Awan Humza, Fatima Urooj, Eaw Ryan, Knox Naomi, Alrubaiy Laith
Department of Metabolism, Digestion and Reproduction, Imperial College London, London, GBR.
Gastroenterology, Swansea University Medical School, Swansea, GBR.
Cureus. 2023 Apr 15;15(4):e37609. doi: 10.7759/cureus.37609. eCollection 2023 Apr.
Biologics have been emerging as promising therapies in ulcerative colitis (UC) patients who are refractory to conventional medical treatment. This literature review aims to appraise the existing evidence on the efficacy and safety of NICE approved biological therapies, of which there are currently five licensed drugs, available for the treatment of UC in adults. An initial search was performed using National Institute of Clinical Excellence (NICE) guidelines. A further literature search of EMBASE, MEDLINE, Science Direct and Cochrane Library databases was done, resulting in a total of 62 studies being included in this review. Recent and seminal papers were included. Inclusion criteria for this review were adult participants and English papers only. In most studies, anti-tumour necrosis factor ɑ (TNFɑ) naïve patients were found to have improved clinical outcomes. Infliximab was found to be highly effective in inducing short-term clinical response, clinical remission as well as mucosal healing. However, loss of response was common and dose escalation was often required for achievement of long-term efficacy. Adalimumab was found to have both short-term and long-term efficacy which was also supported by real-world data. Golimumab was shown to have comparable efficacy and safety profiles to other biologics, although lack of therapeutic dose monitoring and loss of response is a barrier to optimising golimumab treatment efficacy. Vedolizumab was shown to have higher clinical remission rates when compared to adalimumab in a head-to-head trial, and the most cost-effective biologic when calculating quality-adjusted life years. Ustekinumab was found to significantly improve clinical remission rates in UC patients who were previously unresponsive to other biological treatments. However, as this is a newly licensed drug, there is limited literature currently available. Further, head-to-head studies are required to help determine the optimal treatment for patients with UC. With patents expiring, the development of biosimilars will help to reduce costs and increase the availability of these drugs to patients.
生物制剂已成为治疗对传统药物治疗无效的溃疡性结肠炎（UC）患者的有前景的疗法。这篇文献综述旨在评估英国国家卫生与临床优化研究所（NICE）批准的生物疗法的疗效和安全性的现有证据，目前有五种已获许可的药物可用于治疗成人UC。最初使用NICE指南进行了检索。随后对EMBASE、MEDLINE、科学Direct和Cochrane图书馆数据库进行了进一步的文献检索，本综述共纳入62项研究。纳入了近期的重要论文。本综述的纳入标准仅为成年参与者和英文论文。在大多数研究中，未使用过抗肿瘤坏死因子α（TNFα）的患者临床结局有所改善。英夫利昔单抗在诱导短期临床反应、临床缓解以及黏膜愈合方面被发现非常有效。然而，反应丧失很常见，通常需要增加剂量以实现长期疗效。阿达木单抗被发现具有短期和长期疗效，真实世界数据也支持这一点。戈利木单抗显示出与其他生物制剂相当的疗效和安全性，尽管缺乏治疗剂量监测和反应丧失是优化戈利木单抗治疗疗效的障碍。在一项头对头试验中，维多珠单抗与阿达木单抗相比显示出更高的临床缓解率，在计算质量调整生命年时是最具成本效益的生物制剂。乌司奴单抗被发现可显著提高先前对其他生物治疗无反应的UC患者的临床缓解率。然而，由于这是一种新获批的药物，目前可用的文献有限。此外，需要进行头对头研究以帮助确定UC患者的最佳治疗方法。随着专利到期，生物类似药的开发将有助于降低成本并增加这些药物对患者的可及性。
