INGELHEIM, Germany. - Tuesday, September 9th 2014 [ME NewsWire]
A subgroup analysis of the INPULSIS™ data shows that nintedanib* slowed
lung function decline independent of severity of lung function
impairment at baseline1
Nintedanib* also reduced the proportion
of patients with IPF who experienced disease progression as measured by
categorical FVC decline2
Nintedanib* is the first targeted
treatment for IPF to consistently demonstrate its efficacy in two
identically designed Phase III trials and this subgroup analysis further
underscores its value for IPF patients
(BUSINESS WIRE) For media outside UK, US and Canada
A
pre-specified subgroup analysis from the two replicate Phase III
INPULSIS™ trials, presented today at the European Respiratory Society
International Congress (ERS), showed nintedanib* slowed disease
progression in patients with idiopathic pulmonary fibrosis (IPF),
independent of severity of lung function impairment at baseline.1 IPF is
a debilitating and fatal lung disease, with a median survival of 2–3
years after diagnosis.3 It causes progressive scarring of the lungs,
resulting in continual and irreversible deterioration in lung function
and difficulty breathing.4
The pooled analysis of INPULSIS™ data
looked at annual decline in lung function in two pre-specified groups –
baseline forced vital capacity (FVC) of >70% (n=700) and ≤70%
predicted (n=361). The positive effect of nintedanib* on slowing disease
progression was similar for both subgroups:1
FVC >70%
predicted: -111.3mL (nintedanib*) vs. -220.3mL (placebo), difference
109.0 mL (95% CI: 68.2, 149.9) in favour of nintedanib*.
FVC ≤70%
predicted: -119.7mL (nintedanib*) vs. -233.2mL (placebo), difference
113.5 mL (95% CI: 51.3, 175.7) in favour of nintedanib*.
The
results for both subgroups are consistent with the INPULSIS™ primary
endpoint finding for the overall patient population which showed
nintedanib*, one capsule twice a day, slowed disease progression by
reducing the annual rate of decline in lung function by 50% in a broad
range of IPF patient types - including patients with early disease
(FVC>90% pred), no honeycombing on HRCT and/or concomitant
emphysema.5
“Nintedanib* is the first targeted treatment for IPF
to consistently meet the primary endpoint in two identically designed
Phase III trials and this sub-analysis further underscores its efficacy
in IPF patients presenting different ranges of lung function impairment
at baseline,” said Professor Ulrich Costabel, Ruhrlandklinik University
Hospital, Germany.
In a separate, additional analysis of the
INPULSIS™ data, nintedanib* reduced the proportion of patients who
experienced disease progression as measured by categorical (absolute or
relative‡) FVC decline.2 A decline in FVC % predicted of >5% and
>10% over 6 or 12 months in patients with IPF is a marker of disease
progression and associated with reduced survival.3,6,7,8,9,10,11
Results showed:2
In both INPULSIS™-1 and 2, significantly more patients taking placebo
experienced an absolute decline in predicted FVC of >5%, as well as
relative declines of >5% and >10% vs. nintedanib*.
In
INPULSIS™-1, significantly more patients in the placebo group
experienced an absolute decline in predicted FVC of >10%; the
difference in INPULSIS™-2 was numerically in favour of nintedanib* but
did not reach statistical significance.
Further pre-specified
sensitivity analyses of the INPULSIS™ trials presented at the ERS
meeting confirm the robustness of the primary and key secondary endpoint
results for nintedanib* in IPF. 12
In both INPULSIS™ trials, the
most common adverse events were gastrointestinal in nature, of mild or
moderate intensity, generally manageable and rarely leading to treatment
discontinuation.5 The proportion of patients with serious adverse
events was similar in all groups.5
“The results of these analyses
further confirm and support the efficacy of nintedanib* on slowing
disease progression in a wide range of patients with IPF,” said Dr
Susanne Stowasser, Global Team Leader Medical Affairs, Boehringer
Ingelheim. “Boehringer Ingelheim is committed to studying nintedanib*
further and to making it available to patients with IPF and their
treating physicians as soon as possible.”
*Nintedanib is an investigational compound. Its safety and efficacy have not yet been fully established.
‡Categorical
declines in FVC % predicted can be measured as absolute or relative
declines - e.g. 60% to 50% predicted is a 10% absolute decline - e.g.
60% to 54% predicted is a 10% relative decline (Richeldi L, et al.
Thorax 2012;67:407–11)
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/09_september_2014_ipf.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra
Phone: +49 151 1502 1148
Email: linda.calandra@boehringer-ingelheim.com
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