Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
To understand differences in characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.
Interventions
Nintedanib initiators
Pirfenidone initiators
Untreated
Sponsors
Study design
Eligibility
Inclusion criteria
* With ≥ 1 diagnosis for IPF (the International Classification of Diseases, Ninth Revision, Clinical Modification \[ICD-9-CM\] codes 516.3, 516.31, 515, or ICD-10-CM codes J84.112) in the EMR between October 1, 2013 to April 30, 2018 * With ≥ 1 prescription for nintedanib between October 1, 2014 and April 30, 2018 (the selection window) * The date of the first prescription will be defined as the index date * With ≥ 1 record in the EMR database during the 12 months prior to the index date (the pre-index period) * With ≥ 1 diagnosis of IPF during the 12 months prior to the index date * Age ≥ 40 on the index date * IQVIA will explore also requiring ≥ 1 chest CT scan before first IPF diagnosis during the pre-index period
Exclusion criteria
* With ≥ 1 diagnosis of other known causes of interstitial lung disease (ILD) on the date of or after the first IPF diagnosis during the pre-index period * Other known causes of ILD include conditions such as systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjögren disease, and hypersensitivity pneumonitis (ICD-9-CM codes 135, 237.7, 272.7, 277.3, 277.8, 446.21, 446.4, 495, 500-505, 506.4, 508.1, 508.8, 516.0, 516.1, 516.32-516.37, 516.2, 516.8, 516.9, 517.0, 517.2, 517.8, 518.3, 555, 710.0, 710.0-710.4, 714.0, 714.81, 720, and 759.5, or ICD-10-CM equivalent codes) * With ≥ 1 prescription for nintedanib prior to the index date * With ≥ 1 prescription for pirfenidone prior to or on the index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Patient Characteristics: BMI | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
| Baseline Patient Characteristics: Age | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
| Baseline Patient Characteristics: Sex | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
| Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
| Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. |
| Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD \>10% or p-value \<0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model. Backward selection was applied to develop a reduced model, only retaining covariates with p\<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model. Odds presented for key patient characteristics. Odd ratio of \>1 indicates increased odds of receiving treatment. |
Countries
United States
Participant flow
Recruitment details
This retrospective database study was conducted to understand differences in characteristics of Idiopathic pulmonary fibrosis (IPF) patients who were newly prescribed pirfenidone or nintedanib, and those who did not receive a prescription for an antifibrotic treatment.
Pre-assignment details
The study includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data.
Participants by arm
| Arm | Count |
|---|---|
| Nintedanib Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Nintedanib from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Nintedanib prescription. | 347 |
| Pirfenidone Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were first prescribed Pirfenidone from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date was the date of the first Pirfenidone prescription. | 423 |
| Untreated Cohort of patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis who were not prescribed antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone during the data window) from October 1, 2014 to October 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. The index date for the untreated cohort was randomly assigned to mimic the distribution of time from the earliest IPF diagnosis to index in the two treatment cohorts. | 12,494 |
| Total | 13,264 |
Baseline characteristics
| Characteristic | Nintedanib | Pirfenidone | Untreated | Total |
|---|---|---|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 6.7 | 72.1 years STANDARD_DEVIATION 6.8 | 70.9 years STANDARD_DEVIATION 8.9 | 70.96 years STANDARD_DEVIATION 8.79 |
| Race/Ethnicity, Customized Non-white | 16 Participants | 15 Participants | 1093 Participants | 1124 Participants |
| Race/Ethnicity, Customized Unknown | 26 Participants | 38 Participants | 1362 Participants | 1426 Participants |
| Race/Ethnicity, Customized White | 305 Participants | 370 Participants | 10039 Participants | 10714 Participants |
| Sex/Gender, Customized Female | 113 Participants | 142 Participants | 6314 Participants | 6569 Participants |
| Sex/Gender, Customized Male | 234 Participants | 281 Participants | 6179 Participants | 6694 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Baseline Patient Characteristics: Age
IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nintedanib | Baseline Patient Characteristics: Age | 71.6 years | Standard Deviation 6.7 |
| Pirfenidone | Baseline Patient Characteristics: Age | 72.1 years | Standard Deviation 6.8 |
| Untreated | Baseline Patient Characteristics: Age | 70.9 years | Standard Deviation 8.9 |
Baseline Patient Characteristics: BMI
The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nintedanib | Baseline Patient Characteristics: BMI | 29.5 kilogram/height in meters squared(kg/m²) | Standard Deviation 6.4 |
| Pirfenidone | Baseline Patient Characteristics: BMI | 30.1 kilogram/height in meters squared(kg/m²) | Standard Deviation 5.8 |
| Untreated | Baseline Patient Characteristics: BMI | 28.6 kilogram/height in meters squared(kg/m²) | Standard Deviation 6.5 |
Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)
IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nintedanib | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | 0.71 Score on a scale | Standard Deviation 1 |
| Pirfenidone | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | 0.79 Score on a scale | Standard Deviation 1.1 |
| Untreated | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | 1.09 Score on a scale | Standard Deviation 1.4 |
Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline
IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nintedanib | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | 125 Participants |
| Pirfenidone | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | 134 Participants |
| Untreated | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | 3311 Participants |
Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline
IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nintedanib | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | 113 Participants |
| Pirfenidone | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | 133 Participants |
| Untreated | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | 3141 Participants |
Baseline Patient Characteristics: Sex
IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting. One patient from the untreated cohort was missing gender information and is not shown in the table
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nintedanib | Baseline Patient Characteristics: Sex | Male | 234 Participants |
| Nintedanib | Baseline Patient Characteristics: Sex | Female | 113 Participants |
| Pirfenidone | Baseline Patient Characteristics: Sex | Male | 281 Participants |
| Pirfenidone | Baseline Patient Characteristics: Sex | Female | 142 Participants |
| Untreated | Baseline Patient Characteristics: Sex | Male | 6179 Participants |
| Untreated | Baseline Patient Characteristics: Sex | Female | 6314 Participants |
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD \>10% or p-value \<0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model. Backward selection was applied to develop a reduced model, only retaining covariates with p\<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model. Odds presented for key patient characteristics. Odd ratio of \>1 indicates increased odds of receiving treatment.
Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Population: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Age | 1.022 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Gender | 0.490 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | BMI category: Overweight | 1.359 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | BMI category: Obese | 1.833 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | BMI category: Very obese | 1.638 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: COPD | 0.581 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: Heart failure | 0.449 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: Stroke | 0.449 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: Hypertension | 0.663 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: Peripheral arterial diseases | 0.383 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Comorbidities: Severe diseases | 0.463 Odds ratio |
| Nintedanib | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Gastroesophageal reflux disease | 1.621 Odds ratio |