Esbriet and Ofev Use Prior to Lung Transplant Seen as Safe for IPF Patients in Study

Treatment with Esbriet (pirfenidone, Genentech) or Ofev (nintedanib, Boehringer Ingelheim), or with steroids was found to be safe for idiopathic pulmonary fibrosis (IPF) patients needing a bilateral lung transplant (BLTx), a study reports.

The research, “Effect of Antifibrotics on Short-Term Outcome after Bilateral Lung Transplantation A Multi-Centre Analysis,” was published in the European Respiratory Journal.

Esbriet and Ofev are two approved and recommended anti-fibrotic therapies for IPF, a subgroup of interstitial lung diseases (ILD). However, the European Medicines Agency (EMA) recommended stopping Ofev before major surgery due to an increased risk for bleeding events.

Corticosteroids have been the usual approach for treating different types of ILDs, but their efficacy is supported by little evidence. When medicines fail to treat lung disease, a transplant of one or both lungs is an established strategy to improve patients’ quality of life and survival. In a bilateral transplant, both lungs are transplanted but one at a time.

An Austrian and German research team examined ILD patients who underwent BLTx (between January 2014 and February 2017) and compared the effects of treatment with steroids, Ofev and/or Esbriet within four weeks before transplant to those not taking medications.

Patients with IPF, PF and hypersensitivity pneumonitis — a rare immune system disorder of the lungs — were included in the analysis. Duration of mechanical ventilation and complications within four weeks after surgery were recorded. Patients were followed for a median of 21 months, with a maximum of 44 months.

A total of 108 patients using glucocorticoids — including 100 with IPF — were identified among the 132 ILD patients. Of these 108 people 72 received glucocorticoids (46 had IPF), 23 took Esbriet, and 13 were treated with Ofev.

Complication rates were found to be similar between patients using these treatments within four weeks of transplant surgery and those not.

Hemothorax leading to surgical revision, which is characterized by blood accumulation in the space between the chest wall and the lung, occurred in 11 out of 132 patients, with no difference between the groups. Severe wound infections occurred in 12 patients, mostly in patients taking steroids (58%) and Esbriet (13%), but were not observed in those using Ofev.

The incidence of gastro-intestinal bleeding and kidney failure also did not differ.

No difference in overall survival was found across patients taking either treatment or not receiving any of the medications. Calculation of one-year survival probability was 100% among Ofev users, 96% with Esbriet, 90% with steroids, and 100% in the group without these treatments.

A total of nine patients (7%) died after BLTx, four during the first three months after surgery.

“Our data analysis did not find any impairment of the postoperative course after BLTx associated with pre-transplantation treatment with pirfenidone or nintedanib. Antifibrotic drugs and steroids did not increase the risk for bleeding complications, disturb wound healing or impair the survival,” the researchers wrote.

“In this large multicentre study, the use of nintedanib (Ofev) and pirfenidone (Esbriet) alone or in addition to corticosteroids in BLTx patients was safe, even when administered within the last four weeks before surgery,” the researchers concluded.