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

Primary outcomes

1. Percentage of Participants Who Had IBD Relapse

   Time frame: Up to approximately 13 years

   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.

2. Time to Relapse After Biologics Discontinuation

   Time frame: Up to approximately 13 years

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

3. Correlation Between the Clinical Variables and Relapse Post Biologics Discontinuation

   Time frame: Up to approximately 13 years

   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".

4. Percentage of Participants Achieving Clinical Response

   Time frame: Up to approximately 13 years

   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.

5. Percentage of Participants Achieving Clinical Remission

   Time frame: Up to approximately 13 years

   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.

6. Percentage of Participants Achieving Steroid-free Remission

   Time frame: Up to approximately 13 years

   Steroid-free 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. Steroid-free remission for UC is defined as absence of steroid treatment (within 1 week before and after the date of potential clinical remission achieved) among participants on steroids at baseline (index date). Index date: date when the first dose of the biologic was prescribed in each treatment cycle.

7. Percentage of Participants Achieving Mucosal Healing

   Time frame: Up to approximately 13 years

   Mucosal healing is defined as absence of any symptom finding of ulcer or spontaneous bleeding on endoscopic assessment or Crohn's Disease Endoscopic Index of Severity (CDEIS) less than (<) 4 for CD participants and as Mayo endoscopic subscore <=1 for UC participants.

8. Correlation Between the Clinical Variables and Treatment Effectiveness

   Time frame: Up to approximately 13 years

   The relationship between clinical variables and treatment effectiveness will be assessed. The impact of potential bias from the baseline/demographic variables, baseline matching will be performed using propensity score 1:1 matching by each treatment cycle and different types of biologic treatments before performing the comparative analysis for effectiveness outcome. The matching condition will be determined according to the data collection. IBD participants with clinical response, clinical remission, steroid-free remission, and mucosal healing will be analyzed. The difference in effectiveness between IBD participants receiving different types of biologic treatment will be compared using Chi-square test.

9. Percentage of Participants Experiencing Infection

   Time frame: Up to approximately 13 years

   Participants experiencing opportunistic infections, hepatic viral infections, gastrointestinal (GI) infections, respiratory infections, respiratory failure, or sepsis or septic shock among participants receiving vedolizumab versus those receiving anti-TNF-α will be assessed.