Secukinumab (7) – 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, investigates a patient population that has responded to treatment.

Patients aged 6 years and over with active enthesitis-associated arthritis whose condition has responded inadequately to conventional therapy or who are unable to tolerate it

• For patients aged 6 years and over with active enthesitis-associated 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, for the target population under consideration, there is no suitable study available 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.
• Overall assessment
  • On balance, the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.