Bimekizumab (4) – Bimzelx®

• Clinical trials
  • The BE MOBILE 1 study presented in the dossier is a randomised controlled trial comparing bimekizumab with placebo in the treatment of adult patients with active non-radiographic axial spondyloarthritis.

a) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to or are intolerant of non-steroidal anti-inflammatory drugs (NSAIDs)

• For adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or confirmed by magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs) or are unable to tolerate them, the additional benefit is not proven.
• In accordance with the pharmaceutical manufacturer’s approach set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of a comparison with the appropriate comparator therapy.

b) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have had an inadequate response to, or have been unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs)

• For adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to, or are unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs), the additional benefit is not proven.
• In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of a comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.