Cording Jimmi, Blömacher Margit, Wiebe Berit Inga, Langhorst Jost, Kucharzik Torsten, Sturm Andreas, Schreiber Stefan, Helwig Ulf
Kompetenznetz Darmerkrankungen eV, Kiel, Germany.
Klinikum Bamberg, Bamberg, Germany.
JMIR Res Protoc. 2019 Nov 8;8(11):e14335. doi: 10.2196/14335.
Vedolizumab has been shown to induce clinical remission in patients with active ulcerative colitis. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. However, in clinical practice, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest.
The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate-to-severe ulcerative colitis by calculating the probability of clinical response at week 14, on the basis of the data from week 6.
This is a prospective, single-arm, multicentric, noninterventional, observational study with no interim analyses and a sample size of 35 evaluable patients.
The enrollment started in August 2018 and was still open at the date of submission. The study is expected to complete in September 2020.
The early identification of patients who are responding to an integrin antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or nonresponders can thus help prescribing physicians avoid ineffective treatments and stop these very early.
维多珠单抗已被证明可诱导活动性溃疡性结肠炎患者实现临床缓解。使用抗整合素维多珠单抗治疗6周后，16.9%的病例实现临床缓解，47.1%的病例有临床反应。然而，在临床实践中，最早要到14周才会决定停用或继续使用维多珠单抗治疗。
本研究的目的是通过根据第6周的数据计算第14周临床反应的概率，开发一种优化中重度溃疡性结肠炎患者维多珠单抗给药的算法。
这是一项前瞻性、单臂、多中心、非干预性观察性研究，无中期分析，样本量为35例可评估患者。
入组于2018年8月开始，在提交本文时仍在进行。该研究预计于2020年9月完成。
早期识别对整合素抗体有反应的患者具有治疗益处。同时，可以更早地识别无反应的患者。因此，开发一种用于识别反应者或无反应者的治疗算法可以帮助开处方的医生避免无效治疗并尽早停止治疗。
