Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma

Dupilumab, an anti–IL-4 receptor α mAb, inhibits IL-4/IL-13 signaling, key drivers of type 2/TH2 immune diseases (eg, atopic/allergic disease). In a pivotal, phase 2b study (NCT01854047), dupilumab reduced severe exacerbations, improved lung function and quality of life, and was generally well toler...

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Veröffentlicht in:Journal of allergy and clinical immunology 2018-07, Vol.142 (1), p.171-177.e1
Hauptverfasser: Weinstein, Steven F., Katial, Rohit, Jayawardena, Shyamalie, Pirozzi, Gianluca, Staudinger, Heribert, Eckert, Laurent, Joish, Vijay N., Amin, Nikhil, Maroni, Jaman, Rowe, Paul, Graham, Neil M.H., Teper, Ariel
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Sprache:eng
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Zusammenfassung:Dupilumab, an anti–IL-4 receptor α mAb, inhibits IL-4/IL-13 signaling, key drivers of type 2/TH2 immune diseases (eg, atopic/allergic disease). In a pivotal, phase 2b study (NCT01854047), dupilumab reduced severe exacerbations, improved lung function and quality of life, and was generally well tolerated in patients with uncontrolled persistent asthma despite using medium-to-high-dose inhaled corticosteroids plus long-acting β2-agonists. To examine dupilumab's effect on the 22-item Sino-Nasal Outcome Test (SNOT-22) total score and its allergic rhinitis (AR)-associated items in asthma patients with comorbid perennial allergic rhinitis (PAR). A post hoc analysis reporting data from the phase 2b study for the 200 and 300 mg every 2 week (q2w) doses under investigation in phase 3 (NCT02414854) was carried out. PAR was defined at study entry as a specific response to typical perennial antigens (IgE ≥0.35 Ku/L). Overall, 241 (61%) patients had PAR. In asthma patients with PAR, dupilumab 300 mg q2w versus placebo significantly improved SNOT-22 total score (least squares mean difference, −5.98; 95% CI, −10.45 to −1.51; P = .009) and all 4 AR-associated symptoms evaluated (nasal blockage, −0.60; 95% CI, −0.96 to −0.25; runny nose, −0.67; 95% CI, −1.04 to −0.31; sneezing, −0.55; 95% CI, −0.89 to −0.21; postnasal discharge, −0.49; 95% CI, −0.83 to −0.16; all P 
ISSN:0091-6749
1097-6825
DOI:10.1016/j.jaci.2017.11.051