Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table. Disease progression was defined as a 10% relative change between the index date to follow-up FVC result.

Time frame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.

Population: Among the 24,686 fibrosing Interstitial Lung Disease (ILD) patients who initiated oxygen therapy during the Aim 1 follow-up period, 24,680 were successfully matched at a 1:1 ratio with a fibrosing ILD patient who did not yet initiate oxygen therapy.~Patients of the matched cohort are included for which pre-index and follow-up forced vital capacity (FVC) results were available.

The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table. Disease progression was defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the index date.

Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Among the 24,686 fibrosing Interstitial Lung Disease (ILD) patients who initiated oxygen therapy during the Aim 1 follow-up period, 24,680 were successfully matched at a 1:1 ratio with a fibrosing ILD patient who did not yet initiate oxygen therapy.~Patients of the matched cohort are included for which pre-index and follow-up forced vital capacity (FVC) results were available.

The number of participants with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy is reported. Using claims, sustained oxygen therapy use was defined among patients with at least 12 months of follow-up after the index date (oxygen initiation date), as a binary variable for the presence of ≥11 claims for oxygen therapy in a 12-month period.

Time frame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.

Population: Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria.~Population AIM 1 in this endpoint restricted to patients with sustained oxygen therapy use within 12 months of initiating oxygen therapy patients and with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.

Time to all-cause mortality is calculated as time between index date and mortality date. The oxygen therapy cohort index date was defined as the first date of a claim for oxygen therapy. The no oxygen therapy cohort index date was assigned as a date that was eligible to set an index date.

Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure.~For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected.

Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported. Descriptive statistics are rounded to one decimal place.

Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria.~Population AIM 1 in this endpoint restricted to patients without baseline oxygen therapy use.

Time between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use is reported. Sustained oxygen therapy was defined as ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.

Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria.~Population AIM 1 in this endpoint restricted to patients with sustained oxygen therapy use within 12 months of initiating oxygen therapy patients and with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.

Percentage of participants with acute exacerbations in the pre-index baseline period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table. The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.

Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure.~For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected.

Percentage of participants with acute exacerbations within the first 12 month of the follow up period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table. The follow up period (variable period) started on the index date until the earliest of the following: disenrollment from the health plan, death, or the end of the study period.

Time frame: Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure.~For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected.

Percentage of participants with hypoxemia in the pre-index baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table. The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.

Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure.~For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected.

Percentage of participants with hypoxemia in the pre-ILD baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table. The pre-ILD baseline period is defined as 12 months prior to the fibrosing ILD diagnosis date.

Time frame: Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Population: Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure.~For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected.