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• W2895519166 abstract "SESSION TITLE: Allergy/Airway Abstracts SESSION TYPE: Original Investigations PRESENTED ON: 10/09/2018 02:30 PM - 03:30 PM PURPOSE: Dupilumab, a fully human anti-IL-4R-α monoclonal antibody that inhibits signaling of both IL-4 and IL-13, which are key drivers of Type 2-mediated inflammation, is approved for treatment of adults with uncontrolled moderate-to-severe atopic dermatitis. In a phase 3 study (NCT02414854), asthma patients (pts) aged ≥12 years with no minimum baseline (BL) eosinophil requirement, uncontrolled with medium-to-high-dose inhaled corticosteroids plus 1 or 2 controllers, received dupilumab 200/300 mg or placebo (PBO) every 2 weeks for 52 weeks. Dupilumab reduced severe exacerbations, improved forced expiratory volume in 1 second (FEV1) and quality of life measures, and was generally well tolerated in the intent-to-treat population. This pre-specified analysis evaluated dupilumab efficacy and safety in adolescent pts (aged 12–17 years). METHODS: Annualized rate of severe exacerbations during the 52-week treatment period was analyzed using a negative binomial regression model, and change from BL in pre-bronchodilator FEV1 (L) and % predicted FEV1 at Week 12 using a mixed-effect model with repeated measures approach. RESULTS: Adolescents comprised 107 of 1,902 pts enrolled in the study (34 in each dupilumab regimen, 21/18 in matched PBO); 35.5% were female, mean BL FEV1 was 2.33 L, predicted FEV1 70.45%, mean severe exacerbations in the prior year 1.91. Adolescents in PBO groups experienced lower annualized rates of severe exacerbations (0.36/0.33) than adults in PBO groups (0.89/1.00). Dupilumab 200 mg reduced the annualized exacerbation rate by 46.4%, while dupilumab 300 mg did not show treatment effect vs PBO in adolescents, although the unadjusted exacerbation rate was 0.46 for dupilumab 300 mg and 0.76 for PBO. This may be due to the small sample size and an imbalance in the number of prior events (mean 1.53 vs 2.22 for dupilumab 300 mg vs PBO). Significant improvements in change from BL in FEV1 (L) at Week 12 vs PBO (P < 0.05) were seen for both 200 mg (0.36 [95% CI 0.12–0.61]) and 300 mg (0.27 [0.02–0.52]) in adolescents, a magnitude greater than that seen in adults (0.12 [0.07–0.18] for both 200 and 300 mg). The most frequent adverse event (> 10%) in adolescents in the 200 and 300 mg dupilumab-treated groups vs PBO was injection site reactions (9%/12% vs 0%/6%, respectively). CONCLUSIONS: In adolescents, dupilumab 200 mg and 300 mg demonstrated a highly significant improvement in lung function. Dupilumab 200 mg reduced exacerbations at a rate consistent with that seen in adults. The difference between unadjusted and adjusted exacerbation rates for dupilumab 300 mg may be due to the small sample size and imbalanced number of prior events in this subgroup. CLINICAL IMPLICATIONS: Dupilumab may benefit lung function and severe exacerbation rates in adolescents with uncontrolled moderate-to-severe asthma. DISCLOSURES: Employee relationship with Regeneron Pharmaceuticals Please note: >$100000 Added 03/08/2018 by Bolanle Akinlade, source=Web Response, value=Salary Employee relationship with Regeneron Pharmaceuticals Please note: >$100000 Added 03/02/2018 by Nikhil Amin, source=Web Response, value=Salary Advisory Committee Member relationship with AstraZeneca Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Advisory Committee Member relationship with Boehringer Ingelheim Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Advisory Committee Member relationship with GSK Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Advisory Committee Member relationship with Novartis Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Advisory Committee Member relationship with Pfizer Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Advisory Committee Member relationship with TEVA Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Consulting fee Consultant relationship with Amgen Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support Consultant relationship with AstraZeneca Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support Consultant relationship with GSK Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support Consultant relationship with Johnson & Johnson Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support applicant relationship with Sanofi Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support applicant relationship with GSK Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support applicant relationship with Merck Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Grant/Research Support Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Honoraria Speaker/Speaker's Bureau relationship with Boehringer Ingelheim Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Honoraria Speaker/Speaker's Bureau relationship with Merck Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Honoraria Speaker/Speaker's Bureau relationship with Novartis Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Honoraria Speaker/Speaker's Bureau relationship with Pfizer Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Honoraria Employee relationship with Vancouver Coastal Health Please note: $1-$1000 Added 03/09/2018 by Mark FitzGerald, source=Admin input, value=Educational material Employee relationship with Regeneron Pharmaceuticals Please note: >$100000 Added 03/02/2018 by Neil Graham, source=Web Response, value=Salary Employee relationship with Regeneron Pharamaceuticals Please note: $20001 - $100000 Added 03/02/2018 by Jaman Maroni, source=Web Response, value=stock options Consultant relationship with AstraZeneca Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Consulting fee Consultant relationship with Sanofi Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Consulting fee Consultant relationship with GSK Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Consulting fee Consultant relationship with Novartis Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Consulting fee Consultant relationship with Teva Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with GSK Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Menarini Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Novartis Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Genzyme Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Sanofi Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Uriach Please note: $1001 - $5000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Honoraria Research grants relationship with Novartis Please note: $5001 - $20000 Added 03/02/2018 by Jorge Maspero, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with GSK, AZ, BI, Sanofi, Teva. Please note: $1001 - $5000 Added 03/06/2018 by Ian Pavord, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with GSK, AZ, BI, Sanofi, Teva. Please note: $1001 - $5000 Added 03/06/2018 by Ian Pavord, source=Web Response, value=Honoraria Study support relationship with Chiesi Please note: >$100000 Added 03/06/2018 by Ian Pavord, source=Web Response, value=Grant/Research Employee relationship with Sanofi Please note: $1-$1000 Added 03/09/2018 by Gianluca Pirozzi, source=Admin input, value=Salary Employee relationship with Sanofi Please note: $1-$1000 Added 03/09/2018 by Paul Rowe, source=Admin input, value=Salary Employee relationship with Regeneron Pharmaceuticals, Inc. Please note: $1-$1000 Added 03/09/2018 by Marcella Ruddy, source=Admin input, value=Salary Employee relationship with Sanofi Please note: >$100000 Added 03/08/2018 by Ariel Teper, source=Web Response, value=Salary Consultant relationship with Astra Zeneca Please note: $5001 - $20000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Consulting fee Investigator relationship with gsk Please note: $20001 - $100000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Grant/Research Support inve relationship with boehringer-Ingelheim Please note: $20001 - $100000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Grant/Research Support Consultant relationship with sanofi Please note: $5001 - $20000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Consulting fee Investigator relationship with Sanofi Please note: >$100000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Grant/Research Support Investigator relationship with Astra Zeneca Please note: $20001 - $100000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Grant/Research Support Investigator relationship with Novartis Please note: $20001 - $100000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Grant/Research Support Consultant relationship with Merck Please note: $1001 - $5000 Added 03/04/2018 by Sally Wenzel, source=Web Response, value=Consulting fee Employee relationship with sanofi Please note: >$100000 Added 03/02/2018 by Bingzhi Zhang, source=Web Response, value=Salary" @default.
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• W2895519166 title "DUPILUMAB REDUCES SEVERE EXACERBATION RATE AND IMPROVES LUNG FUNCTION IN ADOLESCENT PATIENTS WITH UNCONTROLLED, MODERATE-TO-SEVERE ASTHMA: FROM THE LIBERTY ASTHMA QUEST STUDY" @default.
• W2895519166 doi "https://doi.org/10.1016/j.chest.2018.08.022" @default.
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