In 2012, this blog highlighted a study which showed that “only 31.1% of 206 patients with IBD would have been eligible to participate in any of the selected RCTs.” (Post: According to the study which you would never qualify for…).

A recent study shows the same phenomenon in pediatric IBD studies: O Atia et al. Aliment Pharmacol Ther 2022; 56 (5): 794-801. Open Access! Children included in randomised controlled trials of biologics in inflammatory bowel diseases do not represent the real-world patient mix

This study utilized data for children initiating biologics from two prospective real‐world cohorts and one retrospective cohort.

Key findings:

• Only 62 of 164 (38%) children with moderate–to‐severe disease would have been eligible for inclusion in the original RCTs.
• The steroid-free remission rate was higher in the eligible children (51%) than in the ineligible children (31%; OR 2.3 [95%CI 1.2–4.5]; p = 0.01)
• The main exclusion criterion was prohibited previous therapies (47%)

My take (borrowed from authors): “Remission rates were higher among eligible children raising the concern that results presented in regulatory RCTs in paediatric IBD do not necessarily reflect the patient‐mix in the real‐world and should be interpreted with caution when applied to clinical practice.”

Pictures from VilleFranche-Sur-Mer: