Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma.
J Allergy Clin Immunol Pract
; 8(2): 555-564, 2020 02.
Article
en En
| MEDLINE
| ID: mdl-31626990
ABSTRACT
BACKGROUND:
Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.OBJECTIVE:
To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.METHODS:
We report post hoc analyses of pooled data from duplicate, placebo-controlled phase 3 trials. Patients aged 12 to 75 years with inadequately controlled, moderate-to-severe asthma were randomized 11 to receive intravenous reslizumab 3.0 mg/kg or placebo every 4 weeks for 52 weeks, stratified by oral corticosteroid use at enrollment and by region. Assessments included efficacy and predictors of clinical asthma exacerbation response in oral corticosteroid-dependent patients, and systemic corticosteroids burden in the overall population.RESULTS:
Patients were randomized to reslizumab (n = 477) or placebo (n = 476); 73 (15%) patients in each group were taking oral corticosteroids at baseline. Reslizumab was favored over placebo for all efficacy end points in oral corticosteroid-dependent patients, with numerically greater improvements in oral corticosteroid-dependent patients than the overall population. Having 2 or more versus 1 clinical asthma exacerbation in the previous 12 months was the strongest positive predictor of reduced exacerbation risk with reslizumab (risk reduction, 77.5% vs 15.2%; P ≤ .02). Significantly fewer new systemic corticosteroid prescriptions were issued per patient receiving reslizumab versus placebo (mean ± SD, 0.5 ± 1.07 vs 1.0 ± 1.52; P < .0001). Total and per-patient systemic corticosteroid burdens were lower 121,135 versus 290,977 mg and 254 versus 611 mg/patient, respectively (both P < .0001).CONCLUSIONS:
Oral corticosteroid-dependent patients benefited from reslizumab across asthma efficacy outcome measures. Reslizumab-treated patients required fewer new systemic corticosteroid prescriptions and had a lower systemic corticosteroid burden compared with placebo.Palabras clave
Texto completo:
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Base de datos:
MEDLINE
Asunto principal:
Asma
/
Antiasmáticos
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Anticuerpos Monoclonales Humanizados
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Revista:
J Allergy Clin Immunol Pract
Año:
2020
Tipo del documento:
Article