Ofev-Esbriet Combo Is as Safe as Individual Components as a Pulmonary Fibrosis Therapy, Trial Indicates

A combination of Ofev (nintedanib) and Esbriet (pirfenidone) is as safe a therapy for idiopathic pulmonary fibrosis as the individual components alone, a Phase 4 clinical trial indicates.

Preliminary trial findings also suggested that the combination might be more effective than either therapy alone, although researchers said this needs to be studied further.

The trial results were published in the American Journal of Respiratory and Critical Care Medicine under the title “Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis: Results of the INJOURNEY Trial.”

Boehringer Ingelheim makes Ofev, and Genentech Esbriet. Both slow IPF’s worsening, but do not stop its progression. This prompted researchers to wonder if a combination of the two would be better at slowing progression.

They decided to conduct a 12-week, open-label, randomized trial on the combo’s safety, effectiveness, pharmacokinetics and patients’ ability to tolerate it. Pharmacokinetics refers to the body’s effect on a drug.

The primary objective of the trial was to see how many gastrointestinal adverse events the combo generated. Those events are the most common side effects of treatment with the individual drugs.

Researchers randomized patients who had been on four or five weeks of Ofev, and did not need their dose reduced or their treatment interrupted, to continue receiving Ofev or to receive a combination of Ofev and Esbriet.

Seventy percent of the patients in the combo group had to be treated for gastrointestinal adverse events, compared with 53 in the group that took Ofev alone. Diarrhea, nausea and vomiting were the most common adverse events. Serious adverse events were uncommon in either group.

“Safety always comes first when considering the right medicine for the treatment of an individual IPF patient,”Carlo Vancheri, a respiratory medicine professor at the University of Catania in Italy, said in a press release. “The results from INJOURNEY help to close a gap on the questions of the safety, tolerability and possible interactions of adding pirfenidone to nintedanib background therapy in the treatment of IPF. Furthermore, the results are reassuring and supportive of future research on combination regimens with nintedanib in IPF.”

The combo also led to less reduction in lung function than Ofev alone, researchers said. The lung function measure they used was forced vital capacity, or the amount of air a person can forcibly exhale after taking the deepest breath possible.

But the team said more research is necessary to determine the combination’s effectiveness.

“These new results suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone in people with IPF, but that will need to be further evaluated,” said Thomas Leonard, executive director for Clinical Development & Medical Affairs for IPF/ILD at Boehringer Ingelheim.

“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,” he said.