Vedolizumab-4024: A Multi-center, Longitudinal, Observational Study of the Effectiveness of Vedolizumab on Clinical Outcomes and Health-Related Quality if Life in Biologic Naive Patients with Inflammatory Bowel Diseases in Serbia Over a 2-year Period

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  Adult patients with moderately to severely active ulcerative colitis or Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to conventional therapy, naïve to biologic treatments (including vedolizumab) and targeted therapies such as tofacitinib, will be enrolled in the study.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  140

Study design details

• Study design:
  Prospective, observational, multi-center, longitudinal study
• Main study objective:
  The primary objective of the study is to assess long-term clinical benefit by means of drug discontinuation rate for the biologic-naive patients with inflammatory bowel disease treated with vedolizumab over a duration of 2 years.
• Outcomes:
  Primary outcome will include the drug discontinuation rates in UC and CD patients treated with vedolizumab in the two years follow-up period. Reasons for discontinuation will be collected. Clinical remission and response, change from baseline in Euro quality of life (Qol)-5 Dimension (EQ-5D) questionnaire, rates of dose intensification, discontinuation of corticosteroids in patients using steroids at baseline, impact of treatment with vedolizumab on clinical or patient-reported outcomes (PROs), endoscopic remission, use of biomarkers, safety profile of vedolizumab.
• Data analysis plan:
  The analysis will be descriptive. All categorical variables will be listed and illustrated by absolute and relative frequencies. Continuous variables will be expressed as means, standard deviation (SD), median and range. For primary outcome, the percentage of patients among biologic naïve UC patients and among biologic naïve CD patients that discontinue treatment with vedolizumab within the two years follow up period will be reported, followed by the corresponding 95% confidence interval. For secondary outcomes, similarly, continuous variables will be described as means, standard deviations and quartiles and categorical variables will be summarized as frequencies and percentages.