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The treatment recently became the first ever FDA-approved medication for EoE.
New data shows dupilumab results in clinical improvements for patients witheosinophilic esophagitis (EoE).
A team, led by Evan S. Dellon, MD, MPH, Director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, assessed the efficacy and safety of dupilumab 300 mg weekly or every 2 weeks compared to placebo up to 24 weeks in a large sample size of adult and adolescent patients with EoE.
The data was presented as a late-breaking abstract during 2022 Digestive Disease Week Annual Meeting in San Diego.
Dupilumab is a fully human mAb that blocks the shared receptor component for interleukin-4/13, which are key drivers of type 2 inflammation.
Investigators found in Part A of the 3-part phase 3 TREET trial that the treatment at the 300 mg dose weekly compared to placebo showed efficacy and safety up to 24 weeks in adult and adolescent patients with EoE. For patients who completed Part and continued to the Part C extended active treatment period, the investigators found dupilumab resulted in sustained improvements to 52 weeks.
In Part B, the investigators randomized 240 patients to receive dupilumab 300 mg weekly (n = 80), every 2 weeks (n = 81), or placebo (n = 79).
The investigators sought co-primary endpoints of the proportion of patients achieving peak esophageal intraepithelial eosinophil (eos) count ≤6/high-power field (hpf) and absolute change in Dysphagia Symptom Questionnaire (DSQ) score from baseline (BL) to week 24.
They also sought secondary endpoints, including the percentage change in DSQ, the percentage change in peak eos count, absolute change in Endoscopic Reference Score (EREFS), Histologic Scoring System (HSS) grade and stage scores, proportion of patients achieving peak eos count <15/hpf, and normalized enrichment score (NES) for relative change in EoE diagnostic panel (EDP) or T2 gene expression.
The baseline characteristics were comparable across the different treatment groups.
Overall, patients were symptomatic (mean DSQ 36.7), severely inflamed (mean peak eos count 87.1/hpf), and previously difficult to treat (73.3% prior swallowed topical steroid use, 35.4% history of dilations), while more patients treated with either dupilumab dosage achieved peak eos count ≤6/hpf (58.8/60.5% vs 6.3%; P <0.0001) compared to placebo at week 24.
The weekly dupilumab group had a significantly greater absolute (LS mean difference –9.9; P <0.0001) and percentage (–22.9; P = 0.008) change in DSQ compared to placebo.
The every 2 week dose did not significantly improve the absolute or percentage change in DSQ (P = 0.8; P = 0.5) compared to placebo, but did result, along with the weekly dose, in a greater percentage change in peak eos count (–88.6/–79.2), change in HSS grade (–0.7/–0.7), and stage (–0.7/–0.7) scores, and EREFS (–3.8/–3.9); and proportion of patients achieving <15 eos/hpf (82.5/79.0% vs 7.6%) (all nominal P<0.0001).
Finally, dupilumab suppressed the EDP NES and T2 NES, but placebo did not.
For safety, the treatment was generally well-tolerated, with injection-site reactions and injection site erythema emerging as the most common treatment-emergent adverse events.
“Dupilumab 300mg qw improved clinical, symptomatic, histologic, endoscopic, and molecular aspects of EoE and was well tolerated up to 24wks,” the authors wrote. “While dupilumab 300mg q2w did not meet the co-primary endpoint of change from BL in DSQ or the secondary endpoint % change in DSQ, treatment effects for all other endpoints were comparable between dupilumab qw and q2w.”
Earlier this month, the Food and Drug Administration (FDA) approved dupilumab for the treatment of EoE in adult and pediatric patients 12 years and older weighing at least 40 kg.
With this approval, dupilumab is the first treatment in the US indicated for EoE, a disease estimated to affect more than 300,000 patients in the US.
The study, “867a: CLINICAL AND HISTOLOGICAL IMPROVEMENTS WITH WEEKLY DUPILUMAB TREATMENT IN ADULT AND ADOLESCENT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS AT WEEK 24: WEEKLY AND EVERY 2 WEEKS’ RESULTS FROM PART B OF THE 3-PART LIBERTY EOE TREET STUDY,” was published by DDW 2022.