Real-world evidence underscores the need to improve outcomes in Crohn’s disease and Ulcerative Colitis despite available treatments
GI Mucus Gland

Real-world evidence underscores the need to improve outcomes in Crohn’s disease and Ulcerative Colitis despite available treatments

Crohn’s disease (CD) and ulcerative colitis (UC) are two forms of inflammatory bowel disease (IBD), which together affect about four million Americans.1,2 They are chronic inflammatory diseases with varying symptoms but both can cause abdominal pain, frequent diarrhea, blood in stools, and weight loss.3,4 There is no cure and a considerable number of people with IBD do not respond to available treatments or lose response to therapy over time.5,6,7,8 

Despite the strides in developing treatments for IBD in recent years, new research shows people living with CD and UC 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.9,10 This disease burden points to unmet needs with current treatment options for IBD, particularly among people with difficult-to-treat disease.

At Janssen, we analyze and synthesize real-world data related to patient experience from sources such as electronic health records, claims and billing, disease or product registries and those gathered from patient devices to generate real-world evidence (RWE). We use RWE to complement the information gained from randomized controlled clinical trials and assess impact of these therapies in practice.

Though RWE does not replace the gold standard of randomized controlled trials in assessing the safety and efficacy of a therapy, it provides us with many insights including a better understanding of short- and long-term health outcomes, greater knowledge of diseases and their impact on healthcare practices and healthcare-system costs. It also allows for a deeper awareness of the patient journey, gaps in therapy, and a vision into new areas of research, and smarter, more efficient clinical trial design.

This week we presented real-world data outcomes specifically underscoring the burden of CD and UC disease flares at Digestive Disease Week® (DDW). This research highlights the need to improve healthcare decisions and therapeutics for CD and UC patients.

 

RWE highlights from DDW

In two separate oral presentations, researchers discussed outcomes of studies that assessed the burden of active flares on resource use, HRQoL, and work productivity in patients undergoing treatment for CD and UC.

Researchers analyzed the 2019 National Health and Wellness US Survey, which provides real-world data regarding disease characteristics, diagnosis, treatment and patient-reported outcomes. In each study, survey participants who were being treated for either CD or UC were categorized by disease flare frequency. Of the 74,994 respondents in each survey, 294 and 339 reported being diagnosed with CD or UC, respectively.8,9

The RWE collected in these IBD studies provided us with further insights into characteristics of patients with frequent disease flares:

  • In both studies, patients with frequent flares were younger than those with less active UC or CD
  • A high percentage of patients of Hispanic, Latino or Spanish origin, or who were Native Hawaiian/other Pacific islander experienced frequent flares in both the UC and CD studies

The studies also showed us the extent to which CD and UC flares impact their HRQoL. Not surprisingly, 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 percent of UC and CD patients with frequent flares, respectively, had experienced depression in the past year
  • About two-thirds of patients with CD and 59 percent of those with UC who experienced frequent flares reported overall work productivity impairment
  • Half of all patients with UC and CD who experienced frequent flares visited an emergency room or had been hospitalized within the last six months

 

Why RWE is especially needed in IBD

With high rates of treatment failure and only 10 percent of people with moderate to severe IBD in clinical remission, there is a critical need to pursue multiple strategies in combatting IBD flares, or the reappearance of disease symptoms.10,11 RWE is helping us to better understand unmet therapeutic needs and the burden of IBD as we seek long-term treatment solutions for patients.

 Despite available treatment, we see there is still a high disease burden for those living with IBD. This begs the question why and highlights a need for additional studies to examine possible reasons. Could  under-treatment, non-adherence, and gaps between real world treatment patterns and clinical guidelines be at the root of these discrepancies? The RWE of CD and UC patient journeys allows us to form better research questions as we continue to investigate the long-term efficacy and safety of IBD treatments and develop new therapies that enable more patients to maintain symptom relief and achieve and maintain remission. As we continue to push the boundaries of science, 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.

 #CrohnsDisease #UlcerativeColitis #IBD #DDW2022 #gastroenterology #immunology #jnj #janssen

 Since we’re on LinkedIn, I invite you to explore our career opportunities in immunology at Janssen: https://bit.ly/3wfHucg

 

References: 

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.      Crohn’s & Colitis Foundation. Signs and Symptoms of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed April 2022.

4.      Crohn’s & Colitis Foundation. Signs and Symptoms of Ulcerative Colitis. Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms. Accessed April 2022.

5.      Fine S, Papamichael K, Cheifetz AS. Etiology and Management of Lack or Loss of Response to Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2019 Dec;15(12):656-665. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935028/

6.      Mayo Clinic. Crohn’s disease. Available at: https://www.mayoclinic.org/diseases- conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed April 2022.

7.      Mayo Clinic. Ulcerative Colitis. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326. Accessed April 2022. 

8.      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.

9.      Sanon, M. et al. Impact of Disease Flares of Resource Use, Health-related Quality of Life and Productivity in Patients with Ulcerative Colitis in the United States: An Analysis of National Health and Wellness Survey Data. Presented at DDW 2022, May 21-24.

10.   2020 Decision Resources, 2020 Kantar Health, Data on File/Internal Analysis.

11.   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.

Suneel Mundle

Senior Director, Global Medical Affairs at Janssen Pharmaceuticals; A Johnson & Johnson Company

1y

Congratulations

John Mize

Chief Executive Officer, Americans United for Life

1y

Great article Chetan, the Foundation agrees with your assessment that more work is needed in RWE to address the significant areas of unmet need in IBD

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