Results from a recent open-label trial presented during the European League Against Rheumatism Annual European Congress of Rheumatology showed that ESBRIET met its safety endpoint in the treatment of interstitial lung disease arising from systemic sclerosis.
The 16-week study involved a total of 63 patients with systemic sclerosis (SSc) and related interstitial lung disease (ILD), which were determined with the use of high-resolution CT. The patients who took part in study had diffusing capacity for carbon monoxide (DLCO) of 40% or greater, forced vital capacity (FVC) of 50% or more, and at least 7 years of disease duration.
Study patients were randomized for 2- or 4-week treatment with titration of Esbriet (pirfenidone). The assessment of the drug safety profile involved laboratory tests, the calculation of adverse events related to the treatment-emergent (TEAEs) and monitoring of vital signs with the use of electrocardiogram (ECG).
Results showed that at week 16 there were no clinical changes in laboratory tests, ECGs and vital sign. Three patients experienced serious adverse events such as bronchitis, pulmonary hypertension, small intestinal obstruction and worsening ILD. From the 61 patients (96.8%) who experienced TEAE’s, 19 patients (30.2%) experienced mild TEAEs, 30 (47.6%) experienced moderate TEAEs and 12 patients (19%) experienced severe TEAEs.
The study did not assess any efficacy endpoint, however, the average change between the baseline and at week 16 showed that the FVC was of 0.5%, and that 16.7% of the patients had an increase of 5% or more. There was a decrease of more than 5% in five of the patients. From baseline, there was an average increase of 1.5% in the levels of DLCO . In a total of 19 patients, there was an 5% or more, whereas 10 patients had reduced DLCO 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 according to a recent news release. “The data support further investigation of pirfenidone in SSc-ILD.”