| Autor: |
Gilles Devouassoux, Grigoriy Ursol, Pascal Chanez, Olivier Hermine, Olga Godlevska, Lesia Kuryk, Colin Mansfield, Lavinia Davidescu, Elliot Israel, Eduard Khodosh, Oleksii Korzh, Nortje Monja-Marie, Vikranth Deshmukh |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
Airway pharmacology and treatment. |
| Popis: |
Background: Study AB07015 evaluated oral masitinib (6 mg/kg/d) in severe persistent asthma, uncontrolled by high-dose ICS/LABA and oral corticosteroids (OCS) (≥7.5 mg/d), irrespective of baseline eosinophil levels. Method: Eligible adult patients (pts) were treated for 36 weeks (with possible blinded extension until at least week-96). Primary endpoint was reduction of annualized severe asthma exacerbation rate (SAER) for overall exposure (W0–W96). A key subgroup was defined as pts with initial eosinophil count of ≥150 cells/µL (EOS). Subgroup analysis according to cumulative OCS intake was also performed, a higher dose indicating more severe asthma that is harder to control. Results: MAS (n=240) showed a significant 35% reduction in SAER relative to placebo (PBO, n=115) with a rate ratio (RR) of 0.64 ([95%CI[0.47–0.90];p=0·0103]). For the EOS subgroup, MAS (n=181) showed a significant 38% reduction in SAER (n=87); RR=0.62 ([95%CI[0.42–0.91];p=0·0156). Benefit of MAS increased in pts who had a higher cumulated use of OCS (see Table). In pts receiving an annualized cumulative OCS intake of >1000 mg, SAER was significantly reduced by 51% in the primary analysis population (p=0·0060), and by 71% in the EOS subgroup (p=0·0003). Safety was consistent with the known MAS profile and no new safety signals were observed. Incidence of ≥1 adverse event was 83.4% for MAS vs 82.0% for PBO. Conclusion: Masitinib demonstrated a positive benefit/risk ratio in uncontrolled severe asthma, regardless of baseline eosinophil level. Benefits were greatest in pts with the highest OCS dose dependency. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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