Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Study Overview
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Brief Summary
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The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.

Official Title
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Assessment of the Dose Reduction and Discontinuation Associated With Anti-Fibrotic Medications in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Pirfenidone
* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pirfenidone initiators<br>Patients who initiated pirfenidone treatment | Drug: Pirfenidone<br>* Pirfenidone<br>|
| Nintedanib initiators<br>Patients who initiated nintedanib treatment | Drug: Nintedanib<br>* Nintedanib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose reduction and/or temporary dose reduction | Incidence of dose reduction/interruption will be defined as average daily dose not following the prescribing information of nintedanib and pirfenidone, for at least 60 consecutive days. Correspondence to ≤ 90% dose strength for pirfenidone or ≤ 66.67% dose strength for nintedanib | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug discontinuation | Defined as: Presence of sixty or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib) | up to 12 months |