Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma
(2017) In Journal of Allergy and Clinical Immunology: In Practice 5(6). p.3-1581- Abstract
Background In placebo-controlled trials, reslizumab, an anti-IL-5 monoclonal antibody, significantly reduced asthma exacerbations and improved lung function and asthma control in patients with eosinophilic asthma. Objective This open-label extension study evaluated safety and efficacy of reslizumab for up to 24 months. Methods After participation in 1 of 3 placebo-controlled, phase III trials in moderate-to-severe eosinophilic asthma, patients received reslizumab 3.0 mg/kg intravenously every 4 weeks for up to 24 months. Adverse events (AEs), lung function, and patient-reported asthma control were evaluated. Results In the open-label extension, 1,051 patients received ≥1 reslizumab dose (480 reslizumab-naïve, 571... (More)
Background In placebo-controlled trials, reslizumab, an anti-IL-5 monoclonal antibody, significantly reduced asthma exacerbations and improved lung function and asthma control in patients with eosinophilic asthma. Objective This open-label extension study evaluated safety and efficacy of reslizumab for up to 24 months. Methods After participation in 1 of 3 placebo-controlled, phase III trials in moderate-to-severe eosinophilic asthma, patients received reslizumab 3.0 mg/kg intravenously every 4 weeks for up to 24 months. Adverse events (AEs), lung function, and patient-reported asthma control were evaluated. Results In the open-label extension, 1,051 patients received ≥1 reslizumab dose (480 reslizumab-naïve, 571 reslizumab-experienced); median (range) exposure was 319 (36-840) and 343 (36-863) days in reslizumab-naïve and reslizumab-experienced patients, respectively. Continuous exposure, including during the placebo-controlled studies, was ≥12 months for 740 patients and ≥24 months for 249 patients. The most common AEs were worsening of asthma and nasopharyngitis. Serious AEs affected 78 of 1,051 (7%) patients; 18 of 1,051 (2%) discontinued treatment because of AEs; and there were 3 deaths (all non-treatment-related). Fifteen adult patients (15 of 1,023; 1%) had malignancies of diverse tissue types. Reslizumab-experienced patients maintained improved lung function and asthma control; reslizumab-naïve patients had improvements in these measures throughout open-label treatment. Blood eosinophil counts appeared to be returning to baseline after reslizumab discontinuation. Conclusions In patients with moderate-to-severe eosinophilic asthma, intravenous reslizumab 3.0 mg/kg displays favorable long-term safety and sustained long-term efficacy. Initial improvements in lung function and asthma control were maintained for up to 2 years. These findings substantially add to our understanding of the long-term safety and efficacy of anti-IL-5 strategies.
(Less)
- author
- Murphy, Kevin ; Jacobs, Joshua ; Bjermer, Leif LU ; Fahrenholz, John M. ; Shalit, Yael ; Garin, Margaret ; Zangrilli, James and Castro, Mario
- organization
- publishing date
- 2017-11-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Anti-IL-5, Asthma, Eosinophil, Long-term safety, Open-label extension study, Reslizumab
- in
- Journal of Allergy and Clinical Immunology: In Practice
- volume
- 5
- issue
- 6
- pages
- 3 - 1581
- publisher
- Elsevier
- external identifiers
-
- pmid:29122156
- scopus:85033374560
- ISSN
- 2213-2198
- DOI
- 10.1016/j.jaip.2017.08.024
- language
- English
- LU publication?
- yes
- id
- acaba563-de11-4e6a-8399-5ec3945629aa
- date added to LUP
- 2017-11-24 07:12:02
- date last changed
- 2024-04-29 23:35:03
@article{acaba563-de11-4e6a-8399-5ec3945629aa,
abstract = {{<p>Background In placebo-controlled trials, reslizumab, an anti-IL-5 monoclonal antibody, significantly reduced asthma exacerbations and improved lung function and asthma control in patients with eosinophilic asthma. Objective This open-label extension study evaluated safety and efficacy of reslizumab for up to 24 months. Methods After participation in 1 of 3 placebo-controlled, phase III trials in moderate-to-severe eosinophilic asthma, patients received reslizumab 3.0 mg/kg intravenously every 4 weeks for up to 24 months. Adverse events (AEs), lung function, and patient-reported asthma control were evaluated. Results In the open-label extension, 1,051 patients received ≥1 reslizumab dose (480 reslizumab-naïve, 571 reslizumab-experienced); median (range) exposure was 319 (36-840) and 343 (36-863) days in reslizumab-naïve and reslizumab-experienced patients, respectively. Continuous exposure, including during the placebo-controlled studies, was ≥12 months for 740 patients and ≥24 months for 249 patients. The most common AEs were worsening of asthma and nasopharyngitis. Serious AEs affected 78 of 1,051 (7%) patients; 18 of 1,051 (2%) discontinued treatment because of AEs; and there were 3 deaths (all non-treatment-related). Fifteen adult patients (15 of 1,023; 1%) had malignancies of diverse tissue types. Reslizumab-experienced patients maintained improved lung function and asthma control; reslizumab-naïve patients had improvements in these measures throughout open-label treatment. Blood eosinophil counts appeared to be returning to baseline after reslizumab discontinuation. Conclusions In patients with moderate-to-severe eosinophilic asthma, intravenous reslizumab 3.0 mg/kg displays favorable long-term safety and sustained long-term efficacy. Initial improvements in lung function and asthma control were maintained for up to 2 years. These findings substantially add to our understanding of the long-term safety and efficacy of anti-IL-5 strategies.</p>}},
author = {{Murphy, Kevin and Jacobs, Joshua and Bjermer, Leif and Fahrenholz, John M. and Shalit, Yael and Garin, Margaret and Zangrilli, James and Castro, Mario}},
issn = {{2213-2198}},
keywords = {{Anti-IL-5; Asthma; Eosinophil; Long-term safety; Open-label extension study; Reslizumab}},
language = {{eng}},
month = {{11}},
number = {{6}},
pages = {{3--1581}},
publisher = {{Elsevier}},
series = {{Journal of Allergy and Clinical Immunology: In Practice}},
title = {{Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma}},
url = {{http://dx.doi.org/10.1016/j.jaip.2017.08.024}},
doi = {{10.1016/j.jaip.2017.08.024}},
volume = {{5}},
year = {{2017}},
}