Head-to-head ENERGITO® study comparing benefits of Spiolto® Respimat® to LABA/ICS therapy in COPD1 and sub-analysis of OTEMTO® 1&2 trials showing quality of life improvement
New long-term efficacy and safety data of OFEV® (INPULSIS®-ON) in patients with IPF, plus new analyses from INPULSIS® trials on the efficacy of OFEV® in further patient subgroups
MezzoTinA-asthma® data analysing the benefit of adding Spiriva® Respimat® to at least ICS maintenance therapy in adults, with or without a LTRA* at baseline
Boehringer Ingelheim will present new data from its broad respiratory portfolio, which includes recently approved Spiolto® Respimat® (tiotropium/olodaterol) for COPD, OFEV® (nintedanib) for IPF and Spiriva® Respimat® (tiotropium) in asthma, at the upcoming European Respiratory Society (ERS) International Congress, 26-30 September.
“With the first approvals of OFEV® and Spiolto® Respimat®, 2015 marks a pivotal year for the company and our ongoing commitment to developing innovative solutions for patients with respiratory diseases,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. “The data to be presented at ERS 2015 add to the growing body of evidence across our portfolio and help to further characterise the efficacy and safety of our medicines to support physicians and patients alike.”
COPD: Spiolto® Respimat®
In COPD, the latest results from the Spiolto® Respimat® clinical trial programme include the ENERGITO® Phase IIIb head-to-head study investigating lung function improvements versus the long acting beta2 agonist/inhaled corticosteroid (LABA/ICS) combination salmeterol + fluticasone propionate.1 ICS therapies are only recommended by the GOLD guidelines for use in patients with more severe lung function impairment (GOLD 3/4) and at high risk of exacerbations,4 but they can be associated with potential serious side effects;5,6,7,8,9 there is therefore debate surrounding their widespread use in the management of COPD.
In addition, a sub-analysis of the recently published OTEMTO® 1&2 trial results2 will compare quality of life benefits of Spiolto® Respimat® in patients at different stages of the disease. The OTEMTO® 1&2 trials showed that the lung function improvements provided by Spiolto® Respimat® translate into symptomatic benefits and clinically meaningful quality of life improvement.10 Spiolto® Respimat® has gained approval in over 20 EU countries for use in the treatment of patients with COPD.
These trials are part of the 15,000 patient TOviTO® Phase III clinical trial programme investigating the efficacy and safety of Spiolto® Respimat® in COPD and build on the pivotal phase III TONADO® trials that demonstrated Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva® Respimat®.
COPD: Spiriva® and Spiriva® Respimat®
Exacerbation history is an important stratifying parameter in COPD4, and as a leader in Respiratory, Boehringer Ingelheim continues analysing large pools of data from its landmark trials to investigate this key consideration. New results from a post-hoc analysis of the TIOtropium Safety and Performance In Respimat® (TIOSPIR™) trial12 will be presented to determine whether exacerbation history (greater than or equal to 1 exacerbation in the past year) and inhaled corticosteroid (ICS) use at baseline affected outcomes of patients with COPD.
OFEV® (nintedanib) in Idiopathic Pulmonary Fibrosis (IPF)
Monitoring the long-term efficacy and safety of OFEV® (nintedanib) is important for a progressive disease like idiopathic pulmonary fibrosis (IPF). As IPF is a life-threatening and progressive disease, patients will be on long-term treatment to manage their disease. It is important to assess and continue to monitor the efficacy and safety of OFEV® in these patients. New data from the INPULSIS® extension trial (INPULSIS®-ON) will be presented for the first time demonstrating that the efficacy and safety of OFEV® is sustained long-term.
Further analyses from the two INPULSIS® Phase III clinical trials will also be shared with the respiratory community including the effect of OFEV® on slowing disease progression in patients who were taking anti-acid or corticosteroid medications at treatment baseline.14,15 Anti-acid medications are commonly given to patients with IPF to manage gastroesophageal reflux disease (GERD), a highly prevalent condition in IPF.
Asthma: Spiriva® Respimat®
Highlights from the accepted ERS abstracts include further analysis of data from the two MezzoTinA-asthma® clinical trials to see whether the impact of adding Spiriva® Respimat® to at least ICS maintenance therapy on improvements in lung function is influenced by whether or not the patients are receiving a LTRA* at baseline.
These new data will add to the existing evidence from the UniTinA-asthma® large-scale, Phase III clinical trial programme that has shown the efficacy and safety of Spiriva® Respimat® in patients with asthma who continue to experience symptoms despite treatment with at least ICS with or without LABA therapy.