New Data Published in The Lancet Show Daxas® (Roflumilast) Reduces Exacerbations and Hospitalizations in Sev

Actualizado 14/11/2016 11:26:01 CET

ZURICH, February 13, 2015 /PRNewswire/ --

FOR MEDICAL MEDIA ONLY

- Randomized trial results demonstrate roflumilast decreases exacerbations and hospitalizations in severe COPD patients with uncontrolled chronic bronchitis already

receiving maximal dosage of inhaled dual or triple therapy -

Takeda Pharmaceutical International GmbH today announced results of the REACT study demonstrating Daxas(R)(roflumilast) significantly reduced exacerbations and hospitalizations in patients with severe chronic obstructive pulmonary disease (COPD), who are at risk of frequent and severe exacerbations despite already receiving inhalation therapy with ICS/LABA combinations or triple (LAMA/ICS/LABA) therapy.[1] The study showed that roflumilast significantly reduced the rate of severe exacerbations by 24.3 percent (p=0.0175) and those requiring hospitalization by 23.9 percent (p=0.0209), reducing the clinical and economic burden of this disease.[1] In patients receiving triple therapy, roflumilast significantly reduced the rate of severe exacerbations by 23.3 percent (p=0.0406), indicating how patients with severe COPD may benefit most from the addition of roflumilast to their therapeutic regimen.[1] These results have been published online in The Lancet.

To prevent exacerbations and possible hospitalization, patients with severe COPD are treated with inhaled long-acting muscarinic antagonist (LAMA) alone and/or a fixed combination of inhaled corticosteroids/long-acting beta2-agonists (ICS/LABA). Despite access to these inhaled medications, a significant number of COPD patients still suffer from frequent exacerbations,[2] impacting their overall health and accelerating lung function decline,[3] leading to substantial morbidity and mortality.[4]

"The REACT study aimed to provide a larger analysis of roflumilast as an add-on therapy for patients taking the recommended inhaled therapy who are at ongoing risk for exacerbations," commented Professor Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf. "Results showed a significant reduction in severe exacerbations and subsequent hospitalization in the study population, making it the first COPD treatment to decrease the rate of hospitalization in patients already receiving multiple inhaled treatments."

Already approved as an add-on therapy to long acting bronchodilators for severe COPD,[5] the double-blind REACT study investigated roflumilast as an effective add-on therapy for the reduction of exacerbations, improved lung function and major adverse cardiac events (MACE) in patients not adequately controlled with ICS/LABA combinations or triple LAMA/ICS/LABA therapy in maximal approved dosage. In the overall study population there was a reduction in the rate of moderate-to-severe exacerbations by 13.2 percent (p=0.0529) using a Poisson regression analysis and by 14.2 percent (p=0.0424) in a predefined sensitivity analysis using negative binomial regression, when compared with the placebo.[1] Roflumilast showed a statistically significant improvement in lung function, with a 56 mL (p<0.0001) increase in post-bronchodilator FEV1 and 92 mL increase in FVC, compared to placebo.[1]

"Poorly managed COPD places a considerable burden not only on health systems but also on the lives of patients and their carers. The REACT study continues to reinforce the therapeutic value of roflumilast for patients with severe COPD, allowing physicians to make better informed treatment choices for their patients. Its specific anti-inflammatory mode of action and potential to further stabilize severe COPD patients helps manage this costly and debilitating disease," said Matthias Binek, Global Brand Medical Director, Respiratory Products, Takeda Pharmaceuticals.

Roflumilast, as an add-on to long acting bronchodilators, is approved for severe COPD associated with chronic bronchitis and a history of frequent exacerbations. It has a specific mode of action which targets COPD-specific inflammation and has been shown to reduce exacerbations, with the ability to shift patients from the frequent to more stable infrequent exacerbator status.[6]

About REACT

REACT was a one-year, double blind, placebo-controlled, parallel-group, multicenter study. Patients included were required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and had to be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500mug once daily and placebo) were included and patients were allocated to either roflumilast 500mug and a fixed combination of LABA/ICS +/- LAMA or placebo and a fixed combination of ICS/LABA +/- LAMA in a 1:1 randomization scheme (973 patients roflumilast; 972 patients placebo). Patients were recruited from 203 centers in 21 countries. The primary outcome was the rate of moderate to severe COPD exacerbations per patient per year analyzed using intent-to-treat principles. Adverse events were consistent with previous clinical trials and post-marketing experience. No new safety signals were observed.[1]

About Daxas(R)

Daxas(R) is the only anti-inflammatory treatment developed to target COPD-specific inflammation with a specific mode of action. Its active component, roflumilast, is a potent and selective inhibitor of the PDE4 enzyme.[7] Roflumilast is indicated in the EU for the maintenance treatment of severe chronic COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment.[5]

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH headquartered in Zurich is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited located in Osaka, Japan. Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com .

This press release has been issued by Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zurich), Switzerland.

References:

1. Martinez FJ, et al. Effect Of Roflumilast On Exacerbations In Patients With Severe COPD Uncontrolled By Combination Therapy: A Multicentre Randomised Study. The Lancet 2015. Published Online February 13, http://dx.doi.org/10.1016/ S0140-6736(14)62410-7.

2. Hurst HR, et al. Susceptibility to Exacerbation in Chronic Obstructive Pulmonary Disease. N Engl J Med 2010;363: 1128-38.

3. Vestbo J, Hurd SS, Agusti AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013; 187: 347-365.

4. Wedzicha JA and Seemungal TAR. COPD exacerbations: defining their cause and prevention. The Lancet 2007; 370: 786-96.

5. EU Summary of Product Characteristics, Daxas(R) (available at http://www.ema.europa.eu ).

6. Wedzicha JA, et al. Efficacy Of Roflumilast In The Chronic Obstructive Pulmonary Disease Frequent Exacerbator Phenotype. CHEST 2012; doi:10.1378/chest.12-1489.

7. Hatzelman A, et al. The preclinical pharmacology of roflumilast - A selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease. Pulmonary Pharmacology & Therapeutics 2010; 23: 235-256.

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