Boehringer Ingelheim Release: New Long-Term Data Demonstrates Continued Safety And Beneficial Effect Of OFEV (Nintedanib) For Patients With IPF

• Interim data suggest long-term benefit with consistent yearly changes in forced vital capacity up to 3 years in patients treated with OFEV^® in INPULSIS^® and INPULSIS^®-ON
• Long-term treatment up to 51 months had a manageable safety and tolerability profile, with no new safety signals identified
• Additional INPULSIS^® analyses showed that OFEV^® slows disease progression regardless of baseline physiologic impairment as measured by several pulmonary function tests

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim presented eight IPF-related abstracts at the European Respiratory Society (ERS) International Congress 2016, including new interim data from the INPULSIS^®-ON extension trial assessing long-term treatment with OFEV^® (nintedanib). The results demonstrated that nintedanib has a long-term effect on slowing disease progression and a manageable side effect profile in patients with idiopathic pulmonary fibrosis (IPF), and were consistent with results previously observed in the INPULSIS^® trials. IPF is a chronic, debilitating and fatal lung disease with high mortality, with a median life expectancy after diagnosis of approximately 2–3 years.

“With this further evidence about OFEV® we have even greater treatment confidence. This is important because in a progressive disease like IPF it is so crucial to first discuss treatment options with our patients, get them on treatment early and then encourage them to stay on their medication.”

The INPULSIS^®-ON interim data showed that the change from baseline in forced vital capacity (FVC) in patients continuing treatment with nintedanib in the extension trial between baseline and week 48 and between weeks 48 and 96 was comparable to what was observed in patients on active treatment with nintedanib in the 52 week INPULSIS^® parent trials.

“We now have long-term data for OFEV^® in IPF patients showing that disease progression observed in INPULSIS^® is consistent for up to 3 years. In addition, no new safety signals were identified. This adds to the robust body of evidence demonstrating that OFEV^® is an effective and manageable treatment with clear benefits for patients living with IPF,” said Professor Bruno Crestani, Professor of Pneumology at the Paris Diderot University School of Medicine, France and Head of the Pneumology and Rare Lung Disease Department at Bichat Hospital, France.

The following mean changes in FVC were seen in INPULSIS^® and INPULSIS^®-ON:

• In INPULSIS^®, for patients on nintedanib mean change in FVC from baseline to week 52 was -89 mL compared to – 203 mL for patients on placebo
• In INPULSIS^®-ON, for patients continuing nintedanib mean change in FVC was -96 mL from baseline to week 48
• In INPULSIS^®-ON, for patients continuing nintedanib mean change in FVC was -124 mL from week 48 to week 96

Average total exposure of patients treated with nintedanib in INPULSIS^® and INPULSIS^®-ON trials was approximately 3 years (35.7 months). Long-term treatment with nintedanib (up to 51 months) was associated with a manageable safety and tolerability profile consistent with the findings of the INPULSIS^® studies and with no new safety signals identified. Side effects with nintedanib can be effectively managed in most patients with diarrhoea being the most frequently reported side effect.

Professor Crestani added: “With this further evidence about OFEV^® we have even greater treatment confidence. This is important because in a progressive disease like IPF it is so crucial to first discuss treatment options with our patients, get them on treatment early and then encourage them to stay on their medication.”

Additional INPULSIS^® analyses assessing the effect of nintedanib on FVC

Two additional subgroup-analyses from the INPULSIS^® study examined whether disease extent at baseline as measured by the composite physiologic index (CPI) or the level of gas exchange impairment in the lungs could impact the treatment effect of nintedanib.^* Both analyses confirmed the beneficial effect of nintedanib on annual rate of FVC decline irrespective of the level of baseline impairment, and provide further evidence of the benefits of nintedanib in slowing disease progression in a broad range of IPF patients.^**

These data were presented at the European Respiratory Society International Congress 2016. The corresponding abstracts can be found within the online programme, here: http://www.erscongress.org/programme-2016/access-the-programme.html

^* Gas exchange is the delivery of oxygen from the lungs to the bloodstream, and the elimination of carbon dioxide from the bloodstream to the lungs. The level of gas exchange was assessed by the diffusing capacity of the lungs for carbon monoxide (DLCO). Lower values of DLCO imply a higher impairment of the capacity of the lung to exchange gases. The composite physiologic index (CPI) is an index that more accurately reflects the extent of fibrosis in the lungs than individual lung function tests.

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

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