EoE KIDS Suggests Dupilumab Offers Benefit Regardless of Prior Therapy Exposure

New data from a post-hoc analysis of the phase 3 EoE KIDS trial is shedding further light on the benefits of dupilumab (Dupixent) in children with eosinophilic esophagitis (EoE) and previous exposure to other therapies.

An analysis comparing the effects among patients with prior inadequate response/intolerance/contraindication to swallowed topical corticosteroids, results demonstrate the consistent efficacy and safety profile with dupilumab regardless of exposure to prior therapies.

“We analyze a specific subset of patients who are already severe and have tried diet interventions and steroids and had concerns about steroids or side effects. So, they are a unique group of population and they are also young children from 1 year onwards to 12 years,” explained study presenter Dhandapani Ashok, MBBS, MD, a pediatric gastroenterologist in the Department of Paediatrics at the Children's Hospital, London Health Sciences, in an interview at the North American for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN 2024). “Parents may have a concern about using a new medication on a new drug, but this data shows that it's very effective, even for the patients who fail the other existing modalities.”

The US Food and Drug Administration awarded a historic approval to dupilumab on January 25, 2024—a move which received applause from the medical community as it marked the approval in children aged 1 years and older weighing at least 15 kg with EoE. The application from Sanofi and Regeneron was based on the pivotal EoE KIDS study.²

A 2-part trial, part A of EoE KIDS was a 16-week, placebo-controlled study in which patients were randomized 2:2:1:1 to a weight-tiered, subcutaneous dupilumab with a higher- or lower-exposure treatment regimen, or to a placebo cohort with higher or lower exposure. Those completing part A of the trial could enter part B of EoE KIDS, which was an active treatment extension period lasting up to 52 total weeks.^1,2,3

Results of the overall trial suggested 68% of patients on a higher dose and 58% of patients on a lower dose of dupilumab achieved significant histological disease remission compared to 3% for placebo (both P < .0001) at 16 weeks. Further analysis indicated children on the higher dose regimen also experienced significant improvements in abnormal endoscopic findings of their esophagus, with a reduction of 3.5 points compared to an increase of 0.3 points for placebo (P < .0001).³

In the poster presented at NASPGHAN 2024, Ashok presented data outlining the effects of dupilumab among patients with prior use of or prior inadequate response/intolerance/contraindication to swallowed topical corticosteroids. Among the 102 patients who entered the trial, 80.4% had a history of swallowed topical corticosteroids therapy and 57.8% had a prior inadequate response/intolerance/contraindication to swallowed topical corticosteroids.¹

Results of the analysis suggested dupilumab in its higher-exposure dose improved rates of histologic remission and key secondary endpoints relative to placebo therapy at 16 weeks regardless of prior swallowed topical corticosteroids therapy. Ashok and colleagues also highlighted data from part B of the study indicating these repossess were maintained to week 52 among patients who continued dupilumab use and improved in patients who switched from placebo therapy, with these results consistent regardless of prior swallowed topical corticosteroids therapy use. Additional analysis revealed similar improvements in primary and secondary endpoints were observed in patients with and without prior inadequate response/intolerance/contraindication to swallowed topical corticosteroids.¹

“Also, if you look at the side effect profile, it is considered very safe. That is what patients need, right? It works and it's safe. So, that is the main message,” Ashok said.

References:

1. Chehade M, Oliva S, Ashok D, et al. DUPILUMAB EFFICACY IN CHILDREN WITH EOSINOPHILIC ESOPHAGITIS AND PRIOR USE OF OR PRIOR INADEQUATE RESPONSE, INTOLERANCE, OR CONTRAINDICATION TO SWALLOWED TOPICAL CORTICOSTEROIDS: RESULTS FROM THE PHASE 3 EOE KIDS STUDY. Presented at NASPHGAN 2024 in Hollywood, Florida, from November 7 – November 9, 2024.
2. Sanofi. Press release: DUPIXENT® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EOE). Sanofi. January 25, 2024. Accessed November 8, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-01-25-19-30-00-2817342.
3. Chehade M, Dellon ES, Spergel JM, et al. Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 Years of Age. N Engl J Med. 2024;390(24):2239-2251. doi:10.1056/NEJMoa2312282