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New Study Alert: Self-Injectable Vedolizumab Likely on the Way in 2020

Intravenous Vedolizumab has been commercially available since May 2014 for the treatment of both Crohn’s disease and Ulcerative Colitis (UC). It has been an extremely useful treatment option for many for whom other agents may not have helped. Therefore, a Subcutaneous (SC) option was developed and a study to determine whether SC was as effective as IV Vedoluzimab in UC.

The VISIBLE 1 phase 3 study was a randomized, double-blind, double-dummy, placebo-controlled study assessing the therapeutic efficacy of intravenous (IV) Vedolizumab to subcutaneous (SC) Vedolizumab in patients with active UC.

What is a double-blind double-dummy study?

This means that both doctors and patients did not know when the patient was receiving the IV or SC Vedolizumab or the IV or SC Saline placebo.

Was SC as effective as IV Vedolizumab in UC?

Yes! IV and SC achieved similar rates of both clinical and mucosal remission. This means that SC was as effective as IV. Notably, patients will still undergo IV induction and then be able to transition to SC maintenance thereafter.

When will it be available?

The FDA will conduct its own review of the data and analysis. If FDA approved, the SC version of Vedolizumab may be available in early 2020. Let’s see!

Another trial in Crohn’s is underway and nearing completion too.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.


  • Amanda Osowski moderator
    4 months ago

    I’m so glad you shared this, and hopeful for what it means for patients going forward! As someone who was on Entyvio for 6 months and now has been on Remicade for 2+ years, infusion days are long and exhausting. The idea of at home injections has always sounded preferable! Looking forward to seeing what comes of this and other advancements for IBD treatments!

    Amanda (team member)

  • Neilanjan Nandi, MD, FACP author
    4 months ago

    Absolutely ! To emphasize: Patients will always have the choice of SC or IV which is nice to ensure options and access to whatever works best for them !

  • thedancingcrohnie moderator
    4 months ago

    Great news. Thank you for the information. SC injections are definitely more convenient for the patient, in my opinion.

    Always dancing,
    Elizabeth (team member)

  • Neilanjan Nandi, MD, FACP author
    4 months ago

    Indeed, SC preferable. Exciting that some oral pill treatments are being developed too ! Still a few years away but I am happy to hear that we are trying to develop routes of administration that provide a better patient experience!

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