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Lilly's EBGLYSS Demonstrates Efficacy in Atopic Dermatitis Patients Unresponsive to Dupilumab

• Eli Lilly's EBGLYSS demonstrated significant improvements in skin condition and itch relief in moderate-to-severe atopic dermatitis patients who had an inadequate response to dupilumab. • In the Phase IIIb ADapt study, 57% of patients achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) score by week 16, increasing to 60% by week 24. • 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, with a safety profile consistent with prior Phase III trials.

Eli Lilly's EBGLYSS has shown promising results in a Phase IIIb study, ADapt, for patients with moderate-to-severe atopic dermatitis who did not respond adequately to dupilumab. The open-label, 24-week study assessed the safety and efficacy of EBGLYSS in individuals aged 12 to under 18 years who had previously discontinued dupilumab due to insufficient response, intolerance, or adverse events. The findings offer a potential therapeutic option for a subset of patients with limited treatment alternatives.

Efficacy Outcomes

The primary endpoint of the ADapt study was achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) score by week 16. By week 16, 57% of patients who switched from dupilumab to EBGLYSS achieved EASI-75, and this increased to 60% by week 24. 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.

Itch Relief and Facial Dermatitis Improvement

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. Additionally, clear or almost clear facial dermatitis was observed in 52% of patients treated with EBGLYSS by week 24.

Safety Profile

The safety profile of EBGLYSS in the ADapt study was consistent with prior Phase III trials, with no new safety concerns identified.

Regulatory Status and Commercialization

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 last month. 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. Lilly holds the exclusive rights to develop and commercialize the therapy in the US and globally, excluding Europe, where Almirall is licensed for these activities for dermatological conditions such as eczema.
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Reference News

[1]
Lilly's EBGLYSS shows improvement in Phase IIIb study for atopic dermatitis
clinicaltrialsarena.com · Oct 28, 2024

Eli Lilly’s EBGLYSS showed improvement in skin condition and itch relief in moderate-to-severe atopic dermatitis patient...

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