Secukinumab (2) – Cosentyx®

• Clinical trials
  • The studies supporting the marketing authorisation for secukinumab in the indication of psoriatic arthritis consist of two placebo-controlled studies (F2306 and F2312).
  • The studies supporting the marketing authorisation for secukinumab in the indication ‘ankylosing spondylitis’ consist of two placebo-controlled studies (F2305 and F2310).

a) Psoriatic arthritis (PsA)

• The pharmaceutical manufacturer has been unable to identify any studies suitable for demonstrating the additional benefit of compare secukinumab in adult patients with active psoriatic arthritis with the appropriate comparator therapy (TNF-alpha inhibitors [etanercept or adalimumab or infliximab or golimumab], where appropriate in combination with MTX).
• Furthermore, no indirect comparison was carried out.

b) Ankylosing spondylitis (AS; Bechterew’s disease)

• The pharmaceutical manufacturer has been unable to identify any studies suitable for demonstrating the additional benefit of compare secukinumab in adult patients with ankylosing spondylitis with the appropriate comparator therapy (TNF-alpha inhibitors [etanercept, adalimumab, infliximab or golimumab]).
• Furthermore, no indirect comparison was carried out.

Courtesy translation only, please refer to the German original.