Category: Professional Posters
Purpose: Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that predominantly affects individuals over the age of 60 years. Elderly patients with IPF are more likely to be frail, to have comorbidities, and to experience side-effects from medications. Older age may be a barrier to initiating antifibrotic therapy. We investigated the efficacy and safety of nintedanib, an approved treatment for IPF, in patients aged ≥75 years using pooled data from clinical trials.
Methods: Data were pooled from five clinical trials of nintedanib: the Phase II, 52-week, placebo-controlled TOMORROW trial (NCT00514683), the two replicate 52-week, placebo-controlled INPULSIS trials (NCT01335464, NCT01335477), the 12-week, placebo-controlled period of the INMARK trial (NCT0278847) and the ≥6-month placebo-controlled period of a Phase IIIb trial (NCT01979952). Subgroup analyses were conducted in patients aged < 75 versus ≥75 years at baseline.
Results: 1364 patients (nintedanib 717; placebo 647) were aged < 75 years and 326 patients (nintedanib 178; placebo 148) were aged ≥75 years. Mean FVC at baseline in patients aged < 75 and ≥75 years, respectively, was 82.2% and 87.7% predicted. Nintedanib reduced the annual rate of decline in FVC versus placebo in patients aged < 75 and ≥75 years, with no significant difference in the treatment effect between subgroups (treatment-by-time-by-subgroup interaction p=0.60). In patients aged < 75 years, the annual rate of decline in FVC was −104.3 mL/year with nintedanib and −229.5 mL/year with placebo (difference 125.2 mL/year [95% CI: 90.1, 160.4]); in patients aged ≥75 years, it was −96.0 mL/year with nintedanib and −201.3 mL/year with placebo (difference 105.3 mL/year [95% CI: 39.3, 171.2]). The adverse event profile of nintedanib was similar between the 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). Diarrhea was the most frequent adverse event in patients treated with nintedanib, reported in 59.4% and 60.7% of nintedanib-treated patients aged < 75 and ≥75 years, versus 20.4% and 14.9% of placebo-treated patients in these subgroups, respectively.
Conclusion: 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.