Addition of Granulocyte/Monocyte Apheresis to Oral Prednisone for Steroid-dependent Ulcerative Colitis: A Randomized Multicentre Clinical Trial
Por:
Domenech, E, Panes, J, Hinojosa, J, Annese, V, Magro, F, Sturniolo, GC, Bossa, F, Fernandez, F, Gonzalez-Conde, B, Garcia-Sanchez, V, Dignass, A, Herrera, JM, Cabriada, JL, Guardiola, J, Vecchi, M, Portela, F, Ginard, D, García-Planella E., Vázquez, Narciso
Publicada:
1 jun 2018
Resumen:
Background and Aims: 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.
Methods: 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.
Results: 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].
Conclusions: 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.
Filiaciones:
Domenech, E:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
CIBEREHD, Badalona, Spain
Panes, J:
Hosp Clin Barcelona, Barcelona, Spain
CIBEREHD, Madrid, Spain
Hinojosa, J:
Hosp Manises, Valencia, Spain
Annese, V:
AOU Careggi, Florence, Italy
Magro, F:
Univ Porto, Fac Med, Unit Pharmacol & Therapeut, Porto, Portugal
Univ Porto, Ctr Drug Discovery & Innovat Med, MedInUP, Porto, Portugal
Sturniolo, GC:
Hosp Padova, Padua, Italy
Bossa, F:
Casa Soferenza, San Giovanni Rotondo, Italy
Fernandez, F:
Hosp Costa del Sol, Malaga, Spain
Gonzalez-Conde, B:
Hosp Juan Canalejo, La Coruna, Spain
Garcia-Sanchez, V:
CIBEREHD, Badalona, Spain
Hosp Univ Reina Sofia, Cordoba, Spain
IMIBIC, Cordoba, Spain
Dignass, A:
Charite Campus Virchow Klinikum, Berlin, Germany
Herrera, JM:
Hosp Virgen del Rocio, Seville, Spain
Cabriada, JL:
Hosp Galdakao, Bilbao, Spain
Guardiola, J:
Hosp Univ Bellvitge, Lhospitalet De Llobregat, Spain
Vecchi, M:
Univ Milan, Dept Biomed Sci Hlth, Milan, Italy
IRCCS Policlin San Donato, Milan, Italy
Portela, F:
Hosp Univ Coimbra, Coimbra, Portugal
Ginard, D:
Hosp Son Espases, Palma De Mallorca, Spain
García-Planella E.:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Vázquez, Narciso:
Hospital de Elche, Elche, Spain
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