Adtralza becomes the 2nd reimbursed biological drug for AD

biological drug for atopic dermatitis

Was reimbursed from May 1st …can be used in patients aged 12 years or older

Becomes 2nd biological treatment option for AD following Dupixent…broadens choice

Jiyoung Ahn, Professor of Dermatology at the National Medical Center

LEO Pharma Korea has launched Adtralza (tralokinumab) as the 2nd biologic drug in the atopic dermatitis market and is on its way to take on Dupixent.

 

LEO Pharma has been emphasizing that Adtralza has a longer dosing interval after 16 weeks compared to existing therapies and is relatively cheaper, reducing the cost burden for patients.

 

On March 30, LEO Pharma held a press conference at the Grand Hyatt Hotel in Seoul to celebrate the reimbursed launch of Adtralza.

 

Adtralza is a biological drug that selectively targets interleukin-13 (IL-13).

 

The drug is being reimbursed for the treatment of chronic severe atopic dermatitis in adults and adolescents from the 1st of this month.

 

IL-13 is a key cytokine that causes signs and symptoms of atopic dermatitis, including immune dysregulation and skin barrier dysfunction, and is overexpressed in affected skin and is known to be correlated with the severity of the disease.

 

The launch of Adtralza adds a biologic treatment option for atopic dermatitis alongside Sanofi's Dupixent, which inhibits IL-4 and IL-13.

 

Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years and meets one of the following conditions: ▲patient received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but was unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or was unable to continue their use due to side effects’ or ▲Patients has an EASI of 23 or greater prior to Adtralza use.

 

Adtralza’s clinical efficacy and safety were confirmed through four Phase III ECZTRA 3 and ECZTEND trials.

 

The ECZTRA 3 trial compared Adtralza to placebo in patients 18 years of age and older with moderate-to-severe atopic dermatitis who had not responded adequately to prior topical therapy or requires systemic therapy.

 

The primary endpoint of the trial was the Investigators' Global assessment score of 0 (clear) or 1 (almost clear) and EASI 75 (75% improvement in Eczema Area and Severity Index)at week 16.  Trial results showed that the rate of patients who achieved EASI 75 at Week 16 was 56.0% in the Adtralza group, which is a clinically significant improvement compared with the 35.7% in the placebo group.

 

 Also, 38.9% in the Adtralza group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, compared with 26.2% in the placebo group.

 

Results from the ECZTEND study, which evaluated the long-term efficacy of Adtralza, showed that 84.5% of patients had an EASI-75 at 4 years of Adtralza treatment.

 

Adtralza was also effective in patients with difficult-to-treat head and neck atopic dermatitis.

 

In particular, Adtralza had the advantage of being dosed once every 4 weeks after week 16, ensuring ease of administration for the patients.

 

Jiyoung Ahn, Professor of Dermatology at the National Medical Center, said, “Although the symptoms of atopic dermatitis may not seem serious, the itching and pain that patients experience can interfere with sleep and other daily life activities.

 

Although there are many treatment options available on the market, the number of patients with atopic flare-ups continues to increase, so various treatment options are necessary, We are excited about the increased treatment options that the launch of Adtralza brings to us healthcare providers and patients." Dong Hun Lee, Professor of Dermatology at Seoul National University Hospital, said, “Adtralza is convenient because it can be administered every 4 weeks at the discretion of the physician for patients with clear or nearly clear skin after 16 weeks of treatment.

 

Also, its reimbursed price is lower than its competitors, which will reduce the financial burden borne by the patients."