Ixekizumab (6) – 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 enthesitis-related arthritis and a body weight of at least 25 kg who have responded inadequately to, or are unable to tolerate, 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 accordance with the pharmaceutical manufacturer’s approach set out in the dossier, no suitable studies could be identified for the benefit assessment of ixekizumab.

Courtesy translation only, please refer to the German original.