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Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma

Murphy, Kevin; Jacobs, Joshua; Bjermer, Leif LU ; Fahrenholz, John M.; Shalit, Yael; Garin, Margaret; Zangrilli, James and Castro, Mario (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.

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author
publishing date
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
  • scopus:85033374560
ISSN
2213-2198
DOI
10.1016/j.jaip.2017.08.024
language
English
LU publication?
no
id
acaba563-de11-4e6a-8399-5ec3945629aa
date added to LUP
2017-11-24 07:12:02
date last changed
2018-09-23 04:53:40
@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},
  keyword      = {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},
  volume       = {5},
  year         = {2017},
}