Eli Lilly’s EBGLYSS has demonstrated improvement in skin condition and itch relief in patients with moderate-to-severe atopic dermatitis, according to new results from the Phase IIIb ADapt study.
These findings are particularly relevant for patients who had an inadequate response to the commonly prescribed dupilumab.
Go deeper with GlobalData
The open-label, Phase IIIb, 24-week ADapt study assessed the safety and efficacy of EBGLYSS in individuals aged 12 to less than 18 years, and had previously been treated with dupilumab.
Participants were required to have discontinued dupilumab due to insufficient response, intolerance, or adverse events to get eligibility for the ADapt study.
The trial’s primary endpoint was achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) score by week 16.
Secondary endpoints included a clear or almost clear skin rating according to the Investigator Global Assessment (IGA) and a significant reduction in itch as measured by the Pruritus NRS.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataAt week 16, 57% of patients, and at week 24, 60% of those who switched from dupilumab to EBGLYSS, achieved EASI-75.
Furthermore, more than half of the patients experienced significant itch relief, with 53% at week 16 and 62% at week 24 showing at least a four-point improvement from baseline.
Clear or almost clear facial dermatitis was observed in 52% of patients treated with EBGLYSS by week 24. Its safety profile in the ADapt study was consistent with prior Phase III trials, with no new safety concerns identified.
Lilly holds the exclusive rights to develop and commercialise the therapy in the US and globally, excluding Europe.
In Europe, Almirall is licensed for these activities for dermatological conditions such as eczema.
Last month, EBGLYSS received approval from the US Food and Drug Administration (FDA) as a first-line biologic treatment for adults and children aged 12 and above with moderate-to-severe atopic dermatitis.
It was also approved in the European Union last year and in Japan in January 2024, with plans for further market releases later in the year.
