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A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03958071
Enrollment
13264
Registered
2019-05-21
Start date
2019-02-01
Completion date
2019-05-31
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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

DRUGNintedanib

Nintedanib initiators

DRUGPirfenidone

Pirfenidone initiators

OTHERUntreated Cohort

Untreated

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Baseline Patient Characteristics: BMIBaseline 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: AgeBaseline 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: SexBaseline 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 BaselineBaseline 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 BaselineBaseline 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

MeasureTime frameDescription
Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentBaseline 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

ArmCount
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
Total13,264

Baseline characteristics

CharacteristicNintedanibPirfenidoneUntreatedTotal
Age, Continuous71.6 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 Participants15 Participants1093 Participants1124 Participants
Race/Ethnicity, Customized
Unknown
26 Participants38 Participants1362 Participants1426 Participants
Race/Ethnicity, Customized
White
305 Participants370 Participants10039 Participants10714 Participants
Sex/Gender, Customized
Female
113 Participants142 Participants6314 Participants6569 Participants
Sex/Gender, Customized
Male
234 Participants281 Participants6179 Participants6694 Participants
Sex/Gender, Customized
Unknown
0 Participants0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
NintedanibBaseline Patient Characteristics: Age71.6 yearsStandard Deviation 6.7
PirfenidoneBaseline Patient Characteristics: Age72.1 yearsStandard Deviation 6.8
UntreatedBaseline Patient Characteristics: Age70.9 yearsStandard Deviation 8.9
p-value: 0.281t-test, 2 sided
p-value: 0.1421t-test, 2 sided
p-value: 0.0048t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
NintedanibBaseline Patient Characteristics: BMI29.5 kilogram/height in meters squared(kg/m²)Standard Deviation 6.4
PirfenidoneBaseline Patient Characteristics: BMI30.1 kilogram/height in meters squared(kg/m²)Standard Deviation 5.8
UntreatedBaseline Patient Characteristics: BMI28.6 kilogram/height in meters squared(kg/m²)Standard Deviation 6.5
p-value: 0.1659t-test, 2 sided
p-value: 0.0112t-test, 2 sided
p-value: <0.0001t-test, 2 sided
Primary

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.

ArmMeasureValue (MEAN)Dispersion
NintedanibBaseline Patient Characteristics: Charlson Comorbidity Index (CCI)0.71 Score on a scaleStandard Deviation 1
PirfenidoneBaseline Patient Characteristics: Charlson Comorbidity Index (CCI)0.79 Score on a scaleStandard Deviation 1.1
UntreatedBaseline Patient Characteristics: Charlson Comorbidity Index (CCI)1.09 Score on a scaleStandard Deviation 1.4
p-value: 0.326t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NintedanibBaseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline125 Participants
PirfenidoneBaseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline134 Participants
UntreatedBaseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline3311 Participants
p-value: 0.2042Chi-squared
p-value: <0.0001Chi-squared
p-value: 0.02Chi-squared
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NintedanibBaseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline113 Participants
PirfenidoneBaseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline133 Participants
UntreatedBaseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline3141 Participants
p-value: 0.7395Chi-squared
p-value: 0.0017Chi-squared
p-value: 0.0034Chi-squared
Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
NintedanibBaseline Patient Characteristics: SexMale234 Participants
NintedanibBaseline Patient Characteristics: SexFemale113 Participants
PirfenidoneBaseline Patient Characteristics: SexMale281 Participants
PirfenidoneBaseline Patient Characteristics: SexFemale142 Participants
UntreatedBaseline Patient Characteristics: SexMale6179 Participants
UntreatedBaseline Patient Characteristics: SexFemale6314 Participants
p-value: 0.7681Chi-squared
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
Secondary

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.

ArmMeasureGroupValue (NUMBER)
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentAge1.022 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentGender0.490 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentBMI category: Overweight1.359 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentBMI category: Obese1.833 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentBMI category: Very obese1.638 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: COPD0.581 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: Heart failure0.449 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: Stroke0.449 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: Hypertension0.663 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: Peripheral arterial diseases0.383 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentComorbidities: Severe diseases0.463 Odds ratio
NintedanibOdds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no TreatmentGastroesophageal reflux disease1.621 Odds ratio

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026