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

Autor:	Eugeni, Domènech, Julián, Panés, Joaquín, Hinojosa, Vito, Annese, Fernando, Magro, Giacomo Carlo, Sturniolo, Fabrizio, Bossa, Francisco, Fernández, Benito, González-Conde, Valle, García-Sánchez, Axel, Dignass, José Manuel, Herrera, José Luis, Cabriada, Jordi, Guardiola, Maurizio, Vecchi, Francisco, Portela, Daniel, Ginard
Přispěvatelé:	Otsuka Pharmaceuticals
Rok vydání:	2018
Předmět:	Adult Male medicine.medical_specialty Anti-Inflammatory Agents apheresis Gastroenterology Monocytes law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Prednisone Internal medicine Azathioprine Steroid dependence medicine Clinical endpoint Humans Leukapheresis Intention-to-treat analysis business.industry Anti-Inflammatory Agents Non-Steroidal Remission Induction General Medicine Middle Aged steroid dependence medicine.disease Combined Modality Therapy Ulcerative colitis Intention to Treat Analysis Discontinuation Aminosalicylic Acids 030220 oncology & carcinogenesis Concomitant Colitis Ulcerative Female 030211 gastroenterology & hepatology Apheresis business Immunosuppressive Agents Granulocytes medicine.drug
Zdroj:	JOURNAL OF CROHNS & COLITIS r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname Digital.CSIC. Repositorio Institucional del CSIC
ISSN:	1876-4479 1873-9946
Popis:	[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. This work was supported by an unrestricted research grant from Otsuka Pharmaceuticals.
Databáze:	OpenAIRE
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