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Boehringer Ingelheim welcomes inclusion of Ofev in the updated international treatment guidelines for idiopathic pulmonary fibrosis
16 July 2015 • Author:
Boehringer Ingelheim has welcomed new international evidence-based treatment guidelines for idiopathic pulmonary fibrosis (IPF) which suggest that clinicians use Ofev® (nintedanib) in patients with the disease.
IPF is a fatal lung disease, with a median survival of 2 – 3 years after diagnosis. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing. Worldwide, IPF affects as many as 14 – 43 people per 100,000, most commonly over the age of 50.
The committee behind the “2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline” noted the high value of Ofev on patient-important outcomes such as disease progression as measured by rate of forced vital capacity (FVC) decline and mortality. The recommendation also takes into account the expected cost of treatment and potentially significant adverse effects. However, it noted that there was no increase in serious adverse events with Ofev, and relatively few patients discontinued the study drug secondary to adverse effects.
Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom commented, “These guidelines are important because they provide valuable recommendations to physicians to improve the treatment and management of devastating conditions like IPF. These new guidelines clearly emphasise the role of Ofev in the treatment of IPF.”
Ofev offers IPF patients a convenient, twice daily medicine that slows disease progression
Dr Christopher Corsico, Chief Medical Officer Boehringer Ingelheim commented, “The inclusion of Ofev in the international guideline marks an important step forward for patient care. Until recently no approved treatment options were recommended. Ofev offers IPF patients a convenient, twice daily medicine that slows disease progression across a broad range of IPF patients, resulting in a 50% reduction in the annual rate of decline of lung function.”
The committee analysed the evidence accumulated since the publication of the 2011 official guidelines and updated the treatment recommendations accordingly. Ofev has been studied in two replicate Phase 3 trials (INPULSIS®-1 and INPULSIS®-2) involving more than 1,000 patients in 24 countries and a Phase II trial (TOMORROW) involving 432 patients.
The INPULSIS clinical trials showed that Ofev had a consistent effect on annual rate of FVC decline, with a 50% reduction in the decline of lung function. Ofev is the only treatment to significantly reduce the risk of adjudicated acute IPF exacerbations by 68%. Acute exacerbations in IPF are associated with high morbidity and mortality. They are the leading cause of hospitalisation and death in patients with IPF.
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.
The joint guidelines committee consists of representatives from an international group of leading respiratory societies including the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT).
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