Systematic Review: Inclusion of Patients With Difficult-to-Treat Inflammatory Bowel Disease in Randomized Controlled Trials of Advanced Therapies.
Tommaso Lorenzo Parigi, Virginia Solitano, Hailemichael Desalegn Mekonnen et al.
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In 30 seconds
This systematic review examined how patients with difficult-to-treat inflammatory bowel disease (DTT-IBD) were represented in randomized controlled trials of advanced therapies for ulcerative colitis and Crohn’s disease. Across 179 trials involving 54,258 patients, only 16.1% of ulcerative colitis trials included participants exposed to therapies with at least two mechanisms of action; in Crohn’s disease, 10.5% reported patients with this type of treatment history. Where patient-level data were available, DTT-IBD patients were a minority, and subgroup-specific efficacy results were generally not reported.
Key findings
- Of 93 ulcerative colitis trials, 15 (16.1%) included participants exposed to agents with at least two mechanisms of action.
- Among 10 ulcerative colitis trials reporting patient-level data, DTT-UC accounted for 16.2% (814/5019) of participants.
- Of 86 Crohn’s disease trials, 9 (10.5%) reported patients with DTT-CD due to exposure to multiple classes of advanced therapies.
- In Crohn’s disease, multifailure DTT-CD patients accounted for 22.4% (773/3455) of reported study populations; subgroup-specific efficacy was generally unavailable.
Why it matters
Trial populations may not adequately reflect patients whose disease remains active after multiple advanced therapies. Their limited representation and the scarcity of subgroup-specific efficacy results make it harder to assess how well trial findings apply to this clinically challenging group and to compare treatment effects for them.
What to keep in mind
The review found that subgroup-specific efficacy outcomes were generally not reported, limiting assessment of treatment effects in DTT-IBD.