P728 Comparative assessment of faecal microbiota transplantation and current therapies as induction treatment for active refractory ulcerative colitis: A systematic review and network meta-analysis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S585-S585
Author(s):  
K Malandris ◽  
P Paschos ◽  
A Koukoufiki ◽  
A Katsoula ◽  
A Manolopoulos ◽  
...  

Abstract Background Emerging evidence suggests that faecal microbiota transplantation (FMT) can induce remission in patients with refractory to standard treatment ulcerative colitis (UC). Methods We performed a systematic review and network meta-analysis to assess the comparative efficacy and safety of FMT and current therapies as induction treatments in UC. We searched Medline, Embase, CENTRAL and grey literature sources up to October 2019. We included randomised controlled trials of patients with active UC that compared FMT, infliximab, adalimumab, golimumab, vedolizumab and tofacitinib to each other or placebo. Efficacy outcomes were clinical remission and response. Safety outcomes were incidence of any adverse event (AE), serious AEs and infections. We conducted random-effects network meta-analysis and ranked treatments based on the surface under the cumulative ranking (SUCRA) probabilities. Results Twenty trials (5177 patients) were included in the analysis. There was only one head to head RCT (vedolizumab vs. adalimumab). FMT was superior to placebo for induction of clinical remission (OR 2.80; 95% CI 1.50–5.23) and response (OR 2.53; 95% CI 1.53–4.20). No indirect comparisons between FMT and licensed treatments reached statistical significance for efficacy outcomes. On SUCRA analysis, FMT (SUCRA 0.57, 0.58) had comparable SUCRA values with golimumab (SUCRA 0.53, 0.39) and vedolizumab (SUCRA 0.58, 0.61) in terms of clinical remission and response respectively. Infliximab (SUCRA 0.71, 0.93) and tofacitinib (SUCRA 0.85, 0.75) were ranked highest while adalimumab (SUCRA 0.23, 0.21) was ranked lowest. There was no increase in the rates of any AEs for FMT and licensed therapies and no differences in indirect comparisons. Vedolizumab (SUCRA 0.81) was the safest option, followed by tofacitinib (SUCRA 0.55). FMT (SUCRA 0.38) had comparable SUCRA values with adalimumab (SUCRA 0.37) and golimumab (SUCRA 0.47). Only tofacitinib increased the incidence of infections compared with placebo (OR 1.51; 95%CI 1.05–2.19). Based on SUCRAs, FMT (SUCRA 0.83) was the safest in terms of infections. Vedolizumab had lower incidence of serious AEs compared with FMT and placebo, while FMT was ranked as the least safe treatment. In subgroup analysis, FMT through the lower gastrointestinal (GI) tract was superior to placebo (OR 3.92; 95%CI 1.94–7.92) and performed numerically better than FMT through the upper GI tract (OR 0.29; 95%CI 0.08–1.13). Conclusion Evidence suggests that FMT could be an efficacious and safe alternative induction therapy for refractory UC. Lower GI delivery of FMT might be more effective. Due to the absence of head-to-head trials and the limited size of FMT trials, conclusions must be interpreted with caution.

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S516-S517
Author(s):  
M Khorshid Fasge ◽  
M Alboraie ◽  
W Abbas ◽  
Z E Sayed ◽  
M El-Nady

Abstract Background To perform a systematic review and meta-analysis discussing the efficacy and safety of vedolizumab (VDZ) treatment in patients with active moderate to severe ulcerative colitis (UC). Methods Using relevant keywords, we searched PubMed, Web of Science, Scopus, and Cochrane Central databases, until June 2020. We included interventional and observational cohort studies which assessed the safety and effectiveness of VDZ 300 mg intravenous infusion, in patients with active moderate to severe UC. We used the Cochrane risk of bias assessment tool and the Newcastle-Ottawa scale to assess the quality of included interventional and cohort studies, respectively. Dichotomous outcomes were pooled as proportion, 95% Confidence interval (CI), and p-value under the random-effects model in the open meta-analyst software. Results We found 10 interventional studies and 35 cohort studies, including 4,794 patients eligible for our review. Most of the included citations were single-arm studies. Our meta-analysis showed that VDZ therapy could induce a significant clinical response in UC patients up to 54 weeks (proportion 0.516, 95% CI [0.453, 0.578], p < 0.001). VDZ was associated with clinically significantly clinical remission and steroid-free clinical remission after 54 weeks (p < 0.0001). Durable clinical remission, histological remission, and endoscopic response rates were maintained in UC patients taking VDZ at the 52nd week. There was no significant difference between VDZ and placebo regarding the incidence of drug-related serious adverse events (p = 0.113) and death rates (p = 0.085). Conclusion Our systematic review and meta-analysis showed that the use of VDZ in patients with active moderate to severe UC was associated with high percentages of clinical response and remission rates in induction and maintenance treatment stages. VDZ seems to be well tolerated in UC patients, apart from some infections and inflammations. Future RCTs should compare VDZ to active treatments for longer follow-up periods with larger sample size.


2020 ◽  
Vol 29-30 ◽  
pp. 100642
Author(s):  
Simon Mark Dahl Baunwall ◽  
Mads Ming Lee ◽  
Marcel Kjærsgaard Eriksen ◽  
Benjamin H. Mullish ◽  
Julian R. Marchesi ◽  
...  

Author(s):  
Ajit Sood ◽  
Arshdeep Singh ◽  
Ramit Mahajan ◽  
Vandana Midha ◽  
Kirandeep Kaur ◽  
...  

Abstract Background Faecal microbiota transplantation [FMT] has been shown to be effective for induction of remission in patients with active ulcerative colitis [UC]. At present, the clinical factors impacting the response to FMT in UC remain unclear. Methods Patients with active UC treated with multisession FMT via colonoscopy at weeks 0, 2, 6, 10, 14, 18 and 22 were analysed. Response to FMT was defined as achievement of corticosteroid-free clinical remission at week 30. Patient and disease characteristics were evaluated to determine the predictors of response to FMT. Results Of 140 patients with active UC treated with FMT, 93 (mean age 34.96 ± 11.27 years, 62.36% males [n = 58], mean Mayo clinic score 8.07 ± 2.00) who completed the multisession FMT protocol were analysed. Fifty-seven [61.29%] patients achieved clinical remission. Younger age (odds ratio [OR] for age 0.93, 95% confidence interval [CI] 0.89–0.97, p = 0.001), moderate [Mayo clinic score 6–9] disease severity [OR 3.01, 95% CI 1.12–8.06, p = 0.025] and endoscopic Mayo score 2 [OR 5.55, 95% CI 2.18–14.06, p < 0.001] were significant predictors of remission on univariate analysis. Younger age, disease extent E2 and endoscopic Mayo score 2 [OR 0.925, 95% CI 0.88–0.97, p = 0.002; OR 2.89, 95% CI 1.01–8.25, p = 0.04; and OR 8.43, 95% CI 2.38–29.84, p = 0.001, respectively] were associated with clinical remission on multivariate logistic regression. A mathematical model [nomogram] was developed for estimating the probability of remission with the FMT protocol. Conclusion Younger age, disease extent E2 and endoscopic Mayo score 2 significantly predict achievement of clinical remission with FMT in active UC. The prediction model can help in selecting individuals for FMT. Validation in larger cohorts is needed.


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