Sung Yoon-Kyoung, Cho Soo-Kyung, Kim Dam, Won Soyoung, Choi Chan-Bum, Bang So-Young, Hong Seung-Jae, Kim Hyoun Ah, Koh Eun-Mi, Lee Hye-Soon, Suh Chang-Hee, Yoo Dae-Hyun, Bae Sang-Cheol
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.
Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
Rheumatol Int. 2017 Jun;37(6):1007-1014. doi: 10.1007/s00296-017-3663-z. Epub 2017 Feb 18.
To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab. The drug retention rates of the two groups were also compared. A total of 100 RA patients, 55 biosimilar, and 45 originator infliximab users were included in this analysis. Baseline characteristics of age, disease duration, and previous or current medications were similar in the two groups. Baseline DAS28-ESR was higher in the originator infliximab group (6.3 ± 1.1 vs. 5.8 ± 1.1, p = 0.02). The early DAS28-ESR remission rates observed 7.9 ± 1.8 months after starting biosimilar and originator infliximab were 15.0 and 25.0%, respectively (p = 0.47). The change in HAQ-DI did not differ between the two groups (0.4 ± 0.7 vs. 0.4 ± 0.8, p = 0.94). Patients treated with biosimilar infliximab in clinical practice had lower disease activity at the start of treatment than those receiving originator infliximab. Biosimilar infliximab was well-tolerated, safe, and of similar clinical effectiveness to originator infliximab. Larger number of patient and longer follow-up data will be needed to confirm the effectiveness and safety of biosimilar infliximab in clinical practice.
比较接受生物类似药或原研英夫利昔单抗的类风湿关节炎（RA）患者的特征，并确定生物类似药英夫利昔单抗在实际临床实践中对RA患者的有效性和安全性。使用前瞻性生物改善病情抗风湿药（DMARDs）登记系统：生物制剂药物流行病学研究（BIOPSY），选取开始使用生物类似药或原研英夫利昔单抗的RA患者。比较两组的基线特征，并比较开始使用生物类似药或原研英夫利昔单抗后的短期治疗结果，包括DAS28-ESR和HAQ-DI评分。还比较了两组的药物保留率。本分析共纳入100例RA患者，其中55例使用生物类似药，45例使用原研英夫利昔单抗。两组患者的年龄、病程以及既往或当前用药情况等基线特征相似。原研英夫利昔单抗组的基线DAS28-ESR更高（6.3±1.1 vs. 5.8±1.1，p = 0.02）。开始使用生物类似药和原研英夫利昔单抗后分别在7.9±1.8个月时观察到的早期DAS28-ESR缓解率分别为15.0%和25.0%（p = 0.47）。两组之间HAQ-DI的变化无差异（0.4±0.7 vs. 0.4±0.8，p = 0.94）。在临床实践中接受生物类似药英夫利昔单抗治疗的患者在治疗开始时的疾病活动度低于接受原研英夫利昔单抗治疗的患者。生物类似药英夫利昔单抗耐受性良好、安全，且临床疗效与原研英夫利昔单抗相似。需要更多患者数量和更长随访数据来证实生物类似药英夫利昔单抗在临床实践中的有效性和安全性。
