1. 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
- Author
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Ordás, I, Domènech, E, Mañosa, M, García-Sánchez, V, Iglesias-Flores, E, Peñalva, M, Cañas-Ventura, A, Merino, O, Fernández-Bañares, F, Gomollón, F, Vera, M, Gutiérrez, A, Garcia-Planella, E, Chaparro, M, Aguas, M, Gento, E, Muñoz, F, Aguirresarobe, M, Muñoz, C, Fernández, L, Calvet, X, Jiménez, C E, Montoro, M A, Mir, A, De Castro, M L, García-Sepulcre, M F, Bermejo, F, Panés, J, and Esteve, M
- Abstract
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.
- Published
- 2017
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