Safety and tolerability profile of Esbriet

SAFETY: Safety data were obtained from 1247 patients in 3 randomized, controlled trials 1

*Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.

  • The most common adverse reactions (>1%) leading to discontinuation were rash and nausea
  • In clinical trials, elevated liver enzymes, photosensitivity reactions, and gastrointestinal disorders have been reported with Esbriet

 

TOLERABILITY: Some adverse reactions with Esbriet occurred early and/or decreased over time 1

 

Long-term, open-label, phase 3 extension study

No new safety and tolerability signals for up to 6.7 years 17

  • In a long-term, open-label extension of the phase 3 studies, 1058 patients with IPF were exposed to Esbriet for a median of 88 weeks/1.7 years (range, >0 to 349 weeks/6.7 years) with the primary objective of obtaining additional safety data for Esbriet 2403 mg/day
  • 40.4% (n=427) completed the study, with an overall discontinuation rate of 59.2% (n=626)
    • The most frequent adverse drug reactions were nausea (21.6%), diarrhea (12.3%), and rash (11.6%)
    • The most common treatment-emergent serious adverse events were IPF (21.7%) and pneumonia (8.5%)
    • 42% (n=444) discontinued due to treatment-emergent adverse events, including 16.8% (n=178) who discontinued due to IPF
  • Care should be exercised when interpreting open-label results due to the inability to minimize bias. The data represented are not designed to establish the long-term safety or tolerability profile for Esbriet

Adverse drug reactions are defined as adverse events judged by the investigator as possibly or probably related to pirfenidone.
Treatment-emergent adverse events are defined as all events that occurred from the first dose of pirfenidone through 28 days after the last dose in the long-term, open-label, phase 3 extension study.

 

EXPERT PERSPECTIVE:
PATIENT MANAGEMENT

Watch Robert Sussman, MD, talk about how to manage patients with IPF    

PERSONALIZED SUPPORT

Find out how Esbriet supports your patients with education and inspiration to help them get the most out of therapy    

ESBRIET WORLDWIDE EXPERIENCE

Learn about Esbriet outside the US