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J Allergy Clin Immunol Pract. 2019 Oct 15. pii: S2213-2198(19)30865-7. doi: 10.1016/j.jaip.2019.09.036. [Epub ahead of print]

Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma.

Author information

1
Department of Medicine, McMaster University & St Joseph's Healthcare Hamilton, Hamilton, ON, Canada. Electronic address: parames@mcmaster.ca.
2
Monash Lung and Sleep, Monash Medical Centre and University, Melbourne, VIC, Australia.
3
Université Paris-Sud, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
4
Boys Town National Research Hospital, Boys Town, Neb.
5
Teva Branded Pharmaceutical Products R&D, Inc, Malvern, Pa.
6
Department of Respiratory Diseases, Aix-Marseille University, Marseille, France.

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 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.

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.

KEYWORDS:

Eosinophil; IL-5; Oral corticosteroid; Prednisone; Reslizumab; Severe asthma

PMID:
31626990
DOI:
10.1016/j.jaip.2019.09.036
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