Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma - 04/07/18
, Rohit Katial, MD b, Shyamalie Jayawardena, PhD c, Gianluca Pirozzi, MD c, Heribert Staudinger, MD c, Laurent Eckert, PhD d, Vijay N. Joish, PhD e, Nikhil Amin, MD f, Jaman Maroni, MD f, Paul Rowe, MD c, Neil M.H. Graham, MD f, Ariel Teper, MD cAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Asthma, allergic rhinitis, perennial allergic rhinitis, comorbidity, dupilumab, nasal symptoms
Abbreviations used : AD, AR, CRS, CRSwNP, ICS, LABA, NP, PAR, q2w, SNOT-22, TEAE
Plan
| This work was supported by Sanofi and Regeneron Pharmaceuticals, Inc. |
|
| Disclosure of potential conflict of interest: S. F. Weinstein is a board/advisory committee member of the Teva Respiratory Board and is a speaker for Teva; his institution received research support from Teva, Sanofi, GSK, Merck, BI, Novartis, and Astra-Zeneca. R. Katial is a board/advisory committee member of Teva and a board/advisory committee member of and speaker for Astra-Zeneca; is employed by GSK; and received payment for lectures from Astra-Zeneca; both the author and his institution received research support from Sanofi. S. Jayawardena, G. Pirozzi, H. Staudinger, L. Eckert, P. Rowe, and A. Teper are all employed by Sanofi, and may hold stock and/or stock options in Sanofi. N. Amin, J. Maroni, and N. M. H. Graham are employees of and shareholders in Regeneron Pharmaceuticals, Inc. V. N. Joish was an employee of and shareholder in Regeneron Pharmaceuticals, Inc, at the time the manuscript was developed. |
Vol 142 - N° 1
P. 171 - juillet 2018 Retour au numéro
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