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

Journal of Crohn's & Colitis
Eugeni DomènechATTICA Study Group by the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa [listed at the end of the artic

Abstract

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 = 0.1...Continue Reading

References

Aug 19, 2003·Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy·Abby R SaniabadiRobert Lofberg
Dec 21, 2004·Alimentary Pharmacology & Therapeutics·E DomènechUNKNOWN Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU)
Nov 6, 2010·Alimentary Pharmacology & Therapeutics·S ThanarajA C Ford
Nov 15, 2011·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Esther Garcia-PlanellaEugeni Domènech
Feb 12, 2013·Journal of Crohn's & Colitis·Johan BurischUNKNOWN ECCO -EpiCom
Aug 24, 2013·The New England Journal of Medicine·Brian G FeaganUNKNOWN GEMINI 1 Study Group
Feb 1, 2014·Alimentary Pharmacology & Therapeutics·T LobatónP Rutgeerts
Aug 26, 2015·The American Journal of Gastroenterology·L Peyrin-BirouletJ-F Colombel
Dec 4, 2015·Gastroenterology·Franck CarbonnelUNKNOWN Groupe d'Étude Thérapeutique des Affections Inflammatoires Digestives

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Citations

Oct 3, 2018·Expert Review of Gastroenterology & Hepatology·Zachary A BormanJean-Frédéric Colombel
Mar 30, 2021·World Journal of Gastroenterology : WJG·Eugeni DomènechAxel U Dignass
Jun 24, 2021·Journal of Crohn's & Colitis·Tim RaineGarret Cullen

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