Podcast on Vedolizumab Efficacy for Crohn’s Disease

According to AGA Journals blog, one may need to wait up to 10 weeks to determine whether vedolizumab is effective for Crohn’s disease. Here’s the link: Vedolizumab for Crohn’s.

Here’s an excerpt: (re: Bruce Sands’ article in the September issue of Gastroenterology)

Sands et al. report that vedolizumab, an antibody against the integrin α4β7, is no more effective than placebo in inducing clinical remission at week 6 in patients with Crohn’s disease in whom previous treatment with tumor necrosis factor antagonists had failed.

However, at week 10, a higher proportion of patients given vedolizumab were in remission (26.6%) than of those given placebo (12.1%)… Adverse events were similar between groups.

Related blog post:

4 thoughts on “Podcast on Vedolizumab Efficacy for Crohn’s Disease

  1. Any comments on the pediatric use of vedolizumab?
    Seems the FDA waived the pediatric requirement for approval. The BLA Approval letter states that the date for the protocol for the pediatric dose ranging study is 3/16, study completion date is 7/20. The induction and maintenance study protocol submission date is 8/20 with the final report submission date of 6/28.
    Any place in the US planning to conduct this pediatric study?
    Anybody using it off label? Any success with reimbursement?

    Any ideas on how to make the Pediatric Research Equity Act more responsive to pediatric needs?

    • These are very good questions –I do not have the expertise to answer though. There are several trials listed for vedolizumab at clinicaltrials.gov –I did not look to see the age requirement. At this week’s NASPGHAN meeting, I expect to hear more about efforts for studying vedolizumab in children. It is being used off label. I know of several children who have been receiving the medication. Currently, there are issues with reimbursement; hopefully, this will be worked out soon.

  2. Pingback: NASPGHAN Postgraduate Course 2014 -Intestinal Inflammation | gutsandgrowth

  3. Pingback: Early Look At Entyvio (Vedolizumab) in Pediatrics | gutsandgrowth

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