Issue 08

Clinical Question

Do ulcerative colitis (UC) patients treated to mucosal healing with biologic therapy normalize their symptoms?

Editor’s Bottom Line

Despite endoscopic mucosal healing, after one year of biologic treatment less the half of patients will have normal stool frequency implying post-IBD irritable bowel syndrome.

Reference

Jharap B, Sandborn WJ, Reinisch W, et al. Randomised clinical study: discrepancies between patient-reported outcomes and endoscopic appearance in moderate to severe ulcerative colitis. Aliment Pharmacol Ther. 2015 Nov;42(9):1082–92. https://www.ncbi.nlm.nih.gov/pubmed/26381802

Synopsis

This post hoc study enrolled eligible patients from the ULTRA 1 and 2 studies assessing the efficacy of adalimumab (160/80 mg) for the induction and maintenance of remission in UC. Study endpoints were rectal bleeding and stool frequency subscores in patients with endoscopic scores of either 0 or 0-1 at weeks 8 and 52.

At weeks 8 and 52, 433 and 299 patients were available for analyses. For those with an endoscopic score of 0 at week 8 (i.e., mucosal healing), 87% had no rectal bleeding but only 29% had normal stool frequency. In those patients with mucosal healing, 92% reported no bleeding yet only 41% had normal stool frequency by week 52.

Details

Study Design: Retrospective evaluation of the phase III studies ULTRA 1 and 2
Funding: AbbVie Inc.
Allocation: n/a
Setting: Multicentre study
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.