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Addition of granulocyte/monocyte apheresis to oral prednisone for steroid-dependent ulcerative colitis: A randomized, multicentre, clinical trial

Hospital Universitari Germans Trias i Pujol (Badalona, Spain) and CIBEREHD (Madrid, Spain). Hospital Clinic (Barcelona, Spain) and CIBEREHD (Madrid, Spain). Hospital de Manises (Valencia, Spain). AOU Careggi (Florence, Italy). Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine; MedInUP, Centre for Drug Discovery and Innovative Medicines, University of Porto (Porto, Portugal). Hospital da Padova (Padova, Italy). Casa della Soferenza (San Giovanni Rotondo, Italy). Hospital Costa del Sol (Malaga, Spain). Hospital Juan Canalejo (A Coruna, Spain). Hospital Universitario Reina Sofia amd IMIBIC (Cordoba, Spain) and CIBEREHD (Madrid, Spain). Charite - Campus Virchow Klinikum (Berlin, Germany). Hospital Virgen del Rocio (Sevilla, Spain). Hospital de Galdakao (Bilbao, Spain). Hospital Universitari de Bellvitge (L'Hospitalet del Llobregat, Spain). Department of Biomedical Science for the Health, University of Milan, and IRCCS Policlinico San Donato (Milano, Italy). Hospitais da Universidade da Coimbra (Coimbra, Portugal). Hospital Son Espases (Palma de Mallorca, Spain).

Journal of Crohn's & Colitis. 2018;12((6):):687-694
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Abstract
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 was to evaluate the efficacy and safety of adding granulocyte/monocyte apheresis (GMA) to oral prednisone in patients with steroid-dependent UC. Methods: Randomized, multicentre, open trial comparing 7 weekly sessions of GMA plus oral prednisone (40mg/day and tapering) to 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 end point was steroid-free remission (defined as a total Mayo score ≤2, with no subscore >1) at week 24, with no reintroduction of corticosteroids. Results: One hundred and twenty-three patients were included (63 GMA group, 62 prednisone alone). In the ITT analysis, steroid-free remission at week 24 was achieved in 13% (95%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 (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. ClinicalTrials.gov ID: NCT00702611.
Study details
Language : English
Additional Material : Corrigendum in: Journal of Crohn's & Colitis (2019) PMID: 30951596, 13(6): 814 DOI: <a href="http://dx.doi.org/10.1093/ecco-jcc/jjy211">http://dx.doi.org/10.1093/ecco-jcc/jjy211</a>
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine