Nasal IL-5 levels determine the response to anti–IL-5 treatment in patients with nasal polyps

Chronic rhinosinusitis with nasal polyps is characterized by an eosinophilic inflammation and high IL-5 levels. Antagonizing the effect of IL-5 is a potential new treatment strategy in patients with nasal polyps. In a double-blind, placebo-controlled, randomized, 2-center safety and pharmacokinetic...

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Bibliographic Details
Published in:Journal of Allergy and Clinical Immunology 2006-11, Vol.118 (5), p.1133-1141
Main Authors: Gevaert, Philippe, Lang-Loidolt, Doris, Lackner, Andreas, Stammberger, Heinz, Staudinger, Heribert, Van Zele, Thibaut, Holtappels, Gabriele, Tavernier, Jan, van Cauwenberge, Paul, Bachert, Claus
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - pharmacokinetics
Antibodies, Monoclonal - therapeutic use
Antibodies, Monoclonal, Humanized
anti–IL-5
Biological and medical sciences
Chronic rhinosinusitis
Clinical trials
Double-Blind Method
Drug therapy
eosinophils
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Humans
IL-5
IL-5 receptor α
Immunopathology
Injections, Intravenous
Interleukin-5 - antagonists & inhibitors
Interleukin-5 - biosynthesis
Interleukin-5 - immunology
Interleukin-5 - metabolism
Male
Medical sciences
Middle Aged
Nasal Mucosa - immunology
Nasal Mucosa - metabolism
nasal polyps
Nasal Polyps - immunology
Nasal Polyps - metabolism
Nasal Polyps - therapy
Otolaryngology
Surgery
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Summary:Chronic rhinosinusitis with nasal polyps is characterized by an eosinophilic inflammation and high IL-5 levels. Antagonizing the effect of IL-5 is a potential new treatment strategy in patients with nasal polyps. In a double-blind, placebo-controlled, randomized, 2-center safety and pharmacokinetic study, 24 subjects with bilateral nasal polyps were randomized to receive a single intravenous infusion of reslizumab, a humanized anti-human IL-5 mAb, at 3 mg/kg or 1 mg/kg or placebo. We evaluated the safety and pharmacokinetics of reslizumab, and biologic activity was assessed by means of endoscopic evaluation of polyp size, symptoms, peripheral eosinophil counts, peripheral and local IL-5 levels, eotaxin levels, and eosinophil cationic protein levels. We demonstrated that a single injection of reslizumab up to 3 mg/kg is safe and well tolerated. Blood eosinophil numbers and concentrations of eosinophil cationic protein were reduced up to 8 weeks after treatment in serum and nasal secretions. Individual nasal polyp scores improved only in half of the treated patients for 4 weeks. Responders had increased IL-5 concentrations in nasal secretions at baseline compared with nonresponders, and logistic regression analysis revealed that increased nasal IL-5 levels (>40 pg/mL) predict the response to anti-IL-5 treatment. A single injection of anti–IL-5 reduces the size of nasal polyps for 4 weeks in half of the patients, and nasal IL-5 levels predict the response to anti–IL-5 treatment. Intravenous administration of a humanized anti-human IL-5 mAb is safe and reduces the size of nasal polyps in half of the patients.
ISSN:0091-6749
1097-6825
1365-2567
DOI:10.1016/j.jaci.2006.05.031