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
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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
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)
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