Part C of a 3-part randomised, placebo-controlled Phase 3 study on dupilumab (Dupixient® ) in patients with Eosinophilic Oesophagitis (EoE) has shown that the drug maintains its efficacy and safety up to week 52 in adults and children over 12+. The findings were presented at the ACG Annual Scientific Meeting.

Part C of the LIBERTY EoE TREET trial involved an extended active treatment period of 28 weeks for patients who had completed Parts A and B, with patients receiving treatment for up to 52 weeks in total.

Results

The improvements in histologic, symptomatic, and endoscopic aspects of EoE at Week 24 as a result of dupilumab were sustained to Week 52 with an acceptable safety profile.

Patients who received a placebo in Part A and were switched to dupilumab in Part C showed similar efficacy to dupilumab-treated patients of Part A.

Lead Author of the study, Evan Dellon MD, MPH, said:

Dupilumab is a fully-human monoclonal antibody that blocks the shared component for IL-4 and IL-13, which are key drivers of type 2 inflammation in EoE [...] In this phase 3 study, dupilumab 300 mg demonstrated substantial improvements in clinical, symptomatic, histologic and molecular aspects of disease and had an acceptable safety profile in adults and adolescents up to 24 weeks. These improvements were sustained or further improved up to 52 weeks

Links

• Part A results and method
• ClinicalTrials.gov listing
• FDA approves dupilumab as first drug to treat EoE in the USA