Abstract | BACKGROUND: OBJECTIVE: These post hoc analyses of pooled data from 2 BREATH phase 3 clinical trials, studies 1 and 2 (NCT01287039 and NCT01285323), examined asthma-related outcomes in patients with comorbid, self-reported CRSwNP with and without aspirin sensitivity. METHODS: Patients aged 12-75 years with elevated blood eosinophils (≥400 cells/μL) and inadequately controlled asthma were randomized to receive placebo or reslizumab (3 mg/kg IV) every 4 weeks for 52 weeks. Patients continued their background asthma maintenance therapy during the study. Information regarding the presence of CRSwNP was obtained through patient-reported medical history. RESULTS: Add-on reslizumab treatment reduced the frequency of clinical asthma exacerbations by 83% versus placebo among patients with CRSwNP. Among patients with and without aspirin sensitivity, reductions of 79% and 84%, respectively, were observed. Patients with CRSwNP (with and without aspirin sensitivity) treated with reslizumab add-on therapy also had significant improvements in lung function, as measured by forced expiratory volume in 1 second, compared with placebo. Among patients with CRSwNP, reslizumab was also associated with improvements in patient-reported asthma control and asthma quality of life. CONCLUSIONS: Patients with eosinophilic asthma and self-reported CRSwNP, with and without aspirin sensitivity, are highly responsive to treatment with reslizumab for asthma-related outcomes. These findings suggest that prospective investigation of reslizumab in this patient population is warranted.
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Authors | Steven F Weinstein, Rohit K Katial, Philip Bardin, Stephanie Korn, Mirna McDonald, Margaret Garin, Eric D Bateman, Flavia C L Hoyte, Matthew Germinaro |
Journal | The journal of allergy and clinical immunology. In practice
(J Allergy Clin Immunol Pract)
Vol. 7
Issue 2
Pg. 589-596.e3
(02 2019)
ISSN: 2213-2201 [Electronic] United States |
PMID | 30193936
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Asthmatic Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Antibodies, Monoclonal, Humanized
- reslizumab
- Aspirin
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Topics |
- Adolescent
- Adult
- Aged
- Anti-Asthmatic Agents
(therapeutic use)
- Anti-Inflammatory Agents, Non-Steroidal
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Aspirin
- Asthma
(drug therapy, epidemiology, immunology)
- Child
- Chronic Disease
- Comorbidity
- Eosinophils
(immunology)
- Female
- Humans
- Male
- Middle Aged
- Nasal Polyps
(drug therapy, epidemiology, immunology)
- Pulmonary Eosinophilia
(drug therapy, epidemiology, immunology)
- Rhinitis
(drug therapy, epidemiology, immunology)
- Self Report
- Sinusitis
(drug therapy, epidemiology, immunology)
- Treatment Outcome
- Young Adult
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