Part A of a 3-part randomised, placebo-controlled Phase 3 study on dupilumab (Dupixient) in patients with eosinophilic oesophagitis (EoE) has shown the drug to improve disease-specific quality of life and reduce symptom burden in adults and adolescents.

The research was presented at the American Academy of Allergy, Asthma and Immunology Annual Meeting 2021.

Update - Part C has found dupilumab to maintain its long-term efficacy and safety.

Methods

Of the 81 patients, 42 were given dupilumab and 39 were given placebo.

Health-related quality of life was measured using an 11-item EoE Impact Questionnaire (EoE-IQ) measuring the disease's impact on social, emotional, productivity and sleep. Scoring ranged from 1-5, higher scores indicating greater impact.

Symptom burden was measured using a 5-item EoE Symptom Questionnaire (EoE-SQ-Frequence), which measured EoE symptoms other than dysphagia, such as chest or stomach pain, heartburn, regurgitation and vomiting. Scoring ranged from 5-25, higher scores indicating greater burden.

Scores' least-squares mean change from baseline to Week 24 was used to compare dupilimab vs placebo.

Patient-reported dysphagia improvement was also assessed using the Patient Global Impression of Change (PGIC).

Results

• The mean change in the EoE-IQ score in dupilumab group compared with placebo was -0.4 (95% Confidence Interval, -0.6 to -0.1), (p=0.008)
• The mean change in the EoE-SQ-Frequency score in dupilumab group compared with placebo was -1.7 (95% Confidence Interval, -2.9 to -0.5), (p=0.005)
• 40.5% of dupilumab group reported dysphagia as "very much better" on the PGIC vs 7.7% of placebo group (p<0.001)
• 26.2% of dupilumab group reported dysphagia as "moderately better" vs 10.3% of placebo group (p=0.074)

Dupilimab was well tolerated.

The results show that for these patients, [dupilumab] significantly reduced the burden of EoE symptoms, including those not related to swallowing trouble, and improved health-related quality of life as reported by the patients themselves

- Evan Dellon MD MPH, Lead Author

Links

• Abstract in Journal of Allergy and Clinical Immunology
• Phase 3 study listing in ClinicalTrials.gov
• Evan Dellon MD

Page Updated 27th March 2021