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Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis.
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.
Affiliation
  • Maspero JF; Fundación CIDEA, Buenos Aires, Argentina. Electronic address: jorge.maspero@fundacioncidea.org.ar.
  • Katelaris CH; Campbelltown Hospital, Campbelltown, NSW, Australia; Western Sydney University, Sydney, NSW, Australia.
  • Busse WW; University of Wisconsin School of Medicine and Public Health, Madison, Wis.
  • Castro M; Washington University School of Medicine, Saint Louis, Mo.
  • Corren J; David Geffen School of Medicine at UCLA, Los Angeles, Calif.
  • Chipps BE; Capital Allergy and Respiratory Disease Center, Sacramento, Calif.
  • Peters AT; Division of Allergy-Immunology and the Sinus and Allergy Center, Feinberg School of Medicine, Northwestern University, Chicago, Ill.
  • Pavord ID; University of Oxford, Oxford, United Kingdom.
  • Ford LB; Asthma & Allergy Center, Bellevue, Neb.
  • Sher L; Peninsula Research Associates, Rolling Hills Estates, Calif.
  • Rabe KF; LungenClinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany; Christian-Albrechts-University of Kiel, Member of the German Center for Lung Research (DZL), Kiel, Germany.
  • Rice MS; Sanofi Genzyme, Cambridge, Mass.
  • Rowe P; Sanofi, Bridgewater, NJ.
  • Lu Y; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Harel S; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Jagerschmidt A; Sanofi, Chilly-Mazarin, France.
  • Khan AH; Sanofi, Chilly-Mazarin, France.
  • Kamat S; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Pirozzi G; Sanofi, Bridgewater, NJ.
  • Amin N; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Ruddy M; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Graham NMH; Regeneron Pharmaceuticals, Inc., Tarrytown, NY.
  • Mannent LP; Sanofi, Chilly-Mazarin, France.
  • Teper A; Sanofi, Bridgewater, NJ.
J Allergy Clin Immunol Pract ; 8(2): 527-539.e9, 2020 02.
Article in En | MEDLINE | ID: mdl-31351189
BACKGROUND: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4 and IL-13 signaling, key drivers of type 2 inflammation. In the phase 3 study (NCT02414854), add-on dupilumab 200 mg/300 mg every 2 weeks, versus placebo, significantly reduced severe asthma exacerbations and improved pre-bronchodilator forced expiratory volume in 1 second (FEV1) 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. OBJECTIVE: To assess the efficacy and safety of dupilumab in patients with uncontrolled, moderate-to-severe asthma with or without self-reported comorbid chronic rhinosinusitis (CRS or non-CRS). METHODS: Comorbid CRS was self-reported by patients using an e-diary. Annualized severe exacerbation rates, changes from baseline in pre- and post-bronchodilator FEV1, patient-reported outcomes, type 2 biomarkers, and safety were assessed. RESULTS: CRS was self-reported by 382 of 1902 (20.1%) patients. Dupilumab 200 mg/300 mg 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 time points and sustained at week 52. Improvements observed in the CRS subgroup were similar to or numerically greater than those in the non-CRS subgroup. CONCLUSION: Dupilumab showed efficacy and was generally well tolerated in patients with uncontrolled, moderate-to-severe asthma with or without CRS.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Quality of Life / Asthma / Sinusitis / Rhinitis / Anti-Asthmatic Agents / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials Aspects: Patient_preference Limits: Humans Language: En Journal: J Allergy Clin Immunol Pract Year: 2020 Document type: Article Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Quality of Life / Asthma / Sinusitis / Rhinitis / Anti-Asthmatic Agents / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials Aspects: Patient_preference Limits: Humans Language: En Journal: J Allergy Clin Immunol Pract Year: 2020 Document type: Article Country of publication: