Rhinitis, sinusitis, and upper airway diseaseMepolizumab, a humanized anti–IL-5 mAb, as a treatment option for severe nasal polyposis
Section snippets
Patients
Thirty subjects with chronic rhinosinusitis with primary NPs (grade 3 or 4, see outcome measures) or NPs that are recurrent after surgery (grade 1-4) were included. The inclusion criteria specified that subjects must have had failure of standard care for CRSwNP, and the diagnosis of this condition was based on the European position paper on rhinosinusitis and NPs.1 Use of systemic corticosteroids and surgical intervention was not allowed from 1 month before treatment until the end of the study,
Patients
The baseline characteristics of the study patients are summarized in Table I. The history and symptoms of the mepolizumab and placebo groups were compared. Age and sex were similar. Almost half of the patients were atopic (based on skin prick test responses), and 43% had asthma. The number of patients who had undergone sinus surgery in the past was high. At baseline, our patient population consisted of 3 patients with grade 1, 6 patients with grade 2, 16 patients with grade 3, and 5 patients
Discussion
In this double-blind, randomized, placebo-controlled study we evaluated the effect of 2 intravenous injections of 750 mg of mepolizumab in patients with severe CRSwNP. This treatment produced a significant reduction in TPSs in 12 of 20 patients. These effects were confirmed by changes in CT scan evaluations. Together, the observations support a role for anti–IL-5 in a subgroup of patients with CRSwNP and confirm previous results achieved with a single injection of a different anti–IL-5
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This study (protocol number CRT110178) was supported by GlaxoSmithKline, who also provided mepolizumab. P.G. and T.V.Z. are postdoctoral researchers granted by Research Foundation Flanders (FWO-Vlaanderen). T.C. is a postdoctoral researcher of the Fonds de la Recherche Scientifique (FNRS). T.C. and K.V.S. acknowledge research opportunities offered by the Belgian Network BioMAGNet (Bioinformatics and Modelling: from Genomes to Networks) funded by the Interuniversity Attraction Poles Programme (Phase VI/4) and initiated by the Belgian State, Science Policy Office. Their work was also supported in part by the IST Programme of the European Community under the PASCAL2 Network of Excellence (Pattern Analysis, Statistical Modelling and Computational Learning), IST-2007-216886.
Disclosure of potential conflict of interest: P. Gevaert and C. Bachert have received research support from GlaxoSmithKline. A. R. Sousa and R. P. Marshall are employees of GlaxoSmithKline. The rest of the authors declare that they have no relevant conflicts of interest.
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These authors contributed equally to this work.