Upadacitinib (3) – Rinvoq®

• Clinical trials
  • The SELECT-AXIS-1 trial submitted with the dossier is a placebo-controlled RCT.
  • The study included adult patients with active ankylosing spondylitis who had shown an inadequate response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or who were intolerant to them.
  • They were randomised 1:1 to receive either upadacitinib 15 mg once daily or placebo.

a1) Adults 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 upadacitinib compared with the appropriate comparator therapy is not proven.
• Overall, for adults with active radiographic axial spondyloarthritis (axSpA) who have responded inadequately to conventional therapy, the additional benefit of upadacitinib compared with the appropriate comparator therapy is not proven.
• Overall assessment
  • In its dossier for the assessment of the additional benefit of upadacitinib, the pharmaceutical manufacturer does not present 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.
  • In this placebo-controlled registration trial, the appropriate comparator therapy was not implemented; consequently, no suitable data are available from this trial for the early benefit assessment.

a2) Adults with active radiographic axial spondyloarthritis who have had an inadequate response to, or who are intolerant of, prior treatment with biological anti-rheumatic drugs (bDMARDs)

• 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 upadacitinib compared with the appropriate comparator therapy is not proven.
• Overall, for adults 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 upadacitinib compared with the appropriate comparator therapy is not proven.
• Overall assessment
  • In its dossier for the assessment of the additional benefit of upadacitinib, 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.

Courtesy translation only, please refer to the German original.