scholarly journals P547 Safety and efficacy of vedolizumab in the treatment of patients with moderate to severe Ulcerative Colitis: a systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S516-S517
Author(s):  
M Khorshid Fasge ◽  
M Alboraie ◽  
W Abbas ◽  
Z E Sayed ◽  
M El-Nady
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Cohort Studies ◽  
Clinical Response ◽  
Clinical Remission ◽  
Assessment Tool ◽  
Meta Analysis ◽  
P Value ◽  
Severe Ulcerative Colitis ◽  
Significant Difference

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.

scholarly journals P451 Efficacy and safety of tofacitinib in the treatment of patients with active, moderate to severe, Ulcerative Colitis: a systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S446-S447
Author(s):  
M Khorshid Fasge ◽  
D Dorgham ◽  
A Sharobim ◽  
M Attia ◽  
M Hussein ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Cohort Studies ◽  
Clinical Response ◽  
Meta Analysis ◽  
Drug Discontinuation ◽  
Efficacy And Safety ◽  
Severe Ulcerative Colitis

Abstract Background To perform a systematic review and meta-analysis to discuss the efficacy and safety of tofacitinib in patients with moderate to severe ulcerative colitis (UC). Methods We searched PubMed, Scopus, Web of Science, in addition to Cochrane Central, until May 2020 using relevant keywords. We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree. Quality of included RCTs was assessed by the Cochrane risk of bias assessment tool, whereas the Newcastle-Ottawa scale was applied to assess for bias sources in included cohort studies. Data were pooled, after being extracted, from eligible articles in the review manager software, or the open meta-analyst software. Dichotomous outcomes were pooled as risk ratios (RR) under the fixed effect model, while continuous outcomes were pooled as standardized mean difference (SMD) under the random-effects model. Results pooling data from seven RCTs and four cohort studies, 2728 patients, showed that tofacitinib therapy was superior to placebo in inducing a clinical response in UC patients after eight weeks (p = 0.0001) and 26 weeks, in a proportion 0.4 of patients who took tofacitinib 10 mg BID. Additionally, tofacitinib treatment was associated with significantly higher events of clinical remission of UC, after eight weeks (RR= 3.12, 95% CI [2.34, 4.16], p < 0.0001). Likewise, endoscopic, deep, in addition to symptomatic remission rates were higher in the tofacitinib group, compared to the group of placebo (p ≤ 0.008). Most of the drug-related adverse events were comparable between tofacitinib and placebo groups. However, tofacitinib treatment was associated with fewer serious adverse events (RR= 0.68, 95% CI [0.48, 0.98], p = 0.04); adverse events that led to drug discontinuation (RR= 0.53, 95% CI [0.39, 0.73], p< 0.0001); and worsening of UC (RR= 0.48, 95% CI [0.38, 0.61], p < 0.00001). On the other hand, the placebo group had fewer overall infections (p = 0.002); and elevation in laboratory parameters, including LDL cholesterol, total cholesterol, and triglycerides. Conclusion Our systematic review and meta-analysis showed that, in patients with active moderate to severe UC, tofacitinib treatment was superior to placebo in inducing clinical response and remission, with less adverse reactions. Additionally, treatment with tofacitinib showed beneficial quality of life and survival benefits for UC patients. Future clinical trials should study the effect of higher doses of tofacitinib in larger RCTs, with longer follow up periods.

scholarly journals EFFICACY OF TACROLIMUS FOR INDUCTION OF REMISSION IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

2017 ◽  
Vol 54 (2) ◽  
pp. 167-172 ◽  
Author(s):  
Juan LASA ◽  
Pablo OLIVERA
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Efficacy ◽  
Lower Risk ◽  
Meta Analysis ◽  
Calcineurin Inhibitors ◽  
Cochrane Library ◽  
Severe Ulcerative Colitis ◽  
Risk Of Failure

ABSTRACT BACKGROUND There is evidence that shows that calcineurin inhibitors may be useful for the treatment of severe ulcerative colitis. However, evidence regarding the efficacy of tacrolimus for remission induction in this setting is scarce. OBJECTIVE To develop a systematic review on the existing evidence regarding the clinical efficacy of tacrolimus for the induction of remission in patients with moderate-to-severe ulcerative colitis. METHODS A literature search was undertaken from 1966 to August 2016 using MEDLINE, Embase, LILACS and the Cochrane Library. The following MeSH terms were used: “Inflammatory Bowel Diseases” or “Ulcerative Colitis” and “Calcineurin Inhibitors” or “Tacrolimus” or “FK506”. Studies performed in adult ulcerative colitis patients that evaluated the clinical efficacy of tacrolimus for the induction of remission were considered for revision. A meta-analysis was performed with those included studies that were also placebo-controlled and randomized. Clinical response as well as clinical remission and mucosal healing were evaluated. RESULTS Overall, 755 references were identified, from which 22 studies were finally included. Only two of them were randomized, placebo-controlled trials. A total of 172 patients were evaluated. A significantly lower risk of failure in clinical response was found for tacrolimus versus placebo [RR 0.58 (0.45-0.73)]; moreover, a lower risk of failure in the induction of remission was also found versus placebo [RR 0.91 (0.82-1)]. CONCLUSION Tacrolimus seems to be a valid therapeutic alternative for the induction of remission in patients with moderate-to-severe ulcerative colitis.

scholarly journals Fecal Microbiota Transplantation as Therapy for Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolei Liu ◽  
Yan Li ◽  
Kaichun Wu ◽  
Yongquan Shi ◽  
Min Chen
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Meta Analysis ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Endoscopic Remission

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.

Systematic review and network meta-analysis of treatment for moderate-to-severe ulcerative colitis

2018 ◽  
Vol 40 (6) ◽  
pp. 1411-1419 ◽  
Author(s):  
Cristina Trigo-Vicente ◽  
Vicente Gimeno-Ballester ◽  
Santiago García-López ◽  
Alejandro López-Del Val
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Meta Analysis ◽  
Severe Ulcerative Colitis

Early vs Late Use of Anti-TNFa Therapy in Adult Patients With Crohn Disease: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 26 (12) ◽  
pp. 1808-1818
Author(s):  
Shadi Hamdeh ◽  
Muhammad Aziz ◽  
Osama Altayar ◽  
Mojtaba Olyaee ◽  
Mohammad Hassan Murad ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Response ◽  
Disease Progression ◽  
Crohn Disease ◽  
Meta Analysis ◽  
Adult Patients ◽  
Cochrane Central Register ◽  
Significant Difference ◽  
Clinical Series ◽  
Early Use

Abstract Objectives While anti-tumor necrosis factor alpha (anti-TNFa) therapies for Crohn disease (CD) were initially introduced in 1998 for biologic therapies are often introduced after a minimum of 6 years after diagnosis. The benefit of anti-TNFa early in the course of CD is still controversial, with some studies showing better outcomes but others not. To determine whether earlier introduction of anti-TNFa therapy improves efficacy in clinical trials or clinical series, we aimed to perform a meta-analysis comparing early vs late anti-TNFa use in the management of CD. Methods A comprehensive search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Scopus was conducted from each database’s inception to November 3, 2019. We included comparative studies of early vs late use of anti-TNFa therapy in adult patients with CD. Results Eleven studies were included in the analysis, with a total of 2501 patients. Meta-analysis demonstrated that the early use of anti-TNFa was associated with a statistically significant decrease in the need for surgery (relative risk [RR] = 0.43; 95% confidence interval [CI], 0.26–0.69; I2 = 68%) and disease progression (RR = 0.51; 95% CI, 0.35–0.75; I2 = 61%). Early use also showed an increase in early remission (RR = 1.94; 95% CI, 1.54–2.46; I2 = 0%) and clinical response. There was no statistically significant difference in achieving late remission (RR = 1.39; 95% CI, 0.94–2.05; I2 = 65%) or mucosal healing (RR = 1.10; 95% CI, 0.63–1.91; I2 = 0%). Conclusion This systematic review suggests that using anti-TNFa earlier in the treatment of CD (within 3 years) may improve clinical outcomes compared to late administration in terms of achieving early clinical remission, clinical response, disease progression, and the need for surgery.

Clinical, Endoscopic and Histological Outcomes in Induction of Moderate-to-Severe Ulcerative Colitis: A Systematic Review with Meta-Analysis

2020 ◽  
Author(s):  
Fernando Magro ◽  
Maria Manuela Estevinho ◽  
Cláudia Camila Dias ◽  
Luís Correia ◽  
Paula Lago ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Pharmacological Intervention ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
Histological Remission ◽  
The Impact

Abstract Background and Aims Interest in histology for ulcerative colitis [UC] has increased recently. This systematic review and meta-analysis aims to assess, for the first time, whether histological outcomes are more informative than endoscopic and clinical outcomes in distinguishing the impact of intervention over placebo in induction trials. Methods MEDLINE, ScienceDirect and Cochrane Central Register of Controlled Trials were searched to identify randomized placebo-controlled trials [RCTs] enrolling moderate-to-severe UC patients. Studies were assessed using the Quality Assessment Tool for Studies with Diverse Designs. We analysed the pooled proportion of patients achieving clinical, endoscopic and histological remission and response after a pharmacological intervention and compared the results with those of placebo-treated patients by using a random-effects model. Results From 889 identified records, 13 RCTs were included. The odds ratio [OR] for remission was higher in patients receiving intervention than in those under placebo for clinical (OR 2.13, 95% confidence interval [CI] 1.33–3.43), endoscopic [OR 1.46, 95% CI 0.19–11.18] and histological remission [OR 1.85, 95% CI 1.20–2.84]. Significant differences were observed for all response outcomes [clinical: OR 2.27, 95% CI 1.84–2.85; endoscopic: OR 2.16, 95% CI 1.51–3.10; histological: OR 3.63, 95% CI, 1.41–9.36]. No significant heterogeneity existed; no subgroup effects were found for duration of the induction or histological scale [p > 0.05]. Clinical and histological remission and endoscopic response were concordant in discriminating interventions from placebo. Conclusion Histological outcomes are informative in trials of moderate-to-severe UC. Further studies analysing histology at the end of induction are needed to confirm its relevance in distinguishing the efficacy of an intervention over placebo in comparison to clinical and endoscopic outcomes and to explore its prognostic value.

scholarly journals Systematic Review and Meta-analysis: Optimal Salvage Therapy in Acute Severe Ulcerative Colitis

2019 ◽  
Vol 25 (7) ◽  
pp. 1169-1186 ◽  
Author(s):  
Matthew C Choy ◽  
Dean Seah ◽  
David M Faleck ◽  
Shailja C Shah ◽  
Che-Yung Chao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Single Dose ◽  
Salvage Therapy ◽  
Meta Analysis ◽  
Optimal Dose ◽  
High Dose ◽  
Free Survival ◽  
Severe Ulcerative Colitis ◽  
The Impact

AbstractBackgroundInfliximab is an effective salvage therapy in acute severe ulcerative colitis; however, the optimal dosing strategy is unknown. We performed a systematic review and meta-analysis to examine the impact of infliximab dosage and intensification on colectomy-free survival in acute severe ulcerative colitis.MethodsStudies reporting outcomes of hospitalized steroid-refractory acute severe ulcerative colitis treated with infliximab salvage were identified. Infliximab use was categorized by dose, dose number, and schedule. The primary outcome was colectomy-free survival at 3 months. Pooled proportions and odds ratios with 95% confidence intervals were reported.ResultsForty-one cohorts (n = 2158 cases) were included. Overall colectomy-free survival with infliximab salvage was 79.7% (95% confidence interval [CI], 75.48% to 83.6%) at 3 months and 69.8% (95% CI, 65.7% to 73.7%) at 12 months. Colectomy-free survival at 3 months was superior with 5-mg/kg multiple (≥2) doses compared with single-dose induction (odds ratio [OR], 4.24; 95% CI, 2.44 to 7.36; P < 0.001). However, dose intensification with either high-dose or accelerated strategies was not significantly different to 5-mg/kg standard induction at 3 months (OR, 0.70; 95% CI, 0.39 to 1.27; P = 0.24) despite being utilized in patients with a significantly higher mean C-reactive protein and lower albumin levels.ConclusionsIn acute severe ulcerative colitis, multiple 5-mg/kg infliximab doses are superior to single-dose salvage. Dose-intensified induction outcomes were not significantly different compared to standard induction and were more often used in patients with increased disease severity, which may have confounded the results. This meta-analysis highlights the marked variability in the management of infliximab salvage therapy and the need for further studies to determine the optimal dose strategy.

Comparative clinical efficacy of adjuvant chemotherapy regimens in randomized controlled trials (RCTs) of early-stage colon cancer: Systematic review and meta-analysis.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 498-498
Author(s):  
J. Cassidy ◽  
H. Schmoll ◽  
E. Chu ◽  
N. Hawkins ◽  
I. Tatt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Assessment Tool ◽  
Early Stage ◽  
Meta Analysis ◽  
Group Analysis ◽  
Significant Difference ◽  
Early Stage Colon Cancer

498 Background: A systematic review was conducted to identify RCTs of adjuvant chemotherapy regimens for early-stage colon cancer and a network meta-analysis performed to compare efficacy of oxaliplatin/fluoropyrimidine regimens. Methods: A systematic review identified RCTs recruiting adult patients with early-stage (adjuvant) stage II/III colon cancer. Outcome measures included hazard ratios for DFS and OS. Only publications in English were considered. Study quality was assessed using the Cochrane Collaboration “risk of bias” assessment tool. A single reviewer screened abstracts/titles using predefined selection criteria, with critical appraisal and data extraction conducted independently by two reviewers. A Bayesian network meta-analysis was used to estimate comparative efficacy of adjuvant chemotherapy across RCTs. Results: 56 articles describing 40 trials were selected, of which six reported data on regimens accepted as current standard of care (capecitabine/X-ACT, XELOX/NO16968, FOLFOX/MOSAIC, FLOX/C-07) or common comparators: bolus 5FU/LV and LV5FU2 (C-96-1, PETACC-2). Statistical assessment of heterogeneity was not possible due to the limited study network. Baseline characteristics were similar across trials with the exception of three trials recruiting only stage III patients; sub-group analysis on these trials was not possible due to lack of common comparators. There was no significant difference in DFS at a median follow-up of 3-years (or closest reported analysis) for XELOX vs. FLOX (HR=0.99, 95% CI 0.80–1.22) or FOLFOX (HR=1.00, 95% CI 0.72–1.41). There was also no significant difference in OS at a median follow-up of at least 5 years. Taken as a class, oxaliplatin-containing regimens (XELOX, FOLFOX, FLOX) improved DFS vs. non-oxaliplatin-containing regimens (HR=0.80, 95% CI 0.73–0.87). This result was confirmed for OS. Conclusions: Despite the limited number of available trials, the results of these analyses demonstrate a clear benefit of incorporating oxaliplatin into combination regimens for early-stage colon cancer. XELOX, FOLFOX and FLOX appear to be equivalent in terms of efficacy in this setting. [Table: see text]

scholarly journals Effect of periodontal therapy on the systemic inflammation and metabolic  markers in patients undergoing hemodialysis or/and peritoneal dialysis: a systematic review and meta-analysis

2019 ◽  
Author(s):  
Hui Yue ◽  
Xinxin Xu ◽  
Qin Liu ◽  
Xiaozhi Li ◽  
Yiting Xiao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Peritoneal Dialysis ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Periodontal Treatment ◽  
Sufficient Evidence ◽  
Metabolic Markers ◽  
Significant Difference ◽  
Meta Analyses

Abstract Background: This systematic review aimed to investigate whether periodontal treatment can reduce the systemic inflammatory levels and improve the metabolic levels in patients undergoing hemodialysis (HD) or/and peritoneal dialysis (PD). Methods: Electronic databases (PubMed, EMBASE, CENTRAL, NCKI, and WFPD) were searched up to July 2019. The risk of bias within studies was assessed through the Cochrane Collaboration' s risk assessment tool. The systemic inflammatory and metabolic measures were the highly sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), tumor necrosis factor-α (TNF-a), the albumin (Alb), and lipid metabolic levels. Meta-analyses (MAs) were performed to calculate the overall effect size where appropriate. Results: Five studies were eligible for this systematic review. The result of four studies revealed a significant difference in the CRP level after periodontal treatment in patients receiving HD or/and PD. Two studies reported the IL-6 and the Alb level after periodontal treatment but revealed no significant difference. No MAs could be performed on the TNF- a level and the lipid metabolic markers. Conclusions: Periodontal treatment may moderately reduce the serum of CRP levels in HD or/and PD patients. For the TNF-a, IL-6, Alb levels and lipid metabolic markers, no sufficient evidence supports the difference after periodontal treatment. Therefore, larger scales and high-quality randomized-controlled trials (RCTs) are required to assess the effect of periodontal treatment on systemic inflammatory and metabolic parameters in HD or/and PD patients.

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