Eli Lilly Korea has introduced Ebglyss, a new biologic therapy designed to treat moderate-to-severe atopic dermatitis. The treatment, which comes as a 250 mg pre-filled autoinjector containing the active ingredient lebrikizumab, was officially launched on Wednesday.
Ebglyss targets interleukin-13 (IL-13), a cytokine implicated in the inflammatory response seen in atopic dermatitis. Approved by South Korea’s Ministry of Food and Drug Safety in August 2023, Ebglyss is available for use in adults and adolescents aged 12 and older, provided they weigh at least 40 kilograms. The drug is intended for patients whose condition has not responded adequately to topical therapies or for those for whom such treatments are not appropriate.
The initial treatment phase of Ebglyss involves a 16-week period, after which patients who show a positive response can switch to a maintenance dose of 250 mg every four weeks, offering a convenient option for long-term management.
The approval of Ebglyss in South Korea was supported by data from three pivotal Phase 3 clinical trials—ADvocate-1, ADvocate-2, and ADhere—spanning a total of 1,062 participants. These trials focused on patients with moderate-to-severe atopic dermatitis and assessed the drug’s efficacy in both monotherapy and combination settings.
Results from the ADvocate-1 and ADvocate-2 trials, which evaluated Ebglyss as a monotherapy, demonstrated significant improvements compared to placebo after 16 weeks. The EASI-75 (Eczema Area and Severity Index 75) response rates in the Ebglyss groups were 58.8 percent and 52.1 percent, respectively, versus 16.2 percent and 18.1 percent in the placebo groups. Additionally, the EASI-90 response rates for Ebglyss were 38.3 percent and 30.7 percent, compared to 9 percent and 9.5 percent for placebo.
Long-term effectiveness was also confirmed in the 52-week follow-up, with the EASI-75 response rate increasing to 81.7 percent in the Ebglyss group, compared to 66.4 percent in the placebo group. The EASI-90 response rate also showed substantial improvement, reaching 66.4 percent for Ebglyss versus 41.9 percent for placebo.
While the treatment showed promising results, common adverse events reported during the trials included conjunctivitis (6.9 percent), injection site reactions (2.6 percent), allergic conjunctivitis (1.8 percent), and dry eye (1.4 percent). Most adverse events were mild to moderate in severity and did not lead to discontinuation of treatment. Notably, the safety profile remained consistent throughout the one-year treatment period.
Ebglyss is now positioned as a promising option for patients with moderate-to-severe atopic dermatitis in South Korea, offering a new therapeutic alternative for those who have not found sufficient relief with traditional topical treatments.
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