CONFERENCE UPDATE : ERS2020

AB07015: A randomized, phase 3 trial of masitinib in severe asthma

30 Oct 2020

FINDINGS

  • When compared to placebo, the use of masitinib has shown a 35% reduction in severe asthma exacerbation rate (SAER) (RR=0.64, 95% CI: 0.47-0.90; p=0.0103)
  • In the sequential analysis for patient subgroup having initial eosinophil count of ­150cells/μL, a 38% reduction in SAER was observed in patients treated with masitinib (RR=0.82; 95% CI: 0.42-0.91; p=0.0156)
  • Severe asthma patients with higher cumulated use of OCS >500mg and >1,000mg benefited from the use of masitinib (RR=0.59 and 0.49, 95% CI: 0.39-0.88 and 0.29-0.82; p=0.0092 and 0.0060, respectively)
  • Severe asthma patients with high initial eosinophil count also benefited from the use of masitinib when cumulated use of OCS >500mg and >1,000mg (RR=0.51 and 0.29, 95% CI: 0.32-0.82 and 0.15-0.57; p=0.0049 and 0.0003, respectively)
  • Incidences of at least one adverse event (AE), at least one severe AE and at least one serious non-fatal AE are similar between treatment and placebo groups (83.4% vs. 82.0%, 48.0% vs. 45.9%, and 17.7% vs. 16.5%, respectively); no new safety signals were observed

“The study demonstrated efficacy of masitinib in serious asthma patients regardless of baseline eosinophil count, and showed the greatest benefit of masitinib in patients with severe asthma.”

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