Browse ATS 2021 Abstracts

HomeProgram ▶ Browse ATS 2021 Abstracts

ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.

Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.

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Dupilumab Efficacy and Safety in Children with Uncontrolled, Moderate-to-Severe Asthma: The Phase 3 VOYAGE Study

Session Title
A1204 - Dupilumab Efficacy and Safety in Children with Uncontrolled, Moderate-to-Severe Asthma: The Phase 3 VOYAGE Study
Author Block: L. B. Bacharier1, J. F. Maspero2, C. H. Katelaris3, A. G. Fiocchi4, R. Gagnon5, I. de Mir6, N. Jain7, L. D. Sher8, X. Mao9, D. Liu10, Y. Zhang11, A. H. Khan12, U. Kapoor9, F. A. Khokhar11, P. Rowe9, Y. Deniz11, M. Ruddy11, E. Laws9, N. Amin11, L. P. Mannent12, D. J. Lederer11, M. Hardin13; 1Pediatrics, Monroe Carell Jr Children’s Hospital at Vanderbilt, Nashville, TN, United States, 2Fundación CIDEA, Buenos Aires, Argentina, 3Campbelltown Hospital, Campbelltown, Australia, 4Ospedale Bambino Gesù, Rome, Italy, 5Clinique Spécialisée en Allergie de la Capitale, Quebec, QC, Canada, 6Hospital Vall d'Hebron, Barcelona, Spain, 7Arizona Allergy and Immunology Research, Gilbert, AZ, United States, 8Peninsula Research Associates, Rolling Hills Estates, CA, United States, 9Sanofi, Bridgewater, NJ, United States, 10Sanofi, Beijing, China, 11Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 12Sanofi, Chilly-Mazarin, France, 13Sanofi, Cambridge, MA, United States.
Rationale: Asthma is the most common chronic respiratory condition in children. Despite optimized standard-of-care therapy, children with moderate-to-severe asthma may continue to have uncontrolled disease. Type 2 inflammation, defined by blood eosinophils or fractional exhaled nitric oxide (FeNO) levels, underlies most cases of asthma in children. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/interleukin-13, key and central drivers of type 2 inflammation in multiple diseases. VOYAGE, a 52-week randomized, double-blind, placebo-controlled phase 3 study (NCT02948959), evaluated the efficacy and safety of dupilumab in children aged 6 to <12 years with uncontrolled, moderate-to-severe asthma. Methods: Patients receiving high-dose inhaled corticosteroids (ICS) alone or medium-to-high-dose ICS with a second controller were randomized to add-on subcutaneous dupilumab 100mg or 200mg every 2 weeks (body weight ≤30kg or >30kg, respectively) or matched placebo in a 2:1 fashion. The primary analysis populations were patients with type 2 inflammatory phenotype (baseline blood eosinophils ≥150cells/µL or FeNO ≥20ppb) and patients with baseline blood eosinophils ≥300cells/ µL. Annualized rate of severe asthma exacerbations (primary endpoint), change from baseline in pre-bronchodilator FEV1 percent predicted (FEV1pp) and FeNO level at Week 12, and change in Asthma Control Questionnaire-Interviewer Administered (ACQ-7-IA) at Week 24 were assessed. Safety was reported according to incidence of treatment-emergent adverse events (TEAEs) in the safety population. Results: Of 408 patients randomized, 350 had a type 2 inflammatory asthma phenotype; 259 had blood eosinophils ≥300cells/µL at baseline. In patients with a type 2 phenotype, dupilumab reduced the exacerbation rate by 59.3% (P<0.0001), and improved FEV1pp (least squares [LS] mean difference vs placebo 5.21%; P=0.0009) and reduced FeNO levels (LS mean difference vs placebo −17.84ppb; P<0.0001) at Week 12 compared with placebo. At Week 24, dupilumab showed greater improvement in ACQ-7-IA scores from baseline vs placebo (LS mean difference vs placebo −0.33, P=0.0001). Similar findings were observed in patients with eosinophils ≥300cells/µL (Table). In the safety population, overall rates of TEAEs in dupilumab vs placebo groups were 83% vs 80%. 13/271 (4.8%) dupilumab-treated patients and 6/134 (4.5%) placebo-treated patients reported serious TEAEs; 5/271 (1.8%) dupilumab-treated and 2/134 (1.5%) placebo-treated patients reported AEs leading to permanent study discontinuation. Median blood eosinophil values decreased to below the baseline value by Week 52 in the dupilumab group. Conclusions: Dupilumab demonstrated efficacy and an acceptable safety profile in patients aged 6 to <12 years with uncontrolled, moderate-to-severe asthma with a type 2 inflammatory phenotype.