Trial Outcomes & Findings for Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment (NCT NCT05875532)
NCT ID: NCT05875532
Last Updated: 2024-09-19
Results Overview
The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval. Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
COMPLETED
34960 participants
At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
2024-09-19
Participant Flow
Retrospective cohort study using the Medical Data Vision (MDV) database to study progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILDs) in a real-world setting in Japan. Data was extracted for the period of 01-Jan-2012 to 28-May-2020 for patients presenting pre-specified ILDs that received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) between 01-Jan-2013 to 6 months before 28-May-2020.
Patients that met all inclusion criteria and none of the exclusion criteria were followed from the day after of the second diagnosis of a fibrosing ILD other than IPF - index date - until the end of study period (28-May-2020), the last encounter in the MDV database or in-hospital death, whichever occurs first.
Participant milestones
| Measure |
Patients With an ILD Other Than IPF
Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.
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|---|---|
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Overall Study
STARTED
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34960
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Overall Study
COMPLETED
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34960
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With an ILD Other Than IPF
n=34960 Participants
Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.
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Age, Continuous
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71.13 Years
STANDARD_DEVIATION 12.16 • n=34960 Participants
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Sex: Female, Male
Female
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16597 Participants
n=34960 Participants
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Sex: Female, Male
Male
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18363 Participants
n=34960 Participants
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PRIMARY outcome
Timeframe: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020Population: Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria. The number of patients analyzed displays the number of patients at risk of progression at the time of interest.
The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval. Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Outcome measures
| Measure |
Patients With an ILD Other Than IPF
n=34960 Participants
Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.
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|---|---|
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Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
6 months
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0.147 Cumulative incidence probability
Interval 0.143 to 0.151
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Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
12 months
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0.249 Cumulative incidence probability
Interval 0.244 to 0.253
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Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
18 months
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0.334 Cumulative incidence probability
Interval 0.329 to 0.34
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Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
24 months
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0.395 Cumulative incidence probability
Interval 0.389 to 0.401
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SECONDARY outcome
Timeframe: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020Population: Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria.
Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Outcome measures
| Measure |
Patients With an ILD Other Than IPF
n=34960 Participants
Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.
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Number of Patients With Treatment of Interest During Follow-up Period
Rituximab
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49 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Tacrolimus
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499 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Mycophenolate
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30 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Cyclosporine
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200 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Cyclophosphamide
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225 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Azathioprine
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201 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Oral corticosteroid
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2065 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Tocilizumab
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46 Participants
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Number of Patients With Treatment of Interest During Follow-up Period
Nintedanib
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472 Participants
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SECONDARY outcome
Timeframe: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020Population: Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria.
Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Outcome measures
| Measure |
Patients With an ILD Other Than IPF
n=34960 Participants
Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.
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|---|---|
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Number of Patients With Management of Interest During Follow-up Period
Oxygen therapy (HOT)
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1641 Participants
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Number of Patients With Management of Interest During Follow-up Period
Lung transplant
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0 Participants
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Number of Patients With Management of Interest During Follow-up Period
Palliative care (oxygen inhalation, opioid use)
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9520 Participants
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Adverse Events
Patients With an ILD Other Than IPF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place