Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

NCT05022784 | Completed Results FDA Drug

• 1 other identifier: 1199-0471
• Study Type: observational
• Target: 1,798
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients

  The number of IPF patients per adherence trajectories to nintedanib is presented. The first claim for nintedanib was used for defining the initiation date. For each 30-day month (12 months) following the nintedanib initiation date, the Proportions of Days Covered (PDC) were calculated as the sum of days with supply divided by 30, the monthly nintedanib proportion of days covered was then calculated. The twelve 30-days PDC values were used as outcomes in the Group-based trajectory model (GBTM), the probabilities that a given individual is in each of the latent clusters was calculated by the GBTM estimation procedure using the monthly binary PDC ≥ 0.8 indicators as outcomes. The reported types of trajectories to nintedanib were: * Highly adherent (PDC ≈ 0.9) * Medium adherent (PDC ≈ 0.4-0.6) - Gradual decliners (PDC bottoms out by month 11) * Intermediate decliners (PDC bottoms out by month 8) * Rapid decliners (PDC approaches zero by month 4)

  Up to 1 year

Secondary Outcomes (39)

• Demographic Characteristic: Age According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib

  Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.

• Demographic Characteristic: Sex According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib

  Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.

• Demographic Characteristic: Race/Ethnicity According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib

  Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.

• Demographic Characteristic: Census Region According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib

  Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.

• Demographic Characteristic: Social Deprivation Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib

  Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.

Study Arms (1)

Idiopathic Pulmonary Fibrosis Patients

Medicare beneficiaries with IPF who newly initiated treatment with nintedanib

Drug: Nintedanib

Interventions

Nintedanib DRUG

Nintedanib

Idiopathic Pulmonary Fibrosis Patients

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study sample will consist of community-dwelling Medicare beneficiaries with Idiopathic Pulmonary Fibrosis (IPF) who initiate treatment with nintedanib.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Medicus Economics, LCC

Milton, Massachusetts, 02186, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The use of administrative claims data restricted the ability to observe medication use, the only signal of use was from prescription drug claims, which do not provide any details of use and require the assumption that patients were adherent while they had medication supply. The follow-up period was limited to the first year after nintedanib initiation, therefore may not apply to adherence patterns after this period.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: August 23, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)