medwireNews: Pirfenidone may slow lung function decline in patients with rheumatoid arthritis and interstitial lung disease (RA-ILD), show findings from the TRAIL1 trial.
The trial, presented as a poster at the ACR Convergence 2021 virtual meeting, was unfortunately stopped early due to slow recruitment exacerbated by the COVID-19 pandemic. This meant it was underpowered to detect a significant difference between pirfenidone and placebo for the composite primary endpoint of at least a 10% decline in percent predicted forced vital capacity (FVC%) from baseline or death during 52 weeks of treatment.
Nevertheless, there was a numerical difference, with this endpoint met by 11.1% of 63 patients treated with pirfenidone, compared with 15.0% of 60 patients given placebo.
Presenting author Joshua Solomon (National Jewish Health, Denver, Colorado, USA) also pointed out that pirfenidone significantly slowed lung function decline compared with placebo, as seen on two of the key secondary measures of annual change in absolute FVC and FVC%.
Among the patients given pirfenidone, mean absolute FVC and FVC% declined by a respective 66 mL and 1.02%, compared with a decline of 146 mL and 3.21% among those given placebo.
These differences were particularly pronounced in participants who had a usual interstitial pneumonia pattern on high-resolution computed tomography at baseline. The average annual decreases in absolute FVC in these patients were 43 mL with pirfenidone compared with 169 mL with placebo and for FVC% they were 0.20% versus 3.81%, respectively.
The trial participants were aged 18 to 85 years and had established RA-ILD. The patients had to have at least 10% fibrosis but were not required to have documented progression.
The researchers found no significant difference in the rate of treatment-emergent serious adverse events, at 14.5% in pirfenidone-treated patients and 13.3% in placebo-treated patients.
“Although TRAIL1 was underpowered to detect a difference in the composite primary endpoint, pirfenidone was found to have no new safety signals and slowed decline of FVC over time in subjects with RA-ILD,” Solomon concluded.
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ACR Convergence 2021; 3–9 November