Esbriet (pirfenidone) offers established safety built on multiple clinical studies 2

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

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

  • The most common adverse reactions (>1%) leading to discontinuation were rash and nausea
  • The most common AEs (>3%) leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction
  • Serious AEs, including elevated liver enzymes and drug-induced liver injury, photosensitivity reactions, and gastrointestinal (GI) disorders, have been reported with Esbriet

 

Tolerability with Esbriet

SOME AEs WITH ESBRIET WERE MILD TO MODERATE, OCCURED EARLY, AND DECREASED OVER TIME 2

The first dermatologic AE tended to occur within the first 2 to 3 months of treatment and GI and nausea AEs during the peri-titration period. 19

PHOTOSENSITIVITY REACTIONS AND GI EVENTS TYPICALLY OCCURRED IN THE FIRST 3 TO 6 MONTHS OF TREATMENT AND INFREQUENTLY LED TO DISCONTINUATION 1,2

  • The majority of photosensitivity reactions occurred in the first 6 months of treatment 2
  • Incidence was 9% with Esbriet vs 1% with placebo 2
  • Median time to first photosensitivity AE was 90 (IQR: 48.0–149.0) days 19,20†
  • <1% discontinuation due to photosensitivity with Esbriet 1

IQR=interquartile range.
Median time to first AE of interest.

  • Most GI AEs occurred in the first 3 months of treatment and decreased over time 2
  • Median time to first GI AE was 14 (IQR: 5.0–40.0) days 19,20†
  • Discontinuation due to GI events was 2.2% with Esbriet vs 1% with placebo 2

Flexible dosing (dose modification, interruptions, discontinuations) with Esbriet 267 mg may help manage potential AEs like GI events and photosensitivity reactions. 2  See Adverse Event Management for more on managing AEs

 


 

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

Follow-up safety data available for up to 6.7 years 21

  • In a long-term, open-label extension of the phase 3 studies, 1058 patients with IPF were exposed to Esbriet (2403 mg/day) 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 AEs judged by the investigator as possibly or probably related to pirfenidone.
§Treatment-emergent AEs 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.