AUTHOR=Szemes Kata , Soós Alexandra , Hegyi Péter , Farkas Nelli , Erős Adrienn , Erőss Bálint , Mezősi Emese , Szakács Zsolt , Márta Katalin , Sarlós Patrícia 

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

JOURNAL=Frontiers in Medicine

VOLUME=6

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2019.00338

DOI=10.3389/fmed.2019.00338

ISSN=2296-858X

ABSTRACT=<p><bold>Background:</bold> 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.</p><p><bold>Aim:</bold> To compare long-term efficacy and safety of CYS and IFX in a meta-analysis.</p><p><bold>Methods:</bold> 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.</p><p><bold>Results:</bold> 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, <italic>p</italic> = 0.012; OR = 1.57, 95% CI: 1.14–2.18, <italic>p</italic> = 0.006; and OR = 1.75, 95% CI: 1.08–2.84, <italic>p</italic> = 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, <italic>p</italic> = 0.143; OR = 1.41, 95% CI: 0.94–2.12, <italic>p</italic> = 0.096; and OR = 1.34, 95% CI: 0.89–2.00, <italic>p</italic> = 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.</p><p><bold>Conclusion:</bold> 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.</p>