BACKGROUND/AIMS: In patients with corticosteroid-refractory ulcerative colitis (UC), cyclosporine or infliximab may be added to the treatment regimen to induce remission. Here, we aimed to compare the efficacy of cyclosporine and infliximab.
METHODS: Between January 1995 and May 2012, the medical records of 43 patients with corticosteroid-refractory UC who received either infliximab or cyclosporine as a rescue therapy at a tertiary care hospital in Korea were reviewed.
RESULTS: Among the 43 patients, 10 underwent rescue therapy with cyclosporine and the remaining 33 patients received infliximab. A follow-up of 12 months was completed for all patients. The colectomy rate at 12 months was 30% and 3% in the cyclosporine and the infliximab groups, respectively (p=0.034). However, the Cox proportional hazard model indicated that the treatment of rescue therapy was not an independent associate factor for preventing colectomy (p=0.164). In the subgroup analysis, infliximab with azathioprine was superior to cyclosporine for preventing colectomy (hazard ratio of infliximab with azathioprine compared with cyclosporine only, 0.073; 95% confidence interval, 0.008 to 0.629).
CONCLUSIONS: No difference between infliximab and cyclosporine with respect to preventing colectomy was noted. However, infliximab with azathioprine may be more effective than cyclosporine alone for preventing colectomy.
BACKGROUND: The short-term efficacy of infliximab (IFX) and cyclosporine A (CsA) in steroid-refractory ulcerative colitis (SRUC) has been recently shown to be similar, but long-term outcomes are still unclear. Moreover, the need for further rescue therapies in patients treated with IFX or CsA for SRUC has not been reported. The aims of our study were to compare short-term and long-term efficacy between 2 different strategies based on initial treatment with CsA or IFX for SRUC attacks.
PATIENTS AND METHODS: Between January 2005 and December 2011, all patients admitted for SRUC who required medical rescue therapy were identified from the electronic databases of 3 referral centers and grouped according to whether they received CsA or IFX as first-line rescue therapy, and retrospectively reviewed.
RESULTS: Among 50 SRUC attacks, 20 were treated with CsA as first-line rescue therapy and 30 with IFX. The CsA group had a higher proportion of patients with severe UC activity immediately before rescue therapy (P = 0.03) and a shorter median time from intravenous corticosteroids to rescue therapy (P = 0.03). A higher proportion of patients in the CsA group received second-line drug therapy (switch) as compared with the IFX group (P = 0.04). Fifteen patients (30%) were colectomized during the study period, with no between-group differences. Previous thiopurine exposure (P = 0.004; odds ratio = 6.1 [1.7-20.9]) was the only independent predictor of colectomy.
CONCLUSIONS: CsA- and IFX-based strategies for SRUC seem similarly effective in preventing colectomy in the short and long term, although second-line drug therapy is more often required with CsA-based strategies.
ANTECEDENTES: La ciclosporina e infliximab (IFX) son terapias médicas eficaces para inducir la remisión en pacientes con colitis ulcerosa refractaria a esteroides (UC). Los pacientes con enfermedad aguda grave que no responden a estas terapias requieren colectomía, sin embargo, no se conoce el riesgo de complicaciones postoperatorias en estos pacientes. El análisis de los pacientes con CU grave aguda, se comparó la incidencia de complicaciones postoperatorias en los pacientes que no la terapia de rescate con ciclosporina o con IFX que en los pacientes que recibieron (IV) corticosteroides por vía intravenosa sola.MÉTODOS: Se realizó un estudio retrospectivo de cohortes de pacientes con CU que fueron sometidos a colectomía después del tratamiento para pacientes hospitalizados con ciclosporina además IV corticosteroides (CsA + IVS), infliximab más corticosteroides IV (IFX + IVS), o IV corticosteroides solos (IVS) de la Universidad de Chicago hospitales del 1 de octubre 2006 al 1 de octubre de 2012. principales criterios de valoración fueron las infecciosas, no infecciosas, y las complicaciones totales que ocurren dentro de los 30 días de la colectomía.Resultados: De los 78 pacientes, 19 fueron tratados con CsA + IVS, 24 con IFX + IVS, 4 tanto con CsA y IFX + IVS, y 31 con IVS solos. Los pacientes tratados con terapia de rescate, más IVS no tenían ninguna diferencia en el total de las complicaciones postoperatorias en comparación con los que recibieron solo IVS (CsA + IVS: riesgo relativo (RR) = 0,63, 95% intervalo de confianza (IC), 0,33-1,23; IFX + IVS: RR = 0,65, IC 95%, 0,36-1,17). Quedaba ninguna diferencia en las complicaciones postoperatorias entre la terapia de rescate y grupos solos IVS cuando subcategorizing complicaciones generales en infecciosa (CsA + IVS: RR = 0,54; IC 95%, 0,17-1,76; IFX + IVS: IC RR = 0,86, 95%, 0,36 a 2,09) y no infecciosas (CsA + IVS: RR = 0,88; IC 95%, 0,43-1,80; IFX + IVS: RR = 0,40; IC 95%, 0,15-1,07) provoca.Conclusiones: La ciclosporina y IFX no están asociados con un mayor riesgo de complicaciones postoperatorias en pacientes hospitalizados por graves de CU refractaria a los corticoides.
BACKGROUND: Approximately one third of patients with acute severe ulcerative colitis (ASUC) fail response to steroids. Ciclosporin and anti-TNFα are proven second-line therapies, but evidence of their efficacy has come mainly from tertiary centres and/or selective clinical trial recruitment.
AIM: To assess ASUC outcomes in a large unselected cohort.
METHODS: UK-wide audits of IBD care were conducted in 2008 (209 hospital sites) and 2010 (198 hospital sites), covering >87% of admitting hospitals. Each site entered data from 20 consecutive UC admissions onto a web-based proforma. Admissions included 852 (2008) and 984 (2010) with ASUC, accounting for 35% and 39% of UC admissions, respectively.
RESULTS: ASUC in-hospital mortality was 1.2% in 2008; 0.7% in 2010 (P = 0.22). Response to first-line steroid therapy was 61% (2008); 58% (2010) and mortality was higher in non-responders: 2008: 2.9% (9/315) vs. 0.19% (1/537; P < 0.001); 2010: 1.8% (7/391) vs. 0.0% (0/593; P = 0.002). In 2010, more patients (56%) received second-line medical therapy than in 2008 (47%, P = 0.02). In-hospital mortality was similar to second-line medical therapy vs. surgery without further medical therapy; 2008: 2.7% vs. 2.8%, P = 0.99; 2010: 0.9% vs. 3.1%, P = 0.17. Second-line therapy response was more frequently observed with anti-TNFα than ciclosporin: (2008: 76% vs. 46%, P < 0.001; 2010: 80% vs. 58%, P < 0.001).
CONCLUSIONS: Mortality in acute severe ulcerative colitis was low, but higher in steroid non-responders. Patients treated with second-line medical therapies had no higher risk of in-hospital mortality than those undergoing surgery. Second-line 'rescue' medical therapy usage is increasing; however, ciclosporin response rates were relatively low.
BACKGROUND: Up to 40% of patients who present with acute severe ulcerative colitis (UC) fail to make an adequate response to intravenous corticosteroids. Ciclosporin or infliximab are currently employed as salvage therapy in this clinical scenario.
AIM: To compare clinical outcomes in patients treated with ciclosporin or infliximab in the setting of steroid-refractory acute severe UC.
METHODS: A prospective study of 83 consecutive presentations of steroid-refractory acute severe UC from 1999 to 2009 was conducted. All study participants satisfied the Truelove and Witts' criteria for acute severe UC. The primary outcome measures were rates of colectomy at discharge from hospital and at 3 months and 12 months following admission.
RESULTS: Eighty-three steroid-refractory acute severe UC events were generated by 83 patients. Salvage therapy was instituted with ciclosporin in 45 patients and infliximab in the remaining 38 patients. Of those patients who received ≥72 h of ciclosporin (2-4 mg/kg), 56% (24/43) avoided colectomy at the time of discharge, while this figure was 84% (32/38) for those administered one dose of infliximab (5 mg/kg) (P = 0.006). At 3 months, the colectomy-free rate was 53% for ciclosporin (23/43) vs. 76% for infliximab (28/37) (P = 0.04), and 42% (18/43) vs. 65% (24/37) at 12 months (P = 0.04). There were no deaths and two serious adverse events, both occurring in the ciclosporin group.
CONCLUSIONS: In this large cohort of patients presenting with acute severe UC, we have observed that infliximab salvage therapy is associated with lower rates of both severe adverse events and colectomy than ciclosporin in the short-term and medium-term.
