Approval called for drug switching in atopic dermatitis

Dr. Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center

Emphasizes the importance of a patient-customized strategy, as various treatment options for atopic dermatitis are available

A biological agent, Ebglyss, emerges as a new treatment option…fewer conjunctivitis side effects

Points out the limited treatment options based on a patient's condition…mentions the necessity for drug switching, regardless of drug-type

Atopic dermatitis treatment settings are changing quickly.

 

New treatment options are available as new drugs with fewer side effects and superior treatment effectiveness than existing therapies emerge.

 

There is a growing interest in how atopic dermatitis can be treated rather than just treating it, as changes have been brought to the treatment paradigm.

 

According to health experts, considering many factors contibute to the nature of atopic dermatitis, even if the same medication is used, the treatment effects may vary by patient.

 

Dr.

 

Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center, who has the latest expertise in this field stresses, the importance of treatment choice based on potential treatment effects and side effects and the need for improvement to the system.

 

"New drugs for atopic dermatitis have shifted the treatment paradigm" Dr.

 

Lee says the most significant change he has experienced following the introduction of new drugs for atopic dermatitis is the treatment effects and patient awareness.

 

Dr.

 

Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center

"In the past, patients were reluctant to receive therapy or even avoid getting one because of the notion that atopic dermatitis treatment is not efficacious and long-term steroid therapy may result in side effects.

 

However, the launch of biological agents and targeted therapies such as JAK inhibitors have changed the care settings," Dr.

 

Lee says.

 

New drugs for atopic dermatitis are good news because treatment effects vary greatly depending on the patient's sensitivity.

 

"Atopic dermatitis is a multifactorial disease where it is not affected by just a single factor but caused by various contributing factors, such as genetic factors, skin barrier issues, and dysfunctional immune responses," Dr.

 

Lee stated.

 

"Due to varying patient sensitivity, even if the same medication is used, patients may experience varying treatment effects." For instance, it means that even if biological agents or JAK inhibitors of the same class are used, patient treatment can differ depending on the mechanism.

 

More treatment options became available this year and will likely change the treatment setting.

 

On January 9, Lily Korea's Ebglyss (ingredient name: lebrikizumab), used to treat moderate to severe atopic dermatitis, was launched.

 

Ebglyss was launched six months after obtaining approval from the Ministry of Food and Drug Safety (MFDS) in August 2024.

 

It is a new biologic treatment that selectively blocks interleukin (IL)-13.

 

The efficacy and safety profile of Ebglyss have been confirmed in the Phase 3 clinical trials.

 

Once a patient meets the clinical response after 16 weeks treatment, the drug can be administered every 4 weeks with a maintenance dose (250 mg).

 

Dr.

 

Lee focused on fewer side effects associated with Ebglyss compared to conventional therapies.

 

"While long-term use of cyclosporine or steroids can lead to various side effects, Ebglyss, a biological treatment, is relatively free from such concerns in terms of side effects.

 

It has the advantage of long-term prescriptions and greater efficacy than existing treatments," Dr.

 

Lee says.

 

The basis of approval for Ebglyss was ADvocate-1 and ADvocate-2 Phase 3 studies.

 

According to the results, the most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%).

 

Although dupilumab, a representative treatment for atopic dermatitis, is effective, some patients may experience side effects, including worsening conjunctivitis or facial and neck dermatitis.

 

Therefore, therapies like Ebglyss are seen as potential alternatives.

 

"Compared to dupilumab, Ebglyss shows a relatively lower frequency and severity of side effects such as conjunctivitis or facial and neck dermatitis," Dr.

 

Lee said.

 

"Additionally, if clinical response is achieved, Ebglyss can be administered monthly after 16 weeks.

 

If the efficacy and side effects are comparable, drug adherence can be considered to reduce patient burden." Switching drugs for atopic dermatitis treatment has limitations…"We must provide broader range of treatment options to provide patient-customized treatments" However, there are challenges to overcome to achieve this.

 

The remaining issue is a 'drug switching' between treatments.

 

Last year, the Korean Atopic Dermatitis Association (KADA) submitted a statement to the health authority illustrating that drug switching should be allowed in the field of atopic dermatitis.

 

The government is reviewing this matter, but it is expected to take time.

 

The reimbursement criteria for special cases of atopic dermatitis patients switching treatments are complicated.

 

For example, if patients transition from a biological therapy to a JAK inhibitor, they must meet complicated eligibility requirements from the beginning.

 

Similarly, the same applies when switching from a JAK inhibitor to a biological therapy.

 

"Patients often feel discomfort from the side effects of their current treatments, but due to the reimbursement requirements, which mandate waiting periods of three to four months, they often give up on switching therapies," Dr.

 

Lee explained.

 

"Meeting these conditions is burdensome, leaving patients in a situation where they must continue treatments despite experiencing side effects." "From the patient's perspective, having a broader range of treatment options is essential, and from the doctor's perspective, it is crucial to have multiple tools to combat a disease like atopic dermatitis.

 

Therefore, the drug switching is vital," Dr.

 

Lee emphasized.

 

"If drug switching becomes more accessible, doctors will have a wider range of options for treatment, and patients can look forward to achieving better therapeutic outcomes." Dr.

 

Lee particularly mentioned that if drug switching for atopic dermatitis is approved, the treatment options among drug types and the number of limitations must be discussed.

 

"Patients who do not respond to existing treatments should be able to switch medications immediately.

 

They should be able to choose from the same drug type, such as a biological agent or JAK inhibitor," Dr.

 

Lee says.

 

"In my opinion, not limiting the number of possible drug switching will broaden the range of treatments." "Drug switching is permitted for psoriasis, which is the same inflammatory skin disease.

 

However, unlike psoriasis, atopic dermatitis is significantly limited.

 

Like psoriasis, the treatment setting for atopic dermatitis should improve quickly," Dr.

 

Lee said.

 

Ultimately, Dr.

 

Lee advised actively treating atopic dermatitis with a wider range of treatment options.

 

"In the past, patients treated for atopic dermatitis often experienced several side effects or did not fully benefit from their treatment.

 

However, new drugs provide opportunities for patients.

 

Because many opportunities are open for patients with severe disease who need treatment, we hope patients will participate in getting treatment," Dr.

 

Lee said.