Risk factors associated with relapse after methotrexate dose reduction in patients with rheumatoid arthritis receiving golimumab and methotrexate combination therapy

Author:

Kitamura Noboru1ORCID,Kobayashi Hitomi1,Nagasawa Yosuke1,Sugiyama Kaita1,Tsuzuki Hiroshi1,Tanikawa Yutaka1,Ikumi Natsumi2,Okada Yuito3,Takahashi Yasuo3,Asai Satoshi4,Tamura Naoto5,Ogasawara Michihiro5ORCID,Kawamoto Toshio5,Kuwatsuru Ryohei6,Tamaki Hiromichi7,Kidoguchi Genki7,Tateishi Mutsuto8,Kimura Makiko8,Mochida Yuichi9,Harigane Kengo9,Shimazaki Takayuki9,Koike Takao10,Tanimura Kazuhide10,Kataoka Hiroshi11,Amano Koichi12ORCID,Yasuoka Hidekata13,Takei Masami1

Affiliation:

1. Department of Medicine, Division of Hematology and Rheumatology Nihon University School of Medicine Tokyo Japan

2. Department of Dermatology Nihon University School of Medicine Tokyo Japan

3. Clinical Trials Research Center Nihon University School of Medicine Tokyo Japan

4. Department of Pharmacology and Biofunction Medicine Nihon University School of Medicine Tokyo Japan

5. Internal Medicine and Rheumatology Juntendo University Faculty of Medicine Tokyo Japan

6. Department of Radiology & Center for Promotion of Data Science Juntendo University Graduate School of Medicine Tokyo Japan

7. Immuno‐Rheumatology Center, St. Luke's International Hospital Tokyo Japan

8. Department of Rheumatology Tokyo Metropolitan Ohtsuka Hospital Tokyo Japan

9. Center for Rheumatic Diseases Yokohama City University Medical Center Yokohama Japan

10. Hokkaido Medical Center for Rheumatic Diseases Sapporo Japan

11. Department of Rheumatology and Clinical Immunology Sapporo City General Hospital Sapporo Japan

12. Department of Rheumatology and Clinical Immunology Saitama Medical Center Saitama Medical University Saitama Japan

13. Department of Internal Medicine, Division of Rheumatology Fujita Health University School of Medicine Toyoake Japan

Abstract

AbstractAimTo identify risk factors for relapse after methotrexate (MTX) dose reduction in rheumatoid arthritis (RA) patients receiving golimumab (GLM)/MTX combination therapy.MethodData on RA patients ≥20 years old receiving GLM (50 mg) + MTX for ≥6 months were retrospectively collected. MTX dose reduction was defined as a reduction of ≥12 mg from the total dose within 12 weeks of the maximum dose (≥1 mg/wk average). Relapse was defined as Disease Activity Score in 28 joints using C‐reactive protein level (DAS28‐CRP) score ≥3.2 or sustained (≥ twice) increase of ≥0.6 from baseline.ResultsA total of 304 eligible patients were included. Among the MTX‐reduction group (n = 125), 16.8% of patients relapsed. Age, duration from diagnosis to the initiation of GLM, baseline MTX dose, and DAS28‐CRP were comparable between relapse and no‐relapse groups. The adjusted odds ratio (aOR) of relapse after MTX reduction was 4.37 (95% CI 1.16–16.38, P = 0.03) for prior use of non‐steroidal anti‐inflammatory drugs (NSAIDs), and the aORs for cardiovascular disease (CVD), gastrointestinal disease and liver disease were 2.36, 2.28, and 3.03, respectively. Compared to the non‐reduction group, the MTX‐reduction group had a higher proportion of patients with CVD (17.6% vs 7.3%, P = 0.02) and a lower proportion of prior use of biologic disease‐modifying antirheumatic drugs (11.2% vs. 24.0%, P = 0.0076).ConclusionAttention should be given to RA patients with history of CVD, gastrointestinal disease, liver disease, or prior NSAIDs‐use when considering MTX dose reduction to ensure benefits outweigh the risks of relapse.

Funder

Janssen Pharmaceuticals

Mitsubishi Tanabe Pharma Corporation

Publisher

Wiley

Subject

Rheumatology

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