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Peer-reviewedCC BY 4.0Frontiers in Immunology

The efficacy and safety of dupilumab therapy in pediatric patients with refractory eosinophilic duodenal bulb ulcer: a retrospective cohort study

  • Zhiheng Huang1
  • Ping Li1
  • Ying Zhou1
  • Yangyang Ma2
  • Shengnan Wang1
  • Cuifang Zheng1
  • Lin Wang1
  • Zhinong Jiang3
  • Yuhuan Wang1
  • Ying Huang1
  1. 1Department of Gastroenterology, Children’s Hospital of Fudan University, National Children’s Medical Center
  2. 2Department of Pathology, Children’s Hospital of Fudan University, National Children’s Medical Center
  3. 3Department of Pathology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Abstract

Background: Refractory eosinophilic duodenal bulb ulcer (REDU) is a rare and poorly characterized subtype of non–eosinophilic esophagitis eosinophilic gastrointestinal disease (non-EoE EGID). Standard therapies are often ineffective, and evidence for biologic treatment is limited.

Objective: This study aims to evaluate the efficacy and safety of dupilumab in pediatric patients with REDU.

Methods: This retrospective cohort study included 13 pediatric patients with histologically confirmed REDU treated with dupilumab for 12 weeks between January and December 2025, followed by a 24-week extension period. Primary outcomes were endoscopic healing and histological remission. Secondary outcomes included symptom improvement, laboratory parameters, growth indices, and quality of life (EGGE-QOL). An exploratory cross-sectional transcriptomic analysis compared pretreatment REDU biopsies with healthy-control biopsies.

Results: All patients achieved marked clinical improvement after 12 weeks of treatment. The median duodenal eosinophil count decreased significantly from 95 (IQR 72.5–100.0) to 3.5 (1.5–10.0) cells/HPF (P < 0.001), with histological remission achieved in all cases. Peripheral eosinophil counts and hemoglobin levels were improved significantly (both P < 0.05). Endoscopic mucosal healing was observed in all patients, with 11 achieving scar-stage healing. EGGE-QOL scores improved significantly (61.85 ± 16.90 vs 32.31 ± 18.85, P < 0.001). Exploratory RNA sequencing of pretreatment REDU biopsies versus healthy-control biopsies identified 837 genes meeting the nominal screening criteria, including 472 with higher and 365 with lower expression in pretreatment REDU biopsies. The top-ranked functional annotations were related to immune responses and cytokine signaling.

Conclusions: Dupilumab demonstrated promising efficacy and acceptable safety in pediatric REDU, with consistent clinical, histological, and molecular improvements. These findings support further prospective studies to validate its long-term efficacy in non-EoE EGIDs.

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Cite

BibTeXRIS
BibTeX
@article{huang2026efficacy,
  title = {{The efficacy and safety of dupilumab therapy in pediatric patients with refractory eosinophilic duodenal bulb ulcer: a retrospective cohort study}},
  author = {Zhiheng Huang and Ping Li and Ying Zhou and Yangyang Ma and Shengnan Wang and Cuifang Zheng and Lin Wang and Zhinong Jiang and Yuhuan Wang and Ying Huang},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1953390},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1953390/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - The efficacy and safety of dupilumab therapy in pediatric patients with refractory eosinophilic duodenal bulb ulcer: a retrospective cohort study
AU  - Zhiheng Huang
AU  - Ping Li
AU  - Ying Zhou
AU  - Yangyang Ma
AU  - Shengnan Wang
AU  - Cuifang Zheng
AU  - Lin Wang
AU  - Zhinong Jiang
AU  - Yuhuan Wang
AU  - Ying Huang
PY  - 2026
DA  - 2026/10/27
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1953390
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1953390/full
AB  - Background: Refractory eosinophilic duodenal bulb ulcer (REDU) is a rare and poorly characterized subtype of non–eosinophilic esophagitis eosinophilic gastrointestinal disease (non-EoE EGID). Standard therapies are often ineffective, and evidence for biologic treatment is limited.  Objective: This study aims to evaluate the efficacy and safety of dupilumab in pediatric patients with REDU.  Methods: This retrospective cohort study included 13 pediatric patients with histologically confirmed REDU treated with dupilumab for 12 weeks between January and December 2025, followed by a 24-week extension period. Primary outcomes were endoscopic healing and histological remission. Secondary outcomes included symptom improvement, laboratory parameters, growth indices, and quality of life (EGGE-QOL). An exploratory cross-sectional transcriptomic analysis compared pretreatment REDU biopsies with healthy-control biopsies.  Results: All patients achieved marked clinical improvement after 12 weeks of treatment. The median duodenal eosinophil count decreased significantly from 95 (IQR 72.5–100.0) to 3.5 (1.5–10.0) cells/HPF (P < 0.001), with histological remission achieved in all cases. Peripheral eosinophil counts and hemoglobin levels were improved significantly (both P < 0.05). Endoscopic mucosal healing was observed in all patients, with 11 achieving scar-stage healing. EGGE-QOL scores improved significantly (61.85 ± 16.90 vs 32.31 ± 18.85, P < 0.001). Exploratory RNA sequencing of pretreatment REDU biopsies versus healthy-control biopsies identified 837 genes meeting the nominal screening criteria, including 472 with higher and 365 with lower expression in pretreatment REDU biopsies. The top-ranked functional annotations were related to immune responses and cytokine signaling.  Conclusions: Dupilumab demonstrated promising efficacy and acceptable safety in pediatric REDU, with consistent clinical, histological, and molecular improvements. These findings support further prospective studies to validate its long-term efficacy in non-EoE EGIDs.
SN  - 1664-3224
ER  -