Secukinumab (8) – Cosentyx®

• Clinical trials
  • In the dossier, the pharmaceutical manufacturer refers to the authorisation study CAIN457F2304. This is a withdrawal-design study which, unlike the target population approved for secukinumab, examines a patient population that has responded to treatment.

Patients aged 6 years and over with active juvenile psoriatic arthritis whose condition has responded inadequately to conventional therapy or who cannot tolerate it

• For patients aged 6 years and over with active juvenile psoriatic arthritis whose condition has responded inadequately to conventional therapy or who cannot tolerate it, the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
• Overall, there is no suitable study available for the target population under consideration that allows for either a direct or an indirect comparison of secukinumab with the appropriate comparator therapy.
• On balance, there are no data available that are suitable for a benefit assessment. The additional benefit of secukinumab compared with the appropriate comparator therapy is therefore not proven.

Courtesy translation only, please refer to the German original.