Does nintedanib have the same effect on FVC decline in patients with progressive fibrosing ILDs treated with DMARDs or glucocorticoids?

Background: In the INBUILD trial, nintedanib slowed FVC decline in patients with non-IPF progressive fibrosing ILDs.

Aim: Assess the influence of disease-modifying antirheumatic drugs (DMARDs) and/or glucocorticoids at baseline on the effect of nintedanib in the INBUILD trial.

Methods: The rate of decline in FVC and adverse events (AEs) over 52 weeks were assessed by use of DMARDs and/or glucocorticoids at baseline.

Results: In patients with use vs no use of DMARDs and/or glucocorticoids at baseline, mean (SD) FVC was 2288 (700) vs 2388 (775) mL, age was 65.4 (9.8) vs 66.2 (9.7) years, and 53.1% vs 54.4% were male, respectively. In the placebo group, the rate of FVC decline was numerically greater in patients who used DMARDs and/or glucocorticoids at baseline. Compared with placebo, nintedanib reduced the rate of FVC decline both in patients with use and no use of DMARDs and/or glucocorticoids at baseline; the interaction p-value did not indicate a differential treatment effect of nintedanib between subgroups. AEs leading to discontinuation occurred in similar proportions of patients with use vs no use of DMARDs and/or glucocorticoids at baseline in the nintedanib (17.6% vs 22.1%) and placebo (11.3% vs 8.8%) groups.

Conclusion: In the INBUILD trial, nintedanib reduced the rate of FVC decline both in patients with use and no use of DMARDs and/or glucocorticoids at baseline.