Eli Lilly and Company has announced new long-term data from the ADjoin extension study, demonstrating that EBGLYSS (lebrikizumab-lbkz) provided sustained disease control for up to three years in over 80% of subjects with moderate-to-severe atopic dermatitis.
The ADjoin study evaluated the long-term safety and efficacy of EBGLYSS treatment for up to 100 weeks.
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Participants from the parent studies, ADvocate 1 and 2, ADhere, ADore, and ADopt-VA, were eligible to enrol in ADjoin.
In this analysis, patients received either 250mg EBGLYSS every two weeks or once monthly.
The results showed that 84% of subjects on the monthly regimen and 83% on the bi-weekly regimen of EBGLYSS maintained clear or almost clear skin (IGA 0,1) after three years.
Furthermore, 87% of subjects on the monthly arm and 79% on the bi-weekly dosing arm achieved or maintained a minimum of 90% improvement in disease extent and severity (EASI-90) at the three-year mark.
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By GlobalDataAdditionally, a significant majority of 83% on the monthly and 91% on the bi-weekly regimen did not need high-potency topical corticosteroids or systemic treatments.
EBGLYSS’ safety profile in the ADjoin study was found to be consistent with prior studies without any new safety signals detected in three years of treatment.
Mild or moderate adverse events were observed with less than 3% of subjects experiencing adverse events leading to discontinuation of the treatment.
Conjunctivitis, injection site reactions, and shingles were observed to be the side effects reported in the trial.
Earlier this month, EBGLYSS received approval from the US Food and Drug Administration and is also approved in the European Union and Japan for this indication.
Lilly holds exclusive rights to the development and commercialisation of EBGLYSS in the US and globally, excluding Europe, where Almirall has rights to dermatology indications, including eczema.
Eli Lilly immunology development senior vice-president Mark Genovese said: “Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms.
“EBGLYSS selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most.”
The latest development comes after the company revealed positive topline results from the Phase III clinical trials of once-weekly insulin efsitora alfa to treat adults with type 2 diabetes.
