Long-term treatment of idiopathic pulmonary fibrosis (IPF) patients with Ofev (nintedanib) showed positive effects in keeping disease progression at bay, while inducing manageable side effects, Boehringer Ingelheim Pharmaceuticals announced. This finding comes from the INPULSIS-ON clinical trial — an extension study of the INPULSIS trial — designed to assess the long-term effects of Ofev therapy.
Results of the INPULSIS-ON trial were recently presented at the European Respiratory Society (ERS) International Congress 2016, part of a total of eight IPF-related studies from Boehringer Ingelheim.
Both the Phase 3 INPULSIS and the INPULSIS-ON trials (NCT01619085) were similar in design, dose, inclusion criteria, and endpoints, but the latter was intended to evaluate the safety and efficacy of prolonged treatment with Ofev.
INPULSIS followed 734 patients, including patients with early disease (with a forced vital capacity [FVC; a lung function measure] above 90%). After the 52-week trial period, patients were offered the opportunity to continue with the treatment by entering the INPULSIS-ON trial.
In the INPULSIS trial, IPF patients treated with Ofev showed a mean change in FVC of –89 mL compared to –203 mL for those in the placebo group up until week 52. In the INPULSIS-ON trial, prolonged treatment with Ofev induced a mean change in FVC of −96 mL up to week 48, and of −124 mL from week 48 to week 96. In both trials, the average total exposure of patients treated with Ofev was approximately three years (35.7 months).
In terms of safety, the use of Ofev for up to 51 months was well-tolerated by the patients, inducing manageable side effects consistent with those reported in INPULSIS, including diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
The INPULSIS study also included two other analyses, in order to assess whether Ofev had an effect in two specific IPF parameters — the composite physiologic index (CPI), which reflects the level of lung fibrosis, and the level of impairment in gas exchange, i.e., the delivery of oxygen from the lungs to the bloodstream and the elimination of carbon dioxide from the bloodstream to the lungs.
Both analyses confirmed the beneficial effect of Ofev treatment on annual rate of FVC decline irrespective of the level of baseline impairment. Furthermore, the results also provide evidence of a treatment positive impact in slowing disease progression in a range of IPF patients.
“These new long-term data provide evidence that slowing disease progression with Ofev treatment is sustained for up to three years,” said Lisa Lancaster, MD, with Vanderbilt University Medical Center, in a news release from Boehringer Ingelheim. “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.”
The use of Ofev as an IPF therapy was approved by the U.S. Food and Drug Administration (FDA) in 2014.