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Clinical Trial
. 2018 Jul;142(1):171-177.e1.
doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.

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

Steven F Weinstein  1 , Rohit Katial  2 , Shyamalie Jayawardena  3 , Gianluca Pirozzi  3 , Heribert Staudinger  3 , Laurent Eckert  4 , Vijay N Joish  5 , Nikhil Amin  6 , Jaman Maroni  6 , Paul Rowe  3 , Neil M H Graham  6 , Ariel Teper  3
Affiliations
Free article
Clinical Trial

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

Steven F Weinstein et al. J Allergy Clin Immunol. 2018 Jul.
Free article

Abstract

Background: 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.

Objective: 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).

Methods: 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).

Results: 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 < .01). Dupilumab 200 mg q2w demonstrated numerical, but not statistically significant, decreases in SNOT-22 total score (-1.82; 95% CI, -6.46 to 2.83; P = .443 vs placebo) and in each AR-associated symptom. In patients without PAR, no differences were observed for these measures versus placebo.

Conclusions: Dupilumab 300 mg q2w significantly improved AR-associated nasal symptoms in patients with uncontrolled persistent asthma and comorbid PAR.

Keywords: Asthma; allergic rhinitis; comorbidity; dupilumab; nasal symptoms; perennial allergic rhinitis.

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