N/A
N=1,798
Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05870956 ↗Enrolled (actual)
1,798
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Total All-cause Medical Costs — 12647.73; 13580.61; 17549.74; 15375.10 United States dollars — p=0.516
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nintedanib (Drug)
- Age
- Older Adult · 66+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total All-cause Medical Costs |
12647.73; 13580.61; 17549.74; 15375.10; 18110.14 | 0.516 |
| SECONDARY Total IPF-related Medical Costs |
3239.75; 2935.82; 6011.81; 3696.54; 3860.62 | 0.439 |
| SECONDARY All-cause Inpatient Hospitalization |
20.4; 22.8; 30.0; 29.4; 26.8 | 0.463 |
| SECONDARY IPF-related Inpatient Hospitalization |
10.8; 11.4; 19.5; 14.1; 12.2 | 0.801 |
Summary
This study has two objectives:
1. To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF).
2. To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
Eligibility Criteria
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 of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)
- Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) 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 (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) 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
Data sourced from ClinicalTrials.gov (NCT05870956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.