乌鸦传媒

PHOENIX -- Nearly three-fifths of patients with eosinophilic esophagitis (EoE) achieved remission after treatment with dupilumab (Dupixent), researchers reported.

In a 6-month study, 58.8% of adults and adolescents treated with dupilumab achieved histological remission compared to 6.3% in the placebo group (P<0.0001), according to Marc Rothenberg, MD, PhD, of Cincinnati Children's Hospital, in a pre-recorded presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

Patients treated with dupilumab also experienced reduced dysphagia symptoms, or difficulty swallowing, clocking a 10-point greater improvement on their mean Dysphagia Symptom Questionnaires (DSQ) score than the placebo group (P<0.0001), Rothenberg said.

"Current treatment options lack specificity, present adherence challenges, and may offer suboptimal long-term disease control," he stated. There currently are no FDA-approved medications for EoE, though are used to treat the condition. Dupilumab was granted for EoE in 2020.

EoE is a chronic, progressive disease where the esophagus becomes inflamed due to a build up of eosinophils. Dupilumab acts by blocking interleukin-4 and -13 receptors, which are "central drivers" in EoE inflammation, Rothenberg said.

In part A of the , patients received dupilumab once per week. In part B, participants in the treatment arm received 300 mg of dupilumab either once a week or once every 2 weeks, though only results from those in the once-per-week-arm of part B were reported here.

Rothenberg noted that the results from part B were similar to the part A results, but with a larger sample size for part B. Part A findings were presented during the 2021 virtual .

There was no substantial difference in adverse event (AE) rates across groups, Rothenberg said, describing the intervention as having an "acceptable safety profile." In the part B study, 70.5% of the placebo group experienced a treatment-emergent AE (TEAEs) versus 83.8% of the dupilumab group did.

The most common TEAE (≥10%) were injection-site reactions, which occurred in approximately 20% of participants in both groups. Five people experienced serious AEs in the dupilumab group and one did in the control group, none of which were related to the study drug, according to Rothenberg. There were no deaths in the study.

Patients were included in the three-part study if they were ages 12 years or older, were diagnosed with EoE that did not respond to high-dose PPIs, had at least two episodes of dysphagia per week over the previous month, and logged a DSQ score of at least 10. A total of 159 patients were enrolled, with 80 in the dupilumab arm and 79 in the placebo arm.

Histological remission was defined as achieving peak esophageal intraepithelial eosinophil count of less than or equal to 6 eosinophils per high power field (hpf). At baseline, the mean eosinophils/hpf were 89.2 and 84.3 for the dupilumab and placebo groups, respectively.

The mean DSQ scores of patients at baseline were 38.4 in the dupilumab group and 36.1 in the placebo group. The average age of participants was 28 years, and males made up 58% of the placebo arm and 50% of the treatment arm.

When asked about time-to-event analysis, age-stratified data, and mast cell numbers, co-author Evan Dellon, MD, MPH, of the University of North Carolina at Chapel Hill School of Medicine, who was at the AAAAI meeting in person, said that data were not available yet.