Influence of concomitant methotrexate use on the clinical effectiveness, retention, and safety of abatacept in biologic-naïve patients with rheumatoid arthritis: Post-hoc subgroup analysis of the ORIGAMI study

Takanori Azuma¹, Kenta Misaki², Makio Kusaoi³, Yoko Suzuki⁴, Shinji Higa⁵, Yoshitaka Kumon⁶, Tamami Yoshitama⁷, Taio Naniwa⁸, Shinsuke Yamada⁹, Tadashi Okano¹⁰, Kimihiko Takeuchi¹¹, Kei Ikeda¹², Kenshi Higami¹³, Masayuki Inoo¹⁴, Tetsuji Sawada¹⁵, Chonte Kang¹⁶, Masatoshi Hayashi¹⁷, Yuko Nagaya¹⁸, Takafumi Hagiwara¹⁹, Eisuke Shono²⁰, Shinkichi Himeno²¹, Eiichi Tanaka²², Eisuke Inoue^{22

23}, Yuri Yoshizawa²⁴, Michiaki Kadode²⁵, Hisashi Yamanaka^{22

26}, Masayoshi Harigai²²

Affiliations

¹ Azuma Rheumatology Clinic, Saitama, Japan.
² Department of Rheumatology, Kita-Harima Medical Center, Hyogo, Japan.
³ Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
⁴ Izumi Himawari Clinic, Miyagi, Japan.
⁵ Division of Rheumatology, Daini Osaka Police Hospital, Osaka, Japan.
⁶ Department of Rheumatology, Chikamori Hospital, Kochi, Japan.
⁷ Yoshitama Clinic for Rheumatic Diseases, Kagoshima, Japan.
⁸ Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University, Aichi, Japan.
⁹ Department of Clinical Immunology, Osaka City University, Osaka, Japan.
¹⁰ Department of Orthopedic Surgery, Osaka City University, Osaka, Japan.
¹¹ Departments of Orthopedics and Rheumatology, Isesaki Fukushima Hospital, Gunma, Japan.
¹² Department of Allergy and Clinical Immunology, Chiba University, Chiba, Japan.
¹³ Higami Clinic of Rheumatology and Diabetology, Nara, Japan.
¹⁴ Utazu Hospital, Kagawa, Japan.
¹⁵ Department of Rheumatology, Tokyo Medical University, Tokyo, Japan.
¹⁶ Kang Clinic Rheumatology Orthopedic, Kanagawa, Japan.
¹⁷ Hayashi Rheumatology Orthopaedic Clinic, Nagano, Japan.
¹⁸ Center of Joint Surgery for Rheumatic Diseases and Osteoporosis, Nagoya City University East Medical Center, Aichi, Japan.
¹⁹ Department of Rheumatology, Takarazuka City Hospital, Hyogo, Japan.
²⁰ Shono Rheumatology Clinic, Fukuoka, Japan.
²¹ Himeno Hospital, Fukuoka, Japan.
²² Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
²³ Showa University Research Administration Center, Showa University, Tokyo, Japan.
²⁴ Department of Immunology Medical, Bristol-Myers Squibb K.K., Tokyo, Japan.
²⁵ Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
²⁶ Department of Rheumatology, Sanno Medical Center, Tokyo, Japan.

PMID: 35389481
DOI: 10.1093/mr/roac032

Influence of concomitant methotrexate use on the clinical effectiveness, retention, and safety of abatacept in biologic-naïve patients with rheumatoid arthritis: Post-hoc subgroup analysis of the ORIGAMI study

Takanori Azuma et al. Mod Rheumatol. 2023.

. 2023 Mar 2;33(2):271-278.

doi: 10.1093/mr/roac032.

Authors

Affiliations

¹ Azuma Rheumatology Clinic, Saitama, Japan.
² Department of Rheumatology, Kita-Harima Medical Center, Hyogo, Japan.
³ Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
⁴ Izumi Himawari Clinic, Miyagi, Japan.
⁵ Division of Rheumatology, Daini Osaka Police Hospital, Osaka, Japan.
⁶ Department of Rheumatology, Chikamori Hospital, Kochi, Japan.
⁷ Yoshitama Clinic for Rheumatic Diseases, Kagoshima, Japan.
⁸ Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University, Aichi, Japan.
⁹ Department of Clinical Immunology, Osaka City University, Osaka, Japan.
¹⁰ Department of Orthopedic Surgery, Osaka City University, Osaka, Japan.
¹¹ Departments of Orthopedics and Rheumatology, Isesaki Fukushima Hospital, Gunma, Japan.
¹² Department of Allergy and Clinical Immunology, Chiba University, Chiba, Japan.
¹³ Higami Clinic of Rheumatology and Diabetology, Nara, Japan.
¹⁴ Utazu Hospital, Kagawa, Japan.
¹⁵ Department of Rheumatology, Tokyo Medical University, Tokyo, Japan.
¹⁶ Kang Clinic Rheumatology Orthopedic, Kanagawa, Japan.
¹⁷ Hayashi Rheumatology Orthopaedic Clinic, Nagano, Japan.
¹⁸ Center of Joint Surgery for Rheumatic Diseases and Osteoporosis, Nagoya City University East Medical Center, Aichi, Japan.
¹⁹ Department of Rheumatology, Takarazuka City Hospital, Hyogo, Japan.
²⁰ Shono Rheumatology Clinic, Fukuoka, Japan.
²¹ Himeno Hospital, Fukuoka, Japan.
²² Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
²³ Showa University Research Administration Center, Showa University, Tokyo, Japan.
²⁴ Department of Immunology Medical, Bristol-Myers Squibb K.K., Tokyo, Japan.
²⁵ Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
²⁶ Department of Rheumatology, Sanno Medical Center, Tokyo, Japan.

PMID: 35389481
DOI: 10.1093/mr/roac032

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusion: The effectiveness and safety of abatacept appeared comparable with or without concomitant MTX in this real-world clinical setting.

Keywords: Abatacept; disease-modifying antirheumatic drug; methotrexate; real-world; rheumatoid arthritis.

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Influence of concomitant methotrexate use on the clinical effectiveness, retention, and safety of abatacept in biologic-naïve patients with rheumatoid arthritis: Post-hoc subgroup analysis of the ORIGAMI study

Affiliations

Influence of concomitant methotrexate use on the clinical effectiveness, retention, and safety of abatacept in biologic-naïve patients with rheumatoid arthritis: Post-hoc subgroup analysis of the ORIGAMI study

Authors

Affiliations

Abstract

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Research Materials

Miscellaneous