In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, Nintedanib ( Ofev ) 150 mg twice daily significantly reduced the annual rate of decline in forced vital capacity ( FVC ), the primary endpoint, in patients with idiopathic pulmonary fibrosis ( IPF ).
It is unknown if this effect was uniform across all patients treated with Nintedanib.
A study has investigated the potential association of demographic and clinical variables with the effect of Nintedanib in patients with idiopathic pulmonary fibrosis.
Subgroup analyses of pooled data from the INPULSIS trials were pre-specified. Subgroups were analyzed by sex, age ( less than 65, greater than or equal to 65 years ), race ( White, Asian ), baseline FVC % predicted ( less than or equal to 70%, more than 70% ), baseline St. George's Respiratory Questionnaire ( SGRQ ) total score ( less than or equal to 40, more than 40 ), smoking status ( never, ex/current ), systemic corticosteroid use ( yes, no ) and bronchodilator use ( yes, no ).
1061 patients were treated ( Nintedanib n=638, placebo n=423 ).
There was no statistically significant difference in the effect of Nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup.
Treatment effects for the key secondary endpoints seemed more pronounced in patients with baseline FVC less than or equal to 70% predicted, as the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated patients in this subgroup.
In conclusion, pooled data from the INPULSIS trials support a consistent effect of Nintedanib across a range of IPF patient phenotypes by slowing disease progression across a number of pre-specified subgroups. ( Xagena )
Costabel U et al, Am J Respir Crit Care Med 2015; Epub ahead of print