P303 Real life effectiveness of Adalimumab for the treatment of ulcerative colitis: comparison between anti-TNF-naïve and non-naïve patients. Results from the Spanish ENEIDA Registry.
M. Iborra*1, A. López-García2, M. Boscá3, V. García-Sánchez4, J. Hinojosa5, A. López-Sanromán6, L. Marquez7, P. Camo8, J. P. Gisbert9, M. Aceituno10, M. Calafat11, J. Guardiola12, B. Belloc13, Y. Ber14, B. Luis15, C. Rodríguez-Gutiérrez16, J. Barrio17, M. Rivero18, R. Camargo19, M. Van Domselaar20, D. Hervás21, P. Nos1
1Hospital Universitari i Politecnic La Fe and CIBERehd, Gastroenterology, Valencia, Spain, 2Hospital Clínic Barcelona and CIBERehd, Gastroenterology, Barcelona, Spain, 3Hospital Clínic Valencia, Gastroenterology, Valencia, Spain, 4Hospital Reina Sofia, Gastroenterology, Cordoba, Spain, 5Hospital de Manises, Gastroenterology, Valencia, Spain, 6Hospital Ramón y Cajal, Gastroenterología, Madrid, Spain, 7Hospital del Mar, Gastroenterology, Barcelona, Spain, 8Hospital Miguel Servet, Gastroenterology, Zaragoza, Spain, 9Hospital La Princesa, Gastroenterology, Madrid, Spain, 10Hospital Mutua de Terrassa, Gastroenterology, Barcelona, Spain, 11Hospital germans Trias i Pujol, Gastroenterology, Barcelona, Spain, 12Hospital Universitari Bellvitge, Gastroenterology, Barcelona, Spain, 13Hospital San Jorge, Gastroenterology, Huesca, Spain, 14Hospital Clínico Lozano Blesa, Gastroenterology, Zaragoza, Spain, 15Hospital de Donostia,Instituto Biodonostia, UPV/EHU and CIBERehd, Gastroenterology, Guipúzcoa, Spain, 16Complejo Hospitalario de Navarra, Gastroenterology, Pamplona, Spain, 17Hospital Rio Hortega, Gastroenterology, Valladolid, Spain, 18Hospital Marques de Valdecilla, Gastroenterology, Santader, Spain, 19Hospital Clínico Virgen de la Victoria, Gastroenterology, Málaga, Spain, 20Hospital de Torrejón, Gastroenterology, Madrid, Spain, 21Instituto de Investigación Sanitaria La Fe, Unidad Bioestadística , Valencia, Spain
The benefit of adalimumab (ADA) in anti-TNF naïve vs anti-TNF-exposed patients in active ulcerative colitis (UC) has been evaluated in the placebo-controlled trials (ULTRA-2) and in short cohorts. Objective: To evaluate the efficacy of ADA in UC comparing patients previously treated with anti-TNF(non-naïve) and anti-TNF naïve patients (naïve) in the clinical practice.
Retrospective cohort study based on data obtained from the ENEIDA registry. Demographic data, concomitant therapy, Mayo score (MS) and/or Mayo UC endoscopic score (MES) and cause for anti-TNF discontinuation (non-naïve) were collected at the beginning of the treatment. Clinical response, clinical remission, endoscopic remission, range of adverse events, need for intensification, colectomy and hospitalizations were also evaluated.
Two hundred and forty-five patients were included (163 non-naïve and 82 naïve). Patient demographics and rates of response and remission are summarized in Table1. Adverse events occurred in 11% naïve y 6% non-naïve group. Intensification, hospitalization and colectomy during the first year were required in 26, 21 and 11% of naïve patients and in 40, 43 and 27% of no-naïve patients, respectively. In the multivariate analysis, patients with primary failure and intolerance to the first anti-TNF and severe disease were associated statistically with worse clinical response (p=0.015, p=0.042 and p=0.049). Primary non-response to prior anti-TNF treatment and severe disease were predictive factors of poorer clinical remission (p=0.04 and p=0.026). Endoscopic remission did not show statistical associations.
In real life experience ADA seems an effective treatment in moderate UC especially in anti-TNF naïve patients.