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Quality of Life
QUALITY OF LIFE CHANGES THAT FREE CHILDREN AND CAREGIVERS TO LIVE BEYOND EoE
DUPIXENT significantly improved quality of life of children (PEIS-P) and caregivers (PEIS-C) at Week 16 vs placebo, with continuous improvement at Week 521,2
Children2,a
up to
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up to
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Caregivers2,b
up to
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up to
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QoL CONTINUALLY IMPROVED WITH DUPIXENT THROUGH WEEK 1002,g,h |
QUALITY OF LIFE CHANGES THAT FREE CHILDREN AND CAREGIVERS TO LIVE BEYOND EoE
DUPIXENT significantly improved quality of life of children (PEIS-P) and caregivers (PEIS-C) at Week 16 vs placebo, with continuous improvement at Week 521,2
Children2,a
up to
|
up to
|
Caregivers2,b
up to
|
up to
|
|
QoL CONTINUALLY IMPROVED WITH DUPIXENT THROUGH WEEK 1002,g,h |
aThe Patient Pediatric EoE Impact Scale (PEIS-P) is a patient-reported outcome measure completed independently by pediatric patients with EoE aged 8 to ‹12 years. The PEIS-P assesses the impact of EoE on patients' quality of life during a given week (scored 0-4; higher scores indicate greater burden on QoL).
bThe Caregiver Pediatric EoE Impact Scale (PEIS-C) is an observer-reported outcome measure completed independently by caregivers of pediatric patients with EoE aged 1 to ‹12 years. The PEIS-C assesses the impact of the pediatric patient's EoE on caregiver anxiety, social and professional activities, activities of daily living, and relationships during a given week (scored 0-4; higher scores indicate greater burden on QoL).
cMean percent change in PEIS-P from baseline at Week 16 with DUPIXENT (n=17): -35.8% vs placebo (n=17): -13.4%. d Mean percent change in PEIS-P from baseline at Week 52 with DUPIXENT (n=9): -42.5%. e dMean percent change in PEIS-C from baseline at Week 16 with DUPIXENT (n=37): -54.0% vs placebo (n=34): -7.5%.
eMean percent change in PEIS-C from baseline at Week 52 with DUPIXENT (n=32): -60.9%.
fMean percent change in PEIS-P from baseline at Week 100 with DUPIXENT (n=7): -83.2%. h Mean percent change in PEIS-C from baseline at Week 100 with DUPIXENT (n=24): -80.7%.
EoE, eosinophilic esophagitis; QoL, quality of life.
References:
- 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(24):2239-2251(suppl). doi:10.1056/NEJMoa2312282
- 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 Meeting; November 5-8, 2025; Chicago, IL.
DEMONSTRATED SAFETY IN ADULTS AND ADOLESCENTS THAT PATIENTS CAN TRUST
DUPIXENT is a fully human monoclonal antibody with a safety profile comparable to placebol1,2
INCIDENCE OF ADVERSE EVENTS DURING THE TREATMENT PERIOD2,a
|
PART A |
PART A/C | |||
| DUPIXENT QW
(n=42) | Placebo
(n=39) | DUPIXENT QW
(n=40) | Switched to
DUPIXENT QW (n=37) | |
| Adverse event | 86% | 82% | 60% | 73% |
| Serious adverse eventb | 5% | 0% | 0% | 3% |
| Adverse event leading to discontinuationb | 2% | 0% | 0% | 5% |
| Adverse events occurring in ≥10% of patients in any groupc | ||||
| Injection-site reaction | 17% | 10% | 10% | 22% |
| Injection-site erythema | 7% | 13% | 10% | 14% |
| Injection-site pain | 10% | 8% | 5% | 8% |
| Injection-site swelling | 7% | 3% | 5% | 0% |
| Nasopharyngitis | 12% | 10% | 2% | 8% |
| Headache | 5% | 10% | 8% | 5% |
| Acne | 0% | 3% | 0% | 11% |
| Rash | 0% | 10% | 2% | 0% |
|
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS NO REQUIRED MONITORING1 |
aThe safety analysis set included all the patients who had undergone randomization and received at least one dose or part of a dose of dupilumab or placebo; data were analyzed according to whether the patients received dupilumab or placebo, regardless of trial group assignment. The Part A/C group comprised the eligible patients from Part A who continued the trial in Part C. Switched to DUPIXENT indicates those who received placebo in Part A and dupilumab at a weekly dose of 300 mg in Part C; and DUPIXENT QW indicates those who received dupilumab at a weekly dose of 300 mg in Parts A and C.
bNone of the adverse events or serious adverse events that were assessed were considered by the trial investigators to be related to the trial regimen, with the exception of one serious adverse event of systemic inflammatory response syndrome; the patient with this event continued to be followed in the trial, and the event did not recur.
cAdverse events in this category were reported according to the preferred terms in the Medical Dictionary for Regulatory Activities, version 23.0. QW, once weekly.
References:
- DUPIXENT Summary of Product Characteristics, 2026.
- Dellon ES, Rothenberg ME, Collins MH, et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med. 2022;387(25):2317-2330. doi: 10.1056/NEJMoa2205982
DEMONSTRATED SAFETY IN ADULTS AND ADOLESCENTS THAT PATIENTS CAN TRUST
DUPIXENT is a fully human monoclonal antibody with a safety profile comparable to placebo1
INCIDENCE OF ADVERSE EVENTS DURING THE TREATMENT PERIOD1,a
|
PART A |
PART A/C | |||
| DUPIXENT QW
(n=80) | Placebo
(n=78) | DUPIXENT QW
(n=74) | Switched to
DUPIXENT QW (n=62) | |
| TEAEs | 84% | 71% | 69% | 62% |
| Treatment-emergent SAEsb | 6% | 1% | 4% | 5% |
| TEAEs leading to discontinuation | 3% | 3% | 0% | 0% |
| Adverse events occurring in ≥10% of patients in any groupc | ||||
| Injection-site reactiond | 20% | 21% | 14% | 11% |
| COVID-19 | 5% | 0% | 9% | 11% |
| Nasopharyngitis | 3% | 4% | 4% | 11% |
| Injection-site reactiond | 10% | 12% | 8% | 11% |
| Injection-site swelling | 13% | 3% | 3% | 3% |
|
IN A META-ANALYSIS OF 5 REAL-WORLD STUDIES, NO SEVERE ADVERSE EVENTS WERE ASSOCIATED WITH DUPIXENT. THE MOST COMMON ADVERSE EVENT WAS INJECTION-SITE REACTION.2,e |
aThe safety population included all randomized patients who received at least one dose or part of a dose, and data were analyzed according to the intervention received.
bTreatment-emergent serious adverse events were reported by 3 patients in the DUPIXENT QW/DUPIXENT QW group (preferred terms: diarrhea and rectal tenesmus [two serious adverse events in the same patient], enterocolitis infectious, and chest pain) and two patients in the placebo/DUPIXENT QW group (preferred terms: vomiting and cellulitis). None of the serious adverse events were assessed by the investigator to be related to DUPIXENT.
cAdverse events in this category were reported according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms in the MedDRA, version 24.0 (part B) or version 25.0 (part B-C), unless otherwise indicated.
dNone of the injection-site reactions were severe in intensity, led to permanent discontinuation of DUPIXENT, or met the criteria for a serious adverse event.
eAll 5 studies included were retrospective, involving 209 subjects.
QW, once weekly; SAEs, serious adverse events; TEA, treatment-emergent adverse event.
References:
- Rothenberg ME, Dellon ES, Collins MH, et al. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023;8(11):990-1004. doi:10.1016/S2468-1253(23)00204-2
- Garg A, Mond V, Velpari S, Broder A, Mohan BP. Real-world effectiveness of dupilumab in eosinophilic esophagitis: a systematic review and meta-analysis. J Clin Gastroenterol. 2025;59(6):483-490. doi:10.1097/MCG.0000000000002146
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS DEMONSTRATED SAFETY IN CHILDREN1
During the 16-week double-blind treatment period, safety results were generally consistent with the known safety profile of DUPIXENT, and continued through Week 52 and Week 1002,3
|
Event |
PART A |
PART B
|
PART C
| ||
| DUPIXENT
(n=37) | Placebo
(n=34) | DUPIXENT/DUPIXENT
(n=37) | Placebo/Dupixent
(n=18) | DUPIXENT (n=61)
| |
| Any AE | 73% | 91% | 92% | 83% | 87% |
| Any SAE | 5% | 0% | 5% | 0% | 5% |
| Incidence of adverse events reported by ≥10% of patients, in any groupny group | |||||
| COVID-19° | 14% | 0% | 30% | 28% | - |
| Injection-site reaction | 11% | 21% | 14% | 28% | - |
| Pyrexia | 5% | 3% | 16% | 11% | 16% |
| Upper respiratory tract infection | 0% | 9% | 5% | 6% | 13% |
| Cough | 13% | 3% | 3% | 3% | 3% |
| Vomiting | 8% | 18% | 14% | 11% | 18% |
| Streptococcal pharyngitis | - | - | - | - | 21% |
|
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS NO REQUIRED LAB MONITORING1 |
aThe safety data reported are from Part C of the full analysis set, including all patients who received placebo or DUPIXENT at high or low doses.
bAll cases of COVID-19 were mild or moderate, resolved by the end of the trial period, and did not result in discontinuation of treatment with DUPIXENT.
AE, adverse event; SAE, serious adverse event.
References:
- DUPIXENT Summary of Product Characteristics, 2026.
- 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(24):2239-2251. doi:10.1056/NEJMoa2312282
- 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 Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2025; May 14-17, 2025; Helsinki, Finland.
DEMONSTRATED SAFETY IN ADULTS AND ADOLESCENTS THAT PATIENTS CAN TRUST
DUPIXENT is a fully human monoclonal antibody with a safety profile comparable to placebol1,2
INCIDENCE OF ADVERSE EVENTS DURING THE TREATMENT PERIOD2,a
|
PART A |
PART A/C | |||
| DUPIXENT QW
(n=42) | Placebo
(n=39) | DUPIXENT QW
(n=40) | Switched to
DUPIXENT QW (n=37) | |
| Adverse event | 86% | 82% | 60% | 73% |
| Serious adverse eventb | 5% | 0% | 0% | 3% |
| Adverse event leading to discontinuationb | 2% | 0% | 0% | 5% |
| Adverse events occurring in ≥10% of patients in any groupc | ||||
| Injection-site reaction | 17% | 10% | 10% | 22% |
| Injection-site erythema | 7% | 13% | 10% | 14% |
| Injection-site pain | 10% | 8% | 5% | 8% |
| Injection-site swelling | 7% | 3% | 5% | 0% |
| Nasopharyngitis | 12% | 10% | 2% | 8% |
| Headache | 5% | 10% | 8% | 5% |
| Acne | 0% | 3% | 0% | 11% |
| Rash | 0% | 10% | 2% | 0% |
|
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS NO REQUIRED MONITORING1 |
aThe safety analysis set included all the patients who had undergone randomization and received at least one dose or part of a dose of dupilumab or placebo; data were analyzed according to whether the patients received dupilumab or placebo, regardless of trial group assignment. The Part A/C group comprised the eligible patients from Part A who continued the trial in Part C. Switched to DUPIXENT indicates those who received placebo in Part A and dupilumab at a weekly dose of 300 mg in Part C; and DUPIXENT QW indicates those who received dupilumab at a weekly dose of 300 mg in Parts A and C.
bNone of the adverse events or serious adverse events that were assessed were considered by the trial investigators to be related to the trial regimen, with the exception of one serious adverse event of systemic inflammatory response syndrome; the patient with this event continued to be followed in the trial, and the event did not recur.
cAdverse events in this category were reported according to the preferred terms in the Medical Dictionary for Regulatory Activities, version 23.0. QW, once weekly.
References:
- DUPIXENT Summary of Product Characteristics, 2026.
- Dellon ES, Rothenberg ME, Collins MH, et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med. 2022;387(25):2317-2330. doi: 10.1056/NEJMoa2205982
DEMONSTRATED SAFETY IN ADULTS AND ADOLESCENTS THAT PATIENTS CAN TRUST
DUPIXENT is a fully human monoclonal antibody with a safety profile comparable to placebo1
INCIDENCE OF ADVERSE EVENTS DURING THE TREATMENT PERIOD1,a
|
PART A |
PART A/C | |||
| DUPIXENT QW
(n=80) | Placebo
(n=78) | DUPIXENT QW
(n=74) | Switched to
DUPIXENT QW (n=62) | |
| TEAEs | 84% | 71% | 69% | 62% |
| Treatment-emergent SAEsb | 6% | 1% | 4% | 5% |
| TEAEs leading to discontinuation | 3% | 3% | 0% | 0% |
| Adverse events occurring in ≥10% of patients in any groupc | ||||
| Injection-site reactiond | 20% | 21% | 14% | 11% |
| COVID-19 | 5% | 0% | 9% | 11% |
| Nasopharyngitis | 3% | 4% | 4% | 11% |
| Injection-site reactiond | 10% | 12% | 8% | 11% |
| Injection-site swelling | 13% | 3% | 3% | 3% |
|
IN A META-ANALYSIS OF 5 REAL-WORLD STUDIES, NO SEVERE ADVERSE EVENTS WERE ASSOCIATED WITH DUPIXENT. THE MOST COMMON ADVERSE EVENT WAS INJECTION-SITE REACTION.2,e |
aThe safety population included all randomized patients who received at least one dose or part of a dose, and data were analyzed according to the intervention received.
bTreatment-emergent serious adverse events were reported by 3 patients in the DUPIXENT QW/DUPIXENT QW group (preferred terms: diarrhea and rectal tenesmus [two serious adverse events in the same patient], enterocolitis infectious, and chest pain) and two patients in the placebo/DUPIXENT QW group (preferred terms: vomiting and cellulitis). None of the serious adverse events were assessed by the investigator to be related to DUPIXENT.
cAdverse events in this category were reported according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms in the MedDRA, version 24.0 (part B) or version 25.0 (part B-C), unless otherwise indicated.
dNone of the injection-site reactions were severe in intensity, led to permanent discontinuation of DUPIXENT, or met the criteria for a serious adverse event.
eAll 5 studies included were retrospective, involving 209 subjects.
QW, once weekly; SAEs, serious adverse events; TEA, treatment-emergent adverse event.
References:
- Rothenberg ME, Dellon ES, Collins MH, et al. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023;8(11):990-1004. doi:10.1016/S2468-1253(23)00204-2
- Garg A, Mond V, Velpari S, Broder A, Mohan BP. Real-world effectiveness of dupilumab in eosinophilic esophagitis: a systematic review and meta-analysis. J Clin Gastroenterol. 2025;59(6):483-490. doi:10.1097/MCG.0000000000002146
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS DEMONSTRATED SAFETY IN CHILDREN1
During the 16-week double-blind treatment period, safety results were generally consistent with the known safety profile of DUPIXENT, and continued through Week 52 and Week 1002,3
|
Event |
PART A |
PART B
|
PART C
| ||
| DUPIXENT
(n=37) | Placebo
(n=34) | DUPIXENT/DUPIXENT
(n=37) | Placebo/Dupixent
(n=18) | DUPIXENT (n=61)
| |
| Any AE | 73% | 91% | 92% | 83% | 87% |
| Any SAE | 5% | 0% | 5% | 0% | 5% |
| Incidence of adverse events reported by ≥10% of patients, in any groupny group | |||||
| COVID-19° | 14% | 0% | 30% | 28% | - |
| Injection-site reaction | 11% | 21% | 14% | 28% | - |
| Pyrexia | 5% | 3% | 16% | 11% | 16% |
| Upper respiratory tract infection | 0% | 9% | 5% | 6% | 13% |
| Cough | 13% | 3% | 3% | 3% | 3% |
| Vomiting | 8% | 18% | 14% | 11% | 18% |
| Streptococcal pharyngitis | - | - | - | - | 21% |
|
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND HAS NO REQUIRED LAB MONITORING1 |
aThe safety data reported are from Part C of the full analysis set, including all patients who received placebo or DUPIXENT at high or low doses.
bAll cases of COVID-19 were mild or moderate, resolved by the end of the trial period, and did not result in discontinuation of treatment with DUPIXENT.
AE, adverse event; SAE, serious adverse event.
References:
- DUPIXENT Summary of Product Characteristics, 2026.
- 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(24):2239-2251. doi:10.1056/NEJMoa2312282
- 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 Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) 2025; May 14-17, 2025; Helsinki, Finland.