'One year anniversary of Adtralza's launch in KOR'

Rose as a new alternative atopic dermatitis treatment option

Reimbursement was approved in Korea last May... Second biological agent to enter the market

Effective even on visible areas such as the head and hands... Reduced the conjunctivitis side effect

Shin Jung-bum, CEO of Leo Pharma

Adtralza, which debuted in the market last year, has been shown to improve the quality of life for atopic dermatitis patients during its first year of domestic launch.

 

Experts note that its effectiveness in areas such as the head and neck, where symptoms are more visible, could lead to broader applications.

 

On the 22nd, LEO Pharma held a press conference at the Andaz Hotel in Apgujeong-dong, Gangnam-gu, Seoul, to celebrate the first anniversary of Adtralza’s launch.

 

Adtralza is a biological agent that selectively acts on interleukin (IL)-13 and was approved for reimbursement in May last year as a treatment for chronic severe atopic dermatitis in adults and adolescents.

 

IL-13 is a key cytokine that triggers symptoms and signs of atopic dermatitis, including immune regulation and skin barrier dysfunction.

 

It is known to be overexpressed in the skin with atopic dermatitis symptoms and is associated with the disease severity.

 

Previously, Dupixent, which inhibits IL-4 and IL-23, and Rinvoq, a JAK inhibitor, were primarily used to treat atopic dermatitis.

 

However, the introduction of Adtralza has expanded treatment options.

 

Given that atopic dermatitis is a chronic condition with no cure and a long treatment duration, diverse treatment options are essential.

 

In particular, since March, switching between JAK inhibitors and biological agents has been approved for reimbursement, leading to predictions that the use of Adtralza may increase in the future.

 

Adtralza has demonstrated efficacy and safety in the Phase III ECZTRA3 and ECZTEND studies.

 

The ECZTRA3 trial compared Adtralza with placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had previously failed to respond adequately to topical therapy or required systemic treatment.

 

The primary endpoints were the proportion of patients achieving an improvement in the Validated Investigator Global Assessment scale for Atopic Dermatitis (IGA) to 0 or 1 at Week 16, and the proportion of patients achieving EASI-75 (75% or greater reduction in the Eczema Area and Severity Index (EASI) score from the baseline) The clinical results showed that Adtralza achieved an EASI-75 response rate of 56.0%, an improvement compared to 35.7% in the placebo group.

 

The proportion of patients with an IGA score of 0 or 1 at Week 16 was 38.9% in the Adtralza group and 26.2% in the placebo group.

 

The ECZTEND study evaluated the long-term efficacy of Adtralza.

 

In the clinical trial, 84.5% of patients treated with Adtralza for 4 years achieved EASI-75.

 

Adtralza also demonstrated efficacy in patients with atopic dermatitis in the difficult-to-treat head and neck area.

 

A key advantage of Adtralza is its convenience of administration.

 

While Dupixent requires administration once every two weeks, Adtralza can be administered once every four weeks in patients with clear or almost clear skin after 16 weeks of treatment, based on the judgment of a healthcare professional.

 

Currently, LEO Pharma is conducting clinical studies on patients with hand eczema and pediatric patients aged two years and older.

 

The company also plans to add a pen-type formulation to further improve patient convenience.

 

Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital

Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital, said, “Adtralza showed consistent efficacy in real-world studies, as in clinical trials.

 

In particular, it showed improved symptoms in patients who switched to Adtralza from existing treatments.” He added, “Treatment is particularly difficult when atopic dermatitis occurs on the hands or head and neck, but symptoms improved in these patients as well when treated with Adtralza.”

Ji-Hyun Lee, professor of dermatology at Seoul St.

 

Mary

Ji-Hyun Lee, professor of dermatology at Seoul St.

 

Mary's Hospital, said, “Although biological agents have emerged for atopic dermatitis, lesions often remain in the head and neck area, such as the face and neck.

 

It is known that 17% of patients who are treated with Dupixent experience conjunctivitis.

 

This remains an unmet need for patients who must continue with their social lives.” She added, “Adtralza has been confirmed to reduce EASI scores uniformly across various body areas, including the head and neck and limbs.

 

If visible lesions do not improve, this can significantly impact the quality of life.

 

Since Adtralza has a low incidence of conjunctivitis as a side effect, it may be considered as an alternative to existing treatments like Dupixent if conjunctivitis occurs during their use.” Professor Lee noted, “Currently, there is limited active switching between treatments.

 

However, some patients may benefit from switching, so I anticipate that this will become more common in the future.”