What Comprehensive Disease Control Means for IBD, With David Rubin, MD

For decades, remission in inflammatory bowel disease (IBD) has been measured almost exclusively by what's happening in the bowel. David T. Rubin, MD, a professor of medicine at the University of Chicago, director of the Inflammatory Bowel Disease Center, and chair of the International Organization for the Study of IBD (IOIBD), argues that definition is too narrow to capture what patients actually need.

"What we're trying to do for anybody who's suffering from anything, frankly, is improve their quality of life," Rubin said in an interview with HCPLive.

A Holistic Definition of Disease Control

Rubin's framework, comprehensive disease control (also called comprehensive disease management), reflects a shift in how the field defines success in Crohn's disease and ulcerative colitis. As IBD treatments have multiplied, most clinical trial endpoints have stayed centered on the bowel. But Rubin points out that these conditions extend well beyond the intestines.

"We recognize that these conditions affect much more than the intestines, and therefore, in order to take care of people properly who have these problems, we need to be thinking about the whole person," Rubin said.

That whole-person view includes well-established extraintestinal manifestations like joint pain and skin inflammation, but Rubin extends it further to what he calls atypical extraintestinal manifestations: mental health disorders, sexual health, and sleep quality. Patients with IBD have a higher prevalence of anxiety and depression than those without the disease, and Rubin's goal, he said, is "an unrestricted, high quality of life."

Three Types of Remission

Rubin breaks remission into three sequential categories for his patients. The first is symptomatic: no pain, no diarrhea, no bleeding, no urgency.

The second is control of the underlying disease process itself, confirmed through normalized biological markers on scopes, stool tests, or blood tests (in children, growth and development serve as markers). Rubin emphasizes that this second category is not optional. "50% of people who feel well or feel better will still be inflamed, and if you're still inflamed despite feeling okay, you will relapse," he said.

"I want you to feel perfect, but I want it to last forever, and that means we have to control the disease process," Rubin said.

The third category is what Rubin calls functional remission: no joint pain, no skin inflammation, no depression or anxiety, restored sexual health, and the ability to work, travel, go to school, or have children without the disease getting in the way. He describes this as the ultimate goal, but stresses the categories have to be addressed in order.

Why the Bar Needs to Be Raised

Comprehensive disease control adds standardized quality-of-life measures to the usual clinical trial endpoints of symptom control and endoscopic or biomarker-based disease control. According to Rubin, this reframing exposes a gap that's easy to miss when only looking at the bowel.

"When you raise the bar, you start to realize that even when you have people whose bowels are perfect, you're not improving their quality of life because you haven't addressed the other issues," Rubin said. "Healing is different than just treating inflammation."

Editor’s Note: Rubin reports relevant disclosures with AbbVie, Takeda, Pfizer, Janssen, Bristol Myers Squibb, and others.

References

1. Defining comprehensive disease control for use as a treatment target for ulcerative colitis in clinical practice: international Delphi consensus recommendations. J Crohns Colitis. 2024;18(1):91-105.

2. Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583.