英夫利昔单抗（类克®）在黎巴嫩一家三级中心用于治疗风湿性疾病：一项为期17年的回顾性图表审查。
The Use of Infliximab (Remicade®) for the Treatment of Rheumatic Diseases at a Tertiary Center in Lebanon: A 17-Year Retrospective Chart Review.
作者信息
Nahra Vicky, Hasbani Georges El, Chaaya Monique, Uthman Imad
机构信息
Division of Rheumatology, Department of Internal Medicine, American University of Beirut, Medical Center, Beirut, Lebanon.
Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut, Medical Center, Beirut, Lebanon.
出版信息
Mediterr J Rheumatol. 2020 Dec 22;31(4):400-405. doi: 10.31138/mjr.31.4.400. eCollection 2020 Dec.
OBJECTIVES
Infliximab (Remicade®) was the first tumour necrosis factor-α (TNF) inhibitor to receive its initial marketing approval from the US Food and Drug Administration (FDA) for the treatment of Crohn's disease. Following that, infliximab became approved for several immune-mediated inflammatory diseases. No evidence exists in the Middle East and North Africa region on the experience with infliximab use over an extended period in terms of efficacy and safety.
METHODS
The Rheumatology division at the American University of Beirut Medical Centre (AUBMC), one of the largest tertiary centres in the Middle East and North Africa region, has been using infliximab infusions for the treatment of certain rheumatic diseases for around two decades. By reviewing retrospectively medical charts at AUBMC, we investigate indications, safety and efficacy, rate of withdrawals, rate of switching to another biologic, and financial coverage of the drug to present data for practitioners and patients in the region considering infliximab for treatment of immune-mediated inflammatory diseases.
RESULTS
A total of 198 patients were identified in the past 17 years to have taken infliximab. The largest proportion of treated patients had RA. Fourteen percent of the total cohort experienced serious adverse events, with 96.4% of those events being mild hypersensitivity reactions. Five patients withdrew the medication because of infectious complications, 4 of which were cases of tuberculosis reactivation. Despite that, around half of the patients were switched to another biologic agent such anti-TNF-α, anti-CD20, and anti-IL-6 due to partial response, and less than half were receiving add-on disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, 70% of patients who used infliximab only or were switched achieved complete remission at their last hospital information. Around 98% of infliximab users were financially covered.
CONCLUSION
According to our experience, infliximab has made remission and prevention of long-term disability realistic goals of therapy in the Middle East region.
目的
英夫利昔单抗（类克®）是首个获得美国食品药品监督管理局（FDA）初始上市批准用于治疗克罗恩病的肿瘤坏死因子-α（TNF）抑制剂。此后，英夫利昔单抗被批准用于多种免疫介导的炎症性疾病。在中东和北非地区，尚无关于长期使用英夫利昔单抗的疗效和安全性的证据。
方法
贝鲁特美国大学医疗中心（AUBMC）的风湿病科是中东和北非地区最大的三级医疗中心之一，使用英夫利昔单抗输注治疗某些风湿性疾病约二十年。通过回顾性查阅AUBMC的病历，我们调查了适应症、安全性和疗效、停药率、换用另一种生物制剂的比例以及该药物的医保覆盖情况，以便为该地区考虑使用英夫利昔单抗治疗免疫介导的炎症性疾病的从业者和患者提供数据。
结果
在过去17年中，共识别出198例使用过英夫利昔单抗的患者。接受治疗的患者中比例最大的是类风湿关节炎（RA）患者。整个队列中有14%经历了严重不良事件，其中96.4%的事件为轻度过敏反应。5名患者因感染并发症停药，其中4例为结核病复发。尽管如此，约一半的患者因部分缓解而换用另一种生物制剂，如抗TNF-α、抗CD20和抗IL-6，不到一半的患者同时接受改善病情抗风湿药物（DMARDs），如甲氨蝶呤，仅使用英夫利昔单抗或换用药物的患者中，70%在最后一次住院时达到完全缓解。约98%的英夫利昔单抗使用者有医保覆盖。
结论
根据我们的经验，英夫利昔单抗已使缓解和预防长期残疾成为中东地区治疗的现实目标。
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