DOP75 Frequency and effectiveness of dose escalation of biologic therapy in Inflammatory Bowel Disease: The RAINBOW-IBD study of ENEIDA
Year: 2024
Type: conference-abstract
Abstract: Background Despite their effectiveness in inflammatory bowel disease (IBD), biologic drugs often require dose escalation. Primary aim: To describe the frequency and effectiveness of dose escalation of biologics: infliximab (IFX), adalimumab (ADA), golimumab (GOL), vedolizumab (VED), and ustekinumab (UST). Secondary: To study the reasons for and the durability of escalation, and to identify predictive factors for relapse and for therapy discontinuation after it. Methods Adult patients from ENEIDA registry who received biologics were included. Dose escalations were specifically analysed. Survival curves assessing the impact of several variables on the durability and on clinical relapse were compared using the log-rank test. Predictive factors associated with therapy discontinuation and the risk of relapse after dose escalation were assessed by Cox-regression. Results Out of the 19,720 patients with biologics included in ENEIDA, 5,096 (26%) had their dose escalated, which were analysed. The frequency of escalation per patient-year of follow-up was: 5% (95% confidence interval [CI]=4.3-5.6%), 7% (6.3-7.7%), 7% (6.9-7.1%), 10% (9.9-10.1%), and 12% (11.9-12.1%) in patients receiving IFX, ADA, GOL, VED and UST, respectively (Figure 1). The main reason for dose escalation was loss of response (60%). Remission and clinical response were recaptured after dose escalation, respectively, in: 49% and 89% (IFX), 41% and 86% (ADA), 46% and 85% (GOL), 32% and 87% (VED), and 47% and 92% (UST). The probability of maintaining the dose escalated at 12 and 24 months was: 88% and 78% (IFX); 82% and 71% (ADA); 82% and 66% (GOL); 84% and 75% (VED); and 93% and 88% (UST), respectively (Figure 2). Predictive factors of relapse after re-achieving remission with dose escalation were: 1) IFX: previous biologic exposure (Hazard ratio [HR]=1.2, 95%CI=1.1-1.4), and IBD duration (HR=0.97, 95%CI=0.96-0.99); 2) ADA: ADA monotherapy (HR=1.2, 95%CI=1.01-1.35); 3) VED: Crohn’s disease (HR=1.56, 95%CI=1.1-2.2), and IBD duration (HR=0.9, 95%CI=0.8-0.99); and 4) UST: ulcerative colitis (HR=2.4, 95%CI=1.5-3.9). Predictive factors of therapy discontinuation after dose escalation were: 1) IFX: previous biologic exposure (HR=1.2, 95%CI=1.1-1.4), and disease duration (HR=0.98, 95%CI=0.97-0.99); 2) ADA: ADA monotherapy (HR=1.2, 95%CI=1.1-1.25); and 3) UST: ulcerative colitis (HR=1.4, 95%CI=1.1-1.9). Conclusion A proportion of IBD patients dose escalate biologics in the long-term. Dose escalation is an effective strategy to recapture response and remission. The durability of escalation seems to be relatively high over time. Prior biologic experience, IBD type, and a short evolution of IBD were identified as predictive factors of relapse and therapy discontinuation after dose escalation.
Source: Journal of Crohn s and Colitis
Authors: C Rubín De Célix, E Ricart, M D Martín-Arranz, I Pérez-Martínez, J Barrio, F Mesonero, F Gomollón, L de Castro, L Ramos, S García-López, L Arias, M Mañosa, E Iglesias, X Calvet, I Pascual, M J Casanova, J L Pérez-Calle, A Giordano, M Sierra, I Vera, M Navarro-Llavat, R Lorente, M Piqueras, M Rivero, J Guardiola, M Esteve, A Fuentes Coronel, I Rodríguez-Lago, Á Ponferrada, Y Ber, C Tardillo, L Márquez, D Carpio, C Taxonera, F Bermejo, D Busquets, B Camps, E Domènech, M Chaparro, J P Gisbert
Institutions: Hospital Universitario de La Princesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer, Hospital Universitario La Paz, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario Río Hortega, Hospital Universitario Ramón y Cajal, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón, Hospital Universitario de Canarias, Hospital Universitario Miguel Servet, Hospital Universitario de Burgos, Hospital Universitari Germans Trias i Pujol, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, University of Córdoba, Universitat Autònoma de Barcelona, Corporació Sanitària Parc Taulí, Institute of Research and Innovation Parc Tauli, Hospital Clínico Universitario de Valencia, Hospital Universitario Fundación Alcorcón, Hospital de Sant Pau, Complejo Asistencial Universitario de León, Hospital Universitario Puerta de Hierro Majadahonda, Hospital de Sant Joan Despí Moisès Broggi, Hospital General Universitario de Ciudad Real, Consorci Sanitari de Terrassa, Marqués de Valdecilla University Hospital, Instituto de Investigación Marqués de Valdecilla, Bellvitge University Hospital, University Hospital Mútua de Terrassa, Mútua Terrassa, Universitat de Barcelona, Hospital Virgen de la Concha, Hospital de Galdakao, Hospital Universitario Infanta Leonor, Hospital General San Jorge, Hospital Universitario Nuestra Señora de Candelaria, Hospital Del Mar, Municipal Institute for Medical Research, Hospital del Mar Research Institute, Complejo Hospitalario de Pontevedra, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Hospital Universitario de Fuenlabrada, Hospital Universitari de Girona Doctor Josep Trueta, Hospital General de Granollers
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4391164458