Takahashi Nobunori, Kojima Toshihisa, Kaneko Atsushi, Kida Daihei, Hirano Yuji, Fujibayashi Takayoshi, Yabe Yuichiro, Takagi Hideki, Oguchi Takeshi, Miyake Hiroyuki, Kato Takefumi, Watanabe Tsuyoshi, Hayashi Masatoshi, Kanayama Yasuhide, Funahashi Koji, Asai Shuji, Yoshioka Yutaka, Takemoto Toki, Terabe Kenya, Asai Nobuyuki, Ishiguro Naoki
From the Department of Orthopedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, and Nagoya Medical Centre, and Nagoya Central Hospital, Nagoya; Department of Rheumatology, Toyohashi Municipal Hospital, Toyohashi; Department of Orthopedic Surgery, Konan Kosei Hospital, Konan; Department of Rheumatology, Tokyo Kosei Nenkin Hospital, Tokyo; Department of Orthopedic Surgery, Anjo Kosei Hospital, Anjo; Department of Orthopedic Surgery, Ichinomiya Municipal Hospital, Ichinomiya; Kato Orthopedic Clinic, Okazaki; Department of Orthopedic Surgery, Kariya-Toyota General Hospital, Kariya; Department of Rheumatology, Nagano Red Cross Hospital, Nagano; Department of Orthopedic Surgery, Toyota Kosei Hospital, Toyota, Japan.N. Takahashi, MD, PhD; T. Kojima, MD, PhD; Department of Orthopedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine; A. Kaneko, MD; D. Kida, MD, PhD; Department of Orthopedic Surgery and Rheumatology, Nagoya Medical Centre; Y. Hirano, MD, PhD, Department of Rheumatology, Toyohashi Municipal Hospital; T. Fujibayashi, MD, PhD, Department of Orthopedic Surgery, Konan Kosei Hospital; Y. Yabe, MD, PhD, Department of Rheumatology, Tokyo Kosei Nenkin Hospital; H. Takagi, MD, PhD, Department of Orthopedic Surgery, Nagoya Central Hospital; T. Oguchi, MD, PhD, Department of Orthopedic Surgery, Anjo Kosei Hospital; H. Miyake, MD, PhD, Department of Orthopedic Surgery, Ichinomiya Municipal Hospital; T. Kato, MD, PhD, Kato Orthopedic Clinic; T. Watanabe, MD, PhD, Department of Orthopedic Surgery, Kariya-Toyota General Hospital; M. Hayashi, MD, Department of Rheumatology, Nagano Red Cross Hospital; Y. Kanayama, MD, PhD, Department of Orthopedic Surgery, Toyota Kosei Hospital; K. Funahashi, MD, PhD; S. Asai, MD, PhD; Y. Yoshioka, MD, PhD; T. Takemoto, MD; K. Terabe, MD; N. Asai, MD; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine.
J Rheumatol. 2015 May;42(5):786-93. doi: 10.3899/jrheum.141288. Epub 2015 Apr 1.
Our study aimed to evaluate the longterm efficacy and safety of abatacept (ABA), and to explore factors that increase its longterm efficacy in patients with rheumatoid arthritis (RA) treated in routine clinical practice.
There were 231 participants with RA treated with ABA who were prospectively registered in a Japanese multicenter registry. They were followed up for at least 52 weeks.
Mean age of the patients was 64.3 years, mean disease duration was 12.1 years, mean 28-joint Disease Activity Score (DAS28)-C-reactive protein was 4.49, and 48.5% of patients were concomitantly treated with methotrexate (MTX). Overall retention rate of ABA was 77.1% at 52 weeks; 14.8% of patients discontinued because of inadequate response and 3.5% because of adverse events. The proportion of patients achieving DAS28-defined low disease activity (LDA) significantly increased from baseline to 52 weeks (7.3% to 43.8%, p < 0.01); 40.9% of patients who did not achieve LDA at 24 weeks had more than 1 categorical improvement in DAS28-defined disease activity at 52 weeks. Multivariate logistic regression revealed concomitant MTX use to be an independent predictor of the categorical improvement in DAS28-defined disease activity from 24 to 52 weeks (adjusted OR 3.124, p = 0.010).
In routine clinical practice, ABA demonstrated satisfactory clinical efficacy and safety in patients with established RA for 52 weeks. The clinical efficacy of ABA increased with time even after 24 weeks, and this was strongly influenced by concomitant MTX use. Our study provides valuable real-world findings on the longterm management of RA with ABA.
我们的研究旨在评估阿巴西普（ABA）的长期疗效和安全性，并探索在常规临床实践中接受治疗的类风湿关节炎（RA）患者中提高其长期疗效的因素。
有231例接受ABA治疗的RA患者前瞻性登记于日本多中心登记处。对他们进行了至少52周的随访。
患者的平均年龄为64.3岁，平均病程为12.1年，平均28关节疾病活动评分（DAS28）-C反应蛋白为4.49，48.5%的患者同时接受甲氨蝶呤（MTX）治疗。ABA在52周时的总体保留率为77.1%；14.8%的患者因反应不足而停药，3.5%的患者因不良事件停药。达到DAS28定义的低疾病活动度（LDA）的患者比例从基线到52周显著增加（7.3%至43.8%，p<0.01）；24周时未达到LDA的患者中，40.9%在52周时DAS28定义的疾病活动度有超过1级的改善。多变量逻辑回归显示，同时使用MTX是24至52周时DAS28定义的疾病活动度分级改善的独立预测因素（调整后OR 3.124，p=0.010）。
在常规临床实践中，ABA在确诊的RA患者中显示出52周的满意临床疗效和安全性。即使在24周后，ABA的临床疗效也随时间增加，且这受到同时使用MTX的强烈影响。我们的研究为ABA在RA长期管理方面提供了有价值的真实世界研究结果。
