FDA Labeling Change: Vedolizumab & Interstitial Lung Disease (ILD)

The FDA pursued analyses in the Sentinel System to contextualize background rates of interstitial lung disease (ILD) in patients with inflammatory bowel disease (IBD) and to determine the incidence of ILD in patients with IBD treated with integrin receptor antagonists Entyvio (vedolizumab) or Tysabri (natalizumab), in support of a Newly Identified Safety Signal (NISS) evaluation. Sentinel results did not indicate an increased incidence of ILD in patients treated with vedolizumab or natalizumab for IBD. The incidence rates of ILD for IBD patients treated with integrin receptor antagonists approximates the ILD incidence rates observed separately in patients with IBD who initiated and actively used advanced therapies other than an integrin receptor antagonist or patients with IBD who had a history of treatment with advanced therapies other than an integrin receptor antagonist.  

As part of the NISS evaluation, FDA used the findings from the Sentinel analysis to support contextualizing the identified safety signal and provide additional data on the burden of disease. Based on the entire body of evidence evaluated as part of the NISS, including detailed review of case reports in both the medical literature and from the FDA Adverse Event Reporting System (FAERS), FDA approved a safety-related labeling supplement request for Entyvio (vedolizumab) on April 18, 2024. The safety-related labeling update incorporated the terms “interstitial lung disease, pneumonitis” into the Postmarketing Experience subsection of the Prescribing Information.