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Efficacy of Intravenous Reslizumab in Oral Corticosteroid–Dependent Asthma
- Source :
- The Journal of Allergy and Clinical Immunology: In Practice. 8:555-564
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.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 1:1 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.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).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.
- Subjects :
- Adult
medicine.medical_specialty
Adolescent
Exacerbation
medicine.drug_class
Population
Antibodies, Monoclonal, Humanized
Placebo
Young Adult
Reslizumab
Adrenal Cortex Hormones
Prednisone
Internal medicine
medicine
Humans
Immunology and Allergy
Anti-Asthmatic Agents
Child
Adverse effect
education
Aged
Asthma
education.field_of_study
business.industry
Middle Aged
medicine.disease
Eosinophils
Treatment Outcome
Corticosteroid
business
medicine.drug
Subjects
Details
- ISSN :
- 22132198
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- The Journal of Allergy and Clinical Immunology: In Practice
- Accession number :
- edsair.doi.dedup.....18da07a3d103c44e8fb36bc2a2befc1e