ERS 2015: Landmark year for Boehringer Ingelheim’s respiratory portfolio - new data for COPD, IPF and asthma treatments

  • 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 improvement2
  • 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 baseline3

Ingelheim, Germany, 21 September 2015 - 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.

Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim
Dr William
Mezzanotte, Vice
President and Head
of Respiratory
Medicine at Boehringer 
Ingelheim

“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®.11

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.13

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.16

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.3

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.17,18

Boehringer Ingelheim events at ERS 2015:
Alongside abstract presentations at ERS 2015, Boehringer Ingelheim is hosting a media briefing on September 28 (12.45-14.00 CET, Industry Press Briefing Room, ERS Press Centre) and will be holding the following symposia:

  • COPD symposium: Meeting the patient’s needs in the changing world of COPD management
    September 27 (17:15-19:15 CET, Auditorium)
  • Symptomatic asthma symposium: The challenge of treating uncontrolled asthma at Step 3 and higher: Comparing options
    September 28 (17:15-19:15 CET, Room 4.2)
  • IPF symposium: Idiopathic pulmonary fibrosis – where real world meets science
    September 28 (17:15-19:15 CET, Elicium 1)
  • COPD symposium: Profiles of COPD and what can be achieved with treatment
    September 29 (17:15 – 19:15 CET, Elicium 1)

Spiolto® Respimat® in COPD abstracts
Spiolto® Respimat® is approved as a once-daily maintenance treatment to relieve symptoms in adult patients with COPD.

Title Lead Author Presentation Details
Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo D Singh Session: Poster Discussion: New data on established treatments for asthma, COPD and bronchiectasis
Location: Room E104-106
Session time: 14:45-16:45 (CET)
Date: Monday 28 September 2015
Late breaker    
ENERGITO: efficacy and safety of once-daily combined tiotropium + olodaterol versus twice-daily combined fluticasone propionate + salmeterol K-M Beeh Session: Thematic Poster: Emerging strategies for airways disease treatments
Location: Hall 14-37
Session time: 12:50-14:40 (CET)
Date: Tuesday 29 September 2015

Spiriva® and Spiriva® Respimat® in COPD abstracts
Spiriva®† is approved as a once daily maintenance treatment to relieve symptoms in adult patients with COPD.

Title Lead Author Presentation Details
Safety of tiotropium in patients with cardiac events in the TIOSPIR™ trial R Wise  Session: Thematic Poster: Safety of and interactions between current treatments for asthma and COPD
Location: Hall 14-19
Session time: 12:50-14:40 (CET)
Date: Sunday 27 September 2015
Safety of tiotropium in patients with cardiac events in the UPLIFT® trial D Tashkin Session: Thematic Poster: Safety of and interactions between current treatments for asthma and COPD
Location: Hall 14-19
Session time: 12:50-14:40 (CET)
Date: Sunday 27 September 2015
Investigator-reported vs adjudicated cause of death in the TIOSPIR™ trial R Wise Session: Poster Discussion: New data on established treatments for COPD
Location: Room E104-106
Session time: 14:45-16:45 (CET)
Date: Sunday 27 September 2015
Effect of exacerbation history and ICS use on outcomes in COPD patients from the TIOSPIR™ trial P Calverley Session: Poster Discussion: New data on established treatments for COPD
Location: Room E104-106
Session time: 14:45-16:45 (CET)
Date: Sunday 27 September 2015
Tiotropium efficacy and exacerbation risk in patients with different blood eosinophil levels P Calverley Session: Thematic Poster: Emerging strategies for airway disease treatments
Location: Hall 14-37
Session time: 12:50-14:40 (CET)
Date: Tuesday 29 September 2015

OFEV® in IPF abstracts
Nintedanib is approved under the brand name OFEV® in the US, EU, Japan and other territories for use in patients with IPF.

Title Lead Author Presentation Details
Effect of nintedanib on release of angiogenic/angiostatic cytokines by alveolar macrophages X Long Session Poster Discussion: IPF: From Bench to Bedside
Location: Room E102
Session time: 14.45 – 16.45 (CET)
Date: Monday 28 September 2015
Effect of nintedanib on hyaluronic acid turnover in lung fibroblasts from patients with IPF KE Hostettler Session: Poster Discussion: IPF: From Bench to Bedside
Location: Room E102
Session time: 14.45 – 16.45 (CET)
Date: Monday 28 September 2015
Nintedanib inhibits fibroblast activation and ameliorates pulmonary and dermal fibrosis in models of systemic sclerosis J Huang Session: Poster Discussion: IPF: From Bench to Bedside
Location: Room E102
Session time: 14.45 – 16.45 (CET)
Date: Monday 28 September 2015
Effect of nintedanib compared to pirfenidone on proliferation of lung fibroblasts from patients with IPF J Schuett Session: Thematic Poster:  Interstitial Lung Diseases II
Location: Hall 14-10
Session time: 12.50 – 14.40 (CET)
Date: Tuesday 29 September 2015
Interim analysis of nintedanib in an open-label extension of the INPULSIS® trials (INPULSIS®-ON B Crestani Session: Oral Presentation: Treatment of IPF
Location: Room 4.1
Session time: 14.45 – 16.45 (CET)
Date: Tuesday 29 September 2015
Effect of anti-acid medication on reduction in FVC decline with nintedanib G Raghu Session: Oral Presentation: Treatment of IPF
Location: Room 4.1
Session time: 14.45 – 16.45 (CET)
Date: Tuesday 29 September 2015
Effect of baseline corticosteroid medication on reduction in FVC decline with nintedanib V Cottin Session: Oral Presentation: Treatment of IPF
Location: Room 4.1
Session time: 14.45 – 16.45 (CET)
Date: Tuesday 29 September 2015
Effect of baseline FVC on lung function decline with nintedanib in patients with IPF T Maher Session: Oral Presentation: Treatment of IPF
Location: Room 4.1
Session time: 14.45 – 16.45 (CET)
Date: Tuesday 29 September 2015

Spiriva® Respimat® in asthma abstracts
Spiriva® Respimat® is approved for use in asthma in over 50 countries, including the EU‡, Japan§ and the U.S.**.19 The indication varies by country.

Title Lead Author Presentation Details
Tiotropium Respimat® add-on therapy in children with symptomatic asthma C Vogelberg Session: Poster Discussion: Modulating the immune system in COPD and asthma
Location: Room 13.2
Session time: 10:45-12:45 (CET)
Date: Tuesday 29 September 2015
Efficacy of tiotropium Respimat® in adults with moderate asthma, by baseline LTRA use R Dahl Session: Poster Discussion: Modulating the immune system in COPD and asthma
Location: Room 13.2
Session time: 10:45-12:45 (CET)
Date: Tuesday 29 September 2015
24-h efficacy and pharmacokinetics of tiotropium Respimat® 5 μg in patients with asthma R Buhl Session: Poster Discussion: Immune mechanisms in the human lung
Location: Hall 14-20
Session time: 12:50–14:40 (CET)
Date: Tuesday 29 September 2015

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

Footnotes

* Leukotriene receptor antagonist
† Refers to both Spiriva® Respimat® and Spiriva® HandiHaler®
‡ Spiriva® Respimat® is indicated in the EU as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥ 800 μg budesonide/day or equivalent) and long-acting β2-agonists and who experienced one or more severe exacerbations in the previous year.
§ Spiriva® Respimat® is approved for the relief of various symptoms associated with the obstructive impairment of airways due to bronchial asthma (only use for patients with severe persistent asthma).
** Spiriva® Respimat® is approved by the U.S. Food and Drug Administration (FDA) for the long-term, once-daily, prescription maintenance treatment of asthma in people ages 12 and older. Spiriva® Respimat® is not for the relief of acute bronchospasm.

Referências

  1. Beeh K-M, Derom E, Echave-Sustaeta J, et al. ENERGITO: efficacy and safety of once-daily combined tiotropium + olodaterol versus twice-daily combined fluticasone propionate + salmeterol. Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  2. Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo. Poster PA2958 presented at the European Respiratory Society International Congress, Amsterdam, the Netherlands, 26-30 September 2015.
  3. Dahl R, Casale T, Bleecker E, et al. Efficacy of tiotropium Respimat® in adults with moderate asthma, by baseline LTRA use. Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  4. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org/. (Accessed July 2015).
  5. Barnes P.J. Inhaled Corticosteroids in COPD: A Controversy. Respiration 2010; 80: 89–95
  6. Suissa S, Barnes PJ: Inhaled corticosteroids in COPD: the case against. Eur Respir J 2009; 34: 13–16
  7. Cates C. Inhaled corticosteroids in COPD: quantifying risks and benefits. Thorax 2013; 68: 499-500
  8. Price D, Yawn B, Brusselle G, Rossi A. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD Prim Care Respir J 2013; 22(1): 92-100
  9. Suissa S, Kezouh A, Ernst E. Inhaled corticosteroids and the risks of diabetes onset and progression. American Journal of Medicine 2010; 123: 1001-1006
  10. Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo. Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  11. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur Respir J. 2015; 45: 969–79
  12. Calverley PMA, Tetzlaff K, Mueller A, Metzdorf N, Disse B, Dahl R. Effect of exacerbation history and ICS use on outcomes in COPD patients from the TIOSPIR™ trial. ERS 2015 abstract number: PA1500
  13. Crestani B, et al. Interim analysis of nintedanib in an open-label extension of the INPULSIS trials (INPULSIS-ON). Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  14. Raghu G, et al. Effect of anti-acid medication on reduction in FVC decline with nintedanib. Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  15. Cottin V, et al. Effect of baseline corticosteroid medication on reduction in FVC decline with nintedanib. Abstract presented at the ERS International Congress 2015, Amsterdam, September 26 – 30, 2015
  16. Raghu G et al. High prevalence of abnormal acid gastro-oesphageal reflex in idiopathic pulmonary fibrosis. Eur Respir J. 2006 Jan; 27 (1): 136 – 42
  17. Kerstjens HAM, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367 (13): 1198-1207
  18. Kerstjens HAM, Casale TB, Bleecker ER, et al. Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials. Lancet Respir Med.2015; 3 (5): 367-76.
  19. Boehringer Ingelheim. Data on file.