Ixekizumab (3) – Taltz®

• Clinical trials
  • The COAST-V study is a double-blind, randomised, controlled, multicentre study.
  • The COAST-W trial is a double-blind, randomised, controlled, multicentre trial.
  • The COAST-X trial is a double-blind, randomised, controlled, multicentre trial.

a1) Adult patients with active radiographic axial spondyloarthritis who have responded inadequately to conventional therapy

• For adult patients with active radiographic axial spondyloarthritis who have responded inadequately to conventional therapy, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
• In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer has not provided any suitable direct comparative studies against the appropriate comparator therapy.
• Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
• Overall, for adult patients with active radiographic axSpA who have responded inadequately to conventional therapy, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

a2) Adult patients with active radiographic axial spondyloarthritis who have responded inadequately to prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment

• For adult patients with active radiographic axial spondyloarthritis who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
• In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
• Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
• Overall, for adult patients with active radiographic axSpA who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

b) Adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as evidenced by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs)

• For adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as demonstrated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
• In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
• Furthermore, no indirect comparisons were presented to address the benefit assessment question.
• Overall, for adult patients with active non-radiographic axSpA with objective signs of inflammation, as demonstrated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to non-non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.