Assessment of the Dose Reduction and Discontinuation Associated With Anti-Fibrotic Medications in Patients With Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Not Applicable
- Intervention
- Pirfenidone
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 2778
- Locations
- 1
- Primary Endpoint
- Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date)
- •Evidence of IPF: patient with at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022)
- •At least 18 years old at the index date
- •Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period
Exclusion Criteria
- •Any history of lung transplant during the 12-months pre-index/baseline period
- •Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period
- •Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis).
- •Missing demographic information (i.e., age or sex)
Arms & Interventions
Pirfenidone initiators cohort
IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.
Intervention: Pirfenidone
Nintedanib initiators cohort
IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.
Intervention: Nintedanib
Outcomes
Primary Outcomes
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
Time Frame: From individual index date up to 12 months.
Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported.
Secondary Outcomes
- Time to Treatment Discontinuation(From individual index date up to 12 months.)