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DOI: 10.1055/s-0037-1598508
Twenty-four week decline in forced vital capacity (FVC) predicts mortality at week 52 in the INPULSIS trials
Publication History
Publication Date:
23 February 2017 (online)
Background:
In a pooled analysis of data from the Phase III INPULSIS® trials, a significantly lower proportion of patients with idiopathic pulmonary fibrosis (IPF) treated with nintedanib vs. placebo (PBO) had disease progression defined as absolute decline in FVC of ≥5% or ≥10% predicted at week 52.
Aim:
To explore the impact of change in FVC over 24 weeks on subsequent FVC decline and mortality.
Methods: Post-hoc descriptive analysis of proportions of patients with absolute FVC declines of < 5%, ≥5%,or ≥10% predicted from baseline to week 24 and changes in FVC % predicted and mortality between weeks 24 and 52 in these groups conducted using pooled data from both INPULSIS® trials.
Results:
1061 patients (nintedanib 638, PBO 423) were included. FVC decline of ≥5% or ≥10% predicted from baseline to week 24 did not predict FVC decline of ≥5% or ≥10% predicted, respectively, from week 24 to 52. Among patients with FVC decline < 5% predicted from baseline to week 24, 30.0% and 42.5% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥5% predicted from week 24 to 52. Among patients with FVC decline ≥5% predicted from baseline to week 24, 33.6% and 30.1% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥5% predicted from week 24 to 52. Among patients with FVC decline ≥10% predicted from baseline to week 24, 19.6% and 18.9% of patients in the nintedanib and placebo groups, respectively, had FVC decline ≥10% predicted from week 24 to 52. In total, 1.8% and 2.3% of patients with FVC decline < 5% predicted, 7.7% and 10.3% of patients with FVC decline ≥5% predicted, and 10.9% and 13.2% of patients with FVC decline ≥10% predicted in the first 24 weeks died between weeks 24 and 52 in the nintedanib and placebo groups, respectively.
Conclusion:
FVC declines of ≥5% or ≥10% predicted in the first 24 weeks of the INPULSIS® trails did not predict FVC decline but were associated with higher mortality in the following 24 weeks.
Presented at ERS 2016.