Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD. The purpose of this study is to find out how well the treatments worked. Researchers compare the time to first COPD flare-up (exacerbation) between the 2 treatments. The study analyses anonymous data from pharmacy claims collected over 3.5 years.
Interventions
DEVICETrelegy Ellipta
Trelegy Ellipta
DEVICEStiolto Respimat
Stiolto Respimat
DRUGTiotropium + Olodaterol (5/5 mcg)
Tiotropium + Olodaterol (5/5 mcg)
DRUGFluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)
Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥40 years of age as of the year of the index date * At least one pharmacy claim for Stiolto Respimat or Trelegy Ellipta. * For Stiolto Respimat users, the first pharmacy claim of Fixed Dose Combination (FDC) of Tiotropium + Olodaterol (5/5 micrograms (mcg)) will be defined as the index date. * For Trelegy Ellipta users, the first pharmacy claim of FDC of Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg), will be defined as the index date. * Two medical claims (at least one claim on index date or before in the baseline period) with an International Statistical Classification of Diseases and Related Health Problems (ICD)-9/10 diagnosis code(s) for chronic obstructive pulmonary disease (COPD) in any position during the study period (baseline ± post index date). * At least one year of continuous medical and pharmacy health plan eligibility prior to the index date is required (to allow a baseline period for the covariates and characterizing the study population).
Exclusion criteria
* To increase the likelihood of a true diagnosis of COPD, we will exclude all patients with two medical claims of asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the study period. * To restrict the cohort to first line maintenance therapy of Stiolto Respimat or first line maintenance therapy of Trelegy Ellipta we will exclude: patients on long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; free or FDC of: ICS+LABA, LAMA+LABA, ICS+LABA+LAMA therapy within six months prior to index date. * Pharmacy claims for multiple index medications on the index date. * Pharmacy claims for non-index COPD maintenance medications on the index date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365. |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365. |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365. |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU) | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The total annualized costs of COPD or pneumonia-related health care cost and resource utilization (HCRU) were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. |
| Total Costs of COPD-related HCRU | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The total annualized costs of COPD-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. |
| Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365. |
| Total Costs of COPD or Pneumonia Attributable HCRU | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The total annualized costs of COPD or pneumonia attributable HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. |
| Total Costs of All-cause HCRU | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The total annualized costs of all-cause HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. |
| Total Costs of Pneumonia-related HCRU | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The total annualized costs of pneumonia-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365. |
| Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365. |
| Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365. |
| Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations | From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days. | The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365. |
Countries
United States
Participant flow
Recruitment details
This was a non-interventional, observational, retrospective study using existing real-world data, investigating the risk of Chronic obstructive pulmonary disease (COPD) exacerbations, community acquired pneumonia, and health care utilization in maintenance treatment naive patients treated as first line therapy with Stiolto, in comparison to Trelegy.
Pre-assignment details
All subjects who strictly met all inclusion and none of the exclusion criteria were included.
Participants by arm
| Arm | Count |
|---|---|
| Stiolto Initiators Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017). | 3,996 |
| Trelegy Initiators COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017). | 5,121 |
| Total | 9,117 |
Baseline characteristics
| Characteristic | Stiolto Initiators | Trelegy Initiators | Total |
|---|---|---|---|
| Age, Continuous | 61.7 Years STANDARD_DEVIATION 8.37 | 60.9 Years STANDARD_DEVIATION 78.7 | 61.25 Years STANDARD_DEVIATION 8.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1894 Participants | 2368 Participants | 4262 Participants |
| Sex: Female, Male Male | 2102 Participants | 2753 Participants | 4855 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry | 0.28 exacerbation per patient-year |
| Trelegy Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry | 0.32 exacerbation per patient-year |
p-value: 0.06495% CI: [0.993, 1.293]Regression, Cox
p-value: 0.045Wilcoxon (Mann-Whitney)
p-value: 0.063Log Rank
Primary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had 0 or 1 baseline exacerbation were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation | 0.27 exacerbation per patient-year |
| Trelegy Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation | 0.31 exacerbation per patient-year |
p-value: 0.11495% CI: [0.974, 1.279]Regression, Cox
Primary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subjects with 2 or more baseline exacerbations were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations | 0.49 exacerbation per patient-year |
| Trelegy Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations | 0.58 exacerbation per patient-year |
p-value: 0.27395% CI: [0.779, 2.424]Regression, Cox
Primary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had no baseline exacerbation were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation | 0.25 exacerbation per patient-year |
| Trelegy Initiators | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation | 0.3 exacerbation per patient-year |
p-value: 0.05795% CI: [0.996, 1.372]Regression, Cox
Secondary
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position)
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) | 0.025 pneu. hospitalization per patient-year |
| Trelegy Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) | 0.030 pneu. hospitalization per patient-year |
p-value: 0.42995% CI: [0.78, 1.792]Regression, Cox
p-value: 0.896Wilcoxon (Mann-Whitney)
p-value: 0.932Log Rank
Secondary
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 0 or 1 baseline exacerbation were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation | 0.024 pneu. hospitalization per patient-year |
| Trelegy Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation | 0.028 pneu. hospitalization per patient-year |
p-value: 0.50795% CI: [0.75, 1.79]Regression, Cox
Secondary
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 2 or more baseline exacerbations were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations | 0.075 pneu. hospitalization per patient-year |
| Trelegy Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations | 0.072 pneu. hospitalization per patient-year |
p-value: 0.72695% CI: [0.309, 5.405]Regression, Cox
Secondary
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with no baseline exacerbation were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation | 0.024 pneu. hospitalization per patient-year |
| Trelegy Initiators | Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation | 0.023 pneu. hospitalization per patient-year |
p-value: 0.93595% CI: [0.582, 1.645]Regression, Cox
Secondary
Total Costs of All-cause HCRU
The total annualized costs of all-cause HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Total Costs of All-cause HCRU | 20849 dollars per year |
| Trelegy Initiators | Total Costs of All-cause HCRU | 19384 dollars per year |
p-value: 0.328t-test, 2 sided
Secondary
Total Costs of COPD or Pneumonia Attributable HCRU
The total annualized costs of COPD or pneumonia attributable HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Total Costs of COPD or Pneumonia Attributable HCRU | 5729 dollars per year |
| Trelegy Initiators | Total Costs of COPD or Pneumonia Attributable HCRU | 5409 dollars per year |
p-value: 0.622t-test, 2 sided
p-value: 0.85595% CI: [0.928, 1.094]ZINB regression with log link
Secondary
Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU)
The total annualized costs of COPD or pneumonia-related health care cost and resource utilization (HCRU) were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU) | 9834 dollars per year |
| Trelegy Initiators | Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU) | 10020 dollars per year |
p-value: 0.874t-test, 2 sided
p-value: 0.0195% CI: [0.823, 0.974]ZINB regression with log link
Secondary
Total Costs of COPD-related HCRU
The total annualized costs of COPD-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Total Costs of COPD-related HCRU | 9688 dollars per year |
| Trelegy Initiators | Total Costs of COPD-related HCRU | 9834 dollars per year |
p-value: 0.899t-test, 2 sided
p-value: 0.01295% CI: [0.824, 0.976]ZINB regression with log link
Secondary
Total Costs of Pneumonia-related HCRU
The total annualized costs of pneumonia-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Time frame: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stiolto Initiators | Total Costs of Pneumonia-related HCRU | 2244 dollars per year |
| Trelegy Initiators | Total Costs of Pneumonia-related HCRU | 2274 dollars per year |
p-value: 0.974t-test, 2 sided
p-value: 0.59595% CI: [0.711, 1.812]ZINB regression with log link