P517. Discrepancy between efficiency and effectiveness of biological therapy in inflammatory bowel disease: 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
Randomized controlled trials (RCTs) provide the best scientific evidence for the efficacy of biological drug in the treatment of inflammatory bowel disease (IBD) in selected conditions. In contrast, observational studies provide the biological drug effectiveness in real clinical practice (CP). We aimed to compare the theoretical efficiency of biological drugs (RCTs conditions) in IBD patients with their effectiveness in PC and to assess factors impacting this discrepancy.
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 (EFIFECT cohort). Patients who met the RTCs selection criteria were included for the analysis. Outcomes of biological therapy in CP were compared with those hypothetically obtained if the patient would be included in RCTs.
One hundred seventy-one patients of 378 (130 CD and 41CU) were included. The overall clinical benefit at one year was higher in CP than hypothetical RCTs (68.4% vs. 44.4%, p < 0.001). The percentages of clinical remission and response in CD patients were 50.8% and 19.2% in the CP, compared to 42.3% and 6.9% in RCTs condition (p < 0.001). For UC, 51.2% of patient achieved clinical remission in CP compared to 29.3% in RCTs condition (p < 0.001). 35% of patients with clinical benefit in CP would be considered failure if they have been included in RCTs. The most frequent reasons for discrepancy between CP and RCTs results were the need of drug intensification (75.6%), short steroid therapy (12.2%) and delay in drug administration (4.9%).
The effectiveness of biological drugs in clinical practice exceeds their efficacy in IBD patients.