Rare diseases

Antifibrotic agent slows progression of RA-ILD


Nintedanib slows the rate of decline in forced vital capacity (FVC) in patients with progressive fibrosing RA associated interstitial lung disease (RA-ILD), according to data presented at EULAR 2021.

The subanalysis of the INBUILD trial comprised 89 patients with RA-ILD of which 42 were randomised to nintedanib and 47 to placebo. Most were male (61%), current or former smokers (65%), with a mean duration of RA of 10 years and a mean duration of RA-ILD of 3.5 years.

At baseline, 21.3% of subjects were taking biologics, 53.9% were taking non-biologic DMARDs and 73.0% were taking glucocorticoids (≤20 mg/day prednisone or equivalent).

Dr Clive Kelly, from the Institute of Cellular Medicine at Newcastle University (UK), told the Congress that the adjusted mean rate of decline in FVC over 52 weeks was -82.6 (41.3) mL/year in the nintedanib group versus -199.3 (36.2) mL/year in the placebo group – a difference of 116.7 mL/year (p=0.037).

He said the results were consistent with the findings in the overall INBUILD trial population of 663 patients with a broad range of progressive fibrosing ILDs other than IPF.

The INBUILD trial, published in the NEJM in 2019, found nintedanib resulted in a relative reduction of 57% in the rate of decline in FVC compared to placebo.

Dr Kelly said there was no difference in the effect of nintedanib when further analysed by sub groups based on hs-CRP levels or baseline treatment, although the small numbers of patients in each subgroup limited any interpretation.

“The adverse event profile of patients with RA-ILD taking nintedanib was similar to that seen in the overall trial population.”

The most common adverse events reported were diarrhoea (54.8% nintedanib v 25.5% placebo), bronchitis (21.4% v 17.0%) and nausea (21.4% v 10.6%).

“Over 52 weeks, adverse events led to permanent discontinuation of trial drug in 19.0% of patients with RA-ILD subjects receiving nintedanib compared to 12.8% receiving placebo, consistent with the results in the overall trial population.”

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