DUPIXENT (dupilumab) - Severe atopic dermatitis in children 6 months to 5 years old

The clinical benefit of DUPIXENT 200 mg and 300 mg (dupilumab) solution for injection in pre-filled syringe is substantial in the MA indication.

Considering:

• demonstration of the superiority of dupilumab compared to placebo, in combination with topical corticosteroids, in a phase-3 study of good methodological quality, in children 6 months to 5 years old with moderate to severe atopic dermatitis who are candidates for systemic therapy, with a significant and clinically relevant additional effect size on:
  • the two ranked primary efficacy endpoints after 16 weeks of treatment: percentage of IGA = 0 or 1 responders (27.7% versus 3.9%, p < 0.0001) and percentage of EASI 75 responders (53.0% versus 10.7%, p < 0.0001),
  • the ranked secondary endpoints, including, in particular, the percentage of EASI 90 responses (25.3% versus 2.8%; p < 0.0001), the percentage of patients with a reduction in peak pruritus score ≥ 4 (48.1% versus 8.9%, p < 0.0001), the mean variation in skin pain (VAS from 0 to 10: -3.9 versus -0.6, p < 0.0001),
• demonstration of a statistically significant and clinically relevant improvement in sleep quality, and quality of life of patients and their families (assessed as ranked secondary endpoints) at week 16, and
• similar results (exploratory) observed in the subgroup of children with severe AD (77% of the sample) for all the endpoints,
• similar efficacy and safety to those observed in older children, adolescents and adults,
• the substantial medical need given the absence of validated alternatives in the management of children requiring systemic treatment,

despite:

• uncertainties with respect to maintenance of efficacy beyond 16 weeks and long-term maintenance of the safety profile,
• uncertainties with respect to the efficacy and safety of dupilumab in children 6 months to 1 year of age, who were little represented in the study (6 patients treated),

the Committee deems that DUPIXENT 200 mg and 300 mg (dupilumab) solution for injection in pre-filled syringe provides a moderate clinical added value (CAV III) in the current care pathway for severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.