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Randomized, controlled trial cohorts not representative of IBD patient population
Most patients with IBD fail to meet eligibility criteria for randomized, controlled trials for biologics treating the condition, leading to results that may not be applicable to the general population, according to study results.
Researchers applied exclusion and inclusion criteria from multiple randomized controlled trials to 206 patients with moderate-to-severe IBD. Incorporated trials included seven published studies for biologic treatment for Crohn’s disease (CD) and two for treating ulcerative colitis (UC) with infliximab.
Across the cohort, 31.1% of participants, including 34% of those with CD and 26% with UC, met eligibility criteria for at least one of the trials. Eligibility among CD patients ranged from 8% to 27% for each trial. Common reasons for ineligibility included strictures or abscesses (62.2% of participants), exposure or nonresponse to anti-tumor necrosis factor (TNF) therapy (51.2%) and comorbidities (25.6%) among CD patients. UC patients frequently were excluded because of current topical rectal therapy (56.7%), being steroid and immunomodulator naive (45.0%), and probable colectomy (15.0%).
Ineligible CD patients were treated with immunomodulators, anti-TNF monotherapy or combination therapy, or switched or escalated the dosage of their current biologics. These patients had a significantly lower treatment response rate than those who would have been eligible for clinical trials (60% vs. 89% of patients, P=.03), and nearly half of ineligible CD patients (49.4%) underwent surgery because of lack of response.
Ineligible patients with UC began or altered immunomodulator treatment or received infliximab or cyclosporine, and colectomy was eventually or immediately performed on 23.3% of these patients. No significant difference was observed between eligible and ineligible patients in response or colectomy rates.
Christina Ha
“Our study findings highlight the increasing complexity of IBD patients seen today,” researcher Christina Ha, MD, assistant professor at the Meyerhoff Inflammatory Bowel Disease Center at Johns Hopkins School of Medicine, told Healio.com. “As more potential therapeutic targets are identified, study selection criteria will likely need to evolve to be more inclusive and reflective of patients who are more likely to have run through the course of biologics, have complex disease, multiple surgeries, ostomies or fistulizing disease.”
Disclosure: See the study for a full list of relevant disclosures.