Crohn’s disease (CD) and ulcerative colitis (UC), also known as inflammatory bowel disease (IBD), affect about 3 million people in the United States, of all ages. IBD is a chronic disease of unknown cause, causing inflammation and ulcers in the intestines leading to symptoms of abdominal pain, bloody diarrhea, weight loss, and fatigue. Many patients with IBD are unable to work, go to school, or participate in regular life activities because of these symptoms. IBD can also cause complications that require hospitalization, surgery to remove parts of the intestine, or even result in cancer. There is no cure for this disease, and patients require long-term medications to keep the disease under control. Though these medications are effective, they may cause serious side effects because they suppress the immune system, and are very expensive. Even patients who continuously take medications and whose symptoms are well-controlled can unpredictably have a flare or return of bowel symptoms and require hospitalization and/or surgery. Doctors believe these flares happen because almost half of patients still have inflammation in their intestines even if their symptoms are controlled with medications. Research has shown that patients whose inflammation heals completely have a much lower risk of flares and complications. Because of this, more and more doctors are recommending a “Treat-to-Target” approach for IBD, in which they recommend aggressive treatment of inflammation, even in patients who are feeling well on their current medication, often switching to different medicines without really knowing whether the new medication would control inflammation better. What is unknown, and what the project team is studying in this proposal, is if there is benefit of this strategy of switching medicines as part of the “Treat-to-Target” approach, and what are the risks of switching medicines in patients who are otherwise feeling well.
For this study, the team talked with patients with IBD, as well as other members of the healthcare system, to understand what was important to them about changing medicines in patients who already feel well. Based on their comments, the team decided to study if a “Treat-to-Target” approach can reduce flares that require steroids, reduce fatigue, reduce risk of hospitalization and surgery, and whether this approach increases the risk of medicine side effects and burden of treatment. The team proposes to do this study as part of a larger project sponsored by the Crohn’s & Colitis Foundation called IBD Qorus. IBD Qorus is a large connected network of 55 gastroenterology practices around the country that are already participating in ways to improve the care of patients with IBD by learning from each other and from patients with IBD. As part of this study, over a course of five years, 322 patients who are feeling well but have significant inflammation on endoscopy will be randomly either switched to a different (approved) medicine or continued on their original medicine, and see which group will relapse more frequently. The researchers have assembled a team for this project, which includes patients, doctors, and other members of the healthcare system, who have worked together for years as part of IBD Qorus and agree with the importance of this question. The team’s collaboration with the Crohn’s & Colitis Foundation and other stakeholders will also allow it to share the findings from this study with patients and providers and improve care for patients with IBD around the country.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.