Long-term Comparative Efficacy of Cyclosporine- or Infliximab-based Strategies for the Management of Steroid-refractory Ulcerative Colitis Attacks

Naves, Juan E.; Llaó, Jordina; Ruíz-Cerulla, Alexandra; Romero, Cristina; Mañosa, Míriam; Lobatón, Triana; Cabré, Eduard; García‐Planella, Esther; Guardiola, Jordi; Domènech, Eugeni

doi:10.1097/mib.0000000000000101

Cited by 24 publications

(19 citation statements)

References 27 publications

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“…In the MRUC cohort, our rate of only 23% proceeding to colectomy reinforces similar findings in two recent studies in groups of patients receiving infliximab for steroid refractory UC . This is important as, without this therapy, given the refractory nature of this cohort's disease, surgery or ongoing active disease would have been previously inevitable in the majority, if not all of these patients.…”

Section: Discussionsupporting

confidence: 88%

Compassionate access anti‐tumour necrosis factor‐α therapy for ulcerative colitis in Australia: the benefits to patients

Ghaly

Beswick

Pudipeddi

et al. 2015

Internal Medicine Journal

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Section: Discussionsupporting

confidence: 88%

Compassionate access anti‐tumour necrosis factor‐α therapy for ulcerative colitis in Australia: the benefits to patients

Ghaly

Beswick

Pudipeddi

et al. 2015

Internal Medicine Journal

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“…Intention-to-treat data were extracted from RCTs. If numerical data on long-term colectomy-free survival were not reported (13,23,26,31), we extracted data from the Kaplan-Meier curves by identifying the values on the axes "x" and "y" with a software [GetData Graph Digitizer] according to the method proposed by Guyot et al (32). Data collection was accomplished by two authors independently (KS and PS).…”

Section: Data Extraction Quality Assessmentmentioning

confidence: 99%

“…The studies were published between 2004 and 2018 and the follow-up period ranged at least from 1 year to maximum of 10 years. In the quantitative analysis, we used data from three RCTs (13,18,19) and 12 cohort studies (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). A total number of 1,607 patients with steroid-refractory ASUC were included, 879 of which (54.7%) were treated with CYS and the other 728 (45.3%) with IFX.…”

Section: Characteristics Of the Studies Includedmentioning

confidence: 99%

Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis

et al. 2020

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Background: In steroid-refractory acute severe ulcerative colitis (ASUC), cyclosporine (CYS) or infliximab (IFX) may be considered as a second-line alternative to avoid colectomy. There are short-term data reported, but until now, there is no meta-analysis regarding long-term outcomes of CYS and IFX in patients with ASUC. Aim: To compare long-term efficacy and safety of CYS and IFX in a meta-analysis. Methods: Three electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials) were searched for studies which compared CYS vs. IFX in adults with ASUC. Long-term colectomy-free rate from 1 to 10 years during CYS or IFX therapy was collected, last updated up to 22nd May 2019. Primary outcome was long-term colectomy-free rate, secondary outcomes were adverse events (AE), serious adverse events (SAE), and mortality. Long-term colectomy-free survival and safety measures were pooled with the random-effect model. Odds ratios (OR) with 95% confidence intervals (CI) were calculated. Results: Data from 1,607 patients in 15 trials were extracted. In the first 3 years, pooled OR for colectomy-free survival was higher with IFX than with CYS (OR = 1.59, 95% CI: 1.11-2.29, p = 0.012; OR = 1.57, 95% CI: 1.14-2.18, p = 0.006; and OR = 1.75, 95% CI: 1.08-2.84, p = 0.024; at 1, 2, and 3 years, respectively). However, the significant difference remained undetected from the fourth year of followup and in subgroup of RCTs (OR = 1.35, 95% CI: 0.90-2.01, p = 0.143; OR = 1.41, 95% CI: 0.94-2.12, p = 0.096; and OR = 1.34, 95% CI: 0.89-2.00, p = 0.157; at 1, 2, and 3 years, respectively). No significant difference was detected regarding adverse events, serious adverse events and mortality between the groups. The neutral associations proved to be underpowered with trial sequential analysis. Szemes et al. Steroid-Refractory Acute Severe Ulcerative Colitis Conclusion: However observational studies show IFX as a better choice, according to the RCTs, choosing either CYS or IFX as rescue therapy for ASUC, the long-term outcomes are not different, although further large RCTs are warranted.

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“…4,19,20 Thirty-two studies [8][9][10] were extracted from these four reviews, 20 included more than 30 patients. [8][9][10]35,36,[38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54] We completed these four systematic reviews by a new PubMed search. We identified 941 citations, of which 844 were excluded, based on the titles or abstracts ( Figure 2).…”

Section: Acute Uc In Population-based Studies (Figure 1)mentioning

confidence: 99%

Systematic review with meta‐analysis: mortality in acute severe ulcerative colitis

Dong

Metzger

Holsbø

et al. 2019

Aliment Pharmacol Ther

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Summary Background Acute severe ulcerative colitis (ASUC) is a life‐threatening condition. Mortality in ASUC decreased in published series but there is uncertainty as to whether this also applies to the real‐life setting. Aim To perform a systematic review and meta‐analysis of mortality in ASUC in studies from referral centres and in population‐based studies, separately and combined. A second aim was to identify risk factors of mortality in ASUC. Methods We searched pubmed and embase from 1998 to 2016, to identify studies that reported 3‐month or 12‐month mortalities of acute UC in adult patients treated in referral centres, and in population‐based studies. Results Six population‐based studies with 741 743 patients and 47 referral centre‐based studies with 2556 patients were included. The pooled 3‐month and 12‐month mortalities were respectively 0.84% and 1.01%. Advanced age was significantly associated with both 3 month and 12 month mortalities (OR = 1.15 per year, 95% CI: 1.10‐1.20 and OR = 1.19 per year, 95% CI: 1.15‐1.23 respectively). The pooled 3‐month and 12‐month mortalities were 0.78% and 0.85% in studies with median age of less than 50 and 2.81% and 4.17% in studies with median age of 50 or more, respectively. After adjustment for age, 3‐month and 12‐month mortalities did not differ between population‐based and referral centre‐based studies. Conclusions Mortality in acute severe ulcerative colitis is approximately 1%; it is higher in older patients. Efforts should be made to improve the care of elderly patients with severe UC.

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Long-term Comparative Efficacy of Cyclosporine- or Infliximab-based Strategies for the Management of Steroid-refractory Ulcerative Colitis Attacks

Abstract: 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.

Cited by 24 publications

References 27 publications

Compassionate access anti‐tumour necrosis factor‐α therapy for ulcerative colitis in Australia: the benefits to patients

Compassionate access anti‐tumour necrosis factor‐α therapy for ulcerative colitis in Australia: the benefits to patients

Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis

Systematic review with meta‐analysis: mortality in acute severe ulcerative colitis

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