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Am J Gastroenterol. 2017 Nov;112(11):1709-1718. doi: 10.1038/ajg.2017.180. Epub 2017 Jul 4.

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 information

1
Gastroenterology Department, Hospital Clínic de Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.
2
Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, CIBEREHD, Barcelona, Spain.
3
Hospital Reina Sofía, IMIBIC, Cordoba's Univeristy, Cordoba, Spain.
4
Gastroenterology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.
5
Gastroenterology Department, Parc Salut Mar, Barcelona, Spain.
6
Gastroenterology Department, Hospital de Cruces, Bilbao, Spain.
7
Department of Gastroenterology, Hospital Universitari Mútua Terrassa, University of Barcelona, CIBERHD, Barcelona, Spain.
8
Gastroenterology Department, Hospital Lozano Blesa, CIBEREHD, Zaragoza, Spain.
9
Gastroenterology Department, Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
10
Gastroenterology Department, Hospital Universitario de Alicante, Alicante, Spain.
11
Gastroenterology Department, Hospital de Sant Pau, Barcelona, Spain.
12
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), CIBEREHD, Madrid, Spain.
13
Gastroenterology Department, Hospital la Fe, CIBEREHD, Valencia, Spain.
14
Gastroenterology Department, Hospital General Yagìe, Burgos, Spain.
15
Gastroenterology Department, Complejo Asistencial Universitario de León, Leon, Spain.
16
Gastroenterology Department, Hospital de Galdakao, Bilbao, Spain.
17
Gastroenterology Department, Hospital de Basurto, Bilbao, Spain.
18
Gastroenterology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
19
Gastroenterology Department, Corporació Sanitària Universitària Parc Taulí, CIBEREHD, Barcelona, Spain.
20
Gastroenterology Department, Complejo Hospitalario de Navarra, Navarra, Spain.
21
Gastroenterology Department, Hospital San Jorge, Huesca, Spain.
22
Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.
23
Gastroenterology Department, Complexo Hospitalario Universitario de Vigo-Instituto de Investigación Biomédica, Pontevedra, Spain.
24
Gastroenterology Department, Hospital de Elche, Alicante, Spain.
25
Gastroenterology Department, Hospital de Fuenlabrada, Madrid, Spain.

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.

PMID:
28675163
DOI:
10.1038/ajg.2017.180
[Indexed for MEDLINE]

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