- Masitinib was associated with a positive benefit/risk ratio in patients with severe asthma (SA) uncontrolled by oral corticosteroids (OCS), irrespective of baseline eosinophil levels.
- Patients with the highest OCS dose-dependency had the greatest benefits with masitinib therapy.
Why this matters
- The first-in-class tyrosine kinase inhibitor masitinib simultaneously targets independent mechanisms of SA pathophysiology.
- Clinical efficacy of masitinib has been previously reported in animal and human studies, prompting the need for larger trials.
- AB07015: a double-blind phase 3 trial involving 355 patients with SA unmanaged by OCS dose ≥7.5 mg/day, who were randomly assigned to either masitinib 6 mg/kg/day (n=240) or placebo (n=115).
- Patients with SA having high (≥150 cells/μL) and low (
- Primary endpoint was reduction in annualized severe asthma exacerbation rate (SAER) for overall exposure.
- Funding: AB Science, Paris, France.
- Overall, masitinib significantly reduced SAER by 35% compared with placebo (rate ratio [RR], 0.65; 95% CI, 0.47-0.9; P=.0103).
- In patients with high eosinophil levels, a 38% reduction in SAER was observed vs placebo (RR, 0.62; 95% CI, 0.42-0.91; P=.0156).
- Masitinib benefits were greater in patients with high cumulated use of OCS:
- Overall cohort, cumulative OCS >500 mg: −41%; RR, 0.59; 95% CI, 0.39-0.88; P=.0092;
- Overall cohort, cumulative OCS >1000 mg: −51%; RR, 0.49; 95% CI, 0.29-0.82; P=.0060;
- Patients with high eosinophil levels, cumulative OCS >500 mg: −49%; RR, 0.51; 95% CI, 0.32-0.82; P=.0049; and
- Patients with high eosinophil levels, cumulative OCS >1000 mg: −71%; RR, 0.29; 95% CI, 0.15-0.57; P=.0003.
- Masitinib was not associated with additional safety concerns compared with placebo:
- Adverse event (AE): 83.4% vs 82.0%;
- Severe AE: 48.0% vs 45.9%; and
- Serious, nonfatal AE: 17.7% vs 16.5%.
- Patient characteristics (e.g. age, duration of disease) were not given.