2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline suggests that clinicians use Ofev ( Nintedanib ) in patients with idiopathic pulmonary fibrosis ( IPF ).
The Committee 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.
Until recently no approved treatment options were recommended. Ofev offers patients with idiopathic pulmonary fibrosis a convenient, twice daily medicine that slows disease progression across a broad range of 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 Nintedanib had a consistent effect on annual rate of FVC decline, with a 50% reduction in the decline of lung function.
Nintedanib 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.
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. ( Xagena )
Source: Boehringer Ingelheim, 2015