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OFEV® (nintedanib) safetySafety data INPULSIS®-1 & -2
These slides are provided by Boehringer Ingelheim for medical to medical education only.
Last updated 08.09.2015
Safety endpoints
• Safety was assessed by clinical and laboratory evaluation and the recording of adverse events
• Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 16.1
• Analyses were descriptive
• Analyses were based on patients who received ≥1 dose of study medication
Richeldi L, et al. N Engl J Med 2014;370:2071–2082.
Most frequent adverse events*: Pooled data
Based on adverse events with onset after first dose and up to 28 days after the last dose of trial medication.*Adverse events reported in >10% of patients in either treatment group based on pooled data. †Corresponds to the MedDRA term ‘IPF’, which included disease worsening and IPF exacerbations. Richeldi L, et al. N Engl J Med 2014;370:2071–2082.
Measures recommended in the protocol to manageadverse events
• Treatment interruption and dose reduction from 150 mg bid to 100 mg bid were recommended for the management of adverse events
• Following treatment interruption, treatment could be reinstituted at a dose of 150 mg bid or at a dose of 100 mg bid, which could later be increased to 150 mg bid
• Specific recommendations were provided for the management of diarrhoea and liver enzyme elevations
Richeldi L, et al. N Engl J Med 2014;370:2071–2082.
Algorithm for the management of diarrhea adverse events in the INPULSIS® trials
*Recovery defined as <4 extra stools per day.Richeldi L, et al. N Engl J Med 2014;370:2071–2082 Protocol.
Summary of safety findings
Nintedanib has a manageable side-effect profile
• Mild or moderate diarrhoea was the most frequent adverse event in patients treated with nintedanib
• Approximately 60% of patients treated with nintedanib had at least one diarrhoea adverse event, but fewer than 5% of patients prematurely discontinued nintedanib due to diarrhoea
