Pirfenidone Is Promising as Pulmonary Fibrosis Therapy

TORONTO — Treatment of patients with idiopathic pulmonary fibrosis with pirfenidone was “encouraging” in a phase III study conducted in Japan.

Few treatment options are available for patients with idiopathic pulmonary fibrosis (IPF), Dr. Takashi Ogura said at an international conference of the American Thoracic Society.

A previous phase II study suggested the agent, which has antifibrotic, anti-inflammatory, and antioxidant effects, could be beneficial.

In that study, 107 patients aged 20–75 years were randomized to receive pirfenidone in dosages up to 1,800 mg/day or placebo, and were followed for 9 months, during which time improvements were seen on vital capacity (VC), although not on a 6-minute walk test (Am. J. Respir. Crit. Care Med. 2005;171:1040-7).

The current study included 267 patients from 73 centers. Two radiologists verified the diagnosis in each patient after reviewing chest x-rays and high-resolution CT scans.

Patients were then randomized to receive pirfenidone 1,800 mg/day or 1,200 mg/day, or placebo. Vital capacity was measured every 4 weeks, and lowest oxygen saturation by pulse oximetry (SpO₂) on exertion was measured every 12 weeks.

Statistically significant improvements were seen in both pirfenidone groups on the primary end point, which was change in VC, as well as in an overall slowing of deterioration from the progressive, fatal disease, Dr. Ogura said.

“At week 52, the difference between the pirfenidone high-dose group and placebo was 70 mL, and the difference between the lower-dose group and placebo was 80 mL,” said Dr. Ogura of Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.

Statistically significant changes also were seen in progression-free survival, although not in the lowest SpO₂ on exertion or the incidence of acute exacerbations.

The most common adverse events associated with the treatment were photosensitivity, dizziness, anorexia, and elevated γ-glutamyl transpeptidase. The drug was generally well tolerated, with no significant differences being seen among the three groups for serious adverse events.

A total of 32% of patients dropped out during the course of the study, including 37% of the patients taking 1,800 mg of pirfenidone, 28% of those taking 1,200 mg, and 27% of patients in the placebo group.

The researchers will continue to follow the patients to see if pirfenidone can improve survival, and to see if the drug also may prove useful in other fibrotic lung diseases.

Dr. Ogura noted that he had no relevant financial disclosures.

TORONTO — Treatment of patients with idiopathic pulmonary fibrosis with pirfenidone was “encouraging” in a phase III study conducted in Japan.

Few treatment options are available for patients with idiopathic pulmonary fibrosis (IPF), Dr. Takashi Ogura said at an international conference of the American Thoracic Society.

A previous phase II study suggested the agent, which has antifibrotic, anti-inflammatory, and antioxidant effects, could be beneficial.

In that study, 107 patients aged 20–75 years were randomized to receive pirfenidone in dosages up to 1,800 mg/day or placebo, and were followed for 9 months, during which time improvements were seen on vital capacity (VC), although not on a 6-minute walk test (Am. J. Respir. Crit. Care Med. 2005;171:1040-7).

The current study included 267 patients from 73 centers. Two radiologists verified the diagnosis in each patient after reviewing chest x-rays and high-resolution CT scans.

Patients were then randomized to receive pirfenidone 1,800 mg/day or 1,200 mg/day, or placebo. Vital capacity was measured every 4 weeks, and lowest oxygen saturation by pulse oximetry (SpO₂) on exertion was measured every 12 weeks.

Statistically significant improvements were seen in both pirfenidone groups on the primary end point, which was change in VC, as well as in an overall slowing of deterioration from the progressive, fatal disease, Dr. Ogura said.

“At week 52, the difference between the pirfenidone high-dose group and placebo was 70 mL, and the difference between the lower-dose group and placebo was 80 mL,” said Dr. Ogura of Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.

Statistically significant changes also were seen in progression-free survival, although not in the lowest SpO₂ on exertion or the incidence of acute exacerbations.

The most common adverse events associated with the treatment were photosensitivity, dizziness, anorexia, and elevated γ-glutamyl transpeptidase. The drug was generally well tolerated, with no significant differences being seen among the three groups for serious adverse events.

A total of 32% of patients dropped out during the course of the study, including 37% of the patients taking 1,800 mg of pirfenidone, 28% of those taking 1,200 mg, and 27% of patients in the placebo group.

The researchers will continue to follow the patients to see if pirfenidone can improve survival, and to see if the drug also may prove useful in other fibrotic lung diseases.

Dr. Ogura noted that he had no relevant financial disclosures.

TORONTO — Treatment of patients with idiopathic pulmonary fibrosis with pirfenidone was “encouraging” in a phase III study conducted in Japan.

Few treatment options are available for patients with idiopathic pulmonary fibrosis (IPF), Dr. Takashi Ogura said at an international conference of the American Thoracic Society.

A previous phase II study suggested the agent, which has antifibrotic, anti-inflammatory, and antioxidant effects, could be beneficial.

In that study, 107 patients aged 20–75 years were randomized to receive pirfenidone in dosages up to 1,800 mg/day or placebo, and were followed for 9 months, during which time improvements were seen on vital capacity (VC), although not on a 6-minute walk test (Am. J. Respir. Crit. Care Med. 2005;171:1040-7).

The current study included 267 patients from 73 centers. Two radiologists verified the diagnosis in each patient after reviewing chest x-rays and high-resolution CT scans.

Patients were then randomized to receive pirfenidone 1,800 mg/day or 1,200 mg/day, or placebo. Vital capacity was measured every 4 weeks, and lowest oxygen saturation by pulse oximetry (SpO₂) on exertion was measured every 12 weeks.

Statistically significant improvements were seen in both pirfenidone groups on the primary end point, which was change in VC, as well as in an overall slowing of deterioration from the progressive, fatal disease, Dr. Ogura said.

“At week 52, the difference between the pirfenidone high-dose group and placebo was 70 mL, and the difference between the lower-dose group and placebo was 80 mL,” said Dr. Ogura of Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.

Statistically significant changes also were seen in progression-free survival, although not in the lowest SpO₂ on exertion or the incidence of acute exacerbations.

The most common adverse events associated with the treatment were photosensitivity, dizziness, anorexia, and elevated γ-glutamyl transpeptidase. The drug was generally well tolerated, with no significant differences being seen among the three groups for serious adverse events.

A total of 32% of patients dropped out during the course of the study, including 37% of the patients taking 1,800 mg of pirfenidone, 28% of those taking 1,200 mg, and 27% of patients in the placebo group.

The researchers will continue to follow the patients to see if pirfenidone can improve survival, and to see if the drug also may prove useful in other fibrotic lung diseases.

Dr. Ogura noted that he had no relevant financial disclosures.