IBD Clinical Trials Competitive Landscape

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Medicine and Health Sciences


Background: Inflammatory Bowel Disease (IBD) is a chronic relapsing and remitting inflammatory disease that affects the GI tract. IBD has two major types: Crohn’s disease and Ulcerative Colitis. IBD occurs when the immune system attacks the intestinal lining, which results in prolonged inflammation and damage to the tissue. An IBD pa-tient’s quality of life is often reduced with symptoms of fatigue, urgency, abdominal pain and persistent diarrhea. With the advent of biologics and anti-TNF therapy, treatment options for IBD have vastly improved, yet only about one fifth of patients are in remis-sion one year after diagnosis. Objective: One goal of this project is to assess the competitive environment of biologics clinical trials in IBD. A secondary goal is to summarize mirikizumab’s phase II trial results. Method: This project acts as a secondary analysis and review of the ongoing and completed randomized placebo and active comparator clinical trials for IBD with biologics. Trial data was obtained from clinicaltrials.gov and trialtrove, and focuses on phase II through phase IV trials. The drugs of interest were upadacitinib, filgotinib, tofacitinib, risankizumab, brazikumab, mirikizumab, guselkumab, ustekinumab, vedolizumab, etrolizumab, etrasimod and ozanimod. This analysis compares the key endpoints, endoscopic response, endoscopic remission, PROs and CDAI remission, of RCTs in Ulcerative Colitis and Crohn’s Disease. Results: 24 trials are in progress for Ulcerative Colitis, while 25 trials are in progress for Crohn’s Disease. The mechanisms of action include JAK inhibitors, IL-23 p19 inhibi-tors, IL-12/23 p40 inhibitors, integrin antagonists and sphingosine phosphate receptor agonists. The majority (80% and 84% respectively) of trials were phase III. In UC… • 5 trials are completed with positive results • 5 trails are active, not recruiting • 14 trials are recruiting In CD… • 7 trails are completed with positive results • 1 trial is active, not recruiting • 16 trials are recruiting or planned Conclusion: These trials represent new treatment options for primary nonresponders and refractory patients that previously had no other treatment options. With new medications on the horizon, it is essential to consider which patients will be benefiting most from these treatments. More completed clinical trials are needed to compare these biologics head-to-head for specific patient populations so that clinicians can accurately choose the most effective treatment. Mirikizumab’s phase III trial aims to compare its effectiveness with ustekinumab, an IL-12/23 p40 inhibitor. Inhibition of IL-23 may offer a lower risk of infections compared to anti-TNF therapy.


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