Simulation supports biologic therapy Entyvio as initial biologic ulcerative colitis treatment: 6 things to know

A study in Inflammatory Bowel Diseases used a novel simulation model to assess the optimal treatment positioning for patients with moderately to severely active ulcerative colitis and to predict treatment response. The model supports the use of Entyvio as an initial steroid-sparing therapy in steroid-dependent UC patients.

Here are six things to know:

1. Due to inadequate symptom control, more than 10 percent of UC patients require colectomy within 20 years of diagnosis.

2. Vedolizumab is approved as a humanized monoclonal antibody and is available in the U.S. under the trade name Entyvio. This is the first and only biologic therapy to be approved in the U.S. for treating both adults with moderately to severely active UC or Crohn's Disease who are unable to manage symptoms with other therapies.

3. Using a Markov model, investigators assessed the optimal positioning for initiating Entyvio therapy based on the case of a 35-year-old male with moderately to severely active UC who was steroid-dependent and had not previously received immunomodulators or biologic therapy.

4. The model compared four treatment scenarios over the course of one year, incorporating Entyvio in different positions within a typical treatment paradigm for steroid-dependent patients:

  • Prior to initiating azathioprine
  • Prior to combination therapy with infliximab and azathioprine,
  • Prior to combination therapy with adalimumab and azathioprine and
  • Aas a last-line therapy after combination therapy with adalimumab prior to a colectomy.                                                                                                                 

Primary analyses included simulating 100 trials of 100,000 patients with outcomes assessed in terms of quality-adjusted life years.

5. People with UC and CD have an increased number of inflammatory white blood cells entering the bowel's mucosal ling, which can lead to the most common UC or CD symptoms. Vedolizumab is intended to reduce the inflammation by blocking the movement of the white blood cells into the inflamed gut tissue.

6. Clinical trials are necessary to directly compare sequential treatment algorithms.

"In the absence of clinical trials comparing treatment algorithms for UC, analyses like this simulation provide tools for helping the clinical community determine the best ways to incorporate specific therapies into practice," said Frank Scott, MD, assistant professor of medicine at the University of Colorado School of Medicine in Denver. "The resulting data help provide valuable insights for healthcare providers evaluating the sequence of therapies for certain patients with ulcerative colitis early in the treatment algorithm."

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