TY - JOUR
T1 - Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma
AU - Murphy, Kevin
AU - Jacobs, Joshua
AU - Bjermer, Leif
AU - Fahrenholz, John M.
AU - Shalit, Yael
AU - Garin, Margaret
AU - Zangrilli, James
AU - Castro, Mario
N1 - Funding Information:
Conflicts of interest: K. Murphy has received consultancy and speaker fees and has participated in advisory boards for AstraZeneca, Boehringer Ingelheim, Genentech, Greer, Meda, Merck, Mylan, Novartis, and Teva. J. Jacobs has received research support from Teva, Genentech, and AstraZeneca. L. Bjermer has participated in advisory boards for and has received lecture fees from Aerocrine, Airsonett, ALK, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Genentech, GlaxoSmithKline, Meda, Mundipharma, Nigaard Pharma, Novartis, Regeneron, Sanofi Aventis, Takeda, and Teva. J. M. Fahrenholz has received research support from Teva, GlaxoSmithKline, Amgen, and AstraZeneca. Y. Shalit and M. Garin are employed by Teva. J. Zangrilli was employed by Teva at the time of this study; has a patent for the use of reslizumab to treat moderate-to-severe eosinophilic asthma. M. Castro has received consultancy fees from Asthmatx/Boston Scientific, IPS/Holaira, and Neostem; has received consultancy fees and has participated in advisory boards for Genentech; has received research support from Amgen, Ception/Cephalon/Teva, Novartis, GlaxoSmithKline, Sanofi-Aventis, Vectura, KaloBios, and Medimmune; has received speaker fees from GlaxoSmithKline, Genentech, Boston Scientific, Boehringer Ingelheim, and Teva; receives royalties from Elsevier; has stock in Sparo Inc.
Funding Information:
This study was sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Publisher Copyright:
© 2017 The Authors
PY - 2017/11
Y1 - 2017/11
N2 - 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.
AB - 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.
KW - Anti-IL-5
KW - Asthma
KW - Eosinophil
KW - Long-term safety
KW - Open-label extension study
KW - Reslizumab
UR - http://www.scopus.com/inward/record.url?scp=85033374560&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2017.08.024
DO - 10.1016/j.jaip.2017.08.024
M3 - Article
C2 - 29122156
AN - SCOPUS:85033374560
SN - 2213-2198
VL - 5
SP - 1572-1581.e3
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 6
ER -