Redefining Progress in IBD: Driving Toward Better Patient Outcomes

For people living with ulcerative colitis and Crohn’s disease – the two major types of inflammatory bowel disease (IBD) – daily life can feel like a state of constant disruption. Instead of double-checking they have turned off the stove prior to leaving their homes, people with IBD may be mapping out the nearest restrooms and packing emergency supplies, including diapers, and clothing. Many opt to skip social activities or travel to avoid the potential for a bowel-urgency related accident in public. With symptoms including bowel urgency, abdominal pain and stool frequency, the burden of IBD can be substantial for the more than 2.5 million people in the U.S. living with these diseases.

Despite available treatment options, people living with IBD still need treatments that can address these difficult-to-manage symptoms. In fact, current therapies for IBD often fail to achieve clinical remission for many patients, and of those who do achieve clinical remission, a substantial proportion lose it within the first year. For the IBD community, this gap underscores the urgency for more comprehensive, long-term treatment solutions.

Recent long-term studies in Crohn’s disease and ulcerative colitis have produced encouraging results, even in patients who have previously been treated. However, there is more work to be done. The opportunity to continue advancing innovation that can improve patient outcomes, and the patient experience is what drives our immunology team to explore science that can set higher expectations for IBD therapies.

Setting a High Bar for Progress for Patients

Historically, clinical remission and endoscopic response have long been considered the benchmark of IBD treatment success in controlled trials. But results from these traditional endpoints tell just one part of the story.

“Research shows that despite signs of healing seen during an endoscopy, the underlying inflammation that drives IBD at the cellular level – called histologic inflammation – can remain in up to one-quarter of patients with Crohn's disease,” said Mark Genovese, senior vice president, Immunology Development. “People in the real world need treatments that can show a depth of intestinal healing and relief from disease burden that can be sustained over time.”

This need has driven Lilly to explore innovative treatment measures including histologic and combined histologic-endoscopic outcomes, as well as those that can better evaluate the impact on a patient’s life. This includes novel endpoints evaluating the impact of treatment on bowel urgency and how long a patient can delay a bowel movement after the urge hits – a concept known as stool deferral time.

“It might sound small to someone not living with a chronic disease,” Genovese said, “but to someone with ulcerative colitis, gaining even a few extra minutes to get to the bathroom can be the difference between isolation and freedom to fully participate in life.”

Charting the Next Steps Forward for Science

Some of the most exciting innovations for patients are likely yet to come. With a focus on driving strategic investments in areas of high unmet need, we are taking smart risks on bold science in gastroenterology.

“Across immunology, we are focused on next-generation modalities and the targeted expansion of our small molecule pipeline, including oral medicines,” Genovese said. “In gastroenterology, oral therapies could open new possibilities for earlier intervention and provide the potential for combination therapy to help those with more severe immunologic disease, meaning we can help even more patients.”

With each new milestone, our team is contributing to an evolving understanding of what meaningful progress can look like in Crohn’s disease and ulcerative colitis – progress that reflects both scientific rigor and the real needs of patients whose “normal” often involves a series of accommodations and sacrifices to cope with the burden of IBD. This brings growing optimism that the future of comprehensive IBD care may further improve the experience for those navigating these complex diseases.