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

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...

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Main Authors: Kata Szemes, Alexandra Soós, Péter Hegyi, Nelli Farkas, Adrienn Erős, Bálint Erőss, Emese Mezősi, Zsolt Szakács, Katalin Márta, Patrícia Sarlós
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-01-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/article/10.3389/fmed.2019.00338/full
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author Kata Szemes
Alexandra Soós
Alexandra Soós
Péter Hegyi
Péter Hegyi
Péter Hegyi
Péter Hegyi
Nelli Farkas
Nelli Farkas
Adrienn Erős
Bálint Erőss
Emese Mezősi
Zsolt Szakács
Zsolt Szakács
Katalin Márta
Katalin Márta
Patrícia Sarlós
Patrícia Sarlós
author_facet Kata Szemes
Alexandra Soós
Alexandra Soós
Péter Hegyi
Péter Hegyi
Péter Hegyi
Péter Hegyi
Nelli Farkas
Nelli Farkas
Adrienn Erős
Bálint Erőss
Emese Mezősi
Zsolt Szakács
Zsolt Szakács
Katalin Márta
Katalin Márta
Patrícia Sarlós
Patrícia Sarlós
author_sort Kata Szemes
collection DOAJ
description 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 follow-up 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.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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spelling doaj.art-61bb5921b8b042c985a4bcbf5911e6a62022-12-21T23:39:24ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-01-01610.3389/fmed.2019.00338508659Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-AnalysisKata Szemes0Alexandra Soós1Alexandra Soós2Péter Hegyi3Péter Hegyi4Péter Hegyi5Péter Hegyi6Nelli Farkas7Nelli Farkas8Adrienn Erős9Bálint Erőss10Emese Mezősi11Zsolt Szakács12Zsolt Szakács13Katalin Márta14Katalin Márta15Patrícia Sarlós16Patrícia Sarlós17First Department of Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryDoctoral School of Clinical Medicine, University of Szeged, Szeged, HungaryFirst Department of Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryJános Szentágothai Research Centre, University of Pécs, Pécs, HungaryMomentum Gastroenterology Multidisciplinary Research Group, Hungarian Academy of Sciences, University of Szeged, Szeged, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute of Bioanalysis, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryFirst Department of Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryJános Szentágothai Research Centre, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryJános Szentágothai Research Centre, University of Pécs, Pécs, HungaryFirst Department of Medicine, Medical School, University of Pécs, Pécs, HungaryJános Szentágothai Research Centre, University of Pécs, Pécs, HungaryBackground: 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 follow-up 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.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.https://www.frontiersin.org/article/10.3389/fmed.2019.00338/fullsteroid-refractoryulcerative colitiscyclosporineinfliximabcolectomymeta-analysis
spellingShingle Kata Szemes
Alexandra Soós
Alexandra Soós
Péter Hegyi
Péter Hegyi
Péter Hegyi
Péter Hegyi
Nelli Farkas
Nelli Farkas
Adrienn Erős
Bálint Erőss
Emese Mezősi
Zsolt Szakács
Zsolt Szakács
Katalin Márta
Katalin Márta
Patrícia Sarlós
Patrícia Sarlós
Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
Frontiers in Medicine
steroid-refractory
ulcerative colitis
cyclosporine
infliximab
colectomy
meta-analysis
title Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
title_full Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
title_fullStr Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
title_full_unstemmed Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
title_short Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis
title_sort comparable long term outcomes of cyclosporine and infliximab in patients with steroid refractory acute severe ulcerative colitis a meta analysis
topic steroid-refractory
ulcerative colitis
cyclosporine
infliximab
colectomy
meta-analysis
url https://www.frontiersin.org/article/10.3389/fmed.2019.00338/full
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