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OP-059 Lung function improvement by dupilumab associated with better asthma control in children
  1. Leonard B Bacharier1,
  2. Sharon Dell2,
  3. Inés de Mir3,
  4. Giorgio Piacentini4,
  5. Eckard Hamelmann5,
  6. Jérôme Msihid6,
  7. Rebecca Gall7,
  8. Olivier Ledanois8,
  9. Zhixiao Wang7,
  10. Wei-Han Cheng9,
  11. Harry Sacks7,
  12. Juby A Jacob-Nara10,
  13. Paul J Rowe10,
  14. Sena Dericioğlu11,
  15. Yamo Deniz7
  1. 1Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, TN, USA
  2. 2BC Children’s Hospital, and University of British Columbia, Vancouver, BC, Canada
  3. 3Hospital Universitari Vall d’Hebron, Barcelona, Spain
  4. 4University of Verona, Verona, Italy
  5. 5Bielefeld University, and Children’s Center Bethel, University Hospital OWL, Bielefeld, Germany
  6. 6Sanofi, Gentilly, France
  7. 7Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA
  8. 8Sanofi, Paris, France
  9. 9Sanofi, Cambridge, MA, USA
  10. 10Sanofi, Bridgewater, NJ, USA
  11. 11Sanofi, Istanbul, Turkey


Aim The relationship between lung function improvement and patient-reported outcomes is unclear. In LIBERTY ASTHMA VOYAGE (NCT02948959), dupilumab reduced exacerbations and improved lung function, control, and quality of life in children (aged 6 to 11 years) with uncontrolled, moderate-to-severe asthma, with an acceptable safety profile. This post hoc analysis evaluated association between lung function change and asthma control in children with type 2 asthma (baseline blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide [FeNO] ≥20 ppb) in each treatment group.

Material and Method 321 children were randomized 2:1 to receive add-on dupilumab 100/200 mg q2w (body-weight based) or placebo for 52 weeks. We stratified patients into low, medium, or high tertiles according to change in pre-bronchodilator percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline to Week 52. We assessed proportion and odds ratio (OR) of children achieving controlled and well-controlled asthma (Interviewer-Administered 5-item Asthma Control Questionnaire score [ACQ-5-IA]: <1.5 and ≤0.75, respectively) at Week 52 between tertile subgroups within each treatment arm using logistic regression models with age, weight, region, baseline eosinophils, FeNO, inhaled corticosteroid dose, baseline pre-bronchodilator ppFEV1, baseline ACQ-5-IA, and per-treatment tertile subgroups as covariates.

Results Dupilumab and placebo arms showed a mean reduction from baseline in pre-bronchodilator ppFEV1 at Week 52 in the low tertile and mean improvement in both medium- and high-tertile subgroups (table 1). Significantly greater proportions of children achieved well-controlled asthma in the dupilumab medium- and high-tertile vs low-tertile subgroup (table 1). In the placebo arm, the proportion of well-controlled asthma patients was significantly higher in the high- vs low-tertile subgroup only (table 1). Tertile subgroups were not significantly different in achievement of controlled asthma for dupilumab vs. placebo.

Abstract OP-059 Table 1

Achievement of controlled and well-controlled asthma by ppFEV1 change from baseline to Week 52 tertile subgroups

Conclusions In children with moderate-to-severe type 2 asthma, improvements in lung function were associated with achieving well-controlled asthma within dupilumab and placebo treatment arms.

  • dupilumab
  • asthma
  • FEV1
  • patient-reported-outcomes

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