Pulmonary Arterial Hypertension and Interstitial Lung Disease Events Among Interleukin Inhibitor Users

Basic Details
Date Posted
Monday, December 3, 2018
Status
Complete
Medical Product
interleukin-1/-6 inhibitor
Health Outcome(s)
interstitial lung disease
pulmonary arterial hypertension
Description

The goal of this request is to describe interleukin-1 (IL-1) and interleukin-6 (IL-6) inhibitor use and occurrence of incident pulmonary arterial hypertension (PAH), interstitial lung disease (ILD), and macrophage activation syndrome (MAS) among an adult cohort with Adult-Onset Still's Disease (AOSD) and a pediatric cohort with Systemic Juvenile Idiopathic Arthritis (SJIA) in the Sentinel Distributed Database (SDD). Report 1 contains estimates of PAH, ILD, and MAS events among adults with AOSD and children with SJIA. Report 2 contains estimates of IL-1/-6 use and occurence of incident PAH, ILD, and MAS events among the two the adult and pediatric cohorts.

Data from October 1, 2015 to March 31, 2018 from 15 Data Partners contributing to the SDD were included in these reports. This request was distributed to Data Partners on August 15, 2018.

Additional Details
FDA Center
CDER
Time Period
October 1, 2015 - March 31, 2018
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Population / Cohort
Adults with Adult-Onset Still's Disease (AOSD) and Children with Systemic Juvenile Idiopathic Arthritis (SJIA)
Data Sources
Sentinel Distributed Database (SDD)