Extended Validation of an Ulcerative Colitis Vedolizumab Decision Support Tool for Outcome Prediction with Tofacitinib

Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: Extended Validation of an Ulcerative Colitis Vedolizumab Decision Support Tool for Outcome Prediction with Tofacitinib
Vivli Data Request: 8294
Funding Source: None
Potential Conflicts of Interest: Neeraj Narula has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Lupin and Ferring. None of the listed conflicts of interest are aware of or are involved in this research

Summary of the Proposed Research:
Vedolizumab is biologic approved for moderate to severe ulcerative colitis, which specifically targets the gut to help improve inflammation. Biologics are drugs that are made of animal and/or human cells, viruses, and proteins. Several other biologics are available with various modes of action and the optimal treatment for some patients remain unclear. The majority of guidance surrounding choice of therapy encourages clinicians to consider all available therapies given currently available evidence as opposed to explicitly outlining which therapies are better suited for specific patient populations. In the absence of explicit guidelines, I previously developed and validated a clinical decision support tool specifically for vedolizumab that has demonstrated the ability to identify ulcerative colitis patients who may derive the greatest benefit with vedolizumab. More importantly, I have demonstrated this tool can predict response specifically to vedolizumab rather than anti-TNF therapy, which are drugs that reduce inflammation in conditions such as ulcerative colitis. However, further validation is needed to compare the prognostic value of this tool for vedolizumab compared to therapies with other modes of action in a post-hoc analysis using robust data from randomized clinical trials. The primary aim of this study is to further validate the ability of the clinical decision support tool to identify ulcerative colitis patients suited for vedolizumab treatment compared to tofacitinib, which is as small molecule drug. These drugs have very low molecular weight and can be taken orally. This validation exercise may benefit ulcerative colitis patients as it can provide greater confidence in the use and uptake of the clinical decision support tool in clinical settings for vedolizumab.

Requested Studies:
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer
Study ID: NCT01465763
Sponsor ID: A3921094

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
Data Contributor: Pfizer
Study ID: NCT01458951
Sponsor ID: A3921095

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Data Contributor: Pfizer
Study ID: NCT01458574
Sponsor ID: A3921096