New long-term data demonstrates continued safety and beneficial effect of OFEV® (nintedanib) for patients with IPF
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.
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
~ ENDS ~
Please click on the link below for ‘Notes to Editors’ and ‘References’ :
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.
Media + PR
Phone: +49 6132 – 77 182415
Fax: +49 6132 – 77 6601
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skrive dig op her og du vil løbende modtage pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
CA-THREATMETRIX18.12.2017 14:02 | pressemeddelelse
ThreatMetrix Exceeds 45% Annual Growth as Organizations Embrace Digital Identity as Must-Have Technology
DWC-3.018.12.2017 11:56 | pressemeddelelse
DWC Secures € 10,8 M From GEM Global
EURID18.12.2017 11:02 | pressemeddelelse
EURid Hosts Green Discussion Panel at The 2017 Internet Governance Forum in Geneva
BEARINGPOINT18.12.2017 10:02 | pressemeddelelse
BearingPoint Achieves Platinum Status in the Salesforce Consulting Partner Program
SES/TIMOR-TELECOM18.12.2017 08:57 | pressemeddelelse
Timor Telecom Enhances International Voice Connections in Timor-Leste Through SES Networks
STEEPER-ENERGY18.12.2017 08:02 | pressemeddelelse
Steeper Energy Announces EUR 50.6 M (DKK 377 M) Advanced Biofuel Project with Norwegian-Swedish joint venture Silva Green Fuel in Licensing Deal
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum