Issue 14

Clinical Question

How effective is vedolizumab (VED) for induction and maintenance of remission in patients with moderate–severe ulcerative colitis (UC) who have previously failed other anti-TNFs?

Bottom Line

As with all other biologics, there is a slight decrease in the efficacy of VED if the patient has been previously treated with an anti-TNF.

References

Feagan BG, Rubin DT, Danese S, et al. Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists. Clin Gastroenterol Hepatol. 2017 Feb;15(2):229–39. https://www.ncbi.nlm.nih.gov/pubmed/27639327

Synopsis

The parent study, GEMINI I, assessed the efficacy of VED for induction (weeks 0–6) and maintenance (weeks 6–52) of remission in 374 patients with moderate–severe UC. The two treatment arms differed by VED dosing frequency, either every 4 weeks or 8 weeks. Since the efficacy outcomes were similar, the VED treatment groups were combined in this post hoc analysis. Patients included in this analysis were first categorized by study group (VED vs. placebo) then by prior anti-TNF exposure (naïve vs. failure). Results were expressed as risk ratios (RR) for efficacy.

For both induction and maintenance, VED was superior to placebo in all patients (Table 1). Specifically, for induction of remission, VED therapy was similarly effective for patients with and without prior anti-TNF exposure. During maintenance, anti-TNF naïve patients had higher response rates to both VED and placebo than those who had previous anti-TNF failure. The anti-TNF failure patients, had much higher RRs for clinical remission, mucosal healing, and corticosteroid-free remission than their anti-TNF naïve counterparts. The authors noted that this merits further investigation as this population was characterized as having refractory disease and may have been primed to respond to VED in the long-term rather than placebo.

Details

Study Design: Retrospective analysis of double-blind randomized placebo-controlled trial
Funding: Millennium Pharmaceuticals, Inc (d/b/a Takeda Pharmaceuticals Int Co)
Allocation: Prior anti-TNF exposure
Setting: Post hoc analysis of GEMINI 1 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.