Effect of anti-acid medication on reduction in FVC decline with nintedanib

Abstract

Background: It has been suggested that anti-acid medication may impact the progression of idiopathic pulmonary fibrosis (IPF). The two replicate, 52-week, Phase III INPULSIS^® trials assessed the efficacy of nintedanib 150 mg twice daily (bid) in patients with IPF. In both trials, nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC), the primary endpoint, vs placebo.

Aim: To assess whether use of anti-acid medication at baseline influenced the treatment effect of nintedanib.

Methods: A post-hoc analysis of patients receiving vs not receiving anti-acid medication (proton pump or histamine-receptor-2 inhibitors) at baseline was conducted using pooled data from both INPULSIS^® trials.

Results: At baseline, 406 patients were receiving anti-acid medication (244 nintedanib; 162 placebo) and 655 were not (394 nintedanib; 261 placebo). For patients receiving anti-acid medication, mean age was 67.6 years, 74.6% were male and mean FVC was 79.6% predicted. For patients not receiving anti-acid medication, mean age was 66.2 years, 82.1% were male and mean FVC was 79.5% predicted. In patients receiving anti-acid medication at baseline, the nintedanib vs placebo difference in adjusted annual rate of decline in FVC was 128.6 mL/year (95%CI: 74.9, 182.2); in patients not receiving anti-acid medication at baseline, it was 98.3 mL/year (95%CI: 54.1, 142.5). There was no significant treatment-by-subgroup interaction for the primary endpoint (p=0.1664).

Conclusion: In a subgroup analysis of pooled data from the INPULSIS^® trials, anti-acid medication use at baseline did not influence the treatment effect of nintedanib on reducing decline in FVC in patients with IPF.