Influence of concomitant methotrexate use on the clinical effectiveness, retention, and safety of abatacept in biologic-naïve patients with rheumatoid arthritis:<i>Post-hoc</i>subgroup analysis of the ORIGAMI study
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- Takanori Azuma
- Azuma Rheumatology Clinic , Saitama, Japan
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- Kenta Misaki
- Department of Rheumatology, Kita-Harima Medical Center , Hyogo, Japan
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- Makio Kusaoi
- Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine , Tokyo, Japan
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- Yoko Suzuki
- Izumi Himawari Clinic , Miyagi, Japan
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- Shinji Higa
- Division of Rheumatology, Daini Osaka Police Hospital , Osaka, Japan
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- Yoshitaka Kumon
- Department of Rheumatology, Chikamori Hospital , Kochi, Japan
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- Tamami Yoshitama
- Yoshitama Clinic for Rheumatic Diseases , Kagoshima, Japan
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- Taio Naniwa
- Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University , Aichi, Japan
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- Shinsuke Yamada
- Department of Clinical Immunology, Osaka City University , Osaka, Japan
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- Tadashi Okano
- Department of Orthopedic Surgery, Osaka City University , Osaka, Japan
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- Kimihiko Takeuchi
- Departments of Orthopedics and Rheumatology, Isesaki Fukushima Hospital , Gunma, Japan
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- Kei Ikeda
- Department of Allergy and Clinical Immunology, Chiba University , Chiba, Japan
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- Kenshi Higami
- Higami Clinic of Rheumatology and Diabetology , Nara, Japan
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- Masayuki Inoo
- Utazu Hospital , Kagawa, Japan
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- Tetsuji Sawada
- Department of Rheumatology, Tokyo Medical University , Tokyo, Japan
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- Chonte Kang
- Kang Clinic Rheumatology Orthopedic , Kanagawa, Japan
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- Masatoshi Hayashi
- Hayashi Rheumatology Orthopaedic Clinic , Nagano, Japan
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- Yuko Nagaya
- Center of Joint Surgery for Rheumatic Diseases and Osteoporosis, Nagoya City University East Medical Center , Aichi, Japan
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- Takafumi Hagiwara
- Department of Rheumatology, Takarazuka City Hospital , Hyogo, Japan
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- Eisuke Shono
- Shono Rheumatology Clinic , Fukuoka, Japan
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- Shinkichi Himeno
- Himeno Hospital , Fukuoka, Japan
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- Eiichi Tanaka
- Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine , Tokyo, Japan
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- Eisuke Inoue
- Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine , Tokyo, Japan
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- Yuri Yoshizawa
- Department of Immunology Medical, Bristol-Myers Squibb K.K. , Tokyo, Japan
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- Michiaki Kadode
- Medical Affairs, Ono Pharmaceutical Co., Ltd. , Osaka, Japan
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- Hisashi Yamanaka
- Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine , Tokyo, Japan
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- Masayoshi Harigai
- Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine , Tokyo, Japan
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<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Objectives</jats:title><jats:p>We performed post-hoc analyses of the ORIGAMI study to investigate whether concomitant methotrexate (MTX) influences the clinical outcomes of abatacept in biologic-naïve patients with rheumatoid arthritis.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Enrolled patients (n = 325) were divided into two groups according to whether abatacept was prescribed without (MTX−) or with (MTX+) concomitant MTX. We compared the changes in Simplified Disease Activity Index (SDAI), Disease Activity Score-28 with C-reactive protein (DAS28-CRP), and Japanese Health Assessment Questionnaire (J-HAQ) through to 52 weeks of treatment, the abatacept retention rate, and safety.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>At Week 52, the mean SDAI (8.9 vs. 8.8), DAS28-CRP (2.6 vs. 2.6), and J-HAQ (0.92 vs. 0.91) scores were comparable in the MTX− (n = 129) and MTX+ (n = 150) groups. Multivariable logistic regression revealed no significant association between MTX use and SDAI (low disease activity) or J-HAQ (minimum clinically important difference). The abatacept retention rates, estimated using the Kaplan–Meier method, were 73.2% and 66.7% in the MTX− and MTX+ groups, respectively. Adverse events occurred in 47.5% (of 139) and 52.2% (of 159) of patients in the MTX− and MTX+ groups, respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The effectiveness and safety of abatacept appeared comparable with or without concomitant MTX in this real-world clinical setting.</jats:p></jats:sec>
収録刊行物
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- Modern Rheumatology
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Modern Rheumatology 33 (2), 271-278, 2022-04-07
Oxford University Press (OUP)