Department of Gastroenterology, Hepatology, Oncology and Pneumology, Markus Hospital, Frankfurt, Germany.
OPEN Health HEOR & Market Access, Manchester, UK.
Adv Ther. 2024 Dec;41(12):4446-4462. doi: 10.1007/s12325-024-03003-8. Epub 2024 Oct 15.
This study aimed to compare the efficacy and safety of biologics and small molecules for treatment of adults with moderately-to-severely active ulcerative colitis (UC).
A systematic literature review was conducted to identify randomised controlled trials evaluating approved and emerging targeted therapies for patients with UC. A Bayesian network meta-analysis (NMA) approach was applied. Outcomes assessed included clinical response and remission, endoscopic mucosal healing, and safety.
Thirty studies were included in the NMA following a feasibility assessment comparing approved induction dosing regimens and 22 studies comparing approved maintenance dosing regimens. In the biologic/Janus kinase inhibitor (JAKi)-naïve population, induction studies showed similar clinical response and remission rates across most interventions, with upadacitinib demonstrating significant improvements versus most other interventions. For maintenance studies, mirikizumab demonstrated significant improvements in clinical response and remission versus most other interventions. In the biologic/JAKi-experienced population, no significant differences were observed between most interventions in induction studies, except for significantly improved clinical response and remission for mirikizumab versus adalimumab, and upadacitinib demonstrated significant improvement versus all other interventions. Few differences between active treatments were observed in maintenance studies. In both populations, all active interventions had similar efficacy in terms of endoscopic mucosal healing in both induction and maintenance studies. Regardless of prior treatment exposure, similar rates of serious adverse events were seen across all active interventions in the induction period.
Among the available interventions, owing to its favourable efficacy and safety profile, mirikizumab has a relevant role in the long-term treatment of UC.
本研究旨在比较生物制剂和小分子药物治疗中重度活动溃疡性结肠炎（UC）成人患者的疗效和安全性。
系统检索评估 UC 患者获批和新兴靶向治疗药物的随机对照试验，采用贝叶斯网络荟萃分析（NMA）方法。评估的结局包括临床缓解和缓解率、内镜黏膜愈合和安全性。
在比较获批诱导剂量方案的可行性评估后，30 项研究纳入 NMA，22 项研究比较获批维持剂量方案。在生物制剂/Janus 激酶抑制剂（JAKi）初治人群中，诱导研究显示大多数干预措施的临床缓解和缓解率相似，与大多数其他干预措施相比，乌帕替尼具有显著改善。对于维持研究，与大多数其他干预措施相比，mirikizumab 在临床缓解和缓解方面有显著改善。在生物制剂/JAKi 经验人群中，诱导研究中大多数干预措施之间未观察到显著差异，除了 mirikizumab 与阿达木单抗相比临床缓解和缓解率显著改善，乌帕替尼与所有其他干预措施相比具有显著改善。维持研究中观察到活跃治疗之间几乎没有差异。在两个人群中，所有活性干预措施在诱导和维持研究中内镜黏膜愈合的疗效相似。无论既往治疗暴露情况如何，诱导期所有活性干预措施的严重不良事件发生率相似。
在现有的干预措施中，mirikizumab 因其良好的疗效和安全性，在 UC 的长期治疗中具有重要作用。
