Dupixent can be used by all age groups

Share 52 weeks of long-term data and youth administration experience in Korea

onfirmation of validity and safety profile consistent with clinical practice

Point out rigid benefit standards, the subjective indicators should be reflected

Dupixent, atopic dermatitis (Eczema) treatment that marks its third anniversary, is becoming the only biological agent available for all ages.

 

Doctors agreed, "It is time to show flexibility in applying Dupixent benefits that have secured long-term effectiveness and safety." At an online seminar held by Sanofi to mark the 3rd anniversary of its launch in Korea on the 13th, Ahn Ji-young, a dermatologist at the National Medical Center, and Na Chan-ho, a dermatologist at Chosun University Hospital, shared their long-term Dupixent administration experience in 52 weeks (1 year) in domestic adult atopic dermatitis patients.

 

Professor Ahn's 52-week long-term data is a study that analyzed the medical records of patients treated with Dupixent from September 2018 to December 2020, targeting 99 adult patients with moderate-severe symptoms.

 

In the 52nd week of administration, EASI improved 88.1% compared to 30.02 points in the baseline.

 

89.9% of the administered group achieved EASI-75, and the itching NRS score also improved by 76.6% compared to the baseline of 8.37 points.

 

The POEM score also improved 67.21% compared to the baseline (23.73 points) in week 52, and DLQI improved 69.02% compared to the baseline (22.37 points).

 

Even in long-term administration for 52 weeks, it was consistent with the safety profile shown in phase 3 clinical trials.

 

The main adverse reactions improved as both symptoms were treated, including facial erythema (19.9%) and conjunctivitis (17.17%).

 

Professor Ahn said, "Atopic dermatitis is a chronic disease, and long-term symptom improvement requires safe and continuous treatment," and added, "Dupixent was able to confirm the long-term effectiveness and safety profile up to 52 weeks consistent with clinical trials in domestic patients." Professor Na then announced the results of an analysis of moderate-severe youth patients treated with Dupixent for one year from October last year.

 

He explains that children and adolescents suffering from severe atopic dermatitis are burdened with serious diseases such as study, sleep, and outdoor activities.

 

Until Dupixent received indications for children and adolescents, treatment options such as systemic immunosuppressants were limited.

 

Dupixent improved the EASI score by 82.9% compared to the baseline (25.1 points) in the 16th week of administration, and the CDLQI related to childhood skin also increased by 57.2% compared to the baseline (13.1 points).

 

POEM scores and itching NRS scores improved 54.4% and 53%, respectively, compared to baseline.

 

Like adults, it showed similar effects in domestic youth patients in the actual clinical environment.

 

Furthermore, the EASI-75 achievement rate was 77.8%, which was better than that of phase 3 (41.5%).

 

Recently, Sanofi also confirmed the effectiveness and safety of Dupixent in phase 3 clinical trials for infants and toddlers aged 6 months to 5 years.

 

If the indications expand to that age, Dupixent is expected to be the only biological agent available to patients of all ages suffering from moderate-severe atopic dermatitis.

 

Experts said it was time to give flexibility to Dupixent's conditions, which secured a variety of data.

 

Professor Ahn said, "It is necessary to study whether patients undergoing long-term administration maintain their effectiveness even if the administration interval is increased.

 

At the same time, it would be nice to expand benefits to patients who are initially administered by reflecting subjective indicators in addition to objective indicators, she said.

 

Professor Na also added, "As the guidelines of the Association of Atopic Dermatitis have recently been revised to reflect subjective indicators such as DLQI, it seems necessary to refer to the standards."