Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI)

Kenta Misaki; Eiichi Tanaka; Eisuke Inoue; Naoto Tamura; Fuminori Hirano; Yoshinori Taniguchi; Hiroshi Sato; Taio Naniwa; Hideto Oshikawa; Tamami Yoshitama; Yuya Takakubo; Yoko Suzuki; Shinkichi Himeno; Katsuki Tsuritani; Shigeru Matsumoto; Hisashi Yamanaka; Masayoshi Harigai

doi:10.1093/mr/roae043

Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI)

Mod Rheumatol. 2024 May 10:roae043. doi: 10.1093/mr/roae043. Online ahead of print.

Authors

Kenta Misaki¹, Eiichi Tanaka², Eisuke Inoue^{2

3}, Naoto Tamura⁴, Fuminori Hirano⁵, Yoshinori Taniguchi⁶, Hiroshi Sato⁷, Taio Naniwa⁸, Hideto Oshikawa⁹, Tamami Yoshitama¹⁰, Yuya Takakubo¹¹, Yoko Suzuki¹², Shinkichi Himeno¹³, Katsuki Tsuritani¹⁴, Shigeru Matsumoto¹⁵, Hisashi Yamanaka^{2

16}, Masayoshi Harigai²

Affiliations

¹ Department of Rheumatology, Kita-Harima Medical Center, Hyogo, Japan.
² Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
³ Showa University Research Administration Center, Showa University, Tokyo, Japan.
⁴ Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
⁵ Department of Rheumatology, NHO Asahikawa Medical Center, Hokkaido, Japan.
⁶ Department of Rheumatology, Bayside Misato Medical Center, Kochi, Japan.
⁷ Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo, Japan.
⁸ Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University, Aichi, Japan.
⁹ Department of Rheumatology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
¹⁰ Yoshitama Clinic for Rheumatic Diseases, Kagoshima, Japan.
¹¹ Department of Rehabilitation Surgery, Yamagata University Hospital, Yamagata, Japan.
¹² Izumi Himawari Clinic, Miyagi, Japan.
¹³ Himeno Hospital, Fukuoka, Japan.
¹⁴ Department of Immunology Medical, Bristol-Myers Squibb K.K., Tokyo, Japan.
¹⁵ Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
¹⁶ Department of Rheumatology, Sanno Medical Center, Tokyo, Japan.

PMID: 38727535
DOI: 10.1093/mr/roae043

Abstract

Objectives: We investigated the long-term effectiveness, safety, and factors affecting Japanese Health Assessment Questionnaire (J-HAQ) improvement during abatacept treatment in Japanese rheumatoid arthritis (RA) patients.

Methods: The ORIGAMI study is an ongoing observational study of biologic-naïve RA patients with moderate disease activity treated with subcutaneous abatacept (125 mg, once-weekly). Patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) were extracted from the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry as an historical, weighted control group. The primary endpoint for this interim analysis was the proportion of patients with J-HAQ remission (score ≤0.5) at 3 years.

Results: Among 279 abatacept-treated and 220 csDMARD-treated patients, J-HAQ remission was achieved at 3 years in 40.5% (95% confidence interval [CI] 34.7%-46.2%) and 28.9% (95% CI 9.9%-47.8%), respectively. Age, RA duration <1 year, baseline J-HAQ score, and Simplified Disease Activity Index remission at 6 months were associated with 3-year J-HAQ remission in the abatacept group. Overall, 24/298 patients (8.1%; safety analysis set) experienced serious adverse drug reactions with an incidence of 5.3 per 100 person-years.

Conclusions: This study confirmed the 3-year effectiveness and safety, and revealed potential factors associated with J-HAQ remission in biologic-naïve RA patients treated with abatacept in real-world clinical practice.

Keywords: J-HAQ; abatacept; long-term; quality of life; rheumatoid arthritis.