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

Publication date: Available online 31 January 2018
Source:Journal of Allergy and Clinical Immunology
Author(s): Steven F. Weinstein, Rohit Katial, Shyamalie Jayawardena, Gianluca Pirozzi, Heribert Staudinger, Laurent Eckert, Vijay N. Joish, Nikhil Amin, Jaman Maroni, Paul Rowe, Neil M.H. Graham, Ariel Teper
BackgroundDupilumab, an anti-IL-4Rα monoclonal antibody, inhibits IL-4/IL-13 signaling, key drivers of type 2/Th2 immune diseases (e.g. 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.ObjectiveTo 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).MethodsPost-hoc analysis reporting data from the phase 2b study for the 200 and 300 mg q2w doses under investigation in phase 3 (NCT02414854). PAR was defined at study entry as a specific response to typical perennial antigens (immunoglobulin E [IgE]≥0.35 Ku/L).ResultsOverall, 241 (61%) patients had PAR. In asthma patients with PAR, dupilumab 300 mg q2w vs placebo significantly improved SNOT-22 total score (LS mean difference −5.98 [95% CI, −10.45, −1.51], P = 0.009) and all 4 AR-associated symptoms evaluated (nasal blockage: −0.60 [−0.96, −0.25]; runny nose: −0.67 [−1.04, −0.31]; sneezing: −0.55 [−0.89, −0.21]; post-nasal discharge: −0.49 [−0.83, −0.16]; all P < 0.01]. Dupilumab 200 mg q2w demonstrated numerical, but not statistically significant decreases in SNOT-22 total score (−1.82 [−6.46, 2.83], P = 0.443 vs placebo] and in each AR-associated symptom. In non-PAR patients, no differences were observed for these measures vs placebo.ConclusionDupilumab 300 mg q2w significantly improved AR-associated nasal symptoms in patients with uncontrolled persistent asthma and comorbid PAR.



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