Impact of Exacerbation History on Dupilumab Efficacy in Children with Uncontrolled Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE Study
Why this work is in the frame
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Bibliographic record
Abstract
Theresa W Guilbert,1 Alberto Tolcachier,2 Alessandro G Fiocchi,3 Constance H Katelaris,4,5 Wanda Phipatanakul,6,7 Philippe Begin,8 Inés de Mir,9 Arman Altincatal,10 Rebecca Gall,11 Olivier Ledanois,12 Amr Radwan,11 Juby A Jacob-Nara,13 Yamo Deniz,11 Paul J Rowe13 1Department of Pediatrics, Cincinnati Children’s Hospital and University of Cincinnati, Cincinnati, OH, USA; 2Center for Allergy and Respiratory Diseases, Buenos Aires, Argentina; 3Bambino Gesù Children’s Hospital IRCCS, Rome, Italy; 4Department of Medicine, Campbelltown Hospital, Campbelltown, NSW, Australia; 5Immunology & Allergy Unit, Western Sydney University, Sydney, NSW, Australia; 6Department of Allergy and Immunology, Boston Children’s Hospital, Boston, MA, USA; 7Department of Pediatrics, Harvard Medical School, Boston, MA, USA; 8Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal, QC, Canada; 9Pediatric Pulmonary Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain; 10Sanofi, Cambridge, MA, USA; 11Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 12Sanofi, Paris, France; 13Sanofi, Bridgewater, NJ, USACorrespondence: Theresa W Guilbert, Cincinnati Children’s Hospital and University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, 45229, USA, Tel +1 513-636-6771, Email theresa.guilbert@cchmc.orgPurpose: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4/-13, key and central drivers of type 2 inflammation in multiple diseases. This post hoc analysis of the Phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959) evaluated the efficacy of dupilumab in children aged 6 to 11 years with moderate-to-severe asthma with a type 2 inflammatory phenotype (blood eosinophil count ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) and a history of 1, 2, or ≥ 3 prior exacerbations. The impact of baseline type 2 biomarker levels on the efficacy of dupilumab in this population was also investigated.Patients and Methods: Patients were stratified by the number of exacerbations in the prior year (1, 2, or ≥ 3) and level of FeNO or blood eosinophil count at baseline. Endpoints included rate of severe exacerbations, percentage of non-exacerbators, and change from baseline in both lung function parameters (pre- and post-bronchodilator [BD] percent predicted forced expiratory volume in 1 s (ppFEV1) and ppFEV1/forced vital capacity [FVC] ratio) and Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) score.Results: A total of 350 patients were included in this analysis. Across patients with 1, 2, or ≥ 3 prior exacerbations and different levels of type 2 biomarkers, dupilumab reduced the risk of severe asthma exacerbations vs placebo by 53.0– 96.0% and improved both pre-BD ppFEV1 and pre-BD FEV1/FVC ratio at Week 52. Dupilumab led to significant reductions in ACQ-7-IA scores in all groups of patients by Week 52.Conclusion: In children with uncontrolled, moderate-to-severe asthma with a type 2 phenotype, dupilumab consistently reduced the risk of asthma exacerbations, improved lung function, and reduced ACQ-7-IA scores, regardless of exacerbation history. Keywords: pediatric asthma, type 2 asthma, lung function, asthma control, biologics, anti-interleukin-4 and -13
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it