N/A
N=1,798
Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05022784 ↗Enrolled (actual)
1,798
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients — 781; 202; 190; 255 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nintedanib (Drug)
- Age
- Older Adult · 66+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients |
781; 202; 190; 255; 370 | — |
| SECONDARY Demographic Characteristic: Age According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
74.65; 75.21; 75.89; 76.29; 76.21 | <.0001 sig |
| SECONDARY Demographic Characteristic: Sex According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
530; 113; 124; 138; 193; 251 | <.0001 sig |
| SECONDARY Demographic Characteristic: Race/Ethnicity According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
718; 183; 171; 237; 329; 63 | 0.37 |
| SECONDARY Demographic Characteristic: Census Region According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
172; 46; 51; 55; 92; 104 | 0.477 |
| SECONDARY Demographic Characteristic: Social Deprivation Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
41.63; 39.27; 39.61; 39.61; 40.20 | 0.644 |
| SECONDARY Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
139; 45; 32; 33; 55; 156 | 0.052 |
| SECONDARY Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
139; 45; 32; 33; 55; 156 | 0.052 |
| SECONDARY Clinical Characteristic: Congestive Heart Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
257; 65; 53; 101; 140; 524 | 0.044 sig |
| SECONDARY Clinical Characteristic: Renal Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
116; 40; 31; 39; 62; 665 | 0.525 |
| SECONDARY Clinical Characteristic: Cardiac Arrhythmias According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
232; 60; 72; 84; 141; 549 | 0.024 sig |
| SECONDARY Clinical Characteristic: Peripheral Vascular Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
170; 54; 44; 73; 112; 611 | 0.016 sig |
| SECONDARY Clinical Characteristic: Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
614; 161; 149; 198; 298; 167 | 0.913 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Asthma According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
132; 34; 31; 32; 67; 649 | 0.448 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Chronic Obstructive Pulmonary Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
373; 86; 86; 115; 183; 408 | 0.515 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Gastroesophageal Reflux Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
398; 104; 97; 125; 199; 383 | 0.829 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Hypoxia According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
234; 57; 63; 83; 100; 547 | 0.471 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Pulmonary Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
156; 36; 39; 48; 77; 625 | 0.915 |
| SECONDARY Clinical Characteristic- IPF Comorbid Conditions: Sleep Apnea According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
243; 52; 57; 62; 115; 538 | 0.190 |
| SECONDARY Clinical Characteristic- IPF Medical Services: High-res CT (High-resolution Computed Tomography) Scan According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
597; 157; 144; 200; 280; 184 | 0.928 |
| SECONDARY Clinical Characteristic- IPF Medical Services: Lung Biopsy According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
134; 37; 26; 35; 64; 647 | 0.490 |
| SECONDARY Clinical Characteristic- IPF Medical Services: Oxygen Therapy or Supplemental Oxygen According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
128; 28; 32; 45; 69; 653 | 0.667 |
| SECONDARY Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Medication Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
10.94; 11.38; 11.57; 12.04; 11.77 | 0.032 sig |
| SECONDARY Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
3,670; 3,042; 2,899; 3,711; 3,796 | 0.721 |
| SECONDARY Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
798; 732; 759; 807; 891 | 0.352 |
| SECONDARY Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hospitalization According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
512; 141; 130; 184; 234; 269 | 0.136 |
| SECONDARY Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
0.51; 0.43; 0.44; 0.40; 0.52 | 0.270 |
| SECONDARY Beneficiary Characteristics -Inpatient Hospitalization Use and Spending: Inpatient Hosp - LOS According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
2.55; 2.03; 1.96; 1.99; 2.59 | 0.306 |
| SECONDARY Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
6,721; 5,519; 5,011; 4,783; 6,323 | 0.145 |
| SECONDARY Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
555; 462; 485; 454; 604 | 0.109 |
| SECONDARY Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
8.25; 8.87; 8.35; 8.53; 9.13 | 0.454 |
| SECONDARY Beneficiary Characteristics: Outpatient Facility Use and Spending: Outpatient Facility Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
3,497; 3,623; 3,396; 3,711; 3,846 | 0.960 |
| SECONDARY Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
687; 742; 685; 762; 858 | 0.265 |
| SECONDARY Beneficiary Characteristics -Home Health Use and Spending: Home Health - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
1.31; 0.90; 0.82; 1.38; 2.35 | 0.026 sig |
| SECONDARY Beneficiary Characteristics - Home Health Use and Spending: Home Health Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
280; 232; 177; 286; 495 | 0.016 sig |
| SECONDARY Beneficiary Characteristics - Part B Spending: Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
7,136; 6,907; 7,446; 6,876; 6,916 | 0.937 |
| SECONDARY Beneficiary Characteristics -Part B Spending: Part B Spending - OOP: According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
1,481; 1,432; 1,532; 1,428; 1,438 | 0.948 |
| SECONDARY Beneficiary Characteristics - Total Spending: Total Medical Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
17,634; 16,280; 16,029; 15,656; 17,581 | 0.574 |
| SECONDARY Beneficiary Characteristics - Total Spending: All Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
21,304; 19,323; 18,928; 19,366; 21,377 | 0.491 |
| SECONDARY Beneficiary Characteristics - Total Spending: All Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib |
3,522; 3,367; 3,461; 3,452; 3,791 | 0.432 |
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.
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 (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
Data sourced from ClinicalTrials.gov (NCT05022784). 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.