Vedolizumab-5050: Clinical Perspective of Vedolizumab (Entyvio) use in the Drug Program "Vedolizumab in the Treatment of Ulcerative Colitis" (POLONEZ)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, non-interventional, national, multi-center study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The study population included consecutive patients aged 18 years or older with UC who were initiating vedolizumab treatment in DP.; The patient had to meet all of the following criteria to be eligible for recruitment in the study:; 1. Informed consent signed by the patient, obtained before any study-related activities are undertaken; 2. Age 18 years or more at the time of first VDZ infusion; 3. Moderate to severe UC, Mayo score > 6 (range 0-12); 4. Insufficient response to conventional therapy, including steroids and mercaptopurine or azathioprine, or; ⚫ intolerant to conventional therapy, including steroids and mercaptopurine or azathioprine, or; ⚫ existing contraindication to conventional therapy, including steroids and mercaptopurine or azathioprine, or; ⚫ TNF-α inhibitor failure, defined as primary lack of response or loss of response to TNF-α inhibitor (lack of improvement in partial Mayo score (0-9) of at least 3 or 30% from baseline with concomitant lack of improvement in bleeding in partial Mayo score of at least 1 or lack of improvement in residual bleeding of at least 2), or; ⚫ adverse drug reactions to TNF-α inhibitor with imply inability to continue the treatment.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The primary objective of the study is to assess the clinical data for effectiveness (response rate and remission rate) of vedolizumab in patients with UC administered the drug in the scope of DP.
• Outcomes:
  The primary endpoint will include percentage of patients achieving response or remission on Week 54. The secondary endpoint will include disease activity using mayo score or partial mayo score, disease extent, electronic information management system (EIMs) concomitant treatment, steroids and its discontinuation, immunomodulators, past biological therapies including its number and outcomes, past hospitalization due to UC including number and duration, comorbidities and safety.
• Data analysis plan:
  Standard descriptive statistic methods will be used which comprise the number of patients, arithmetic mean, standard deviation, minimum, median and maximum. For categorical variables tables of frequencies (absolute and relative frequencies) will be presented. The difference in proportion of response and remission rates after 54 weeks of treatment and subsequently after 6 months of forced discontinuation of the drug administration will be statistically compared. The safety endpoints will be presented as incidence rate calculated using person-time analyses. Reported adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) dictionary and all adverse event summaries will present preferred terms and System Organ Class. Where appropriate 95 percent (%) confidence intervals will be provided.