Boehringer Ingelheim to present comprehensive data supporting broad respiratory portfolio in COPD, asthma and IPF at ERS 2014

The European Respiratory Society (ERS) International Congress, in Munich, Germany, September 6-10, 2014 sets the scene for important announcements across the substantial Boehringer Ingelheim respiratory portfolio. Data to be presented cover new advances in chronic obstructive pulmonary disease (COPD) treatment approaches, further supporting data for tiotropium Respimat^® in asthma and rare disease insights for idiopathic pulmonary fibrosis (IPF).

With a total of 18 abstracts presented during ERS 2014, the data will highlight the importance of the company’s focus on respiratory research and advances in addressing unmet needs for patients living with certain lung diseases. Further detailed presentations and information will be provided in two media briefings during the congress.

COPD:Tiotropium + olodaterol Respimat® FDCand Spiriva® (tiotropium)

For the first time, data from the pivotal, 52-week TONADO™ Phase III studies^§ involving more than 5,000 patients with COPD will be presented. The TONADO™ studies compared clinical outcomes in patients receiving tiotropium + olodaterol FDC delivered via the Respimat^® Soft Mist^™ Inhaler with those on tiotropium or olodaterol (Striverdi^®) alone. The data from the TONADO™ studies formed a major part of Boehringer Ingelheim’s recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat^® FDC in COPD.

These important advances are underpinned by in-depth analyses of Spiriva^® clinical trials that demonstrate an extensive wealth of experience since its introduction over 10 years ago^** and over 40 million patient-years of real life experience supporting its safety and efficacy.^1-7

Further analysis of one of the largest COPD trials, TIOSPIR™, highlights the predictors of debilitating COPD exacerbations and reinforces the need to treat COPD patients early. Spiriva^® has shown a positive impact on reducing the risk of these lung attacks across a broad range of severities of COPD patients.^††,3,6,8

Tiotropium Respimat^®in asthma

Further highlights from the accepted ERS abstracts include studies looking at the impact of adding tiotropium Respimat^® to at least ICS maintenance therapy on improving symptom control and reducing the risk of exacerbations across asthma severities. Using results pooled from the large UniTinA-asthma^® international Phase III clinical trial programme including the PrimoTinA-asthma^®, MezzoTinA-asthma^® and GraziaTinA-asthma^® trials, these new data will add to existing evidence that has shown the efficacy and safety of tiotropium Respimat^® in patients with asthma who continue to experience symptoms despite treatment with at least ICS with or without LABA therapy. Despite current treatment options, almost one in two patients with asthma still have asthma symptoms^9,10,11 and may experience frightening and life-threatening asthma exacerbations.

Idiopathic Pulmonary Fibrosis (IPF)

Abstracts to be presented at ERS show further data from the two Phase III INPULSIS^TM trials, investigating nintedanib^‡ 150 mg twice daily in the treatment of IPF.¹² The primary endpoint was the annual rate of decline in forced vital capacity (FVC).¹² Key secondary endpoints were: change from baseline in health-related quality of life, as assessed by the Saint-George’s Respiratory Questionnaire (SGRQ) and time to first acute exacerbation.¹² The robustness of the primary and key secondary endpoint results is supported by sensitivity analyses.¹³

A pre-specified subgroup analysis of pooled data from the INPULSIS™ trials showed that nintedanib^‡ 150 mg twice daily slowed the decline in lung function in patients with IPF, independent of severity of lung function impairment at baseline.¹⁴ In addition, nintedanib^‡ reduced the proportion of patients with IPF who experienced disease progression as measured by categorical FVC decline.¹⁵

References

1. Boehringer Ingelheim. Data on file.
2. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat Inhaler and the Risk of Death in COPD: The TIOSPIR Trial. N Engl J Med 2013;369(16):1491-501.
3. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002;19:217-24.
4. Anzueto A, Tashkin D, Menjoge S, et al. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm Pharmacol Ther 2005;18:75-81.
5. Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003;124:1743-8
6. Tashkin DP, Celli B, Senn S, et al. On behalf of the UPLIFT® (Understanding Potential Long-term Impacts on Function with Tiotropium) study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-54.
7. Bateman E, Tashkin D, Siafakas N, et al. The one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104: 1460-1472.
8. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364:1093-103.
9. Bateman ED, Boushey HA, Bousquet J, et al. GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004; 170 (8): 836-844.
10. Partridge MR, Dal Negro RW, Olivieri D. Understanding patients with asthma and COPD: insights from a European study. Prim Care Respir J 2011; 20 (3): 315-323.
11. Demoly P, Paggiaro P, Plaza V, et al. Prevalence of asthma control among adults in France, Germany, Italy, Spain and the UK. Eur Respir Rev 2009; 18: (112): 105–112.
12. Richeldi L, du Bois RM, Raghu G, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82.
13. Kolb M, Collard HR, Stowasser S, et al., Sensitivity analyses from the INPULSIS™ trials of nintedanib. Data to be presented at ERS International Congress, Sept 2014.
14. Costabel U, Inoue Y, Richeldi L, et al., Effect of baseline FVC on decline in lung function with nintedanib: results from the INPULSIS™ trials. Data to be presented at ERS International Congress, Sept 2014.
15. Cottin V, Taniguchi H, Collard HR, et al., Reduction in disease progression with nintedanib in the INPULSIS™ trials. Data to be presented at ERS International Congress, Sept 2014.