A combination of Boehringer Ingelheim‘s Ofev (nintedanib) and Genentech’s Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis (IPF) was safe and well tolerated, according to the latest data from the Phase 4 INJOURNEY trial.
The results were reported in an article titled “Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis: Results of the INJOURNEY Trial“ in the American Journal of Respiratory and Critical Care Medicine.
Both Ofev and Esbriet are approved drugs that studies have shown slow the progression of IPF. But researchers have wondered whether a combination of the drugs would be safe and benefit patients more than the component therapies alone.
Sponsored by Boehringer Ingelheim, the INJOURNEY trial (NCT02579603) tried to address this question by evaluating the safety, tolerability, and the drugs’ distribution and stability in the body. The 104 patients randomly received either 150 mg of Ofev alone or a combination of 150 mg of Ofev plus Esbriet in dosages up to 801 mg.
After 12 weeks of follow-up, the researchers found that 69.8% of the patients treated with the combo experienced gastrointestinal adverse events, versus 52.9% of patients treated with Ofev alone.
The most frequent events were diarrhea, nausea and vomiting, a finding that fit the safety profiles previously reported for the individual drugs.
While there was a slightly higher incidence of adverse gastrointestinal events in the combo group, no new safety issues surfaced, and all events were manageable, researchers said.
“Safety always comes first when considering the right medicine for the treatment of an individual IPF patient,” Carlo Vancheri, professor of Respiratory Medicine at the University of Catania in Italy, said in a press release. He is also director of the Regional Referral Center for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.
“The results from INJOURNEY help to close a gap on the questions of the safety, tolerability, and possible interactions of adding Esbriet to Ofev background therapy in the treatment of IPF. Furthermore, the results are reassuring and supportive of future research on combination regimens with Ofev in IPF,” Vancheri added.
The latest trial results also touched on the combo’s effectiveness. They showed that the combo slowed IPF patients’ decline in lung function better than Ofev alone. The yardstick researchers used was changes in patients’ forced vital capacity, or FVC, between the start and end of treatment. FVC is the amount of air a person can forcibly exhale from their lungs after taking the deepest breath possible.
Researchers called for additional studies on the combo’s effectiveness, however.
“As a company dedicated to respiratory care, we remain focused on continually uncovering new insights into IPF and to help support physicians as they have more informed treatment discussions with their patients,” said Thomas Leonard, executive director of Clinical Development and Medical Affairs, Specialty Care at Boehringer Ingelheim.
As part of its commitment to helping those with serious respiratory diseases, Boehringer is enrolling participants in two trials of Ofev as a treatment for fibrosis lung diseases.
The SENSCIS study (NCT02597933) is going to enroll about 520 patients with systemic sclerosis who have developed interstitial lung disease, or SSc-ILD. The company is also exploring Ofev’s effects on progressive fibrosing interstitial lung disease (PF-ILD) in a Phase 3 clinical trial (NCT02999178) that is expected to enroll about 600 patients.