Cure8 research brief
People with IBD who have failed multiple advanced therapies are often the most difficult to treat, yet this review shows they are under-represented in clinical trials. That limits direct evidence about how well new treatments work for this group.
Patients with multifailure IBD, clinicians treating refractory IBD, clinical trialists, and researchers.
This systematic review looked at randomized controlled trials (RCTs) of advanced therapies for ulcerative colitis and Crohn’s disease to see how often trials included patients described as difficult-to-treat (DTT) — defined here as active disease despite exposure to ≥2 different mechanisms of action.
The authors screened 179 RCTs (93 UC, 86 CD; >54,000 patients). Most trials allowed some prior exposure to advanced therapies, but only a minority explicitly enrolled or reported patients meeting the DTT definition (≈16% of UC trials; ≈10% of CD trials).
Where patient-level data were available, DTT participants were a minority of study populations (examples: 16.2% of reported UC participants; 22.4% of reported multifailure CD participants). Subgroup efficacy results specific to DTT-IBD were generally not reported.
The paper concludes that patients with DTT-IBD are under-represented in RCTs of advanced medications, and subgroup data on treatment effects for these patients are sparse.
The article is a systematic review/analysis of trial eligibility and reporting (abstract-level summary). It assesses representation and reporting rather than producing new efficacy findings; subgroup-specific efficacy data for DTT patients were largely missing.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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