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Long-term Safety an...
Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma
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- Murphy, Kevin (author)
- Boys Town National Research Hospital
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- Jacobs, Joshua (author)
- Allergy & Asthma Medical Group of the Bay Area, Inc
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- Bjermer, Leif (author)
- Lund University,Lunds universitet,Lungmedicin, allergologi och palliativ medicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Respiratory Medicine, Allergology, and Palliative Medicine,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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- Fahrenholz, John M. (author)
- Nashville Veterans Affairs Medical Center
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- Shalit, Yael (author)
- Teva Pharmaceutical Industries Ltd.
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- Garin, Margaret (author)
- Teva Pharmaceutical Industries Ltd.
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- Zangrilli, James (author)
- Teva Pharmaceutical Industries Ltd.
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- Castro, Mario (author)
- Washington University in St. Louis
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(creator_code:org_t)
- Elsevier BV, 2017
- 2017
- English.
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In: Journal of Allergy and Clinical Immunology: In Practice. - : Elsevier BV. - 2213-2198. ; 5:6, s. 3-1581
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Keyword
- Anti-IL-5
- Asthma
- Eosinophil
- Long-term safety
- Open-label extension study
- Reslizumab
Publication and Content Type
- art (subject category)
- ref (subject category)
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