Boehringer Ingelheim Release: New Data Demonstrate Sustained Long-Term Efficacy Of OFEV* On Slowing Disease Progression And Safety In Patients With IPF

• Interim analysis of INPULSIS^®-ON study shows:
  Beneficial effect of OFEV^®* on slowing disease progression was maintained and the change from baseline in FVC was consistent over 2 years¹
• Long-term treatment with OFEV^®* had a manageable safety and tolerability profile (mean exposure of 2.4 years, maximum exposure of more than 3 years)¹
• Commonly used concomitant medications, such as anti-acids or systemic steroids, do not influence the beneficial effect of OFEV^®* on slowing disease progression^2,3

INGELHEIM & AMSTERDAM--(BUSINESS WIRE)--An interim analysis of the INPULSIS^®-ON extension trial has confirmed the efficacy and safety of OFEV^®* (nintedanib) previously observed in the INPULSIS^® trials.¹ The results were presented at the European Respiratory Society (ERS) International Congress 2015, and confirm that OFEV^®* has a long-term effect on slowing disease progression and a manageable side effect profile in patients with idiopathic pulmonary fibrosis (IPF).¹ This new data is important in light of the fact that IPF is a life-threatening and progressive disease, requiring patients to be on long-term treatment.⁴

“The safety and efficacy data presented for OFEV®* is very reassuring with regards to the long-term outcomes of treatment with OFEV®* and its effect on slowing disease progression”

The INPULSIS^®-ON interim analysis showed that the change from baseline in forced vital capacity (FVC) at 48 weeks in patients continuing treatment with OFEV^®* in the extension trial was comparable to what was observed in the 52 weeks INPULSIS^® trial.¹ This provides further evidence that the beneficial effect of OFEV^®* on slowing disease progression is maintained in the long-term.¹

“The safety and efficacy data presented for OFEV^®* is very reassuring with regards to the long-term outcomes of treatment with OFEV^®* and its effect on slowing disease progression,” said Professor Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom. “They add further weight to the growing body of evidence in support of OFEV^®* as an effective and manageable treatment for IPF. When managing IPF it is important that physicians discuss with their patients what to expect from treatment and which treatment is right for them, to initiate this treatment early and then to ensure the patient stays on it as long as possible.”

Key results from the interim analysis of INPULSIS^®-ON

INPULSIS^®-ON is an open-label single arm study. More than 90% of IPF patients participating in INPULSIS^® and eligible for open-label treatment with nintedanib in INPULSIS^®-ON opted to participate. Patients on placebo treatment in the INPULSIS^® trials newly initiated treatment with OFEV^®* in the extension trial and patients already treated with OFEV^®* in the INPULSIS trials continued to receive OFEV^®*. The effect of OFEV^®* on the mean change from baseline in FVC at week 48 of the INPULSIS^®-ON trial was comparable to the one seen at 52 weeks in the INPULSIS^® trial:

• In INPULSIS^®-ON: -87 mL for all patients, -96,4 mL for patients continuing treatment with OFEV^® in the extension trial and -73,1 mL for patients initiating treatment with OFEV^®1
• In INPULSIS^® (pooled data): -88,9 mL (OFEV^®) vs. -203,0 mL (placebo)¹

The analysis substantiates the effects of OFEV^®* on slowing disease progression and confirms the long-term efficacy of OFEV^®*.¹ Additionally no new safety signals were identified following long-term treatment with OFEV^®* in INPULSIS^®-ON.¹ The most frequent adverse events were gastrointestinal in nature with diarrhoea affecting 64% of patients but leading to drug discontinuation in only 5%.¹

Effect of OFEV^®* on a broad range of IPF patients^**

New subgroup-analyses from the INPULSIS^® study presented at the congress examined whether OFEV^®* had a consistent effect on patients with IPF who were also taking commonly used medications, including anti-acids and corticosteroids, when they were enrolled in the study.^2,3

Anti-acid medications are often given to patients with IPF to manage gastroesophageal reflux disease (GERD), which is common in patients with IPF and is considered to be a risk factor for IPF disease progression and acute exacerbations.⁵ IPF patients are also sometimes treated with low doses of corticosteroids (e.g. prednisone) and therefore subjects receiving low doses of corticosteroids were allowed in the INPULSIS^® trials.⁶

The analyses confirm that these concomitant medications taken at baseline do not influence the beneficial effect of OFEV^®* on annual rate of FVC decline.^2,3

The two analyses provided further evidence that OFEV^®* slows disease progression in a broad range of IPF patients^**.^2,3

These data are presented at the European Respiratory Society International Congress on 29 September 2015 at 14.45 CEST in Room 4.1. The corresponding abstracts can be found within the online programme, here: http://www.erscongress.org/programme-2015/access-the-programme.html

• Interim analysis of nintedanib in an open-label extension of the INPULSIS^® trials (INPULSIS^®-ON)
• Effect of anti-acid medication on reduction in FVC decline with nintedanib
• Effect of baseline corticosteroid medication on reduction in FVC decline with nintedanib

New IPF treatment guidelines emphasise the role of OFEV^®* in the treatment of IPF

In July 2015, the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis was published giving a conditional recommendation for the use of OFEV^® (nintedanib*) in patients with IPF^***.⁷ The committee noted the high value of OFEV^® on patient-important outcomes such as disease progression as measured by rate of forced vital capacity (FVC) decline and mortality. The recommendation also takes into account the expected cost of treatment and potentially significant adverse effects.

*Nintedanib is approved under the brand name OFEV^® in the US, EU, Japan and other territories for use in patients with IPF

**Including those with preserved lung function (FVC>90%pred), no honeycombing on HRCT and concomitant emphysema

*** This conditional recommendation means that clincians are encouraged to discuss preferences with their patients when making treatment decisions

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Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/29_september_2015_ipf.html

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