The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.

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)

Patients with idiopathic pulmonary fibrosis (IPF) who initiated either pirfenidone or nintedanib between October 2014 and September 2021.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients >= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021.

Adverse event information was not applicable for this study.

This was an observational study and was not designed to assess adverse event; therefore safety reporting was not applicable for this study. Adverse events were not planned to be collected as defined in the study protocol. Adverse Events were not monitored/assessed.

Healthcare claims data not designed for research, may not represent actual medication use.

Reasons for discontinuations/dose reduction could not be ascertained as are not captured in claims database (CDB).

Adverse events could not be evaluated as these are not reliably captured in CDB.

Due to lack of availability of laboratory data/clinical information, severity of IPF+results of laboratory tests were not observed.

ORD only covers patients with commercial insurance or Medicare Advantage plan.