Conclusion: The appropriate MTX doses in combination with ADA to achieve LDA and/or remission at week 24 were different between biologic-naive and biologic-exposed patients with RA, suggesting that 8 mg/week of MTX would be enough for biologic-naive patients.
Rights: https://creativecommons.org/licenses/by-nc/4.0/
Type: article
URI: http://hdl.handle.net/2115/62851
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

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