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.
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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.
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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.
