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Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma With Self-reported Chronic Rhinosinusitis

The Journal of Allergy and Clinical Immunology: In Practice, ISSN: 2213-2198, Vol: 8, Issue: 2, Page: 527-539.e9
2019
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1Department of Otolaryngology-Head and Neck Surgery, the Third Xiangya Hospital, Central South University, Changsha, Hunan, People’s Republic of China; 2Department of Pathology, the Third Xiangya

Article Description

Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13 signaling, key drivers of type 2 inflammation. In the phase 3 study (NCT02414854), add-on dupilumab 200mg/300mg every 2 weeks, versus placebo, significantly reduced severe asthma exacerbations and improved pre-bronchodilator forced expiratory volume in 1 second (FEV 1 ) and quality-of-life measures in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in those with a high baseline type 2 phenotype. To assess the efficacy and safety of dupilumab in uncontrolled, moderate-to-severe asthma patients with or without self-reported comorbid chronic rhinosinusitis (CRS or non-CRS). Comorbid CRS was self-reported by patients using an e-diary. Annualized severe exacerbation rates, changes from baseline in pre- and post-bronchodilator FEV 1, patient-reported outcomes, type 2 biomarkers, and safety were assessed. CRS was self-reported by 382/1902 (20.1%) patients. Dupilumab 200mg/300mg reduced annualized severe exacerbation rates by 63%/61%, respectively, in patients with CRS, and by 42%/40% in patients without CRS (all P <.001 vs placebo). Dupilumab also improved lung function and patient-reported asthma control and quality of life, and suppressed type 2 biomarkers versus placebo in both subgroups. Clinical responses were rapid, with near-maximal responses observed at the earliest measured timepoints and sustained at week 52. Improvements observed in the CRS subgroup were similar to or numerically greater than those in the non-CRS subgroup. Dupilumab showed efficacy and was generally well tolerated in patients with uncontrolled, moderate-to-severe asthma with or without CRS.

Bibliographic Details

Maspero, Jorge F; Katelaris, Constance H; Busse, William W; Castro, Mario; Corren, Jonathan; Chipps, Bradley E; Peters, Anju T; Pavord, Ian D; Ford, Linda B; Sher, Lawrence; Rabe, Klaus F; Rice, Megan S; Rowe, Paul; Lu, Yufang; Harel, Sivan; Jagerschmidt, Alexandre; Khan, Asif H; Kamat, Siddhesh; Pirozzi, Gianluca; Amin, Nikhil; Ruddy, Marcella; Graham, Neil M H; Mannent, Leda P; Teper, Ariel

Elsevier BV

Medicine

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