Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching

Pub Date : 2021-06-15 DOI:10.5639/gabij.2021.1002.007

Mansour Somaily, Hana S Alahmari, W. Abbag, Shahenda Yousif, Nawar Tayfour, N. Almushayt, Saleh Alhusayni, Saeed Almajadiah

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引用次数: 1

Abstract

Background: A biosimilar version of infliximab ( CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however, there is a lack of local data regarding the efficacy and tolerability of CT-P13 among patients with rheumatological disorders in Saudi Arabia. Objectives: To investigate the feasibility, tolerability and immunogenicity of switching from originator infliximab to biosimilar infliximab, CT-P13, in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and Behçet’s disease (BD). Methodology: The study included patients who were being treated with originator infliximab in the Department of Rheumatology in Khamis Mushayt General Hospital, Saudi Arabia, and were required to switch to biosimilar infliximab (CT-P13) between January 2018 and June 2019. Patient follow-up was carried out every three months for one year. The disease activity score 28 (DAS28) was used to assess RA severity. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was used to measure disease activity in patients with AS, while BD disease activity was based on clinical assessment. Results: In total, 13 patients (six with RA, five with AS and two with BD) were switched to biosimilar infliximab. The majority (n = 11/13) remained on biosimilar infliximab throughout the follow-up period with no reported major adverse events. Overall, there was a significant improvement in RA disease activity following biosimilar treatment, with the mean DAS28 decreasing from 3.61±1.24 before biosimilar therapy to 2.63±1.54 one year after switching. Conclusion: In patients with AS, BD, or RA who switched from originator infliximab to the biosimilar, CT-P13, we did not observe any significant differences in tolerability or efficacy between biosimilar and originator. Furthermore, disease activity significantly declined in RA patients following biosimilar treatment

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沙特阿拉伯的生物仿制药:单中心，开放标签病例系列检查英夫利昔单抗切换

背景:英夫利昔单抗(CT-P13)的生物仿制药版本最近被批准在沙特阿拉伯使用。临床数据支持其在风湿病治疗中的应用，然而，沙特阿拉伯缺乏关于CT-P13在风湿病患者中的疗效和耐受性的本地数据。目的:探讨类风湿性关节炎(RA)、强直性脊柱炎(AS)和behet病(BD)患者从原药英夫利昔单抗转向生物仿制药英夫利昔单抗CT-P13的可行性、耐受性和免疫原性。方法:该研究纳入了在沙特阿拉伯Khamis Mushayt总医院风湿病科接受原药英夫利昔单抗治疗的患者，这些患者被要求在2018年1月至2019年6月期间改用生物仿制药英夫利昔单抗(CT-P13)。患者每3个月随访1年。疾病活动评分28 (DAS28)用于评估RA的严重程度。巴斯强直性脊柱炎疾病活动性指数(BASDAI)评分用于衡量AS患者的疾病活动性，而BD疾病活动性基于临床评估。结果:共有13例患者(6例RA, 5例AS, 2例BD)改用英夫利昔单抗生物仿制药。大多数(n = 11/13)在整个随访期间仍在使用英夫利昔单抗生物仿制药，没有报告重大不良事件。总体而言，生物仿制药治疗后RA疾病活动性显著改善，平均DAS28从生物仿制药治疗前的3.61±1.24降至切换后一年的2.63±1.54。结论:在从原药英夫利昔单抗切换到生物仿制药CT-P13的AS, BD或RA患者中，我们没有观察到生物仿制药和原药之间的耐受性或疗效有任何显着差异。此外，RA患者在接受生物类似药治疗后，疾病活动性显著下降

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