Ofev Preserves Pulmonary Function of IPF Patients Awaiting a Lung Transplant, Study Finds
Boehringer Ingelheim‘s Ofev (nintedanib) preserved the lung function of nine idiopathic pulmonary fibrosis patients waiting for a lung transplant, a study reported.
The research, “Safety of nintedanib before lung transplant: an Italian case series,” appeared in the journal Respirology Case Reports.
A lung transplant is the only way to cure IPF.
But “the availability of donor organs significantly limits the number of transplants that can be performed,” according to the team that did the research. “Therefore, pharmacological therapies that prolong patient survival until suitable organs become available are important.”
Ofev is a therapy that fights lung tissue scarring. Studies have shown it to be safe, but there has been lack of data on its safety in IPF patients awaiting a lung transplant.
Researchers decided to see how well it would work, and how safe it was, in nine patients with IPF. The patients received 150 mg of Ofev twice a day for between three and 30 months as they waited for a transplant.
Doctors administered the treatment until the day of surgery. All patients also received continuous oxygen therapy before their operation.
Seven patients had lost an average of 7.8 percent of their lung function before starting Ofev. The measure researchers used was forced vital capacity, or the amount of air a person can exhale after taking the deepest breath possible.
Once patients began taking it, the lung function decline of eight of them averaged only 3.2 percent over 12 weeks.
A year after surgery, eight of the nine were alive and had stable lung function. One died of septic shock — a reaction to a blood infection — seven months after transplant.
Researchers said Ofev had a good safety profile in these patients. None had an IPF flare-up, liver dysfunction or weight loss during treatment. Three experienced diarrhea. None had to discontinue treatment because of side effects.
The team also noted that Ofev treatment before surgery did not lead to any problems after the transplant.
“It is highly relevant that we found no problem with bleeding or thoracic wound healing in the postoperative period,” they wrote. “Based on our experience, nintedanib appears to be safe in IPF patients undergoing lung transplantation.
“Nintedanib preserved lung function up to transplantation, was well tolerated, and had no detrimental effects on the short‐term outcome of lung transplant,” the team said.
They cautioned that the small number of patients in the study should lead to caution in drawing conclusions about Ofev’s safety and effectiveness in this group. They called for larger studies to confirm their results.