Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT05022784

1199-0471

Details and patient eligibility

About

This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.

This study has two objectives:

• Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
• Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.

Enrollment: 1,798 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly initiated nintedanib during 10/01/2014 to 12/31/2018
• Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
• Qualified for Medicare based on age
• Had at least 12 months (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
• Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period

Exclusion criteria

• Had any history of pirfenidone or nintedanib use during the baseline period
• Had any history of lung transplant during the baseline, index date or follow-up periods
• Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
• Had evidence during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e. rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
• Had dual eligibility of Medicare and Medicaid
• Had history of using pirfenidone at the same time with nintedanib during follow-up

Trial design

1,798 participants in 1 patient group

Idiopathic Pulmonary Fibrosis Patients

Description:

Medicare beneficiaries with IPF who newly initiated treatment with nintedanib

Treatment:

Drug: Nintedanib