Vedolizumab has demonstrated efficacy among individuals with moderate to severe active Crohn disease, according to a study recently published in Gastroenterology. Improvements were observed in radiologic, histologic, and endoscopic outcomes.
This open-label, phase-3b trial (VERSIFY; ClinicalTrials.gov identifier: NCT02425111) included 101 individuals who had experienced active Crohn disease for 3 months or more between March 2015 and December 2017. Active disease was defined by a Crohn Disease Activity Index score between 220 and 450, failure of conventional therapy, a simple endoscopic score for Crohn disease (SES-CD) of 7 or higher, and 1 or less mucosal ulcerations.
At baseline, 44.6% (n=45) of participants had SES-CD of 15 or higher, and 54.5% (n=55) had previously failed at least 1 tumor necrosis factor (TNF) antagonist. Intravenous vedolizumab 300 mg was administered at the start of the study and at weeks 2 and 6, then once every 8 weeks for either 26 (n=101) or 52 (n=56) weeks.
At week 26, the primary end point was SES-CD 4 or higher, signifying endoscopic remission, with other end points being a 50% reduction in SES-CD (endoscopic response), magnetic resonance index of activity score 7 or less (radiologic remission), and modified-global histologic disease activity score 4 or less (histologic response). The Clopper Pearson method was used for point estimates in proportion-based efficacy end points, and descriptive statistics were used for continuous variables.
Endoscopic remission occurred in 12 participants (11.9%; 95% CI, 6.3-19.8) at week 26, and in 18 participants at week 52 (17.9%; 95% CI, 8.9-30.4). TNF antagonist-naivety was associated with greater endoscopic remission compared with TNF antagonist failure (19.6% vs 5.5% at week 26, respectively; 25.0% vs 8.3% at week 52, respectively). Moderate Crohn disease was associated with better endoscopic remission rates than acute Crohn disease (17.0% vs 6.7% at week 26, respectively; 20.7% vs 14.8% at week 52, respectively). Complete mucosal healing increased with time, and outcomes were better in colonic segments than in the ileum.
At week 26, 21.9% (95% CI, 9.3-40.0) of participants were in magnetic resonance enterography-detected remission, and at week 52, 38.1% (95% CI, 18.1-61.6) were in remission. A colonic histologic response was detected in 24.4% (95% CI, 15.3-35.4) of participants at week 26 and 20.5% (95% CI, 9.8-35.3) at week 52; in the ileum, a histologic response was detected in 28.3% (95% CI, 17.5-41.4) at week 26 and 34.3% (95% CI, 19.1-52.2) at week 52.
Study researchers demonstrated “the efficacy of vedolizumab to induce and sustain endoscopic improvements, along with good safety [and] tolerability, in patients with treatment-resistant moderately-to-severely active [Crohn disease]. Improvements were observed in several clinically relevant treatment targets, supporting vedolizumab as a first-line biologic therapeutic option.”
Disclosure: This clinical trial was supported by Takeda Development Center Americas, Inc. Please see the original reference for a full list of authors’ disclosures.
Danese S, Sandborn WJ, Colombel JF, et al. Endoscopic, radiologic, and histologic healing with vedolizumab in patients with active Crohn’s disease [published online July 4, 2019]. Gastroenterology. doi:10.1053/j.gastro.2019.06.038