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Addition of Granulocyte/Monocyte Apheresis to Oral Prednisone for Steroid-dependent Ulcerative Colitis: A Randomized Multicentre Clinical Trial

2018; Oxford University Press; Volume: 12; Issue: 6 Linguagem: Inglês

10.1093/ecco-jcc/jjy023

1876-4479

Eugeni Domènech, Julián Panés, Joaquín Hinojosa, Vito Annese, Fernando Magro, Giacomo Carlo Sturniolo, Fabrizio Bossa, F. FERNÁNDEZ, Benito González-Conde, Valle García–Sánchez, Axel Dignaß, José M. Herrera, José Luis Cabriada, Jordi Guardiola, Maurizio Vecchi, Francisco Portela, Daniel Ginard, Luis Abreu, Xavier Aldeguer, Montserrat Andreu, Vito Anesse, Juan Ignacio Arenas, Daniel C. Baumgart, Manuel Barreiro–de Acosta, Stephan H. Böhm, Fabrizzio Bossa, José Luis Cabriada, Félix Calvo, Fernando Carballo, Xavier Cortés, Silvio Danese, Axel Dignaß, Eugeni Domènech, María Esteve, F. FERNÁNDEZ, Esther García-Planella, Bastianello Germanà, Daniel Ginard, B González, Federico Gómez-Camacho, Jordi Guardiola, Ana Gutiérrez, José M. Herrera, Vicent Hernández, Joaquín Hinojosa, Paula Lago, Fernando Magro, Míriam Mañosa, José Miguel Marrero, Paula Ministro, Fernándo Muñoz, Francesco Pallone, Julián Panés, Jóse Lázaro Pérez-Calle, Francisco Portela, Walter Reinisch, Giacomo Carlo Sturniolo, Carlos Taxonera, Narcís Vázquez, Maurizio Vecchi,

Liver Diseases and Immunity

Steroid-dependency occurs in up to 30% of patients with ulcerative colitis [UC]. In this setting, few drugs have demonstrated efficacy in inducing steroid-free remission. The aim of this study was to evaluate the efficacy and safety of adding granulocyte/monocyte apheresis [GMA] to oral prednisone in patients with steroid-dependent UC.This was a randomized, multicentre, open trial comparing 7 weekly sessions of GMA plus oral prednisone [40 mg/day and tapering] with prednisone alone, in patients with active, steroid-dependent UC [Mayo score 4-10 and inability to withdraw corticosteroids in 3 months or relapse within the first 3 months after discontinuation]. Patients were stratified by concomitant use of thiopurines at inclusion. A 9-week tapering schedule of prednisone was pre-established in both study groups. The primary endpoint was steroid-free remission [defined as a total Mayo score ≤2, with no subscore >1] at Week 24, with no re-introduction of corticosteroids.In all 123 patients were included [63 GMA group, 62 prednisone alone]. In the intention-to-treat analysis, steroid-free remission at Week 24 was achieved in 13% (95% confidence interval [CI] 6-24) in the GMA group and 7% [95% CI 2-16] in the control group [p = 0.11]. In the GMA group, time to relapse was significantly longer (hazard ratio [HR] 1.7 [1.16-2.48], P = 0.005) and steroid-related adverse events were significantly lower [6% vs 20%, P < 0.05].In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse.