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P510. Do patients enrolled in pivotal trials represent all inflammatory bowel disease population? EFIFECT study

D. Ginard1, S. Khorrami1, L. Pérez-Carazo1, E. Tavío2, A. López-Sanromán2, M. García-Alvaredo3, F. Muñoz3, L. Ibañez4, I. Marín-Jiménez4, J. Guevara5, F. Casellas5, 1Hospital Universitario Son Espases, Gastroenterology, Palma de Mallorca, Spain, 2Hospital Universitario Ramón y Cajal, Gastroenterology, Madrid, Spain, 3Complejo Hospitalario de León, Gastroenterology Unit, León, Spain, 4Hospital Universitario Gregorio Marañón, Gastroenterology, Madrid, Spain, 5Hospital Universitari Vall d'Hebron, Unitat Atenció Crohn-Colitis, Barcelona, Spain

Background

Randomized controlled trials (RCTs) provide the best scientific evidence for the efficacy of biological drug in the treatment of inflammatory bowel disease (IBD). RCTs use strict selection criteria and defined protocol study in order to eliminate potential bias. Therefore, findings obtained from these trials might not be assumed in general clinical practice (CP). The aim of this study was to estimate the percentage of IBD patients treated with biologic drugs in CP who would have been eligible for RCTs and to compare one-year outcomes between eligible and non-eligible patients.

Methods

We performed a retrospective multicenter cohort study of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated with anti-TNF agents and followed-up for at least 1 year, randomly selected from five Spanish tertiary centers. The inclusion and exclusion criteria for RCTs were extracted from ACCENT 1, ACCENT 2 and SONIC trials for infliximab in CD, CLASSIC 1 and CHARM trials for adalimumab in CD, ACT 1 and ACT 2 trials for infliximab in UC.

Results

Three hundred and seventy-eight IBD patients (276 CD and 99 UC) were included. Only 45.2% of patients (47.1% with CD and 41.4% with UC) would have been eligible for pivotal RCTs. The most common reasons for non-eligibility were indications other than moderate–severe IBD flare or perianal disease (36.2%), the presence of symptomatic stenosis (17.9%) and the use of topical drugs (12.1%). One-year outcomes were similar for both eligible and non-eligible CD (67.1% vs. 70.1%, p = 0.608) and UC patients (72.4% vs. 63.4%, p = 0.342).

Conclusion

More than half of IBD patients treated with biologic drugs would not be represented in RCTs. Anti-TNF agents might have similar effectiveness in non-eligible IBD patients than in those eligible for RCTs.