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DOI: 10.1055/s-0039-3403289
Efficacy and safety of nintedanib in the elderly patient with IPF*
Publication History
Publication Date:
28 February 2020 (online)
Introduction: Elderly patients with IPF are more likely to be frail, have comorbidities, and experience side-effects from medications. Older age may be a barrier to initiating antifibrotic therapy.
Aim: To investigate the efficacy and safety of nintedanib 150 mg bid in elderly patients with IPF.
Methods: Data were pooled from the periods of the TOMORROW trial (NCT00514683) (52 weeks), INPULSIS trials (NCT01335464, NCT01335477) (52 weeks), INMARK trial (NCT0278847) (12 weeks) and a Phase III b trial (NCT01979952) (~ 6 months) in which patients were randomised to nintedanib or placebo. Subgroup analyses were conducted in patients aged < 75 vs. ≥ 75 years at baseline.
Results: At baseline, mean FVC was 82.2% and 87.7% predicted in patients aged < 75 years (n = 1364) and ≥ 75 years (n = 326), respectively. Nintedanib reduced the annual rate of decline in FVC by > 50% in both age subgroups, with no difference observed between subgroups ([Fig. 1]). The adverse event profile of nintedanib was similar in both subgroups, but a greater proportion of patients aged ≥ 75 years discontinued treatment due to adverse events (26.4% with nintedanib, 12.2% with placebo) than patients aged < 75 years (16.0% with nintedanib, 10.8% with placebo).
Conclusions: Nintedanib has the same benefit on reducing the progression of IPF in patients aged ≥ 75 years as in younger patients. Proactive management of adverse events is important to help maintain patients on antifibrotic therapy.
* presented at ERS 2019, ‡ presenting on behalf of the authors
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