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Esbriet meets safety targets in systemic sclerosis-related interstitial lung disease

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New data suggested Esbriet met its safety targets in the treatment of interstitial lung disease arising from systemic sclerosis, according to researchers who presented at the European League Against Rheumatism Annual European Congress of Rheumatology.

The researchers conducted an open-label, 16-week study including 63 patients with systemic sclerosis (SSc) and related interstitial lung disease (ILD) confirmed with high-resolution CT. Eligible patients had forced vital capacity (FVC) of 50% or more, diffusing capacity for carbon monoxide (DL_CO) of 40% or greater, and a disease duration of at least 7 years. Pulmonary hypertension and severe gastroesophageal reflux disease were exclusion criteria. Mean patient age was 50.6 years; 82.5% of the patients were women, and 76.2% were white.

Dinesh Khanna

Patients were randomly assigned to 2- or 4-week titration of Esbriet (pirfenidone, Genentech). Safety assessments included the evaluation of treatment-emergent adverse events (TEAEs) and monitoring of vital signs with electrocardiogram (ECG) and laboratory tests.

At week 16, no clinical changes in vital signs, ECGs or laboratory tests were observed. Serious adverse events occurred in three patients and included small intestinal obstruction, bronchitis, pulmonary hypertension and worsening ILD. Of the 61 patients (96.8%) who reported any TEAE, 19 patients (30.2%) reported mild TEAEs, 30 (47.6%) reported moderate TEAEs and 12 patients (19%) reported severe TEAEs.

Although the study endpoints did not include efficacy data, the median change from baseline at week 16 for FVC was 0.5%, and 10 patients (16.7%) showed an increase of 5% or more, whereas a decrease of more than 5% was observed in five patients. A median increase in DL_CO from baseline of 1.5% was observed. In 19 patients, the increase was 5% or more, whereas 10 patients had reduced DL_CO by more than 5%.

“The observed [adverse events] were expected and consistent with those previously seen with pirfenidone treatment in [pulmonary fibrosis] trials,” the researchers wrote. “The data support further investigation of pirfenidone in SSc-ILD.” – by Shirley Pulawski

Reference:

Khanna D, et al. Paper #SAT0433. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosures: Khanna reports grant/research support from Actelion, Astra-Zeneca, EMD Serono, Bristol Myers Squibb, Bayer and InterMune and is a consultant for Takeda, Sanofi-Aventis/Genzyme, EMD Serono, InterMune, Glaxo SmithKline, Genentech/Roche, Bristol Myers Squibb, Actelion, Astra-Zeneca, Bayer and Biogen Idec. Please see the full study for a list of all other authors’ relevant financial disclosures.