Dupilumab (12) – Dupixent®

Adults and adolescents aged 12 years and over with moderate to severe chronic spontaneous urticaria who have had an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment

• For adults and adolescents aged 12 years and over with moderate to severe chronic spontaneous urticaria who have an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment, The additional benefit compared with the appropriate comparator therapy is not proven.
• In its dossier, the pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of dupilumab compared with the appropriate comparator therapy.
• Overall, there are therefore no data available to enable an assessment of the additional benefit of dupilumab for the treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents (aged 12 years and over) who respond inadequately to treatment with H1 antihistamines and have not previously received anti-IgE antibodies as part of their CSU treatment.
• The pharmaceutical manufacturer has not submitted any data to demonstrate the additional benefit of dupilumab compared with the appropriate comparator therapy. Consequently, there is no evidence of additional benefit from dupilumab for the treatment of adults and adolescents aged 12 years and over with moderate to severe chronic spontaneous urticaria who have an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment. No proof.

Courtesy translation only, please refer to the German original.