Frequency and Effectiveness of Dose Escalation and De-Escalation of Biologic Therapy in Inflammatory Bowel Disease: The RAINBOW-IBD Study of ENEIDA.
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Rubín de Célix Cristina, Ricart Elena, Martín-Arranz M Dolores, de Francisco Ruth, García-Alonso Francisco Javier, Mesonero Francisco, Gomollón Fernando, de Castro Luisa, Ramos Laura, García-López Santiago, Arias Lara, Mañosa Miriam, Iglesias Eva, Calvet Xavier, Suria Bolufer Carles, Casanova María José, Pérez-Calle José Lázaro, Giordano Antonio, Sierra-Ausín Mónica, Vera Isabel, Navarro-Llavat Mercè, Lorente Rufo, Piqueras Marta, Rivero Montserrat, Guardiola Jordi, Esteve María, Fuentes Coronel Ana, Rodríguez-Lago Iago, Ponferrada-Díaz Ángel, Ber Yolanda, Tardillo Carlos, Márquez Lucía, Carpio Daniel, Taxonera Carlos, Bermejo Fernando, Busquets David, Camps Blau, Gutiérrez Ana, García-Sepulcre Mariana Fe, Barreiro-de Acosta Manuel, Marín-Jiménez Ignacio, Huguet José M, Fernández-Salazar Luis Ignacio, Jaó Jordina, Rodríguez-Gutiérrez Cristina, Martínez-Flores Carlos, Bujanda Luis, Lucendo Alfredo J, Sesé Eva, Robledo Andrés Pilar, Ginard Daniel, Vega Pablo, Riera Joan, Pajares Ramón, Van Domselaar Manuel, Almela Pedro, Martínez Pérez Teresa, Muñoz-Villafranca Carmen, Varela Pilar, Argüelles-Arias Federico, Nos Pilar, Alcaín Guillermo, Hernández Luis, Fernández Hipólito, Muñoz Fernando, Gilabert Pau, Navas-López Victor Manuel, Ramírez de la Piscina Patricia, Buendía Sánchez Lidia, Legido Gil Jesús, Valldosera Gemma, Muñoz Rosa Ana, Frago Santiago, Domènech Eugeni, Chaparro María, Gisbert Javier P
Аннотация
AIMS: To assess the frequency, effectiveness and durability of escalation/de-escalation of infliximab, adalimumab, golimumab, vedolizumab and ustekinumab in IBD, and to identify factors influencing relapse and drug discontinuation and re-escalation efficacy.
METHODS: We included patients from the ENEIDA registry of GETECCU who were exposed to biologics and analysed escalations/de-escalations. We assessed the impact of variables on durability, drug discontinuation and relapse after escalation/de-escalation.
RESULTS: Of 19,720 patients on biologics, 5096 (26%) underwent dose escalation. Frequency of escalation per patient-year was 5% (infliximab), 7% (adalimumab), 7% (golimumab), 10% (vedolizumab) and 12% (ustekinumab). Clinical remission was recaptured in 32%-49% of patients. Durability of escalation (24 months) ranged from 66% to 88%. Drug discontinuation was associated with previous biologic exposure and disease duration (infliximab), monotherapy (adalimumab) and ulcerative colitis (ustekinumab). There were 669 de-escalations. The frequency per patient-year was 6%, 9%, 5%, 6% and 3% for infliximab, adalimumab, golimumab, vedolizumab and ustekinumab. Maintenance of remission after de-escalation was observed in 75%-100%. Durability of de-escalation (12 months) was 82%-90%. Factors associated with relapse were biologic exposure (infliximab) and age at de-escalation (adalimumab). Re-escalation benefited most patients.
CONCLUSIONS: In the long term, some patients with IBD need biologic escalation, which frequently recaptures durable clinical remission. De-escalation is feasible in some patients. Re-escalation is generally effective after relapse.