Treatment with dupilumab for up to 100 weeks reduces the frequency and severity of symptoms in children with eosinophilic esophagitis (EoE), as measured by the validated Pediatric Eosinophilic Esophagitis Symptom Score version 2.0 (PEESSv2.0), as shown by results of the open-label extension of the phase 3 EoE KIDS study.
“Reductions in gastroesophageal reflux disease (GERD), dysphagia, pain, and nausea/vomiting domain scores were also maintained or, in some cases, further improved,” said Dr Salvatore Oliva, University Hospital Umberto, Sapienza University of Rome, Rome, Italy.
Oliva and his team performed this post hoc analysis to examine the effects of long-term dupilumab treatment on PEESSv2.0 scores during the Part C open-label extension of EoE KIDS.
In EoE KIDS, patients who completed week 52 in Part B were eligible for Part C. Here, they received the open-label, weight-tiered dupilumab regimen that was later approved by the FDA (similar to the higher-exposure regimen in Parts A and B).
Oliva and colleagues then assessed the changes from Part A baseline in the PEESSv2.0 total, frequency, severity, and domain scores at week 52 (Part C baseline), 76, and 100 in patients treated with placebo or dupilumab higher exposure during Parts A and B.
Symptom improvements
From baseline, the mean change in PEESSv2.0 total score at week 52 was ‒23.8 (95 percent confidence interval [CI], ‒32.1 to ‒15.6). This score further decreased to ‒31.5 (95 percent CI, ‒41.5 to ‒21.4) at week 100. [ESPGHAN 2026, abstract OP145]
Likewise, the mean changes from baseline in PEESSv2.0 frequency and severity scores further dropped from week 52 (frequency: ‒25.1, 95 percent CI, ‒34.2 to ‒16.1; severity: ‒22.2, 95 percent CI, ‒30.3 to ‒14.1) to week 100 (frequency: ‒33.8, 95 percent CI, ‒44.9 to ‒22.7; severity: ‒28.6, 95 percent CI, ‒38.3 to ‒19.0).
These reductions persisted for the individual primary domain scores, namely GERD (‒25.27, 95 percent CI, ‒37.29 to ‒13.25), dysphagia (‒38.18, 95 percent CI, ‒50.40 to ‒25.96), pain (‒31.52, 95 percent CI, ‒43.68 to ‒19.37), and nausea/vomiting (‒24.18, 95 percent CI, ‒33.45 to ‒14.92).
“We can say that children with EoE treated with dupilumab in the EoE KIDS study up to 100 weeks experienced sustained, and in some cases, additional improvements in frequency and severity of symptom as measured by the PEESSv2.0,” Oliva said.
Study limitations
This post hoc analysis was limited by the inclusion of only patients in the open-label phase. The study was also not designed to look in detail the differences between the frequency and the severity and the domain of the PEESSv2.0 score.
“EoE is a chronic, often progressive, type 2 inflammatory disease of the esophagus,” Oliva said. [Gastroenterology 2018;154:346-359; Gastroenterology 2018;154:319-332]
“Children with EoE may experience symptoms such as food refusal, feeding difficulties, dysphagia, abdominal and/or chest pain, GERD, nausea, and vomiting,” he added. [Allergy 2012;67:477-490; Ital J Pediatr 2021;47:230]
A fully human monoclonal antibody, dupilumab works by blocking interleukin (IL)-4 and IL-13. It is approved in the US and EU for patients with EoE aged ≥1 year and weighing ≥15 kg. [https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf]