Part A of a 3-part randomised, placebo-controlled Phase 3 study on dupilimab (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.

Methods

Of the 81 patients, 42 were given dupilimab 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 dupilimab 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 dupilimab group compared with placebo was -1.7 (95% Confidence Interval, -2.9 to -0.5), (p=0.005)
  • 40.5% of dupilimab group reported dysphagia as "very much better" on the PGIC vs 7.7% of placebo group (p<0.001)
  • 26.2% of dupilimab 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 PhD, Lead Author

Links

Page Updated 27th March 2021