Bimekizumab (3) – Bimzelx®

• Clinical trials
  • The BE MOBILE 2 study presented in the dossier is a randomised controlled trial comparing bimekizumab with placebo in the treatment of adult patients with active ankylosing spondylitis.

a) Adults with active ankylosing spondylitis who have responded inadequately to, or are unable to tolerate, conventional therapy

• For adults with active ankylosing spondylitis 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 for either patient population to assess the additional benefit of bimekizumab compared with the appropriate comparator therapy.
• Overall assessment
  • An additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.

b) Adults with active ankylosing spondylitis who have responded inadequately to, or are unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs)

• For adults with active ankylosing spondylitis who have responded inadequately to, or are intolerant of, prior treatment with biological anti-rheumatic drugs (bDMARDs), the additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of bimekizumab compared with the appropriate comparator therapy.
• Overall assessment
  • An additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.