Clinical Trial: Dupilumab Improves Eosinophilic Oesophagitis Outcomes Versus Placebo Regardless of Comorbidities or Treatment History in a Randomised Clinical Trial.

BACKGROUND

Patients with eosinophilic oesophagitis (EoE) can present with differing disease characteristics, treatment resistance, and associated type 2 inflammatory comorbidities. We assessed the efficacy of dupilumab in subgroups of patients with EoE from the LIBERTY EoE TREET study across a range of demographics, characteristics, treatments, and comorbidities.

METHODS

Patients were categorised by subgroups based on weight (< 60 kg or ≥ 60 kg), body mass index (< 18.5 kg/m2, ≥ 18.5 to < 30 kg/m2, ≥ 30 kg/m2), disease duration before study entry (< 5 years, ≥ 5 to < 10 years, ≥ 10 years), history of type 2 inflammatory comorbidities (with/without asthma, allergic rhinitis, atopic dermatitis, or food allergy), history of elimination diet, concurrent elimination diet, concurrent proton pump inhibitor use, and prior oesophageal dilation. Outcomes were analysed post hoc and included the proportion of patients achieving ≤ 6 eosinophils per high-power field (eos/hpf) and change from baseline in Dysphagia Symptom Questionnaire (DSQ) and total Endoscopic Reference Score (EREFS).

RESULTS

At Week 24, dupilumab treatment increased the proportion of patients achieving histological remission (peak eosinophil count ≤ 6 eos/hpf) versus placebo in all subgroups. At Week 52, improvements were maintained with continued dupilumab treatment. Improvements were also observed through Week 52 in patients who switched from placebo to dupilumab at Week 24. Similar results were observed for change from baseline in DSQ and EREFS.

CONCLUSIONS

Dupilumab treatment improved histological, symptomatic, and endoscopic outcomes versus placebo in patients with EoE, regardless of demographics, disease characteristics, treatment history, or type 2 inflammatory disease comorbidities.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03633617.