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

Author:

Azuma Takanori1,Misaki Kenta2,Kusaoi Makio3,Suzuki Yoko4,Higa Shinji5,Kumon Yoshitaka6,Yoshitama Tamami7,Naniwa Taio8,Yamada Shinsuke9,Okano Tadashi10,Takeuchi Kimihiko11,Ikeda Kei12,Higami Kenshi13,Inoo Masayuki14,Sawada Tetsuji15,Kang Chonte16,Hayashi Masatoshi17,Nagaya Yuko18,Hagiwara Takafumi19,Shono Eisuke20,Himeno Shinkichi21,Tanaka Eiichi22,Inoue Eisuke2223,Yoshizawa Yuri24,Kadode Michiaki25,Yamanaka Hisashi2226,Harigai Masayoshi22

Affiliation:

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

Abstract

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.

Funder

Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd.

Publisher

Oxford University Press (OUP)

Subject

Rheumatology

Reference23 articles.

1. Rheumatoid arthritis;Smolen;Nat Rev Dis Primers,2018

2. Prevalence of patients with rheumatoid arthritis and age-stratified trends in clinical characteristics and treatment, based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan;Nakajima;Int J Rheum Dis,2020

3. American College of Rheumatology guideline for the treatment of rheumatoid arthritis;Fraenkel;Arthritis Care Res (Hoboken),2021

4. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update;Smolen;Ann Rheum Dis,2020

5. Japan College of Rheumatology guideline for the use of methotrexate in patients with rheumatoid arthritis;Kameda;Mod Rheumatol,2019

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