The FINANCIAL — Roche on September 29 announced that new clinical data and abstracts on Esbriet® (pirfenidone) in the treatment of idiopathic pulmonary fibrosis (IPF) are being presented at the European Respiratory Society (ERS) congress in Amsterdam. A pooled analysis from the ASCEND and CAPACITY phase III studies showed a 38% reduction in risk of death (p=0.0515) in IPF patients who stayed on Esbriet treatment up to two years (120 weeks) compared with placebo.
“These new data demonstrate Esbriet’s ability to reduce the risk of death for patients with this severe, progressive lung disease,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “As the first long-term mortality data in IPF patients treated with Esbriet, these results provide valuable information to help physicians and patients make decisions about their treatment.”
Previously reported data at one year showed the risk of mortality was reduced by 48% after treatment with Esbriet, a statistically significant result. The new data at 120 weeks show a strong trend in a reduced risk of death with long-term Esbriet treatment in IPF, according to Roche.
Also presented at the ERS, an ad-hoc analysis of the pooled ASCEND and CAPACITY data showed patients who are hospitalised within the first six months of treatment saw their risk of disease progression (≥10% decline in lung function) or death reduced by more than two-thirds (relative difference = 72.2%) at one year by remaining on Esbriet treatment, compared with placebo.2 These clinical results show the benefits of continuing treatment. It is one of the first analyses on this topic and is of particular value for physicians and patients, as there is currently limited information to inform clinical decisions.
“These additional data show that continuing treatment with Esbriet after early hospitalisation may help slow disease progression,” said Horning.
Both analyses reinforced the well-established safety profile of Esbriet and were consistent with previous trial results.3 For more than four years, Esbriet has been available to physicians and IPF patients in Europe and was approved last year in the United States. More than 20,000 IPF patients worldwide have been treated with Esbriet for the equivalent of a year.