Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Pirfenidone; Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT05779007

1199-0526

Details and patient eligibility

About

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

Enrollment: 2,778 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,778 participants in 2 patient groups

Pirfenidone initiators cohort

Description:

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.

Treatment:

Drug: Pirfenidone

Nintedanib initiators cohort

Description:

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.

Treatment:

Drug: Nintedanib