Comorbidities

DUPIXENT DEMONSTRATED EFFICACY EVEN IN CHILDREN WITH TYPE 2 COMORBIDITIES

DUPIXENT led to a greater proportion of children achieving histologic remission and histologic response vs placebo at Week 16, regardless of type 2 comorbidities^1,2

PROPORTION OF CHILDREN WITH COMORBIDITIES ACHIEVING HISTOLOGIC RESPONSE (<15 EOS/HPF) AND HISTOLOGIC REMISSION (≤6 EOS/HPF) WITH DUPIXENT VS PLACEBO AT WEEK 16^1,2,a

^aAt baseline 100% of patients receiving DUPIXENT (n=32/32) and 90% of placebo patients (n=26/29) had 21 atopic comorbidity.

^bHistologic response at Week 16, in patients with history of AD, rate difference: 95.2% with DUPIXENT (n=21) vs placebo (n=22); in patients with no history of AD: 60.4% with DUPIXENT (n= 16) vs placebo (n=12).

^cHistologic response at Week 16, in patients with history of asthma, rate difference: 68.3% with DUPIXENT (n=24) vs placebo (n=15); in patients with no history of asthma: 100% with DUPIXENT (n=13) vs placebo (n=19).

^dHistologic response at Week 16, in patients with history of AR, rate difference: 78.2% with DUPIXENT (n=29) vs placebo (n=22); in patients with no history of AR: 87.5% with DUPIXENT (n=8) vs placebo (n= 12).

^eEREFS, mean difference vs placebo in patients with/without AD: -4.4 (95% Cl: -5.9 to -2.9)/-3.0 (95% Cl: -5.0 to -1.1); in patients with a history of asthma/without a history of asthma: -3.8 (95% Cl: -5.4 to -2.1)/(95%: -5.7, -1.9); in patients with a history of AR/without a history of AR: -3.2 (95% Cl: -4.7 to -1.8/-4.6 (95% Cl: -6.3 to - 2.9).

^fPESQ-C score, mean difference vs placebo in patients with/without AD: 0.06 (95% Cl: -0.10 to 0.22)/-0.37 (95% Cl: -0.61 to -0.13); in patients with a history of asthma/without a history of asthma: -0.09 (95% Cl: 0.28 to 0.11)/-0.14 (95% Cl: -0.37 to 0.08); in patients with history of AR/without a history of AR: 0.03 (95% Cl: -0.13 to -0.18)/-0.35 (95% Cl: -0.67 to - 0.03).

^gEoE-HSS grade score, mean difference vs placebo in patients with/without AD: - 0.91 (95% Cl: -1.06 to - 0.77)/-0.96 (95% Cl: -1.22 to - 0.70); in patients with a history of asthma/without a history of asthma: -0.89 (-1.07 to -0.70)/-0.92 (95% Cl: -1.13 to -0.71); in patients with a history of AR/without history of AR:-0.89 (95% Cl: -1.03 to -0.75)/-0.89 (95% Cl: -1.21 to -0.56).

^hEE-HSS stage score, mean difference vs placebo in patients with/without AD: - 0.96 (95% Cl: -1.09 to -0.82/-0.83 (95% Cl: 1.07 to - 0.60); in patients with a history of asthma/without a history of asthma: -0.86 (-1.04 to -0.68)/-0.96 (95% Cl: -1.16 to -0.76); in patients with a history of AR/without a history of AR:-0.86 (95% Cl: -1.01 to -0.72)/-0.94 (95% Cl: -1.23 to - 0.64).

AD, atopic dermatitis; AR, allergic rhinitis; AS, asthma; EoE-HSS, Eosinophilic Esophagitis-Histology Scoring System; EOS/HPF, eosinophils per high-power field; EREFS, Endoscopic Reference Score; PESQ-C, Pediatric Eosinophilic Esophagitis Sign/Symptoms Questionnaire-Caregiver.

Reference:

1. Spergel JM, Dellon ES, Xia C, et al. Dupilumab is efficacious in children (aged 1 to <12 years) with eosinophilic esophagitis regardless of prior history of comorbidities. Paper presented: Annual Meeting of the American Society of Pediatric Otolaryngology (ASPO);May 1-3, 2025; Montreal, Canada.
2. Cianferoni A, Chehade M, Gold BD, et al. Dupilumab is efficacious in children with eosinophilic esophagitis weighing ≥15 kg independent of individual atopic comorbidity history: 16-week results from the phase 3 EoE KIDS study. Poster 454 presented at the American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress (AAAAI/WAO); February 28-March 3, 2025; San Diego, CA.

Summary 1-11 Years

DUPIXENT DEMONSTRATES DISEASE CONTROL IN 4 DIFFERENT DOMAINS^1,a

DUPIXENT targets type 2 inflammation, an underlying cause of EoE, to deliver rapid and sustained improvements across key clinical disease measures^2-4

^a86% of patients who received DUPIXENT from baseline achieved histologic response (n=35) and 65% of patients who switched from placebo to DUPIXENT at Week 16 (n=7) achieved histologic response at Week 52

^bEoE grade score from baseline at Week 52 in patients who received DUPIXENT during 52 weeks: -0.97 (n=37, baseline of 1.3) and -0.89 in patients who received placebo and switched to DUPIXENT at Week 16 (n=14, baseline 1.3).

^cEoE stage score from baseline at Week 52 in patients who received DUPIXENT during 52 weeks: -0.89 (n=37, baseline of 1.3) and -0.86 in patients who received placebo and switched to DUPIXENT at Week 16 (n=14, baseline 1.3).

^dPESQ-C percent change from baseline at Week 52 in patients taking DUPIXENT (n=37): 81% and in patients who switched to DUPIXENT from placebo at Week 16: 83%.

^eAn EREFS score of ≤2 indicates endoscopic normalization.

^fAt Week 52, 30.3% of patients with DUPIXENT since baseline (n=33) achieved EREFS=0, and 12.5% of placebo patients who switched to DUPIXENT at Week 16 (n=16).

^gMean percent change in PEIS-C from baseline at Week 52 with DUPIXENT (n=37): -60.9%.

EoE-HSS, Eosinophilic Esophagitis-Histology Scoring System; EOS/HPF, eosinophils per high-power field; EREFS, Endoscopic Reference Score; PEIS-C, Pediatric EoE Impact Scale-Caregiver; PESQ-C, Pediatric Eosinophilic Esophagitis Sign/Symptoms Questionnaire-Caregiver; QoL, quality of life.

References:

1. Savarino EV, Fassan M, de Bartoli N, et al. Italian EoExpert panel recommendation for disease control, switching citeria, and follow-up in eosinophilic esophagitis from pediatric to adult age. Ther AdvGastroenterol. 2025:18:17562848251337515. doi:10.1177/17562848251337515
2. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50. doi:10.1038/nrd4624
3. van Rhijn BD, Bredenoord AJ. Management of eosinophilic esophagitis based on pathophysiological evidence. J Clin Gastroenterol. 2017;51(8):659-668. doi:10.1097/MCG.0000000000000879
4. DUPIXENT Summary of Product Characteristics, 2026.
5. Chehade M, Dellon ES, Spergel JM, et al. Dupilumab for eosinophilic esophagitis in patents 1 to 11 years of age. N Engl J Med. 2024;390(24):2239-2251(suppl). doi:10.1056/NEJMoa2312282
6. Collins MH, Rothenberg ME, Lerner D, et al. Dupilumab improves histopathologic endpoints in children with eosinophilic esophagitis: 52-week results from the phase 3 EoE KIDS trial. Poster presented at: Digestive Disease Week (DDW) 2024; May 18-21, 2024; Washington, DC.
7. Spergel JM, Chehade M, Ashok D, et al. Impact of dupilumab on caregiver reported signs of EoE, using PESQ-C over 52 weeks: results from the phase 3 EoE KIDS study. Poster presented: European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2025 Annual Meeting; May 14-17, 2025; Helsinki, Finland.
8. Schroeder S, Menard-Katcher C, Schlag C, et al. Impact of dupilumab in pediatric patients with EoE over 52 weeks: endoscopic results from the phase 3 EoE KIDS study. Paper presented at: Societa Italiana di Gastroenterologia Epatologia e Nutrizione Pediatrica, (SIGENP) 2025; September 25-27, 2025; Rome, Italy.
9. Schroeder S, Chehade M, Dellon ES, et al. Long-term dupilumab maintains improvements in esophageal fatures of eosinophilic esophagitis (EoE) as measured by endoscopic reference score in children with EoE: 100-week results from EoE KIDS. Poster P2801 presented: 2025 American College of Gastroenterology (ACG) Annual Meting; October 24-29, 2025; Phoenix, AZ.
10. Chehade M, Oliva S, Tzivinkos C, et al. Dupilumab is effective in maintaining long-term improvements in disease severity and quality of life in children with eosinophilic esophagitis: 100-week results from the open label extension of the EoE KIDS study. Poster 66 presented: The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2025 Annual Meting; November 5-8, 2025; Chicago, IL.
11. Oliva S, Gold BD, Parrish C, et al. Dupilumab maintains long-term symptomatic improvement in children with eosinophilic esophagitis, as reported by their caregivers: 100-week results from the open-label extension of the EoE KIDS study. Paper presented at: European Academy of Allergy and Clinical Immunology - Pediatric Allergy and Asthma Meting (EAACI-PAAM) 2025; October 23-26, 2025; Palma de Mallorca, Spain.
12. Chehade M, Dellon ES, Pesek RD, et al. Long-term dupilumab maintains histologic and endoscopic improvements in children with eosinophilic esophagitis (EoE): 100-week results from the open-label extension (OLE) of the EoE KIDS study. Poster presented at: European Society for Padiatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2025; May 14-17, 2025; Helsinki, Finland.

Body Weight

FOR CHILDREN STRUGGLING WITH EoE, BODY-WEIGHT-FOR-AGE PERCENTILE IMPROVED ON DUPIXENT

DUPIXENT offered children improvement in body-weight-for-age percentile at Week 16 with continued improvement through Week 52^1,2

^aThe change from baseline to Week 16 in body weight-for-age percentile was +3.09 units with DUPIXENT (from a baseline of 47.2, n=37) and +0.29 with placebo (from a baseline of 47.7, n=32); (exploratory endpoint). The change from baseline at Week 52 in body weight-for-age percentile was +5.96 units with DUPIXENT (n=35) and +5.48 for patients who switched from placebo to DUPIXENT at Week 16 (n=16).

EoE, eosinophilic esophagitis.

References:

1. Chehade M, Pesek RD, Menard-Katcher C, et al. Effect of dupilumab on weight in pediatric patients aged 1 to ‹12 years with active EoE enrolled in the Phase 3 KIDS study. Poster Sa12581 presented at Digestive Disease Week (DDW) 2024; May 18-21, 2024; Washington, DC.
2. Chehade M, Dellon ES, Spergel JM, et al. Dupilumab for eosinophilic esophagitis in patients 1 to 11 years of age. N Engl J Med. 2024:390:2239-2251(suppl). doi. 101056/NEJMoa2312282