ESBRIET Found To Be Safe in Patients with Interstitial Lung Disease Associated With Systemic Sclerosis

Dr. Dinesh Khanna from the University of Michigan Health System recently presented at the European League Against Rheumatism (EULAR) 2015 Annual European Congress of Rheumatology in Rome new positive safety data regarding ESBRIET for the treatment of interstitial lung disease (ILD).

ILD is a group of disorders that cause progressive scarring of lung tissue compromising the respiratory function and blood oxygenation. Patients with systemic sclerosis have a high risk for developing progressive ILD. Systemic sclerosis, also known as scleroderma, is a rare, chronic autoimmune disease in which the body’s own immune system attacks healthy tissues resulting in a hardening and tightening of the skin and connective tissues. The disease usually affects the skin, but it can also affect internal organs such as the lungs.

Esbriet (pirfenidone) is an oral drug developed for the treatment of pulmonary fibrosis. It is an anti-fibrotic drug thought to act by decreasing the production of collagen, growth and inflammation factors, ultimately leading to a reduction in lung fibrosis.

The research team conducted a 16-week, multinational, randomized, open-label Phase 2 trial (NCT0193334) to assess Esbriet’s safety profile. In total, 63 systemic sclerosis patients with related ILD confirmed by high-resolution computed tomography (CT) were analyzed. The patient cohort had a mean age of 50.6 years.

Patients received either 2 or 4 week titration of Esbriet. Safety was assessed by the occurrence of adverse events related to treatment and the monitoring of the patient’s vital signs through electrocardiogram (ECG) and laboratory tests.

Researchers found no changes in vital signs, ECG or laboratory test results at week 16 post-treatment. In total, 61 patients (96.8%) reported adverse events, with 19 patients reporting mild events, 30 reporting moderate events and 12 severe events. Serious adverse events were only reported in three patients where complication like pulmonary hypertension, bronchitis, worsening ILD and small intestinal obstruction were detected.

The research team concluded that Esbriet is overall a safe treatment for patients with ILD associated with systemic sclerosis. “The observed [adverse events] were expected and consistent with those previously seen with pirfenidone treatment in [pulmonary fibrosis] trials,” wrote the research team according to a news release. “The data support further investigation of pirfenidone in SSc [systemic sclerosis]-ILD.”