P327 Evolution after a “de-intensification” strategy with anti-TNF therapy in patients with inflammatory bowel disease in clinical remission: multicenter study
Benítez J.M.*1, Barreiro-de Acosta M.2, Chaparro M.3, Vázquez J.M.4, Iglesias-Flores E.1, Tosca J.5, García-Planella E.6, García-Lόpez S.7, Taxonera C.8, Muñoz-Villafranca M.9, Pajares R.10, Barrio J.11, Arias L.12, Nantes O.13, Fernández-Salazar L.14, Hervías D.15, Martín-Arranz M.16, Mesonero F.17, Moraleja-Yudejo I.18, Pineda J.19, Argüelles-Arias F.20, Huguet J.21, Hernández-Martínez A.22, Pérez-Calle J.23, Leo E.24, Merino O.25, Van Domselaar M.26, Gutiérrez A.27, Lorente R.28, Castro M.29, Algaba A.30, Castro E.31, Robles-Alonso V.32, Ceballos D.33, Gόmez-García R.34, Domínguez J.35, Fernández E.36, Vega-Lόpez A.37, Trapero A.38, Talavera A.39, Royo V.40, Gisbert J.P.3, García-Sánchez V.1
1Hospital Universitario Reina Sofía, Gastroenterology, Cόrdoba, Spain 2Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain 3Hospital Universitario de La Princesa, Madrid, Spain 4Hospital Juan Ramόn Jiménez, Huelva, Spain 5Hospital Clínico Valencia, Valencia, Spain 6Hospital de la Santa Creu I Sant Pau, Barcelona, Spain 7Hospital Universitario Miguel Servet, Zaragoza, Spain 8Hospital Universitario Clínico San Carlos, Madrid, Spain 9Hospital de Basurto, Bilbao, Spain 10Hospital Universitario Infanta Sofía, Madrid, Spain 11Hospital Universitario Río Hortega, Valladolid, Spain 12Hospital Universitario de Burgos, Burgos, Spain 13Complejo Hospitalario de Navarra, Pamplona, Spain 14Hospital Clínico Universitario de Valladolid, Valladolid, Spain 15Hospital Virgen de Altagracia, Ciudad Real, Spain 16Hospital Universitario La Paz, Madrid, Spain 17Hospital Universitario Ramόn y Cajal, Madrid, Spain 18Hospital de Galdakao-Usansolo, Galdakao, Spain 19Complejo Hospitalario Universitario de Vigo, Vigo, Spain 20Hospital Universitario Virgen Macarena, Sevilla, Spain 21Consorcio Hospital General Universitario de Valencia, Valencia, Spain 22Hospital Torrecárdenas, Almería, Spain 23Hospital Universitario Fundaciόn de Alcorcόn, Madrid, Spain 24Hospital Universitario Virgen del Rocío, Sevilla, Spain 25Hospital Universitario Cruces, Barakaldo, Spain 26Hospital de Torrejόn de Ardoz, Madrid, Spain 27Hospital General Universitario de Alicante, Alicante, Spain 28Hospital General de Ciudad Real, Ciudad Real, Spain 29Hospital Universitario de Valme, Sevilla, Spain 30Hospital Universitario de Fuenlabrada, Madrid, Spain 31Hospital Lucus Augusti, Lugo, Spain 32Hospital Universitario Vall d'Hebron, Barcelona, Spain 33Hospital Universitario Dr. Negrín, Las Palmas, Spain 34Hospital Universitario Virgen de las Nieves, Granada, Spain 35Hospital Alto Guadalquivir, Andújar, Spain 36Hospital Provincial de Pontevedra, Pontevedra, Spain 37Hospital de Viladecans, Viladecans, Spain 38H. de Jaén, Jaén, Spain 39H. Infanta Elena, Huelva, Spain 40H. Son Espases, Palma Mallorca, Spain
The “de-intensification” of anti-TNF therapy in IBD patients with sustained remission may be considered for cost and safety reasons. Our aims were: 1) to evaluate the risk of relapse after antiTNF “de-intensification” in clinical remission; 2) to identify predictive factors associated with relapse; 3) to assess the effectiveness of a second “re-intensification”; and 4) to analyze safety of this strategy.
An observational, retrospective and multicenter study was performed. Patients with Crohn's disease (CD) and ulcerative colitis (UC) who achieved remission on intensified anti-TNF therapy and then de-intensified a standard dose being in clinical remission were included. The follow-up after “de-intensification” was at least 6-months.
287 patients were included (50.9% male, mean age 43.1 years, 64.8% CD). Previous antiTNF intensification was due to loss of response (58.9%) and partial response (35.6%). The reasons of “de-intensification” were: 87.7% medical decision following sustained clinical remission, 6.7% patient decision and 3.5% adverse events. 31.4% of patients relapsed with a median of 8 months (95% CI: 6.14–9.85). The cumulative rate of relapse was 11.5% at 6 months, 23.9% at 1 year, 33.4% at 2 years and 47.9% at 5 years; and the incidence rate of relapse was 18.9% patient-year. At time of “de-intensification”, endoscopy was performed in 32.2% of patients, out of them 66.3% had no activity and 31.5% mild activity. 48.4% continued combotherapy with immunomodulators after “de-intensification”. In the multivariate analysis, the variables associated with a higher risk of relapse were: presence of extraintestinal manifestations (HR=1.72, 95% CI: 1.04–2.85, p=0.032), and previous surgery related to IBD (HR=2.30, 95% CI: 1.21–4.38, p=0.011). The factors associated with a lower risk of relapse: concomitant treatment with immunomodulator after “de-intensification” (HR=0.406; 95% CI: 0.23–0.70, p=0.001) and inflammatory behavior CD vs. structuring-fistulizing pattern (HR=0.385, 95% CI: 0.20–0.72, p=0.003). 74.2% of patients who relapsed were treated with a new antiTNF intensification, 57.6% achieved remission in early 8 weeks, and 71.2% at the end of follow-up. After that, only 6% had adverse effects, most of them mild.
The incidence rate of inflammatory bowel disease relapse after “de-intensification” in patients with clinical remission was 18.9% patient-year. Extraintestinal manifestations and previous surgery for IBD were predictors of relapse; while concomitant treatment with immunomodulator and inflammatory behavior CD were associated with lower risk of relapse. The treatment of relapse with the new “re-intensification” was safe and effective in 3 out of 4 patients.