Baricitinib (2) – Olumiant®

• Clinical trials
  • The JAIN trial is a randomised, double-blind, four-arm trial comparing baricitinib (at three different doses, including the authorised dose of 4 mg taken orally) with placebo plus TCS.
  • The CAFE study is a randomised, double-blind, 3-arm study comparing dupilumab (at 2 different doses) with placebo.

Adult patients with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy

• For adult patients with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy, the additional benefit of baricitinib compared with the appropriate comparator therapy is not proven.
• Consequently, there is no hint that baricitinib offers any additional benefit over the appropriate comparator therapy; an additional benefit is therefore not proven.
• Overall assessment
  • However, the adjusted indirect comparison presented by the pU is not suitable for assessing additional benefit.
  • Although the populations studied in the JAIN and CAFE trials consist of patients for whom continuous systemic therapy is indicated, the duration of treatment in the CAFE study – and thus also the adjusted indirect comparison presented at week 16 – is too short to draw conclusions regarding the additional benefit of long-term treatment for chronic atopic dermatitis.
  • This adjusted indirect comparison is therefore not suitable for drawing conclusions regarding the additional benefit of baricitinib, as the study included on the comparator side for dupilumab (the CAFE study), with a treatment duration of 16 weeks, is too short.
  • There are therefore no suitable data available for assessing the additional benefit of baricitinib compared with the appropriate comparator therapy in the treatment of adult patients with moderate to severe atopic dermatitis who are eligible for systemic therapy and for whom continuous systemic therapy is indicated.

Courtesy translation only, please refer to the German original.