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)

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: Biological DMARDs; Drug: Non-Biologic DMARDs

• Study Type: Observational
• Enrollment (Actual): 4557

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

JIA participants treated with biologic and non-biologic DMARDs from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Estimate): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile; Antirheumatic Agents
• Other Study ID Numbers: GA29396