Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
Interventions
DRUGPirfenidone
Pirfenidone
DRUGNintedanib
Nintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date) * Evidence of IPF: patient with at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022) * At least 18 years old at the index date * Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period
Exclusion criteria
* Any history of lung transplant during the 12-months pre-index/baseline period * Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period * Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis). * Missing demographic information (i.e., age or sex)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | From individual index date up to 12 months. | Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Discontinuation | From individual index date up to 12 months. | Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib) |
Countries
United States
Participant flow
Recruitment details
This was a retrospective cohort study to assess the dose reduction/interruption and discontinuation with nintedanib and pirfenidone initiators among patients with Idiopathic Pulmonary Fibrosis (IPF) from the Optum Research Database (ORD) who initiated either pirfenidone or nintedanib between October 2014 and December 2021.
Pre-assignment details
Patients with IPF who presented at least one pirfenidone or nintedanib prescription during the identification period and with at least 12 months of continuous enrollment in the health plan during pre- and post-index period. A total of 1,389 new users of nintedanib were matched to equal number of new pirfenidone users.
Participants by arm
| Arm | Count |
|---|---|
| Nintedanib Initiators Cohort IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period. | 1,389 |
| Pirfenidone Initiators Cohort IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period. | 1,389 |
| Total | 2,778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not meeting eligibility criteria | 3,517 | 2,009 |
Baseline characteristics
| Characteristic | Total | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort |
|---|---|---|---|
| Age, Continuous | 73.52 years STANDARD_DEVIATION 7.54 | 73.4 years STANDARD_DEVIATION 7.6 | 73.9 years STANDARD_DEVIATION 7.6 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 1083 Participants | 534 Participants | 549 Participants |
| Sex: Female, Male Male | 1695 Participants | 855 Participants | 840 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
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported.
Time frame: From individual index date up to 12 months.
Population: Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nintedanib Initiators Cohort | Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | 301 Participants |
| Pirfenidone Initiators Cohort | Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | 373 Participants |
Secondary
Time to Treatment Discontinuation
Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)
Time frame: From individual index date up to 12 months.
Population: Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021. Only IPF patients with event were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nintedanib Initiators Cohort | Time to Treatment Discontinuation | 257.47 Days | Standard Deviation 130.29 |
| Pirfenidone Initiators Cohort | Time to Treatment Discontinuation | 246.56 Days | Standard Deviation 134.55 |