Lilly launches Ebglyss in Korea… sparks competition

a three-way competition for next-generation atopic dermatitis treatments

Ebglyss reimbursed starting this month, a biological agent that blocks IL-13

Effective in clinical trials for moderate-to-severe patients, maintenance therapy possible with once-monthly dosing

“Treatment options have increased, but accessibility remains limited due to restrictions on switching and other factors.”

Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital

The official launch of Lilly's Ebglyss has expanded treatment options for atopic dermatitis patients in Korea.

 

With the arrival of Ebglyss, the number of biological agents available for the treatment of atopic dermatitis in Korea has increased to three.

 

Experts welcomed the emergence of diverse treatment options but emphasized that there is still room for improvement in terms of patient access, due to the inability to switch between different classes of drugs.

 

On the 2nd, Lilly Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of Ebglyss.

 

Ebglyss is a new biological agent that selectively blocks interleukin (IL)-13, a cytokine that is a major cause of atopic dermatitis.

 

This treatment was approved in August last year as a treatment for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weighing 40 kg or more) who are not adequately controlled with topical treatments or for whom these treatments are not recommended, and was granted reimbursement starting this month.

 

Previous atopic dermatitis treatments included Dupixent, which inhibits IL-4 and IL-13, the Janus kinase (JAK) inhibitor Rinvoq, and Adtralza, which targets IL-13.

 

However, the introduction of Ebglyss has expanded treatment options.

 

As atopic dermatitis is a chronic condition with no cure and a long treatment period, diverse treatment options are essential.

 

Ebglyss has demonstrated efficacy and safety in Phase III clinical trials, including ‘ADvocate-1,’ 'ADvocate-2,‘ and 'ADhere.’ In the ‘ADvocate-1’ and ‘ADvocate-2’ studies evaluating Ebglyss monotherapy, the Ebglyss group achieved an EASI-75 response rate of 58.2% and 52.1% during the induction period (0–16 weeks), compared to 16.2% and 18.1% in the placebo group.

 

The EASI-90 rate was 38.3% and 30.7% in the Ebglyss group, respectively, while the placebo group was 9% and 9.5%.

 

EASI measures the severity and spread of atopic eczema.

 

Also, after one year of maintenance therapy, the EASI-75 achievement rate in the severity group at Week 52 was 81.7%, and the EASI-90 ratio was 66.4%.

 

These figures were higher than those in the placebo group (66.4% and 66.4%, respectively).

 

In terms of safety, the most common adverse reactions were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eyes (1.4%).

 

Most adverse reactions were mild or moderate and did not lead to treatment discontinuation.

 

Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital commented, “Dupixent can be administered at two-week intervals, but extending the interval tends to reduce its efficacy.

 

Ebglyss demonstrated sustained clinical efficacy and safety even with monthly maintenance therapy.

 

Its long-lasting therapeutic effect also offers the advantage of greater convenience in administration.” He added, “In particular, Dupixent had a high rate of erythema and conjunctivitis, and this rate was lower in the pivotal clinical trial for Ebglyss.

 

In terms of safety, Ebglyss did not show any notable adverse reactions compared to the placebo group.” Despite the emergence of various treatments, unmet needs remain Ebglyss is the third biological agent to enter this market.

 

With the introduction of Ebglyss, patients, following Dupixent from Sanofi and Adtralza from Leo Pharma.

 

However, some experts say that despite the introduction of various treatments, there are still unmet medical needs.

 

According to domestic atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis.

 

However, while the proportion of moderate-to-severe patients among domestic atopic dermatitis patients increased from 30.9% in 2002 to 39.7% in 2019, the prescription rate for systemic immunosuppressants in this patient group remained at just 5%.

 

Professor Min-kyung Shin of the Department of Dermatology at Kyung Hee University Medical Center,

Min-kyung Shin, a professor of dermatology at Kyung Hee University Medical Center, said, “The effectiveness and side effects of each treatment may vary depending on the age and immune status of patients with severe atopic dermatitis.

 

We are treating patients in consideration of their response to side effects such as latent tuberculosis, as well as whether the treatment can help with comorbidities, patient preferences, and clinical phenotypes.” Shin added, “Even though biological agents and JAK inhibitors are reimbursed in Korea, many patients are unable to receive optimal treatment due to financial burdens.

 

Although it is possible to switch between biological agents and JAK inhibitors, it is still not possible to switch between treatments within the same class, so there is room for improvement.”