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Background: Ulcerative colitis (UC) has been the focus of numerous observational studies over the years and a common strategy employed in their design is the use of composite and aggregate outcomes.Objective: This systematic review and meta-analysis aims to identify composite and aggregate outcomes of observational studies in UC and to evaluate how the number and type of variables included and the length of follow-up affect the frequency of patients that achieve these outcomes.Methods: A systematic literature search was carried out using MEDLINE [via PubMed], Scopus, and Web of Science online databases. Observational studies that included UC patients and reported composite or aggregate outcomes were identified. A set of variables considered to be representative of progressive or disabling UC was defined, the proportion of patients attaining the outcomes was determined and a random-effects meta-analysis was performed by dividing the identified studies into subgroups according to different criteria of interest.Results: A total of 10,264 records were identified in the systematic search, of which 33 were retained for qualitative analysis and 20 were included in the meta-analysis.The mean frequency for composite outcomes was 0.363 [95% confidence interval (CI) 0.323-0.403]. The frequency of composite outcome for the subgroup of studies that included the variable "Biologics" was significantly higher than for those in which this variable was not reported [0.410; 95% CI 0.364-0.457 versus 0.298; 95% CI 0.232-0.364; p = 0.006]. Composite outcomes were also more frequent as the follow-up duration increased. Conclusion:The frequency of composite outcomes in observational studies of UC is dependent on the specific identity of the variables being reported. Moreover, longer

Background and Aims The availability of biological agents for inflammatory bowel disease has increased over the past years. In this systematic review and meta‐analysis, we aimed to explore time trends in clinical response and clinical remission rates in Crohn's disease (CD) patients treated with biologics while discussing the need for new strategies. Methods MEDLINE, Cochrane, and ISI Web of Science databases were searched for randomized placebo‐controlled trials with biological agents in moderate‐to‐severe CD patients. Sub‐group and meta‐regression analyses compared treatment and placebo by calculating the pooled odds ratios of clinical remission and clinical response, across time categories and publication year. We also estimated the proportion of patients achieving clinical remission and clinical response by comparing both groups according to the publication year. Results Twenty‐five trials were included in the systematic review, which enrolled 8879 patients between 1997 and 2022. The clinical remission and clinical response odds, in induction and maintenance, have been constant over time, as no statistically significant differences were found between time categories (interaction p‐values: clinical remission [induction, p = 0.19; maintenance, p = 0.24]; clinical response [induction, p = 0.43; maintenance, p = 0.59]). In meta‐regression analyses, publication year did not influence these outcomes (clinical remission [induction, OR 1.01{95% CI 0.97–1.05}, p = 0.72; clinical response [induction, OR 1.01{95% CI 0.97–1.04]; p = 0.63; maintenance, OR 1.03{95% CI 0.98–1.07}; p = 0.21]), with the exception of clinical remission in maintenance studies, which presented a decreased effect (odds ratio 0.97{95% CI 0.94–1.00}, p = 0.03]). Conclusions Our review highlights that the odds of clinical outcomes in CD patients receiving biological treatment relative to placebo have been stable in the last decades.

Background: Crohn’s disease (CD) and ulcerative colitis (UC) arise from a dysregulation of the balance between commensal microbiota and mucosal-associated immune system, in patients with genetic and environmental predisposition. Different pathophysiological mechanisms have been reported to influence disease history, with impact on disease phenotype and risk of complications. Objectives: This review aims to summarize the definitions of early CD and UC, analyze the underlying immunological mechanisms, and evaluate the impact of recognizing and treating early inflammatory bowel disease (IBD) on patients’ prognosis (short- and long-term outcomes). Design: To address this issue, we have performed a scoping review. Data sources and methods: Three online databases (MEDLINE, Web of Science, and ScienceDirect) were searched and the results were independently screened by two reviewers. Results: From 683 records identified, 42 manuscripts evaluating early IBD in adult patients were included. The ‘early CD’ concept was first described in 2008. Four years later, an international consensus proposed the definition of diagnosis up to 18 months, in patients without previous or current need for disease-modifying therapies. Several other definitions have been proposed; the ‘2 years since diagnosis’ is the most used, regardless of disease characteristics or medication. The amount of evidence on early UC is lower and more recent. Regarding early disease pathogenesis, most theories emphasize the prominent role of innate immunity, followed by early-Th1 adaptive response. Conclusion: The treatment of early CD seems to be crucial for the management of CD patients, impacting short-, medium-, and long-term outcomes. On the other hand, the early treatment of UC appears to be less advantageous, yet evidence comes from only a few retrospective studies.

Background The effectiveness of Crohn’s disease treatments for inducing histological outcomes has not been addressed systematically. We performed a systematic review and meta-analysis of randomized controlled trials in Crohn’s disease to assess the impact of therapies on mucosal histopathology. Methods Databases (MEDLINE, CENTRAL, Web of Science, EMBASE) were searched for randomized controlled trials including adult patients and evaluating histological outcomes. Risk of bias was evaluated using the Critical Appraisal Skills Programme. Histological outcomes, pooled frequencies, pooled odds ratios, and standard mean differences of the histological scores were compared between the intervention and placebo groups using a random-effects model. Results Out of 2070 records, 10 studies were included. The quality of the studies ranged from moderate to high, but they were clinically and methodologically diverse. All interventions were superior to placebo. Histological response was achieved by 68% of patients, and 38% achieved remission. Pooled odds ratio for histological remission in patients receiving intervention vs placebo was 4.14 (95% CI, 2.28-7.50; I2 0%; P < .01). Heterogeneity in histological response estimates was significant, and subgroup analysis of the odds ratio results was limited by the low number of studies per group. The standard mean difference of histological scores was higher for patients receiving intervention in both induction and maintenance studies (−2.95; 95% CI, −4.17 to −1.74; I2 83% P < .00; and −2.58; 95% CI, −3.89 to −1.27; I2 56% P < .00). Conclusions Crohn’s disease therapies are effective for achieving histological outcomes. Adherence to recently published consensus on histopathology harmonization assessment in Crohn’s disease would facilitate adequate comparison between studies in the future.