The results were presented at the European Respiratory Society (ERS) International Congress 2015, and confirm that OFEV has a long-term effect on slowing disease progression and a manageable side effect profile in patients with idiopathic pulmonary fibrosis (IPF).
This new data is important in light of the fact that IPF is a life-threatening and progressive disease, requiring patients to be on long-term treatment.4
The INPULSIS-ON interim analysis showed that the change from baseline in forced vital capacity (FVC) at 48 weeks in patients continuing treatment with OFEV in the extension trial1 was comparable to what was observed in the 52 weeks INPULSIS trial.1 This provides further evidence that the beneficial effect of OFEV on slowing disease progression is maintained in the long-term.
"The safety and efficacy data presented for OFEV is very reassuring with regards to the long-term outcomes of treatment with OFEV and its effect on slowing disease progression," said Professor Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom.
"They add further weight to the growing body of evidence in support of OFEV as an effective and manageable treatment for IPF. When managing IPF it is important that physicians discuss with their patients what to expect from treatment and which treatment is right for them, to initiate this treatment early and then to ensure the patient stays on it as long as possible."
Key results from the interim analysis of INPULSIS-ON
INPULSIS-ON is an open-label single arm study. More than 90% of IPF patients participating in INPULSIS and eligible for open-label treatment with nintedanib in INPULSIS-ON opted to participate. Patients on placebo treatment in the INPULSIS trials newly initiated treatment with OFEV in the extension trial and patients already treated with OFEV in the INPULSIS trials continued to receive OFEV. The effect of OFEV on the mean change from baseline in FVC at week 48 of the INPULSIS-ON trial was comparable to the one seen at 52 weeks in the INPULSIS trial:
In INPULSIS-ON: -87 mL for all patients, -96,4 mL for patients continuing treatment with OFEV in the extension trial and -73,1 mL for patients initiating treatment with OFEV
In INPULSIS (pooled data): -88,9 mL (OFEV) vs. -203,0 mL (placebo)1
The analysis substantiates the effects of OFEV®* on slowing disease progression and confirms the long-term efficacy of OFEV. Additionally no new safety signals were identified following long-term treatment with OFEV in INPULSIS-ON.1 The most frequent adverse events were gastrointestinal in nature with diarrhoea affecting 64% of patients but leading to drug discontinuation in only 5%.1
Effect of OFEV on a broad range of IPF patients**
New subgroup-analyses from the INPULSIS study presented at the congress examined whether OFEV had a consistent effect on patients with IPF who were also taking commonly used medications, including anti-acids and corticosteroids, when they were enrolled in the study.2,3
Anti-acid medications are often given to patients with IPF to manage gastroesophageal reflux disease (GERD), which is common in patients with IPF and is considered to be a risk factor for IPF disease progression and acute exacerbations.5 IPF patients are also sometimes treated with low doses of corticosteroids (e.g. prednisone) and therefore subjects receiving low doses of corticosteroids were allowed in the INPULSIS trials.6
The analyses confirm that these concomitant medications taken at baseline do not influence the beneficial effect of OFEV on annual rate of FVC decline.2,3
The two analyses provided further evidence that OFEV slows disease progression in a broad range of IPF patients**.2,3