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$2.4 Million Grant to Fund Trial Comparing IBD Therapies
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A new study comparing the efficacy of newer biologic and small-molecule therapies for inflammatory bowel disease will receive funding via a $2.4 million grant from the Patient-Centered Outcomes Research Institute and the Crohn’s & Colitis Foundation.
The study will test agents like Stelara (ustekinumab, Janssen) and Entyvio (vedolizumab, Takeda) which could provide additional therapy options for patients who do not respond to anti-TNF therapy, according to a press release.
“Selecting the most effective treatment is incredibly important to our patients,” Angela Dobes, the CCF’s senior director of IBD Plexus — a research exchange platform — and one of the study’s principal investigators, said in the press release. “This study will engage key stakeholders, most importantly patients, at each phase to ensure that the results provide patients, and their physicians, with strong evidence to support important treatment decisions.”
Dobes and colleagues will compare ustekinumab and vedolizumab among patients with Crohn’s disease who are anti-TNF primary or secondary non-responders, as well as the efficacy of vedolizumab vs. the small molecule Xeljanz (tofacitinib, Pfizer) among anti-TNF refractory patients with ulcerative colitis.
The study will include 180 patients from across the United States and focus on patient-reported outcomes including pain, fatigue and other symptoms collected through electronic surveys. Investigators will use real-world data to compare the efficacy of the different therapies, according to the press release.
“This study focuses on outcomes that really matter to patients, including various aspects related to quality of life. We will also evaluate the ability to prevent hospitalization and surgery, and the length of time patients remain on treatment,” Michael Kappelman, MD, MPH, professor at the University of North Carolina at Chapel Hill, and the study’s principal investigator, said in the press release. “Using varied real-world data sources, our study findings will be broadly generalizable and directly inform these important patient treatment decisions.”
Disclosures: Healio Gastroenterology and Liver Disease could not confirm Dobes’ and Kappelman’s relevant financial disclosures prior to publication.