Issue 14

Clinical Question

Are anti-tumor necrosis factor (TNF) agents effective for patients with refractory ulcerative proctitis?

Editor’s Bottom Line

These observational data suggest efficacy for anti-TNF therapy in patients with refractory ulcerative proctitis. However, controlled clinical trials targeting this challenging IBD subgroup are still needed.

Reference

Pineton de Chambrun G, Amiot A, Bougen G, et al. Efficacy of Tumor Necrosis Factor Antagonist Treatment in Patients With Refractory Ulcerative Proctitis. Clin Gastroenterol Hepatol. Epub ahead of print June 13, 2019; https://doi.org/10.1016/j.cgh.2019.05.060

Synopsis

Researchers in Europe retrospectively examined data from 104 consecutive patients with active ulcerative proctitis (UP) treated at one of 16 centers in France or Belgium. Patients had not responded to prior treatment with 5-aminosalicylates (5-ASA), corticosteroids or immunosuppressants and, a median 46 months after diagnosis (Interquartile range: 198–110.5 months), received at least one dose of infliximab, adalimumab or golimumab. There was no standardized protocol for anti-TNF use and concomitant medications were permitted. For example, 38% of patients received a thiopurine concomitantly.

A median of three months following initiation of anti-TNF treatment, 77% of patients experienced a clinical response, which the researchers defined as a significant improvement in ulcerative colitis (UC)-related symptoms, and 50% achieved clinical remission, which was defined as complete disappearance of UC-related symptoms. A median of 23.6 months after anti-TNF initiation, 64% of patients were in clinical remission at the most recent follow-up.

Among those with primary non-response to an initial anti-TNF treatment, 75% were switched to another anti-TNF and 46% eventually received vedolizumab, with 22% and 82% of these patients, respectively, subsequently experiencing clinical remission.

Sixty percent of patients who had an endoscopy at baseline and during the study period experienced mucosal healing.

Multivariate analysis showed the likelihood of clinical remission was lower among those with extra-intestinal manifestations (Odds Ratio [OR], 0.24; 95% Confidence Interval [CI], 0.08–0.7; P=0.009), and those who received ongoing topical corticosteroids treatment (OR, 0.14; 95% CI, 0.03–0.73; P=0.019) or topical 5-ASA (OR, 0.21; 95% CI, 0.07–0.62; P=0.007).

Details

Study Design: Retrospective cohort
Funding: Associaton François Aupetit.
Allocation: Not applicable
Setting: Multicenter
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.