Dupilumab provides long-term symptom relief at 100 weeks in children with eosinophilic esophagitis

The EoE KIDS study (NCT04394351) was a phase 3 randomized placebo-controlled trial, assessing dupilumab in paediatric patients with eosinophilic esophagitis (EoE). The long-term extension continued in 3 parts, with outcomes being assessed at week 52, week 76, and week 100.

Future Leader, Dr Salvatore Oliva (Sapienza University of Rome, Rome, Italy) spoke with touchIMMUNOLOGY around the known efficacy and safety profile of dupilumab and how approval has impacted the treatment paradigm for paediatric EoE. Dr Oliva also highlighted the findings from his post-hoc analysis investigating long-term symptom improvement at 100-weeks in the open-label extension study.

The abstract “MP624 DUPILUMAB IS EFFECTIVE IN MAINTAINING LONG-TERM SYMPTOMATIC IMPROVEMENT IN CHILDREN WITH EOSINOPHILIC ESOPHAGITIS (EOE), AS REPORTED BY THEIR CAREGIVERS: 100-WEEK RESULTS FROM THE OPEN-LABEL EXTENSION OF THE EOE KIDS STUDY” was presented at UEG Week, 4–7 October, Berlin, Germany.

touchIMMUNOLOGY coverage of UEG Week 2025:

I’m Salvatore Oliva, Professor of Paediatrics at Sapienza University of Rome. I’m responsible for paediatric endoscopy at Sapienza University and at the Umberto I University Hospital.

How has the approval of dupilumab impacted the treatment paradigm for paediatric EoE?

We have moved from conventional treatments to a very advanced, specific treatment, which has already happened for many other atopic conditions. I think the arrival of dupilumab really is a game changer in terms of offering a new option for patients with very severe EoE, who were not eligible for other treatments in the past. This drug is very selective for the mechanism of action of the disease.

On the other hand, we want to understand which patients will be good candidates for upfront therapy with dupilumab. If patients can access an anti-inflammatory drug from the beginning, it can really change the natural history of the disease, instead of just controlling the disease.

What do we already know about the efficacy and safety profile of dupilumab from the EOE KIDS Study?

In the phase 3 EOE Kids study, which looked at children aged between 1 and 11 years, we confirmed what we already knew from the adult studies, that dupilumab is a very efficient drug in terms of symptomatic, endoscopic and histological improvement. Dupilumab is also a safe drug, the related adverse events with this drug are very mild and the rate is very low. We also saw lower rates of adverse events the longer the duration of therapy.

These findings are why the drug was approved in younger children, which is often difficult in the field of biologics. The approval of dupilumab for patients as young as one year old by the European Regulatory Agency indicates that the drug has been shown to be safe and effective.

What were the aims and methodology of the post-hoc analysis?

The patients who were good candidates for continuing dupilumab in an open-label study were enrolled in the Part C open-label extension, which ran for up to 100 weeks. We analysed the effects of the drug in the long term, by looking at the symptom score, the endoscopy score and the histological score.

What were the findings from the study?

The longer the patients received therapy, the better the effects in terms of symptom improvement. Even the patients who received placebo in Part A, switched to dupilumab in Part B, and continued the drug in the open-label phase, were able to reach almost the same score as the group who received dupilumab from the start. This shows that the drug needs time to improve the inflammatory process and to restore a normal epithelium.

What was the importance of using a patient-reported symptom metric in the study?

I think it is very important in the paediatric population, where we need to objectively analyse symptoms. In this age range, we need to consider many domains and not only dysphagia, which is very frequent in the adult population. We also need to understand domains like GERD-like symptoms, vomiting, and abdominal pain, which are very unspecific, but are clinical manifestations of the disease.

How will these findings impact clinical practice?

I think the message is that with continuing the drug over 1 year of treatment, we see better results with a longer duration of therapy. So even for those patients who did not have a very impressive improvement in the first phase of treatment, we can wait to see if we have a better improvement over time.