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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Medication Adherence

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OFEV
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• 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.