Efficacy: progression-free survival in IPF
PROGRESSION-FREE SURVIVAL
In a prespecified exploratory analysis, a trend in favor of JASCAYD® in progression-free survival was observed1
Progression-free survival is defined as patients who had ≤10% absolute decline in FVC percent predicted from baseline and survived over the duration of the trial.1
The key secondary endpoint (time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death over duration of trial) was not met. The analyses of the secondary and further endpoints of time to death and time to progression were not part of confirmatory testing and are exploratory in nature.2
PROGRESSION-FREE SURVIVAL OVER THE DURATION OF THE TRIAL (UP TO 109 WEEKS)1
Limitations: Results from the blinded trial analysis (up to 91 weeks) and end of trial analysis (up to 109 weeks) are explorative in nature and for descriptive purposes only.
According to the ATS/ERS/JRS/ALAT Guideline, >10% decline in FVC is an established marker of disease progression and a surrogate marker for mortality. The hazard ratio for progression-free survival, assessed until the end of trial (up to 109 weeks), did not show a significant treatment difference for JASCAYD® compared to placebo (HR: 0.75 [0.59, 0.95]).1,3
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References
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Data on file. Boehringer Ingelheim International GmbH. FIBRONEER-ILD CTR. 2025.
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Richeldi L, Azuma A, Cottin V, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2025;392(22):2193–2202.
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Raghu G, Collard HR, Egan JJ, et al. ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. Idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183(6):788-824.
MLR ID: PC-AE-102892
Expiry Date: 10/05/2028