FDA Approves Subcutaneous Vedolizumab for Moderate to Severe UC


Data from the VISIBLE 1 trial showed more patients receiving subcutaneous vedolizumab achieved clinical remission, mucosal healing, durable clinical response, durable clinical remission, and corticosteroid-free clinical remission compared to those receiving placebo.

Bruce Sands, MD, MS | Credit: Alimentiv

Bruce Sands, MD, MS

Credit: Alimentiv

The US Food and Drug Administration (FDA) has approved a subcutaneous administration of vedolizumab (Entyvio) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with intravenous vedolizumab.

Announced by Takeda on September 27, 2023, the approval is supported by data from the phase 3 VISIBLE 1 study, which showed 46% of patients receiving subcutaneous vedolizumab 108 mg maintenance therapy achieved clinical remission compared to 14% of patients receiving placebo (P < .001).1

“The VISIBLE 1 trial demonstrated that ENTYVIO SC can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients. Since its approval in 2014, ENTYVIO has continued to build a robust safety and efficacy profile,” said Bruce Sands, MD, MS, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai.1 “I appreciate now having a subcutaneous administration option that provides a clinical profile consistent with ENTYVIO IV while also giving me and my appropriate UC patients a choice of how they receive their maintenance therapy.”

A humanized monoclonal antibody designed to antagonize the alpha4beta7 integrin, vedolizumab inhibits the binding of the alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 and limits the ability of certain white blood cells to infiltrate gut tissues. It was approved by the FDA in 2014 as an intravenous formulation.1

VISIBLE 1, a phase 3, randomized, double-blind, placebo-controlled trial, assessed the safety and assessing the safety and efficacy of subcutaneous vedolizumab as maintenance therapy. Specifically, the trial examined the treatment in adult patients with moderately to severely active UC who achieved clinical response at week 6 after 2 doses of open-label intravenous vedolizumab therapy at weeks 0 and 2.1

To be included in the study, patients were required to have a UC diagnosis at least 6 months prior to screening, moderately to severely active UC as determined by a complete Mayo score of 6-12, evidence of UC extending proximal to the rectum, and demonstrate an inadequate response to, loss of response to, or intolerance to at least a single 12-week regimen of azathioprine or 6-mercaptopurine, induction with a tumor necrosis factor blocker, or corticosteroids. In total, 162 patients were randomized 2:1 to either vedolizumab subcutaneous 108 mg or placebo by subcutaneous injection every 2 weeks.2

The primary endpoint was clinical remission at week 52, which was defined as a total Mayo score of ≤2 and no individual subscore >1. Secondary outcome measures included the percentage of participants achieving mucosal healing, durable clinical response, durable clinical remission, and corticosteroid-free remission.2

Presented at the 2018 United European Gastroenterology Week congress, results from the trial revealed more patients receiving subcutaneous vedolizumab achieved clinical remission compared to patients receiving placebo (46.2% vs 14.3%; P < .001), with a similar rate of clinical remission observed in the intravenous vedolizumab reference arm (42.6%). Vedolizumab also achieved increased mucosal healing compared to placebo (56.6% vs 21.4%; P < .001). Durable clinical response (64.2% vs 28.6%; P < .001), durable clinical remission (15.1% vs 5.4%; P = .076), and corticosteroid-free clinical remission (28.9% vs 8.3%; P = .067) were also greater in vedolizumab compared to placebo.3

The safety profile was generally consistent with the known safety profile of intravenous vedolizumab. Injection-site reactions were experienced by 9.4% of patients in the vedolizumab treatment group, with none leading to treatment discontinuation.3

“With the FDA approval of subcutaneous ENTYVIO, patients and physicians who want ENTYVIO’s clinical profile along with flexibility of administration now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis,” said Brandon Monk, senior vice president and head of the US Gastroenterology Business Unit of Takeda.1 “Takeda is committed to meeting the varied medical needs, circumstances and personal preferences of people living with UC as they progress in their lifelong journey with the disease. ENTYVIO is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”


  1. Takeda. U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis. Press Releases. September 27, 2023. Accessed September 28, 2023. https://www.takeda.com/newsroom/newsreleases/2023/US-FDA-Approves-Subcutaneous-Administration-of-Takeda-ENTYVIO-vedolizumab-for-Maintenance-Therapy-in-Moderately-to-Severely-Active-Ulcerative-Colitis/
  2. Clinicaltrials.gov. Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis. May 25, 2022. Accessed September 28, 2023. https://classic.clinicaltrials.gov/ct2/show/results/NCT02611830
  3. Takeda. Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis. Press Releases. October 22, 2018. Accessed September 28, 2023. https://www.takeda.com/newsroom/newsreleases/2018/investigational-subcutaneous-vedolizumab-achieves-and-maintains-clinical-remission-and-mucosal-healing-at-week-52-in-patients-with-ulcerative-colitis/
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