The rate of severe asthma exacerbation was significantly reduced after 36 weeks of treatment with oral masitinib in a phase 3 randomized, placebo-controlled trial.
At a dose of 6 mg/kg daily, masitinib, a tyrosine kinase inhibitor, was effective in patients with severe, persistent asthma not controlled with high-dose inhaled corticosteroids, long-acting beta agonists (LABAs), or oral corticosteroids, regardless of baseline eosinophil levels.
The 240 patients in the masitinib group experienced a significant 35% reduction in the rate of severe exacerbations, compared with the 115 patients in the placebo group (rate ratio [RR), 0.64; 95% CI, 0.47 - 0.90; P = .0103). Patients with the highest dependency on oral corticosteroids — a cumulative dose of more than 1500 mg — benefited most, with a 72% reduction in exacerbations.
In the subgroup of patients with a baseline eosinophil count of at least 150 cells/µL, the 181 patients in the masitinib group showed a significant 38% reduction in severe exacerbations, compared with the 87 patients in the placebo group (RR, 0.62; 95% CI, 0.42 - 0.91; P = .0156).
"Overall, the safety was equivalent between the two arms — placebo and masitinib — and there was no difference in serious adverse events," said Pascal Chanez, MD, PhD, from the University of Aix-Marseille in France, who presented the study results at the virtual European Respiratory Society International Congress 2020 (ERS2020).
