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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Biologic DMARDs Participants who received biologic DMARDs as per standard of care were included in this arm. |
Drug: Biological DMARDs
Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.
|
| Non-biological DMARDs Participants who received non-biologic DMARDs as per standard of care were included in this arm. |
Drug: Non-Biologic DMARDs
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with pulmonary arterial hypertension [up to the end of the study (up to overall period of 12 years)]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GA29396