Dupixent Approved by European Commission as First and Only Biologic for Severe Atopic Dermatitis in Children Aged 6 to 11

Compiled by Ke Ke

On November 30, Regeneron and Sanofi announced that the European Commission (EC) had expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include the treatment of children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy. Dupixent became the first and only biologic therapy approved by the EC for pediatric patients aged 6 to 11 years with severe atopic dermatitis, as well as the only systemic medication approved for the treatment of these patients.

Dupixent has previously been approved in the European Union for the treatment of atopic dermatitis and other type 2 inflammatory diseases, such as asthma and chronic rhinosinusitis with nasal polyps in adult patients.

As approved, for children aged 6 to 11 years weighing 15 to <60 kg, administer Dupixent 300 mg subcutaneously every four weeks, with the two injections spaced 14 days apart. For patients weighing ≥60 kg, after administering the initial loading dose on the same day, administer Dupixent 300 mg every two weeks. Based on physician assessment, the dosage for patients weighing 15 to <60 kg may be increased to 200 mg every two weeks.

The EC’s decision was primarily based on efficacy and safety data from a pivotal Phase 3 clinical study. This pediatric trial compared the efficacy and safety of Dupixent in combination with topical corticosteroids (TCS) versus TCS alone (as the placebo group) in children aged 6 to 11 years with severe atopic dermatitis. The co-primary endpoints were skin clearance, assessed by an Investigator’s Global Assessment (IGA) score of 0 or 1, and disease extent and severity, measured by the Eczema Area and Severity Index (EASI-75). Secondary endpoints included the mean change from baseline in EASI score, as well as a reduction of at least 4 points on a 0–10 scale in itch severity (weekly average of the daily Peak Pruritus Numerical Rating Scale). Furthermore, improvements in health-related quality of life (HR QoL) were evaluated based on the proportion of patients achieving at least a 6-point improvement in the patient-reported Children’s Dermatology Life Quality Index (CDLQI), along with additional measures from the Patient-Oriented Eczema Measure (POEM) and the Scoring Atopic Dermatitis (SCORAD) index.

At Week 16, patients in the treatment group receiving either 300 mg of Dupixent every four weeks (N=122) or 200 mg of Dupixent every two weeks (N=59), in combination with TCS, experienced the following changes:

Improvement in Disease Severity and Grade:

· Compared with the placebo group, patients treated with Dupixent every four weeks showed a mean improvement of 82%, and those treated every two weeks showed a mean improvement of 80%.

· In the treatment group receiving therapy every four weeks, 70% of patients achieved at least a 75% improvement, compared to only 17% in the placebo group;

· In the biweekly treatment group, 75% of patients achieved at least a 75% improvement, compared to only 26% in the placebo group.

Skin Cleansing:

· Among patients treated with Dupixent every four weeks, 33% achieved clear or almost clear skin, compared with 11% in the placebo group;

· Among patients treated with Dupixent every two weeks, 39% achieved clear or almost clear skin, compared with 10% in the placebo group.

Reduce Itching:

· Among patients treated with Dupixent every four weeks, 51% experienced significant relief from pruritus, compared to only 12% in the placebo group;

· 61% of patients treated with Dupixent every two weeks experienced significant relief from pruritus, compared to only 13% in the placebo group.

HR QoL：

· In the HR QoL report, 77% of patients treated with Dupixent every four weeks experienced clinically meaningful improvement, compared to 39% in the placebo group;

· 81% of patients treated with Dupixent every two weeks achieved clinically meaningful improvement, compared to 36% in the placebo group.

· Dupixent-treated patients also showed improvements in HRQoL assessments of disease severity and patient-reported outcomes such as pruritus and sleep.

Furthermore, based on the open-label extension study, the safety profile of Dupixent in children aged 6 to 11 years over 52 weeks was similar to that observed at Week 16 and consistent with the safety profile in adults and adolescents with atopic dermatitis.

References:

1.Dupixent approved in EU for atopic dermatitis in children

2.Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe Atopic Dermatitis