Summary

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• This summary is based on the review of two systematic reviews/meta-analyses. ^[1-2]
• Jascayd (nerandomilast) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients.
• Progressive Pulmonary Fibrosis (PPF): At week 52, adjusted mean change in FVC was -98.6 ml (95% CI, -123.7 to -73.4) with nerandomilast 18 mg twice daily, -84.6 ml (95% CI, -109.6 to -59.7) with nerandomilast 9 mg twice daily, and -165.8 ml (95% CI, -190.5 to -141.0) with placebo; adjusted differences vs. placebo were 67.2 ml (95% CI, 31.9 to 102.5; P<0.001) for 18 mg and 81.1 ml (95% CI, 46.0 to 116.3; P<0.001) for 9 mg.
• IPF: At week 52, adjusted mean change in FVC was -114.7 ml (95% CI, -141.8 to -87.5) with nerandomilast 18 mg twice daily, -138.6 ml (95% CI, -165.6 to -111.6) with nerandomilast 9 mg twice daily, and -183.5 ml (95% CI, -210.9 to -156.1) with placebo; adjusted differences vs. placebo were 68.8 ml (95% CI, 30.3 to 107.4; P<0.001) for 18 mg and 44.9 ml (95% CI, 6.4 to 83.3; P=0.02) for 9 mg.
• In both studies, patients were stratified by background antifibrotic therapy (nintedanib or pirfenidone vs. none) and, for PPF, additionally by fibrotic pattern (usual interstitial pneumonia-like vs. other patterns); no direct comparative effectiveness data were provided for other antifibrotic drugs.
• In patients with PPF, the most frequent adverse event was diarrhea (nerandomilast 18 mg: 36.6%; nerandomilast 9 mg: 29.5%; placebo: 24.7%); serious adverse events occurred in similar percentages across trial groups (specific percentages not provided).
• In patients with IPF, the most frequent adverse event was diarrhea (nerandomilast 18 mg: 41.3%; nerandomilast 9 mg: 31.1%; placebo: 16.0%); serious adverse events were balanced across trial groups (specific percentages not provided).
• There is no population type or subgroup information available in the reviewed studies.