Study to compare the effectiveness of biologic or small molecule therapies in IBD receives funding

Crohn’s disease (CD) and ulcerative colitis (UC), collectively referred to as inflammatory bowel diseases (IBD), which may affect as many as 3 million Americans, cost over $6 billion annually, and cause substantial patient morbidity, missed work and school, and diminished quality of life. Currently, anti-TNF therapy is considered first line treatment for moderate-to-severe IBD. However, up to 80 percent of patients do not respond or, ultimately, lose response to anti-TNF. New treatments provide additional options from which to choose, however, there are no head-to-head studies that compare these new treatments.

The Crohn’s and Colitis Foundation is a leader in a $2.4 million funding award recently approved by the Patient-Centered Outcomes Research Institute (PCORI) to study comparative effectiveness of biologic or small molecule therapies in inflammatory bowel diseases. Leveraging the research infrastructure developed by PCORnet, the National Patient-Centered Clinical Research Network, and by IBD Plexus, the Foundation’s new research exchange platform, this project will compare the effectiveness of these newer treatment options, providing needed data that will help patients and physicians make more informed healthcare decisions.

“Selecting the most effective treatment is incredibly important to our patients,” said Angela Dobes, the Foundation’s senior director of IBD Plexus and one of the study’s principal investigators. “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.”

The aims of the study are to compare the effectiveness of newer biologic agents (ustekinumab versus vedolizumab) among patients with Crohn’s disease who are anti-TNF primary or secondary non-responders; and to compare the effectiveness of vedolizumab versus a small molecule (tofacitinib) among anti-TNF refractory ulcerative colitis patients.

The study will recruit 180 patients across the country with each condition who are starting one of the treatments being compared. Participants may also be referred by partner health plans, Anthem Blue Cross Blue Shield and Humana, or join the study directly through IBD Partners, the Foundation’s patient-powered research network (www.ibdpartners.org). The study will focus on patient-reported outcomes including pain, fatigue, and other symptoms, collected through electronic surveys. The study will also analyze the real-world data collected on thousands of patients by the health plan partners to further compare the effectiveness of these agents.

“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,” said the study’s principal investigator Michael Kappelman, MD, MPH, a professor at the University of North Carolina at Chapel Hill and a co-principal investigator of IBD Partners. “Using varied real-world data sources, our study findings will be broadly generalizable and directly inform these important patient treatment decisions.”

Source: Crohn’s and Colitis Foundation

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