Identifying treatment discontinuation with biological drugs for immune-related inflammatory diseases using administrative healthcare data: a scoping review

Study type

• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  scoping review

Study drug and medical condition

• Name of medicine, other:
  Any biologic used for IMIDs
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA24) abatacept

  abatacept

  (L04AG05) vedolizumab

  vedolizumab

  (L04AB01) etanercept

  etanercept

  (L04AB02) infliximab

  infliximab

  (L04AB04) adalimumab

  adalimumab

  (L04AB05) certolizumab pegol

  certolizumab pegol

  (L04AB06) golimumab

  golimumab

  (L04AC03) anakinra

  anakinra

  (L04AC05) ustekinumab

  ustekinumab
• Medical condition to be studied:
  Fibromyalgia

  Arthritis

  Ankylosing spondylitis

  Psoriasis
• Additional medical condition(s):
  Any immune-related inflammatory diseases (IMIDs)

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The objective of this scoping review is to describe and discuss the different approaches adopted in the published literature to identify in administrative/claims data the discontinuation of biological drugs in patients affected by IMIDs
• Data analysis plan:
  Information extracted from included studies will be described accconcerned three main domains: the datasource characteristics (data source name, catchment area, healthcare setting of collection of drug utilization records), biological drug and population (substance name, indication/study cohort, study period), and the method applied for measuring discontinuation (measure of discontinuation frequency/probability, observed frequency/probability of discontinuation, follow-up duration, censoring criteria, unit of measurement of duration of a single drug utilization record e.g. DDD, grace period, stockpiling, identification of the discontinuation date, overall description of discontinuation-finding algorithm). The synthesis included quantitative analysis (e.g. frequency analysis) of the scoping review conduct (i.e. methodological steps) and qualitative analysis (i.e. content analysis) of the components of the research purpose, and conceptual definition of scoping reviews