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Long-Term Efficacy and Safety of Cyclosporine in a Cohort of Steroid-Refractory Acute Severe Ulcerative Colitis Patients from the ENEIDA Registry (1989–2013): A Nationwide Multicenter Study

2017; Lippincott Williams & Wilkins; Volume: 112; Issue: 11 Linguagem: Inglês

10.1038/ajg.2017.180

1572-0241

Íngrid Ordás, Eugeni Domènech, Míriam Mañosa, Valle García–Sánchez, E Iglesias-Flores, Mireia Peñalva, A. Cañas-Ventura, Olga Merino, Fernando Fernández–Bañares, Fernando Gomollón, Magdalena Vera, Ana Gutiérrez, Esther García-Planella, María Chaparro, Mariam Aguas, Elena Gento, Fernándo Muñoz, Maddi Aguirresarobe, Clara Muñoz, L Fernández, Xavier Calvet, Carlos E. Jiménez, Miguel Montoro, A. Mir, M L De Castro, Mariana Fe García-Sepulcre, Fernando Bermejo, Julián Panés, María Esteve,

Helicobacter pylori-related gastroenterology studies

Objectives: To determine the efficacy and safety of cyclosporine (CyA) in a large national registry-based population of patients with steroid-refractory (SR) acute severe ulcerative colitis (ASUC) and to establish predictors of efficacy and adverse events. Methods: Multicenter study of SR-ASUC treated with CyA, based on data from the ENEIDA registry. SR-ASUC patients treated with infliximab (IFX) or sequential rescue therapy (CyA-IFX or IFX-CyA) were used as comparators. Results: Of 740 SR-ASUC patients, 377 received CyA, 131 IFX and 63 sequential rescue therapy. The cumulative colectomy rate was higher in the CyA (24.1%) and sequential therapy (32.7%) than in the IFX group (14.5%;P=0.01) at 3 months and 5 years. There were no differences in early and late colectomy between CyA and IFX in patients treated after 2005. 62% of patients receiving CyA remained colectomy-free in the long term (median 71 months). There were no differences in mortality between CyA (2.4%), IFX (1.5%) and sequential therapy (0%;P=0.771). The proportion of patients with serious adverse events (SAEs) was lower in CyA (15.4%) than in IFX treated patients (26.5%) or sequential therapy (33.4%;P<0.001). This difference in favor of CyA was maintained when only patients treated after 2005 were analyzed. Conclusions: Treatment with CyA showed a lower rate of SAE and a similar efficacy to that of IFX thereby supporting the use of either CyA or IFX in SR-ASUC. In addition, the risk-benefit of sequential CyA-IFX for CyA non-responders is acceptable.