Treatment with Ofev (nintedanib; Boehringer Ingelheim) demonstrated long-term safety, efficacy, and tolerability in patients with idiopathic pulmonary fibrosis (IPF) with clinical efficacy lasting beyond 4 years, according to findings published in Lancet Respiratory Medicine.
The data also suggested that the long-term efficacy of Ofev in slowing disease progression may be sustained in patients who need dosage adjustments. These results were consistent with those from the phase 3 INPULSIS trials, further demonstrating manageable safety and tolerability with no new safety signals.
The open-label extension trial, INPULSIS-ON (N=734), included a large population of patients with IPF who received Ofev. The primary objective was to characterize the long-term safety and tolerability of Ofev in patients with IPF; efficacy endpoints included annual rate of decline in forced vital capacity (FVC) calculated over 192 weeks, absolute change in FVC from baseline to week 192, time to first acute exacerbation, and time to death.
Efficacy assessments of lung function showed an annual rate of decline in FVC of -135.1mL/year over 192 weeks. This value was consistent with the annual rate of FVC decline in study patients from the INPULSIS trials (-113.6mL/year) treated with Ofev; the annual rate of decline in FVC was consistent regardless of age, race, and FVC percentage predicted at the start of the trial.
Also, the incidence rate of acute exacerbations in INPULSIS-ON was similar to that in patients treated with Ofev in the INPULSIS trials. Regarding safety, diarrhea was the most common adverse event during INPULSIS-ON, which is similar to the INPULSIS and TOMORROW (Phase 2) trials.
Ofev, a kinase inhibitor, is currently approved to treat IPF in adults. It is available as 100mg and 150mg capsules in 60-count bottles.
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