Jordan Axelrad, MD, on Vedolizumab in IBD

Subcutaneous vedolizumab is a well-tolerated option for patients with inflammatory bowel disease (IBD) who responded to induction dosing or have been on stable maintenance infusions, Jordan Axelrad, MD, said during his presentation on April 6 at the Advances in Inflammatory Bowel Disease Regional meeting in Boston, Massachusetts.

Dr Axelrad is an associate professor of medicine in the division of gastroenterology and hepatology at NYU Grossman School of Medicine in New York, New York.

In general, vedolizumab is an “effective treatment strategy for moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC),” Dr Axelrad added.

The findings of a study spearheaded by David Faleck et al proved that patients who had CD for 2 years or less were significantly more likely to achieve a complete response or endoscopic response to vedolizumab than patients with longer disease duration. However, in the case of UC, disease duration was not associated with response to vedolizumab.

The EARNEST study—focused on vedolizumab among patients with UC who underwent restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA)—found vedolizumab to be more effective than placebo in inducing remission. Among 102 randomized patients, 31% of the patients achieved remission at week 14 with vedolizumab versus 10% of the patients with placebo.

Moving on to patients with CD treated with vedolizumab, Dr Axelrad referenced the VERSIFY trial, a phase 3B open-label multicenter study. In this study, patients with moderately to severely active CD were enrolled to receive vedolizumab 300 mg intravenously at weeks 0, 2, 6, and then every 8 weeks for 26 weeks, followed by a 26-week treatment extension period.

“Vedolizumab demonstrated the ability to induce endoscopic remission and healing in a refractory population,” Dr Axelrad said of the results. The remission rates were higher in anti-TNF-naïve patients with CD.

VISIBLE 1 trial found that subcutaneous (SC) vedolizumab was effective as maintenance therapy in patients with moderately to severely active UC who had a clinical response to intravenous vedolizumab induction therapy. It also had a consistently favorable safety and tolerability profile.

The phase 3, double-blind, double-dummy trial at 141 sites in 29 countries from 2015 to 2018 enrolled 216 randomly selected patients. At week 52, 42.6% of patients treated with intravenous vedolizumab and 46.2% of those treated with subcutaneous vedolizumab achieved clinical remission compared to14.3% of patients treated with placebo. The patients treated with subcutaneous vedolizumab also had greater endoscopic improvement and durable clinical response at week 52 compared with placebo.

VISIBLE 2 trial focused on the efficacy and safety of vedolizumab SC among patients with moderately to severely active CD. Following vedolizumab intravenous induction, 275 patients were randomized to vedolizumab SC and 135 to placebo maintenance. While 48.0% of patients receiving vedolizumab SC were in clinical remission at week 52, only 34.3% receiving placebo were in clinical remission,=.

Similarly, patients receiving vedolizumab SC versus placebo achieved enhanced clinical response at week 52 (52.0% versus 44.8%)

“At Week 52, 45.3% of patients receiving vedolizumab SC and 18.2% of patients receiving placebo were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission,” Dr Axelrad said.

“Vedolizumab SC is an effective and safe maintenance therapy among patients with CD who responded to two infusions of vedolizumab intravenous induction therapy,” Dr Axelrad explained.

Reference:
Axelrad J. The IBD toolkit: An update on anti-integrins. Presented at: Advances in Inflammatory Bowel Disease Regional Meeting. April 6, 2024. Boston, Massachusetts.