Lilly’s Ebglyss emerges as 3rd biologic option for atopic dermatitis in Korea

With the recent reimbursement launch of Ebglyss (ingredient: lebrikizumab), a new biologic treatment developed by Eli Lilly, Korean dermatologists are calling for greater flexibility in prescribing options, particularly the need to allow reimbursement for switching between same-class biologics to better tailor treatment for moderate to severe atopic dermatitis patients.

Ebglyss, which selectively inhibits interleukin (IL)-13, a key cytokine involved in skin inflammation, is now the third biologic approved in Korea for atopic dermatitis, following Sanofi’s Dupixent (dupilumab) and Leo Pharma’s Adtralza (tralokinumab). The drug was officially introduced to the Korean market on Tuesday with reimbursement coverage.

Ebglyss received approval from the Ministry of Food and Drug Safety (MFDS) in August 2024 for use in adults and adolescents aged 12 and older (weighing at least 40 kg) with moderate-to-severe atopic dermatitis who are not adequately controlled with or are not suitable for topical therapies. Reimbursement applies to patients aged 12 and up who have had persistent symptoms for more than three years and who have failed to respond to topical corticosteroids and systemic immunosuppressants, with a baseline EASI score of 23 or higher.

The National Health Insurance Service (NHIS) has set the maximum reimbursement price at 952,277 won ($700).

At a press briefing on Wednesday at a hotel in Seoul, leading dermatologists highlighted the unmet needs that persist despite the growing number of biologic and small molecule therapies available for atopic dermatitis.

“Ebglyss provides a new option for patients who are not adequately controlled with topical treatments,” Professor Shin Min-kyung of the Department of Dermatology at Kyung Hee University Medical Center said. “But in real-world practice, we need to consider switching between same-class biologics based on patient characteristics, side effects, or treatment response.”

Korean reimbursement guidelines currently do not allow for switching between IL-13 or IL-4/13 inhibitors, such as from Dupixent or Adtralza to Ebglyss, even if a patient experiences side effects or inadequate response. However, switching between biologics and JAK inhibitors is permitted.

Professor Shin noted that this restriction could hinder personalized treatment for severe atopic dermatitis patients, whose responses may vary depending on age, immune profile, latent infections like tuberculosis, and comorbidities.

Strong efficacy, convenient dosing schedule

Professor Koh Hyun-chang of the Department of Dermatology at Pusan National University Yangsan Hospital emphasized the clinical strength of Ebglyss, referencing phase 3 trials such as ADvocate-1, ADvocate-2, and ADhere.

“Patients saw itch reduction as early as week two, and skin symptom improvements from week four,” he noted. “After one year of maintenance therapy, the IGA 0/1 response rate was 76.9 percent, and EASI-90 was achieved by 66.4 percent of patients, demonstrating durable efficacy with a convenient once-monthly dosing schedule.”

In ADvocate-1 and ADvocate-2, patients receiving Ebglyss achieved EASI-75 response rates of 58.8 percent and 52.1 percent, respectively, by week 16, compared to 16.2 percent and 18.1 percent in placebo groups. EASI-90 rates were 38.3 percent and 30.7 percent in Ebglyss arms versus 9 percent and 9.5 percent in placebo groups. These results were sustained at week 52 in maintenance therapy.

The most commonly reported side effects in clinical trials were conjunctivitis (6.9 percent), injection site reactions (2.6 percent), allergic conjunctivitis (1.8 percent), and dry eyes (1.4 percent), all mostly mild to moderate in severity and not leading to treatment discontinuation.

Compared to Dupixent, Ebglyss was associated with lower rates of conjunctivitis in its pivotal studies, Professor Koh added.

Remaining barriers to optimal care

Despite an expanding therapeutic arsenal, experts stressed that gaps remain in patient access and disease management.

According to domestic treatment guidelines, systemic therapy is strongly recommended for moderate-to-severe atopic dermatitis. Yet a retrospective study found that although the proportion of such patients rose from 30.9 percent in 2002 to 39.7 percent in 2019, only 5 percent received systemic immunosuppressants.

Cost remains another major barrier, despite the fact that biologics and JAK inhibitors are now reimbursed in Korea. Experts pointed out that some patients still do not receive optimal care due to financial constraints.

“Personalized treatment is essential, but access remains limited,” said Professor Shin. “We must re-evaluate the reimbursement policies that prevent same-class switching among biologics, especially as new agents like Ebglyss enter the field.”