Eugeni Domènech1, Julián Panés2, Joaquín Hinojosa3, Vito Annese4, Fernando Magro5, Giacomo Carlo Sturniolo6, Fabrizio Bossa7, Francisco Fernández8, Benito González-Conde9, Valle García-Sánchez10, Axel Dignass11, José Manuel Herrera12, José Luis Cabriada13, Jordi Guardiola14, Maurizio Vecchi15, Francisco Portela16, Daniel Ginard17. 1. Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and CIBEREHD, Madrid, Spain. 2. Hospital Clínic, Barcelona, Spain and CIBEREHD, Madrid, Spain. 3. Hospital de Manises, Valencia, Spain. 4. AOU Careggi, Florence, Italy. 5. Unit of Pharmacology and Therapeutics, Faculty of Medicine; MedInUP, Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal. 6. Hospital da Padova, Padova, Italy. 7. Casa della Soferenza, San Giovanni Rotondo, Italy. 8. Hospital Costa del Sol, Málaga, Spain. 9. Hospital Juan Canalejo, A Coruña, Spain. 10. Hospital Universitario Reina Sofía amd IMIBIC, Córdoba, Spain, and CIBEREHD, Madrid, Spain. 11. Charité-Campus Virchow Klinikum, Berlin, Germany. 12. Hospital Virgen del Rocío, Sevilla, Spain. 13. Hospital de Galdakao, Bilbao, Spain. 14. Hospital Universitari de Bellvitge, L'Hospitalet del Llobregat, Spain. 15. Department of Biomedical Science for the Health, University of Milan, and IRCCS Policlinico San Donato, Milano, Italy. 16. Hospitais da Universidade da Coimbra, Coimbra, Portugal. 17. Hospital Son Espases, Palma de Mallorca, Spain.
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 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.
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.