AAAAI 2022: New study found patients with eosinophilic esophagitis who received dupilumab experienced clinically meaningful improvements in symptoms.
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.”