Biologics in Focus: A Comprehensive Review of the Current Biological Therapies for Ulcerative Colitis in the United Arab Emirates (UAE)

Ahmed El-Sayed, C. Oztumer, Camellia Richards, O. Salim, Mathuri Sivakumar, Laith Alrubaiy
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Abstract

Background: Ulcerative colitis (UC) is a relapsing–remitting inflammatory condition that has an increasing incidence across the world, including in the Middle East. Biological monoclonal antibody drugs (biologics) have been shown to be advantageous in treating UC. We undertook a review of the currently available biological and small-molecule therapies, with a particular emphasis on those currently licensed in the United Arab Emirates (UAE). Methods: We conducted a literature search for studies on biological therapies using the PubMed, MEDLINE, and Embase databases using a list of keywords that were generated following referral to existing treatment guidelines for UC. Papers looking at biological and small-molecule treatments for UC in adult populations were included. Pediatric, pregnancy, and cost-effectiveness studies were excluded. Results and Discussion: There are currently three classes of biologics (anti-tumor necrosis factors (anti-TNFs), anti-integrins, and anti-interleukins) and one class of small-molecule therapy (Janus kinase (JAK) inhibitor) licensed for UC treatment in the UAE. Within the anti-TNF class, three medications have been approved: infliximab, adalimumab, and golimumab. For JAK inhibitors, there are two: tofacitinib and upadacitinib. There is only one licensed medication in the remaining classes: vedolizumab (anti-integrin) and ustekinumab (anti-interleukin). The length of studies varied from 6–8 weeks for induction studies and 52 weeks for maintenance studies. The studies demonstrated increased efficacy in these medications compared to placebos when clinical response, clinical remission, and other secondary measures such as mucosal healing were assessed following the induction and maintenance phases. Biosimilars of infliximab and adalimumab are also available for treating UC, and their safety and efficacy were compared to their biologic originators. Conclusions: The introduction of biologics has been proven to be beneficial for the treatment of UC. This review summarizes the efficacy and safety of each biological class in the treatment of the disease; however, biological drug registries and further studies are required to offer more insight into the comparative efficacy and safety of these agents.
聚焦生物制剂:阿拉伯联合酋长国(UAE)当前治疗溃疡性结肠炎的生物疗法综述
背景:溃疡性结肠炎(UC)是一种复发性-缓解性炎症,在包括中东在内的世界各地发病率越来越高。生物单克隆抗体药物(生物制剂)已被证明在治疗溃疡性结肠炎方面具有优势。我们对目前可用的生物制剂和小分子疗法进行了审查,重点是目前在阿拉伯联合酋长国(UAE)获得许可的疗法。研究方法我们使用 PubMed、MEDLINE 和 Embase 数据库对生物疗法的研究进行了文献检索,并参考了现有的 UC 治疗指南。研究对象包括研究成人 UC 生物疗法和小分子疗法的论文。儿科、妊娠和成本效益研究除外。结果与讨论:阿联酋目前有三类生物制剂(抗肿瘤坏死因子(anti-TNFs)、抗整合素和抗白细胞介素)和一类小分子疗法(Janus 激酶(JAK)抑制剂)获准用于治疗 UC。在抗肿瘤坏死因子类药物中,有三种药物已获得批准:英夫利昔单抗(infliximab)、阿达木单抗(adalimumab)和戈利木单抗(golimumab)。JAK抑制剂有两种:托法替尼(tofacitinib)和乌达替尼(upadacitinib)。其余类别中只有一种获得许可的药物:vedolizumab(抗整合素)和ustekinumab(抗白细胞介素)。研究时间长短不一,诱导研究为 6-8 周,维持研究为 52 周。研究表明,在诱导和维持阶段评估临床反应、临床缓解以及粘膜愈合等其他次要指标时,这些药物的疗效均优于安慰剂。英夫利昔单抗和阿达木单抗的生物仿制药也可用于治疗 UC,其安全性和疗效与生物原研药进行了比较。结论:事实证明,引入生物制剂有利于治疗 UC。本综述总结了各类生物制剂在治疗该疾病方面的疗效和安全性;然而,还需要生物制剂登记和进一步的研究,才能更深入地了解这些制剂的疗效和安全性比较。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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