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.

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.

• Authors: I Ordás, E Domènech, M Mañosa, V García-Sánchez, E Iglesias-Flores, M Peñalva, A Cañas-Ventura, O Merino, F Fernández-Bañares, F Gomollón, M Vera, A Gutiérrez, E Garcia-Planella, M Chaparro, M Aguas, E Gento, F Muñoz, M Aguirresarobe, C Muñoz, L Fernández, X Calvet, C E Jiménez, M A Montoro, A Mir, M L De Castro, M F García-Sepulcre, F Bermejo, J Panés, M Esteve
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 112 Issue 11 Pg. 1709-1718 (Nov 2017) ISSN: 1572-0241 [Electronic] United States
• PMID: 28675163 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Gastrointestinal Agents
• Immunosuppressive Agents
• Cyclosporine
• Infliximab

Topics

• Acute Disease
• Adolescent
• Adult
• Age Factors
• Aged
• Aged, 80 and over
• Child
• Colectomy (statistics & numerical data)
• Colitis, Ulcerative (drug therapy)
• Cyclosporine (therapeutic use)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Immunosuppressive Agents (therapeutic use)
• Infections (chemically induced)
• Infliximab (therapeutic use)
• Male
• Middle Aged
• Mortality
• Registries
• Severity of Illness Index
• Treatment Outcome
• Young Adult