OFEV ® (nintedanib) efficacy INPULSIS ® trial results for acute IPF exacerbations Last updated 08.09.2015 These slides are provided by Boehringer Ingelheim.

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OFEV ® (nintedanib) efficacy INPULSIS ® trial results for acute IPF exacerbations Last updated These slides are provided by Boehringer Ingelheim for medical to medical education only.

Acute exacerbations Acute exacerbations were defined in the trial protocol as events meeting all of the following criteria: Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray and/or HRCT, or parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since last visit Causes of the acute worsening, including infection, left heart failure, pulmonary embolism or any identifiable cause of acute lung injury, were to be excluded as per routine clinical practice and microbiological studies Collard HR, et al. Am J Respir Crit Care Med 2007;176:636–643. Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Time to first acute exacerbation (investigator-reported): INPULSIS ® -1 Nintedanib 150 mg bid (n=309)Placebo (n=204) Patients with ≥1 acute exacerbation, n (%)19 (6.1)11 (5.4) Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Nintedanib 150 mg bid (n=329)Placebo (n=219) Patients with ≥1 acute exacerbation, n (%)12 (3.6)21 (9.6) Time to first acute exacerbation (investigator-reported): INPULSIS ® -2 Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Nintedanib 150 mg bid (n=638)Placebo (n=423) Patients with ≥1 acute exacerbation, n (%)31 (4.9)32 (7.6) Time to first acute exacerbation (investigator-reported): Pooled data Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Adjudicated acute exacerbations An adjudication committee categorised the investigator-reported acute exacerbations according to pre-specified criteria 1 as: –Confirmed acute exacerbation –Suspected acute exacerbation –Not an acute exacerbation The adjudication committee was blinded to treatment allocation and events were adjudicated before database lock and data unblinding Richeldi L, et al. N Engl J Med 2014;370:2071– Collard HR, et al. Am J Respir Crit Care Med 2007;176:636–643.

Time to first adjudicated confirmed or suspected acute exacerbation: Pooled data Richeldi L, et al. N Engl J Med 2014;370:2071–2082. Nintedanib 150 mg bid (n=638)Placebo (n=423) Patients with ≥1 acute exacerbation, n (%)12 (1.9)24 (5.7)

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