Early Monitoring of Response (MORE) to Golimumab Therapy Based on Fecal Calprotectin and Trough Serum Levels in Patients With Ulcerative Colitis: A Multicenter Prospective Study

BACKGROUND: The treatment of ulcerative colitis (UC) patients with moderate to severe inflammatory activity with anti-tumor necrosis factor alpha (TNFα) antibodies leads to a clinical remission rate of 10% after 8 weeks of therapy. However, it must be taken into account that patient selection in clinical trials clearly influences both response and remission rates. An unsatisfactory response to anti-TNFα medication after week 12 often leads to a discontinuation of treatment. The early prediction of clinical response could therefore help optimize therapy and potentially avoid ineffective treatments. OBJECTIVE: The aim of this study is to develop an algorithm for optimizing golimumab administration in patients with moderate to severe UC by calculating the probability of clinical response in Week 26 based on data from Week 6. METHODS: The study is designed as a prospective, single-arm, multicenter, non-interventional observational study with no interim analyses and a sample size of 58 evaluable patients. The primary outcome is the prediction of clinical response in Week 26 based on a 50% reduction in fecal calprotectin and a positive golimumab trough level in Week 6. RESULTS: Enrollment started in October 2014 and was still open at the date of submission. The study is expected to finish in December 2016. CONCLUSIONS: The early identification of patients who are responding to an anti-TNFα 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 anti-TNFα antibody administration. CLINICALTRIAL: German Clinical Trials Register, Deutsches Register Klinischer Studien DRKS00005940; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005940 (Archived by WebCite at http://www.webcitation.org/6i4Xoo1sH)