Rhinitis, sinusitis, and upper airway diseaseOmalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma
Section snippets
Subjects
Twenty-four subjects 18 years or older with CRSwNP (according to the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines4) and comorbid asthma (based on Global Initiative for Asthma guidelines20 and diagnosed by a respiratory physician) for more than 2 years were included. Total serum IgE levels were between 30 and 700 kU/mL. All patients received an allergy skin prick test; however, both allergic (n = 13) and nonallergic (n = 11) patients were allowed in this study. More
Patient enrollment and baseline characteristics
Twenty-four patients were randomly assigned to a study group (Fig 1). One patient withdrew just before the first injection, and therefore 23 of the 24 subjects who were screened started treatment and constituted the intention-to-treat population. The baseline characteristics are summarized in Table II. Twelve of 24 patients were given a diagnosis of aspirin hypersensitivity based on history. Fifteen patients received omalizumab, and 8 patients received placebo. After the official medication
Discussion
Both CRSwNP and asthma have a serious effect on quality of life and represent a large financial burden for society.21, 22 Previous case reports and case series suggested the beneficial effect of omalizumab in patients with CRSwNP and comorbid allergic asthma.23, 24, 25 This is the first double-blind, randomized controlled trial investigating the clinical efficacy of a new treatment option, omalizumab, in patients with CRSwNP and comorbid asthma.
Our study shows, for the first time, a significant
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Cited by (0)
This investigator-initiated study was supported by research grants from Ghent University and the Flemish Scientific Research Board. P.G. and T.V.Z. received grants as postdoctoral researchers from the Flemish Scientific Research Board. L.C. receives funds from the Belgian Research Fund (B/11005/02). This work was also supported by grants to C.B. from the Flemish Scientific Research Board, (no. A12/5-HB-KH3 and G.0436.04), the Interuniversity Attraction Poles program (IUAP)–Belgian state–Belgian Science Policy P6/35, and the Global Allergy and Asthma European Network (GA²LEN). Furthermore, this study received an unrestricted grant from Novartis, and Novartis provided the study medication.
Disclosure of potential conflict of interest: P. Gevaert, L. Calus, T. Van Zele, K. Blomme, N. De Ruyck, and C. Bachert were provided with medication by Novartis. 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.