Ixekizumab (5) – Taltz®

• Clinical trials
  • The COSPIRIT-JIA trial, on which the marketing authorisation is based, was an open-label, randomised trial comparing ixekizumab with adalimumab.

Children and adolescents aged 6 years and over with active juvenile psoriatic arthritis and a body weight of at least 25 kg, who have responded inadequately to, or are intolerant of, conventional therapy

• The additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any data to assess the additional benefit of ixekizumab compared with the appropriate comparator therapy.
• In line with the pharmaceutical manufacturer’s approach in the dossier, no studies could be identified that allow a comparison of ixekizumab with the appropriate comparator therapy.
• An additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.