Skip to main content

Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis

Basic Details
Date Posted
Status
In progress
Medical Product
natalizumab
vedolizumab
Health Outcome(s)
interstitial lung disease
Description

The goals of this analysis were to estimate rates of interstitial lung disease (ILD) among patients with inflammatory bowel disease (IBD) and among patients with IBD who initiated vedolizumab or natalizumab in the Sentinel Distributed Database (SDD). Patients with evidence of Crohn’s disease or ulcerative colitis were also examined as separate populations. The study period includes data from January 1, 2006 to April 30, 2023. We distributed this request to six Sentinel Data Partners on October 12, 2023.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (1)
Sentinel Analytic Package: Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2006 – April 30, 2023
Analysis Type
Descriptive
Population / Cohort
Individuals 18 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Entyvio (Vedolizumab) and Tysabri (Natalizumab) & Interstitial Lung Disease
Interstitial Lung Disease Algorithm Defined in "Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis"