Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)

Study Overview
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Brief Summary
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This study is designed to analyze the frequency and incidence rate of pulmonary complications in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants having evidence of of a prescription or administration of one of the biologic or non-biologic DMARDs will be included in five different treatment groups. Data from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate the incidence rate of pulmonary complications.

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: Biological DMARDs
* Drug: Non-Biologic DMARDs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with less than (<) 18 years of age at index Continuously enrolled for greater than (>) 6 months prior to index (baseline period) One diagnosis of JIA (714.3) on a non-diagnostic claim either during the baseline period (the complete participant record prior to the episode index will be defined as the episode baseline period) or within the first 30 days following the index date Had both medical and pharmacy benefit plus complete data availability during both baseline and follow-up periods Exclusion Criteria: For biologic DMARD cohorts, prior use of any qualifying biologic belonging to the biologic DMARD of interest (using all available claims history) For non-biologic DMARD cohort, prior use of any non-biologic DMARD or biologic DMARD Any record of rituximab use in complete participant record A prior safety event during the baseline period

Ages Eligible for Study
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Maximum 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 |
| --- | --- |
| Biologic DMARDs<br>Participants who received biologic DMARDs as per standard of care were included in this arm. | Drug: Biological DMARDs<br>* Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.<br>|
| Non-biological DMARDs<br>Participants who received non-biologic DMARDs as per standard of care were included in this arm. | Drug: Non-Biologic DMARDs<br>* Participants will receive non-biologic DMARDs as per standard of care. The choice of specific non-biologic DMARD will be at the descretion of treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with pulmonary arterial hypertension |  | up to the end of the study (up to overall period of 12 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with interstitial lung disease |  | up to the end of study (up to overall period of 12 years) | 
| Percentage of participants with alveolar proteinsis |  | up to the end of study (approximately 2.2 years) | 
| Percentage of participants with lipoid pneumonia |  | up to the end of study (up to overall period of 12 years) | 
| Percentage of participants with pulmonary hypertension |  | up to the end of study (up to overall period of 12 years) | 
| Percentage of participants with overall composite pulmonary complications |  | up to the end of study (up to overall period of 12 years) |