Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: Results from registered data analyses

Yasuharu Nakashima, Hisaaki Miyahara, Masakazu Kondo, Takaaki Fukuda, Hiroshi Harada, Akihisa Haraguchi, Yasushi Inoue, Takashi Ishinishi, Masayuki Maekawa, Akira Maeyama, Munetoshi Nakashima, Eisuke Shono, Eiichi Suematsu, Takashi Shimauchi, Tomomi Tsuru, Hiroshi Tsukamoto, Shigeru Yoshizawa, Seiji Yoshizawa, Yukihide Iwamoto

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Abstract

Objective: Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice. Method: Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria. Results: The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10 mg group (26.1%). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10 mg group compared with 52.0% in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1% vs. 12.0%). Conclusions: These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.

Original languageEnglish
Pages (from-to)15-21
Number of pages7
JournalModern Rheumatology
Volume27
Issue number1
DOIs
Publication statusPublished - Jan 2 2017

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Methotrexate
Rheumatoid Arthritis
Adalimumab
Japan
Multivariate Analysis
Odds Ratio

All Science Journal Classification (ASJC) codes

  • Rheumatology

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Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis : Results from registered data analyses. / Nakashima, Yasuharu; Miyahara, Hisaaki; Kondo, Masakazu; Fukuda, Takaaki; Harada, Hiroshi; Haraguchi, Akihisa; Inoue, Yasushi; Ishinishi, Takashi; Maekawa, Masayuki; Maeyama, Akira; Nakashima, Munetoshi; Shono, Eisuke; Suematsu, Eiichi; Shimauchi, Takashi; Tsuru, Tomomi; Tsukamoto, Hiroshi; Yoshizawa, Shigeru; Yoshizawa, Seiji; Iwamoto, Yukihide.

In: Modern Rheumatology, Vol. 27, No. 1, 02.01.2017, p. 15-21.

Research output: Contribution to journalArticle

Nakashima, Y, Miyahara, H, Kondo, M, Fukuda, T, Harada, H, Haraguchi, A, Inoue, Y, Ishinishi, T, Maekawa, M, Maeyama, A, Nakashima, M, Shono, E, Suematsu, E, Shimauchi, T, Tsuru, T, Tsukamoto, H, Yoshizawa, S, Yoshizawa, S & Iwamoto, Y 2017, 'Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: Results from registered data analyses', Modern Rheumatology, vol. 27, no. 1, pp. 15-21. https://doi.org/10.3109/14397595.2016.1170958
Nakashima, Yasuharu ; Miyahara, Hisaaki ; Kondo, Masakazu ; Fukuda, Takaaki ; Harada, Hiroshi ; Haraguchi, Akihisa ; Inoue, Yasushi ; Ishinishi, Takashi ; Maekawa, Masayuki ; Maeyama, Akira ; Nakashima, Munetoshi ; Shono, Eisuke ; Suematsu, Eiichi ; Shimauchi, Takashi ; Tsuru, Tomomi ; Tsukamoto, Hiroshi ; Yoshizawa, Shigeru ; Yoshizawa, Seiji ; Iwamoto, Yukihide. / Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis : Results from registered data analyses. In: Modern Rheumatology. 2017 ; Vol. 27, No. 1. pp. 15-21.
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abstract = "Objective: Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice. Method: Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria. Results: The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8{\%}) with DAS28-remission compared with the MTX <10 mg group (26.1{\%}). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2{\%} in MTX ≥10 mg group compared with 52.0{\%} in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1{\%} vs. 12.0{\%}). Conclusions: These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.",
author = "Yasuharu Nakashima and Hisaaki Miyahara and Masakazu Kondo and Takaaki Fukuda and Hiroshi Harada and Akihisa Haraguchi and Yasushi Inoue and Takashi Ishinishi and Masayuki Maekawa and Akira Maeyama and Munetoshi Nakashima and Eisuke Shono and Eiichi Suematsu and Takashi Shimauchi and Tomomi Tsuru and Hiroshi Tsukamoto and Shigeru Yoshizawa and Seiji Yoshizawa and Yukihide Iwamoto",
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T1 - Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis

T2 - Results from registered data analyses

AU - Nakashima, Yasuharu

AU - Miyahara, Hisaaki

AU - Kondo, Masakazu

AU - Fukuda, Takaaki

AU - Harada, Hiroshi

AU - Haraguchi, Akihisa

AU - Inoue, Yasushi

AU - Ishinishi, Takashi

AU - Maekawa, Masayuki

AU - Maeyama, Akira

AU - Nakashima, Munetoshi

AU - Shono, Eisuke

AU - Suematsu, Eiichi

AU - Shimauchi, Takashi

AU - Tsuru, Tomomi

AU - Tsukamoto, Hiroshi

AU - Yoshizawa, Shigeru

AU - Yoshizawa, Seiji

AU - Iwamoto, Yukihide

PY - 2017/1/2

Y1 - 2017/1/2

N2 - Objective: Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice. Method: Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria. Results: The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10 mg group (26.1%). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10 mg group compared with 52.0% in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1% vs. 12.0%). Conclusions: These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.

AB - Objective: Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice. Method: Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria. Results: The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10 mg group (26.1%). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10 mg group compared with 52.0% in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1% vs. 12.0%). Conclusions: These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.

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