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The Complementary Role of Real-World Evidence and Clinical Trials in Addressing Unmet Needs for IBD Patients


Patients with Crohn's disease and ulcerative colitis face a high disease burden.

Chetan Karyekar

Chetan Karyekar, MD, PhD

There is a profound need to develop new strategies in combatting Crohn’s disease (CD) and ulcerative colitis (UC), two forms of inflammatory bowel disease (IBD) that affect about four million Americans.1,2 There is currently no cure for IBD. In addition, a considerable number of people with IBD do not respond to the available treatments. Furthermore, only 10% of people with moderate to severe IBD are able to get the disease in sustained clinical remission, and there is a high rate of treatment failure as patients combat IBD flares.3,4

While there are multiple treatments available, patients living with IBD still face a high disease burden. Even with new treatment options approved in recent years, people living with CD and UC continue to experience disease flares that negatively impact their health-related quality of life (HRQoL) and work productivity and result in high levels of healthcare resource usage.3,5

To explore the disease burden of these patients, we need to understand if under-treatment, non-adherence, or gaps between real-world treatment patterns and clinical trial results play a role in the differing patient outcomes. Analysis of real-world evidence (RWE) data from sources such as electronic health records, claims and billing, disease or product registries, and those gathered from patient devices, can complement clinical trial results and help us better assess the impact of therapies in practice, rather than in theory.

New research into treatments for CD and UC presented at the Digestive Disease Week (DDW) held in San Diego in May 2022 analyzed the 2019 National Health and Wellness US Survey, which provides real-world data regarding disease characteristics, diagnosis, treatment, and patient-reported outcomes, assessing the burden of active flares on resource use, HRQoL, and work productivity in patients undergoing treatment for CD and UC.

These studies provided insights into characteristics of patients with frequent disease flares. Such patients were younger than those with less active UC or CD, and a higher percentage of patients of Hispanic, Latino, or Spanish origin, or who were Native Hawaiian/other Pacific islander, experienced frequent flares.8 In addition, these studies demonstrated that the more frequent a patient experiences flares, the lower their HRQoL and work productivity, and the higher their healthcare resource use.1,2

Forty-four percent and 38% of UC and CD patients with frequent flares, respectively, had experienced depression in the past year, with two-thirds of patients with CD and 59% of those with UC who experienced frequent flares reporting overall work productivity impairment. In total, half of all patients with UC and CD who experienced frequent flares visited an emergency room or had been hospitalized within the past six months.

Managing chronic illness like CD and UC is becoming increasingly patient-centric. These patients are experiencing an impact on their daily lives, both physically as well as emotionally. Future studies need to not only increase access to care of therapeutic options but make sure clinical trial sites are accessible to historically underserved communities, to reach a representative population in trials to ensure we are learning everything about how well our new therapies are addressing the unmet medical need across all races, ethnicities, and genders.

RWE is not a replacement for randomized clinical trials in assessing the safety and efficacy of therapies but does provide insights including a more comprehensive understanding of short- and long-term health outcomes, and their impact on healthcare practices and healthcare-system costs in different practice settings. This approach capitalizes on effectiveness of treatment strategies by curating not only clinical data in patients’ medical charts, labs, and/or imaging, but also adherence, compliance, and quality outcomes.

This helps develop a precise disease classification system that brings us a step closer in the path toward precision medicine and to be able to design smarter, more efficient clinical trials that better represent the target patient populations. Taken together, RWE points us toward areas of research, and smarter, more efficient drug development strategies with a deeper awareness of the patient journey and any gaps in therapy.

As we continue to push the boundaries of science and pursue new pathways and modalities to outperform today’s solutions, real-world data, and the technologies to gather and analyze it, will play an increasingly important role in our pursuit of remission for people living with IBD and other immune-mediated diseases.


  1. Crohn’s & Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed April 2022.
  2. Garland CF, et al. Incidence rates of ulcerative colitis and Crohn’s disease in 15 areas of the United States. Gastroenterology. 1981 Dec; 81(6):1115-24.
  3. 2020 Decision Resources, 2020 Kantar Health, Data on File/Internal Analysis.
  4. Crohn’s & Colitis Foundation. Managing Flares and IBD Symptoms. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-07/managing-flares-brochure-final-online.pdf. Accessed April 2022.
  5. Sanon, M. et al. Impact of Disease Flares of Resource Use, Health-related Quality of Life and Productivity in Patients with Crohn’s Disease in the United States: An Analysis of National Health and Wellness Survey Data. Presented at DDW 2022, May 21–24.

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