Dupilumab Found to Improve Clinical, Histologic Aspects of Eosinophilic Esophagitis

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Patients with eosinophilic esophagitis (EoE) who received dupilumab experienced clinically meaningful improvements in symptoms in a new study presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology, held February 25-28, 2022.

Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13.

The study reported results from part B of the 3-part, phase 3 LIBERTY-EoE-TREET study. Part A and C demonstrated the efficacy and safety of dupilumab 300 mg weekly (qw) in adolescent and adult patients (aged ≥12 years) with EoE for 24 weeks, which was sustained up through week 52.

Part B examined the efficacy and safety of dupilumab 300 mg qw or every 2 weeks compared with placebo up to 24 weeks in a larger patient sample size. A total of 159 patients were included in part B and randomized to receive dupilumab (n=80) or placebo (n=79).

Coprimary endpoints were proportion of patients achieving histological remission—defined for the purpose of the study as peak esophageal intraepithelial eosinophil count of ≤6 eosinophils/hpf—and improvement in dysphagia (absolute change in Dysphagia Symptom Questionnaire [DSQ] score [range 0–84] from baseline), according to the study abstract.

Researchers reported similar baseline demographics/disease severity for both treatment groups. Among patients in the dupilumab arm,baseline mean eosinophils/hpf and mean DSQ scores were 89.2 and 38.4. In the placebo group, baseline mean eosinophils/hpf and mean DSQ scores were 84.3 and 36.1, according to investigators.

At week 24, 58.8% of dupilumab-treated participants achieved histological remission compared to 6.3% of placebo-treated participants (P<.001). Least squares mean absolute changes in DSQ score were -23.78 for dupilumab and -13.86 for placebo (P<.001).

Investigators found that rates of treatment-emergent adverse events were similar for dupilumab- (83.8%) and placebo-treated participants (70.5%), with the most common being injection-site reactions and fever. In addition, no mortalities occurred.

“Weekly dupilumab vs placebo demonstrated statistically significant, clinically meaningful improvements in symptoms in adults/adolescents with EoE, with a greater proportion of patients achieving histological remission,” concluded researchers. “Dupilumab had an acceptable safety profile. These results replicate results from Part A.”