Pirfenidone disappoints in SSc–ILD trial
medwireNews: Randomized trial findings presented at the EULAR 2019 congress in Madrid, Spain, suggest that pirfenidone does not stabilize or improve lung function in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD).
However, presenting author Nupoor Acharya (Post Graduate Institute of Medical Education and Research, Chandigarh, India) cautioned that the trial was limited by small participant numbers, and that a larger study with longer follow-up may be needed.
The researchers found that the proportion of patients with improvement or stabilization in forced vital capacity (FVC) over 6 months was not significantly different among the 17 participants randomly assigned to receive pirfenidone (initial dose 600 mg/day and increased to 2400 mg/day over 1 month) compared with the 17 given placebo, at 94.1% and 76.5%, respectively.
A number of secondary outcomes, including change in median FVC, 6-minute walk distance, and modified Rodnan skin score, were also comparable between the two groups at the 6-month follow-up. Median TGF-β levels decreased by 186.73 pg/mL in the pirfenidone arm and increased by 24.29 pg/mL in the placebo arm, but Acharya noted that the difference did not reach statistical significance.
In all, 27 adverse events occurred in the pirfenidone group, and 19 in the placebo group, most commonly gastrointestinal events.
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