Revisions to the guidelines for atopic dermatitis treatment

With a focus on replacement therapy

New treatment options all rated grade 'A' recommendations…no restrictions on the type of medicines for replacement therapy when initial treatment fails

Emphasizes the necessity of 'biological agent-JAK inhibitor' replacement therapy for treating moderate-to-severe atopic dermatitis

As the market for atopic dermatitis rapidly shifts due to the introduction of new drugs, domestic guidelines are being revised in nine years, and therapeutic guidelines are also changing.

 

The guidelines now suggest a higher recommendation grade for treatments, including biological agents and JAK inhibitors, for use in patients with moderate-to-severe symptoms.

 

They also include detailed recommendations to solve the issue of replacement therapy, which experts focus on.

 

(Clockwise from upper left) Product photos of Dupixent, Rinvoq, Olumiant, Adtralza, and Cibinqo.

The Korea Atopic Dermatitis Association (KADA) announced on July 31st the '2024 Guidelines for the Treatment of Atopic Dermatitis in Korea.' This guidelines have been revised after nine years, since 2015.

 

Biological agents (injectable medicines), such as Dupixent (dupilumab, approved Oct.

 

2018), and JAK inhibitors, such as Olumiant (baricitinib, approved May 2021), have completely changed the paradigm of the treatment for atopic dermatitis.

 

Changes in therapeutic strategy have been reflected in the guidelines following the introduction of new medicines, which can now be prescribed with less economic burden due to reimbursement coverage.

 

The degree of recommendation for biological agents depends on domestic approval.

 

Dupixent and Adtralza (tralokinumab, approved August 2023) were rated as Grade A, the highest recommendation, for treating patients with moderate or severe symptoms that cannot be treated with topical therapy.

 

The basis for a high recommendation grade for these two medicines was based on having real-world studies aligning with clinically shown effects.

 

Considering this factor, medicines that have yet to receive domestic approval, such as lebrikizumab and nemolizumab, were rated as Grade B.

 

Additionally, JAK inhibitors that received domestic approval for treating atopic dermatitis, including Olumiant, Rinvoq (upadacitinib, approved Oct.

 

2021), and Cibinqo (abrocitinib, approved Nov.

 

2021), were all rated as Grade A.

 

However, the recommendation was based on the premise that Olumiant and Rinvoq, which also have indications to treat inflammatory diseases, may be more effective than Cibinqo, which is indicated only to treat atopic dermatitis.

 

Furthermore, unlike biological agents, JAK inhibitors were granted a Grade A recommendation based on conducting early diagnostic monitoring testing.

 

The KADA emphasized that patients be tested for hemocyte count and kidney and liver function four weeks after the treatment for monitoring, and re-assessment every three months during the treatment.

 

The KADA emphasizes replacement therapy…"should be allowed to be used when there are insufficient medicines" Despite the growing number of atopic dermatitis treatment options, clinical practices advocate lifting restrictions on replacement therapy.

 

The issue arises because replacement therapy is authorized for psoriasis within the same dermatology practice.

 

Therefore, itt has been included in the revised guidelines.

 

The main point of the argument is that patients with atopic dermatitis may have different responses.

 

Although biological agents may be effective in treating moderate-to-severe atopic dermatitis, some patients may not respond well to the treatment.

 

Insufficient response, as defined by the KADA, is 'Meeting one or more criteria of having not reached 50% in Eczema Area and Severity Index (EASI) score, suffering from daytime or nighttime pruritus with NRS score ≥4, or having Dermatology Life Quality Index (DLQI) ≥6.

 

The KADA explained, "There are no useful biomarkers to predict the treatment outcomes of biological agents or JAK inhibitors for atopic dermatitis treatment." They added, "Currently, when patients with moderate atopic dermatitis do not respond well or have adverse reactions to the treatment with biological agents or JAK inhibitors, they cannot switch to other medicines for effective treatment." However, the revised guidelines have not specified which biological agents and JAK inhibitors can be used for replacement therapy.

 

Some studies suggest concrete clinical evidence for replacement therapy, but studies with low-grade evidence exist.

 

The KADA stresses that it will not set a hurdle for replacement therapy between biological agents and JAK inhibitors when patients do not respond well to initial treatments.

 

During a press conference, Professor Ahn Ji Young at the National Medical Center, stated, "The sequence for replacement therapy has not been determined as we have not yet concluded the appropriate medicines for this purpose.

 

The KADA hopes that replacement therapy will be possible regardless of types of medicines used." According to the pharmaceutical industry, unlike the initial request for authorization of replacement therapy, the government may be more willing to bring changes now.

 

For instance, the Health Insurance Review and Assessment Service (HIRA) has recently requested supplementary documents.

 

Therefore, replacement therapy may be considered based on KADA's suggestion for patients with insufficient response.

 

An industry official said, "The revised guidelines in South Korea and other countries, such as the United States and Europe, now include various recommendations and evidence for replacement therapy when a patient fails initial treatment." He added, "We cannot predict an accurate date for change, but we hope that accumulating evidence will be used toward opening positive discussion."