Dupixent, 1st biologic approved for pruritic rash indication

This marks the third indication for Dupixent, following its approval for treating ‘atopic dermatitis and asthma’

Dupixent demonstrated efficacy in the PRIME clinical study, showing improvement in the Worst-Itch Numeric Rating Scale (WI-NRS)

Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center.

As Dupixent is approved to treat prurigo nodularis (nodular itchy rash), the drug emerged as the only available treatment option among biologic agents.

 

Previously, there were limited treatment options for treating prurigo nodularis, a condition that causes extreme itchiness.

 

Sanofi hosted a press conference at Novotel Ambassador Seoul Gangnam on the 28th to commemorate the company’s expansion of Dupixent indications to treat prurigo nodularis.

 

Dupixent is a biological agent designed to target interleukin (IL)-4 and IL-13 signaling pathway, biomarkers of type 2 inflammation, and regulates the symptoms.

 

The drug has shown effects in inflammatory diseases such as atopic dermatitis and eosinophilic esophagitis.

 

Moreover, Dupixent secured an expanded indication for prurigo nodularis.

 

Last December, Dupixent was approved in Korea for treating moderate to severe prurigo nodularis in patients aged 18 years and older who had inadequate responses to or were not recommended for a topical treatment.

 

Prurigo nodularis is a chronic dermatitis associated with type 2 inflammation.

 

It is known to significantly impact a patient’s quality of life more than any other inflammatory skin disease due to extreme itchiness.

 

High-dosage topical steroids are commonly prescribed for the treatment, but their long-term use can pose safety risks.

 

These risks include dermal atrophy, infection, blurry vision, and vision deterioration.

 

The introduction of Dupixent, which has confirmed efficacy and safety, may improve patient’s quality of life.

 

This approval was based on the PRIME and PRIM2 Phase 3 clinical studies.

 

The studies included 311 patients aged 18 and older with prurigo nodularis.

 

The primary endpoint was the proportion of patients who achieved scores of 4 points or greater reduction in the Worst-Itch Numeric Rating Scale (WI-NRS) at 12 weeks and 24 weeks.

 

In PRIME clinical results, the patients who received Dupixent showed nodule reduction at 12 weeks and 24 weeks.

 

At 24 weeks, 48% of patients with Dupixent showed an improvement in their condition measured by a WI-NRS score of 4 points and a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S).

 

Therefore, the improvement by Dupixent treatment was significantly greater than the 18% observed in the placebo group.

 

Furthermore, the PRIME2 clinical study also demonstrated that 45% of patients who received Dupixent showed an improvement by a WI-NRS score of 4 points or more and a score of 0 or 1 point in the IGA PN-S, a significantly higher proportion of patients with improvements compared to the 16% in the placebo group.

 

Throughout the first 24 weeks, Dupixent displayed a consistent safety profile that is similar to what is known from other indications.

 

“Prurigo nodularis is often associated with type 2 inflammatory diseases such as atopic dermatitis and asthma.

 

Almost half of the patients with prurigo nodularis also have atopic disease.

 

Dupixent is the only biologic agent available for targeting this disease,” Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center, said.

 

“Over 60% of patients suffer from sleep-related deterioration due to chronic itch, which is often linked to psychological disorders such as depression or anxiety,” Ahn added.

 

“The previous treatment options for prurigo nodularis were limited.

 

Therefore, the introduction of biologic agent that is effective and has fewer side effects can improve the quality of life of the patients,” Ahn emphasized.