Pirfenidone found safe, efficacious in idiopathic pulmonary fibrosis

Pirfenidone has been found safe, and efficacious in idiopathic pulmonary fibrosis (IPF) in a real-world cohort study.

Pirfenidone is an antifibrotic agent approved for the treatment of idiopathic pulmonary fibrosis (IPF). The PolExPIR study aimed to describe the real-world data (RWD) on the Polish experience of pirfenidone therapy in IPF with respect to safety and efficacy profiles.

Researchers have found in a retrospective, observational study that Pirfenidone is safe and effective in idiopathic pulmonary fibrosis (IPF) in a real-world setting.

The PolExPIR study for ascertaining the effectiveness of Pirfenidone in idiopathic pulmonary fibrosis (IPF) is the first real-world cohort study although 16.6% of patients dropped out of it because of adverse drug reactions, and dose-adjustment rates were high. The findings of research have been published in BMC Pulmonary Medicine.

The researchers conducted a retrospective, multicenter study in Poland of 307 patients with IPF, covering 2017-2019.

The researchers identified a total of 307 patients receiving pirfenidone for analysis. The mean age was 68.83 (8.13) years and 77% were males. The median time from the first symptoms to IPF diagnosis was 15.5 (9.75-30) months and from diagnosis to start of pirfenidone treatment was 6 (2-23) months. Patients were followed on treatment for a median of 17 (12-22.75) months. The

Mean age was 68.83 (standard deviation, ±8.13) years and 77% of subjects were males.

The median time from first symptoms to IPF diagnosis was15.5 (interquartile range [IQR], 9.75-30) months.

The Patients were followed on pirfenidone for a median of 17 (IQR, 12-22.75) months.

In all 24.1% of patients needed dose adjustments and 11.4% were treated with a dose different from the full recommended dose.

A total of45.92% of patients discontinued therapy because of:

Adverse drug reactions (16.61%, most of them gastrointestinal or skin-related).

Disease progression (6.51%).

Patient request (5.54%).

Neoplastic disease (3.91%).

Lung transplantation (0.33%).

The Researchers found that Pulmonary function remained largely stable during 24 months of follow-up:

Median (IQR) annual decline in forced vital capacity:

First year: −20 (−200 to 100) mL.

Second year: −120 (−340 to 30) mL.

10.75% of patients died.

The researchers concluded that

the PolExPIR study was a source of longitudinal RWD on pirfenidone therapy in the Polish cohort of patients with IPF supporting its long-term acceptable safety and efficacy profiles and reinforce findings from the previous randomised clinical trials and observational studies.

For further Reference log on to:

Majewski S, Białas AJ, Buchczyk M, Gomółka P, Górska K, Jagielska-Len H, Jarzemska A, Jassem E, Jastrzębski D, Kania A, Koprowski M, Krenke R, Kuś J, Lewandowska K, Martusewicz-Boros MM, Roszkowski-Śliż K, Siemińska A, Sładek K, Sobiecka M, Szewczyk K, Tomczak M, Tomkowski W, Wiatr E, Ziora D, Żołnowska B, Piotrowski WJ. A multicentre retrospective observational study on Polish experience of pirfenidone therapy in patients with idiopathic pulmonary fibrosis: the PolExPIR study. BMC Pulm Med. 2020;20(1):122. doi: 10.1186/s12890-020-1162-6. PMID: 32366291