Real-World Medication Adherence Trajectories to Nintedanib among Idiopathic Pulmonary Fibrosis Patients

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Medication Adherence
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  OFEV
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EX09) nintedanib

  nintedanib
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  Community-dwelling Medicare beneficiaries with IPF who initiate treatment with nintedanib.
• Age groups:
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1.500

Study design details

• Study design:
  Non-interventional, retrospective cohort study
• Main study objective:
  Identification of adherence trajectories of nintedanib use among patients with idiopathic pulmonary fibrosis.
• Outcomes:
  Adherence trajectories based on monthly proportion of days covered (PDC)
• Data analysis plan:
  This study will use group-based trajectory modeling (GBTM) method to identify trajectories of adherence. The output of GBTM will include estimated probabilities of cluster membership for each individual and an estimated trajectory curve over time for each cluster. Best final model will be selected based on statistical and clinical considerations. The association between membership of trajectories and characteristics (e.g. sociodemographics, clinical, economic burden) will be assess by using polynomial logistic regression models.
• Summary results:
  Among included population, mean age was 75.4±5.5 years. 1098 (61.1%) were male, and 1638 (91.1%) were non-Hispanic white. The best-fitting GBTM had five adherence trajectory groups: highly adherent, medium ; adherent, gradual decliners, intermediate decliners, and rapid-decliners. Some of patients’ characteristics (e.g., age (p-value<0.001) and sex (p-value<0.001)) were significantly different among adherence trajectories.