Switch pattern of biological drugs for the treatment of inflammatory bowel diseases through the VALORE distributed database network

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Anti-TNF-alpha, anti-ILs and anti-Integrins approved for IBDs
• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB

  GOLIMUMAB

  INFLIXIMAB

  USTEKINUMAB

  VEDOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB02) infliximab

  infliximab

  (L04AB04) adalimumab

  adalimumab

  (L04AG05) vedolizumab

  vedolizumab

  (L04AB06) golimumab

  golimumab

  (L04AC05) ustekinumab

  ustekinumab
• Medical condition to be studied:
  Inflammatory bowel disease

Population studied

• Short description of the study population:
  The regional claims databases previously described will be considered. From this source, subjects will be included in the study based on the presence of all the following criteria: 1) At least two records of biological drugs (approved for IBDs – see table A1 of the appendix) dispensing during the study period (2010 to 2022). The first date of a biological drug dispensing will be considered as the index date and the biological drug as the index drug. Only incident users of biological drugs will be included, i.e. biological drugs users with no prior dispensings of a biological drug; 2) At least one year of look-back period in the database and at least one year of follow up after index date; 3) Patients with any of these indications: Crohn's disease and ulcerative colitis (see variable section for the identification of exposure and indication of use)

Study design details

• Study design:
  Descriptive, cohort, retrospective, multicenter study will be conducted.
• Main study objective:
  To describe the pattern of switch and swap among incident biological drug users approved for IBDs.
• Setting:
  Italy
• Data analysis plan:
  Cohort characterization; Incident users stratified by class of biological drugs (TNF-alpha inhibitors, anti-interleukin drugs and anti-integrin) and on the basis of occurrence of at least one switch/swap during follow up, will be characterized at baseline in terms of sex, age, type of index drug (originator/biosimilar), previous use of other drugs approved for IMID (cDMARDs, JAK-i, NSAIDs, corticosteroids), and comorbidities (hypertension, MACE, diabetes, previous infections, depression other IMIDs in the look-back period). ; ; Pattern of switch and swap; The absolute frequency, mutually exclusive, in terms of single switch, single swap, multiple switches, by pharmacological class and active ingredient will be reported. This analysis will be performed 1) considering only the first one, three and five years of follow up after the index date (only patients with at least 1 year, three year and five years of follow up will be counted as denominator, respectively) and 2) for the entire duration of follow-up. Whether possible, the analysis will be stratified by sex (female/male) and age (≤18/19-44/45-64/65-79/≥80). ; ; Time to switch and swap; Time to switch and swap will be described using a Kaplan Meier approach stratifying class of biological drugs/active ingredient according to indication. Time to 1) first medical switch/swap, 2) non-medical switch, 3) switch back, 4) multiple switches. Median time for such events will be also calculated.