A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)

Percentage of Participants Who Had IBD Relapse

IBD Relapse includes re-treatment with biologics, steroid use, IBD-related hospitalization record, IBD-related ER visits, IBD-related surgery, increase in disease index. The occurrence of any of the above records will be regarded as an IBD relapse.

Time frame: Up to approximately 13 years

Time to Relapse After Biologics Discontinuation

Time to relapse is defined as the time interval from end of treatment (EOT) to the first IBD relapse.

Time frame: Up to approximately 13 years

Correlation Between the Clinical Variables and Relapse Post Biologics Discontinuation

The identifying predictors of relapse, survival distributions will be studied using the log-rank test for the univariate analysis and then using time dependent Cox regression models for the multivariate analysis. The potential confounders of relapse including demographics, disease status, IBD-related treatment, symptom control treatment, lab and complication will be assessed. Two predictive models will be built in the study, one is "on biologics treatment", and other is "off biologics treatment".

Time frame: Up to approximately 13 years

Percentage of Participants Achieving Clinical Response

Clinical Response for CD is defined as Crohn's disease active index (CDAI) greater than or equal to (\>=) 70 points reduction from the index date. For UC, Mayo score \>=3 points reduction and \>=30 percent (%) decrease from the index date with an accompanying rectal bleeding subscore \>=1 points reduction or with absolute rectal bleeding subscore less than or equal to (\<=) 1 and as \>=2 point reduction in partial Mayo score. Index date: date when the first dose of the biologic was prescribed in each treatment cycle.

Time frame: Up to approximately 13 years

Percentage of Participants Achieving Clinical Remission

Clinical Remission for CD is defined as CDAI \<=150 point.CDAI assesses CD based on clinical signs such as number of liquid stools,intensity of abdominal pain,general wellbeing,presence of comorbid conditions,antidiarrheal use,physical examination and laboratory findings.Total score ranges from 0 to 600 points.Clinical Remission for UC is defined as Mayo score \<=2 and no individual subscore \>1 and partial Mayo score \<=1.Mayo score measure disease activity of UC.Mayo score consists of 4 sub-scores: stool pattern,most severe rectal bleeding of the day,endoscopic findings,global assessment by physician,each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 12.Partial Mayo score consists of 3 sub-scores:stool pattern,most severe rectal bleeding of the day, global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 9.