Treatment patterns and outcomes of Crohn’s disease and ulcerative colitis patients initiated with biologic therapies in Denmark (IBDBIODK)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB04) adalimumab

  adalimumab

  (L04AB02) infliximab

  infliximab

  (L04AA33) vedolizumab

  vedolizumab

  (L04AB06) golimumab

  golimumab

  (L04AC05) ustekinumab

  ustekinumab
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

• 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:
  2300

Study design details

• Main study objective:
  The primary objectives of the study are to characterize patients with CD and UC who initiate biologic therapy, and to assess outcomes and comparative effectiveness of specific biologics for CD and UC separately
• Outcomes:
  Discontinuation of biologic therapy Switch from one biologic therapy to another, • All-cause hospital contacts • IBD-related acute hospital contacts • IBD-related surgery • Need for corticosteroid treatment • General practitioner visits • Change in Inflammatory biomarker levels
• Data analysis plan:
  The risk of the outcome will be analyzed using Cox proportional hazard regression comparing the study drugs, providing hazard ratios. Estimates are presented crude and adjusted for relevant background factors.