Baricitinib (4) – Olumiant®

• Clinical trials
  • In the BREEZE-AD-PEDS trial, which formed the basis for marketing authorisation, a randomised comparison with placebo was conducted over 16 weeks.

a) Children aged 2 to 11 years with moderate atopic dermatitis who are eligible for systemic therapy

• For children aged 2 to 11 years with moderate atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
• No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
• An additional benefit of baricitinib over the appropriate comparator therapy is not proven.
• The G-BA defined the appropriate comparator therapy as a treatment regimen optimised for the individual patient depending on the severity of the condition and taking into account prior treatment, taking into account topical glucocorticoids of classes 1 to 3 and topical calcineurin inhibitors.

b) Children aged 2 to 11 years with severe atopic dermatitis who are eligible for systemic therapy

• For children aged 2 to 11 years with severe atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
• No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
• An additional benefit of baricitinib compared with the appropriate comparator therapy is not proven.
• The G-BA has designated treatment with dupilumab (where appropriate, in combination with TCS and/or TCI) as the appropriate comparator therapy.

c) Adolescents aged 12 to 17 with moderate to severe atopic dermatitis who are eligible for systemic therapy

• For adolescents aged 12 to 17 with moderate to severe atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
• No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
• An additional benefit of baricitinib over the appropriate comparator therapy is not proven.
• The G-BA has designated treatment with dupilumab (where appropriate, in combination with TCS and/or TCI) as the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.