Dupilumab safely and efficaciously improved clinical, histologic, endoscopic, and symptomatic measures of eosinophilic esophagitis (EoE), regardless of previous treatment with swallowed topical corticosteroids (STCs), according to study results presented at the American College of Gastroenterology (ACG) 2022 Annual Meeting, held from October 21 to 26, 2022, in Charlotte, North Carolina, and virtually.
Researchers conducted a 24-week, placebo-controlled trial, called LIBERTY-EoE-TREET (ClinicalTrials.gov Identifier: NCT03633617), to analyze the efficacy of 300 mg dupilumab administered weekly to 80 patients in a treatment group compared with 79 patients in a placebo group. Patients in both groups either had or did not have prior history receiving treatment with STCs. The current analysis focused on Part B of the phase 3 study.
Among the dupilumab treatment and placebo groups, 69% and 71% had previously used STCs, respectively. In the treatment group, 48% of patients either responded poorly to STCs, did not tolerate STCs well, or had contraindications to treatment using STCs, compared with 49% of patients in the placebo group.
After 24 weeks, 63.6% of patients treated with dupilumab who previously received STCs achieved peak eosinophil count (PEC) less than or equal to 6/high power field (hpf) compared with 5.4% in the placebo group. Additionally, 48% of patients without prior use of STCs in the dupilumab group achieved PEC) less than or equal to 6/hpf compared with 8.7% in the placebo group.
Scores on the Dysphagia Symptom Questionnaire (DSQ) changed more significantly for patients taking dupilumab (absolute change, -11.63; 95% CI, -17.64 to -5.62) compared with placebo (absolute change, -6.79; 95% CI, -15.78 to 2.20), regardless of previous STC use.
Not only did patients with EoE experience symptom relief, but histological grade and stage scores also improved after taking dupilumab, compared with placebo, according to Histologic Scoring System (HSS) results (absolute change for HSS grade: -0.73 vs -0.58; absolute change for HSS stage: -0.74 vs -0.54, respectively)
Similar trends in improvement occurred between the 2 groups on the Endoscopic Reference Score (EREFS) (dupilumab group absolute change: -4.2 vs placebo group absolute change: -2.7).
The most common adverse effects in both the treatment and placebo groups consisted of injection site reactions (37.5% and 33.3%, respectively).
“In Part B of this phase 3 study, dupilumab improved clinical, symptomatic, histologic, and endoscopic aspects of EoE regardless of STC use history,” the study authors wrote.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Bredenoord A, Dellon E, Lucendo A, et al. Dupilumab improves clinical, symptomatic, histologic, and endoscopic aspects of EoE, regardless of prior swallowed topical steroid use. Abstract presented at: ACG 2022 Annual Meeting; October 21-26, 2022; Charlotte, NC. Abstract #D0194.
This article originally appeared on Gastroenterology Advisor.