Roche announced results of a six month study combining Esbriet (pirfenidone) and nintedanib treatment, showing a similar safety profile for the combination treatment to that expected for each treatment alone. The majority of the 89 patients included in the study tolerated the combination treatment. The study further suggested that over the six month period, lung function change from baseline was small, and quality of life scores did not deteriorate in patients who completed the 6 months of combination treatment. Data were presented at the European Respiratory Society (ERS) congress 9-13 September in Milan, Italy.

“IPF is a devastating condition that progressively scars the lungs, leads to deteriorating lung function and makes it difficult to breathe,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This study data assesses a combination treatment regimen where it was shown that the combination, based on Esbriet, was well tolerated”.

The majority of patients with IPF will be treated with either Esbriet or nintedanib. However, robust information regarding the safety and tolerability of the combination therapy was not available up until now.

For the combination study patients were given a stable dose of Esbriet for at least 16 weeks before initiation of nintedanib. 16.9% of patients experienced at least one treatment-emergent adverse event (TEAE) related to Esbriet only, compared to 74.2% of patients who experienced at least one TEAE that investigators attributed as related to nintedanib only. Importantly, combining Esbriet and nintedanib for 24 weeks did not reveal a different safety profile to that expected for either treatment alone.

Important efficacy parameters routinely assessed when measuring lung function in IPF, such as change from baseline forced vital capacity (FVC), diffusing capacity of the lungs for carbon monoxide (DLco) and King’s brief interstitial lung disease (K-BILD) score, were assessed at 24 weeks as exploratory endpoints in the study. The results support Esbriet’s known efficacy profile and suggest stability over time in K-BILD parameters in patients completing the 6 months combination treatment.

In a second new, post-hoc, analysis of pooled phase III trial studies, treatment with Esbriet showed that the number of progression events was reduced when patients received treatment with Esbriet compared to placebo (188/624 vs 106/623, P < 0.0001). Progression events were defined as relative decline in % predicted FVC =10%, absolute decline in 6MWD =50 m; respiratory hospitalization, or death from any cause. There was also reduced mortality following one progression event when patients were treated with Esbriet, compared to placebo (39/624 vs 13/623, P=0.0002). These data support the continuation of treatment with Esbriet in case of disease progression.

A third study, involving real-world post-authorisation safety data from over 1,000 European patients receiving treatment with Esbriet and followed for up to 2 years, was also presented at ERS. The data of this real-world study showed that occurrence of adverse drug reactions (ADRs) was consistent with the known safety profile of Esbriet, with no new safety signals observed.