S1058 Real-World Effectiveness of Dupilumab in Patients With Eosinophilic Esophagitis

Introduction: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease defined by eosinophils within the esophageal mucosa, typically presenting with dysphagia and often progressing to fibrostenotic changes. Dupilumab, an Interleukin (IL)-4/IL-13 inhibitor, was approved for the treatment of EoE in 2022 based on a phase 3 clinical trial. Real-world data remains limited, especially outside of the clinical trial and quaternary referral centers. This study assessed dupilumab’s effectiveness in a tertiary care setting uninvolved in prior trials. Methods: We conducted a retrospective cohort study of adults (≥18 years) with confirmed EoE on biopsy (≥15 eos/hpf) who initiated dupilumab therapy between January 2022 and October 2024. Clinical outcomes were assessed at baseline and at follow-up visits after starting therapy. Measures included symptom burden (Brief Esophageal Dysphagia Questionnaire [BEDQ], Eckardt), endoscopic severity (Endoscopic Reference Score [EREFS]), histologic activity (peak eos/hpf), and adverse events (AE). The primary endpoint was histologic remission (<15 eos/hpf). Pre/post-dupilumab changes were tested for significance via the Wilcoxon signed-rank test. Results: Forty-four patients were included. From baseline to follow-up 1 (median 20.5 weeks), paired BEDQ scores decreased by a median of 4.5 (N = 10; P = 0.0076) and Eckardt scores by 1.0 (N = 10; P = 0.0160). EREFS scores declined by a median of 2.0 from baseline to follow-up 1 (N = 29; P < 0.0001), with sustained improvement at follow-up 2 (Δ = 2.0, N = 10; P = 0.0169). Peak eosinophil burden fell by 47.5 (N = 26; P < 0.0001) at follow-up 1, which was sustained at follow-up 2 (Δ = 37.0, N = 11; P = 0.0069), with no significant change between follow-up 1 and 2 (N = 11; P = 0.31). Histologic remission was achieved in 76.9% at follow-up 1 and 72.7% at follow-up 2. Fifteen point 9 percent of patients reported AEs and 9.1% discontinued therapy. Conclusion: In this cohort from a general practice setting, dupilumab was associated with durable histologic and endoscopic improvements and early symptom relief. These findings are consistent with the clinical trial and recent observational data, supporting dupilumab’s effectiveness and generalizability in real-world practice. AEs were less frequent in our study (15.9%) when compared to the clinical trial (60-86%). These findings add to growing evidence that dupilumab is effective in the real-world environment.

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Publication Details

Journal
The American Journal of Gastroenterology
Published
2025-10-01
DOI
https://doi.org/10.14309/01.ajg.0001131692.54497.3c
Primary Topic
Eosinophilic Esophagitis
Type
article
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article

S1058 Real-World Effectiveness of Dupilumab in Patients With Eosinophilic Esophagitis

Joshua A. Sloan, Carl Olson, Jameel Alp
The American Journal of Gastroenterology
Eosinophilic Esophagitis
article

S1058 Real-World Effectiveness of Dupilumab in Patients With Eosinophilic Esophagitis

Joshua A. Sloan, Carl Olson, Jameel Alp
article en

Abstract

Introduction: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease defined by eosinophils within the esophageal mucosa, typically presenting with dysphagia and often progressing to fibrostenotic changes. Dupilumab, an Interleukin (IL)-4/IL-13 inhibitor, was approved for the treatment of EoE in 2022 based on a phase 3 clinical trial. Real-world data remains limited, especially outside of the clinical trial and quaternary referral centers. This study assessed dupilumab’s effectiveness in a tertiary care setting uninvolved in prior trials. Methods: We conducted a retrospective cohort study of adults (≥18 years) with confirmed EoE on biopsy (≥15 eos/hpf) who initiated dupilumab therapy between January 2022 and October 2024. Clinical outcomes were assessed at baseline and at follow-up visits after starting therapy. Measures included symptom burden (Brief Esophageal Dysphagia Questionnaire [BEDQ], Eckardt), endoscopic severity (Endoscopic Reference Score [EREFS]), histologic activity (peak eos/hpf), and adverse events (AE). The primary endpoint was histologic remission (<15 eos/hpf). Pre/post-dupilumab changes were tested for significance via the Wilcoxon signed-rank test. Results: Forty-four patients were included. From baseline to follow-up 1 (median 20.5 weeks), paired BEDQ scores decreased by a median of 4.5 (N = 10; P = 0.0076) and Eckardt scores by 1.0 (N = 10; P = 0.0160). EREFS scores declined by a median of 2.0 from baseline to follow-up 1 (N = 29; P < 0.0001), with sustained improvement at follow-up 2 (Δ = 2.0, N = 10; P = 0.0169). Peak eosinophil burden fell by 47.5 (N = 26; P < 0.0001) at follow-up 1, which was sustained at follow-up 2 (Δ = 37.0, N = 11; P = 0.0069), with no significant change between follow-up 1 and 2 (N = 11; P = 0.31). Histologic remission was achieved in 76.9% at follow-up 1 and 72.7% at follow-up 2. Fifteen point 9 percent of patients reported AEs and 9.1% discontinued therapy. Conclusion: In this cohort from a general practice setting, dupilumab was associated with durable histologic and endoscopic improvements and early symptom relief. These findings are consistent with the clinical trial and recent observational data, supporting dupilumab’s effectiveness and generalizability in real-world practice. AEs were less frequent in our study (15.9%) when compared to the clinical trial (60-86%). These findings add to growing evidence that dupilumab is effective in the real-world environment.

The American Journal of GastroenterologyVol. 120(10S2)
Openalex Percentile: Top 48%
Eosinophilic Esophagitis
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