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N/A N=1,798

Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Idiopathic Pulmonary Fibrosis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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