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

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

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54 Scopus citations

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 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.

Original languageEnglish
Pages (from-to)1572-1581.e3
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume5
Issue number6
DOIs
StatePublished - Nov 2017

Keywords

  • Anti-IL-5
  • Asthma
  • Eosinophil
  • Long-term safety
  • Open-label extension study
  • Reslizumab

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    Murphy, K., Jacobs, J., Bjermer, L., Fahrenholz, J. M., Shalit, Y., Garin, M., Zangrilli, J., & Castro, M. (2017). Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma. Journal of Allergy and Clinical Immunology: In Practice, 5(6), 1572-1581.e3. https://doi.org/10.1016/j.jaip.2017.08.024