The interim findings from the INPULSIS-ON extension trial were presented at the European Respiratory Society (ERS) International Congress 2016 in London.
The findings were consistent with those previously reported from the INPULSIS Phase 3 trials (INPULSIS-1 and -2). The interim analysis from the extension trial demonstrated that Ofev slows disease progression in IPF patients. In addition, long-term treatment with Ofev (up to 51 months) was associated with manageable side effects in most patients, with diarrhea being the most frequently reported side effect.
Results from the interim analysis of INPULSIS-ON demonstrated that in terms of forced vital capacity (FVC, a measure of lung function) in IPF patients who continued Ofev treatment in the extension trial, the change between baseline and week 48 and between weeks 48 and 96 was similar to what was seen in IPF patients who were on active treatment with Ofev in the 52-week INPULSIS clinical trials.
“These new long-term data provide evidence that slowing disease progression with Ofev treatment is sustained for up to three years,” Dr. Lisa Lancaster, MD, associate professor, Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center, said in a press release.
“These results are important because they add to the consistent body of evidence demonstrating the long-term, beneficial effect of Ofev for people living with IPF.”
Findings from the trials on the effect of Ofev on FVC demonstrated that:
- In INPULSIS, the mean FVC change from baseline to week 52 was −89mL compared to –203mL for placebo-treated patients;
- In INPULSIS-ON, the mean FVC change for patients who continued treatment was −96 mL from baseline to week 48;
- In INPULSIS-ON, the mean FVC change for patients who continued treatment was −124mL from week 48 to week 96;
- In INPULSIS and INPULSIS-ON, the average exposure to Ofev was around three years (35.7 months).
Two additional sub-group analyses from the trials revealed that treatment with Ofev has a beneficial effect on the annual rate of FVC decline regardless of the patients’ baseline lung impairment, providing additional evidence of the benefits of the drug in slowing disease progression in a range of IPF patients.
Ofev is a small molecule tyrosine kinase inhibitor, which has been approved and marketed globally for treating IPF in adults. Ofev blocks multiple signaling pathways that may be involved in the scarring of lung tissue and fibrotic processes, reducing disease progression in IPF and slowing lung function decline.