JMIR Publications

ABSTRACT

Background:

Vedolizumab has been shown to induce clinical remission in patients with active UC. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. In clinical practice, however, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest.

Objective:

The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate to severe Ulcerative colitis (UC) by calculating the probability of clinical response in Week 14 based on data from Week 6.

Methods:

The study is designed as a prospective, single-arm, multicentric, non-interventional observational study with no interim analyses and a sample size of 35 evaluable patients.

Results:

Enrollment started in August 2018 and was still open at the date of submission. The study is expected to finish in September 2020.

Conclusions:

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 non-responders can thus help prescribing physicians to both: avoid ineffective treatments and adjust dosages when necessary. This in turn promotes a higher degree of treatment tolerance and patient safety in the case of the anti-Integrin antibody Vedolizumab administration. Clinical Trial: German Clinical Trials Register, Deutsches Register Klinischer Studien DRKS00014249; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014249