Upadacitinib (6) – Rinvoq®

• Clinical trials
  • The SELECT-AXIS 2 trial is a placebo-controlled RCT.
  • The study included adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation who had shown an inadequate response to treatment with NSAIDs, or for whom treatment with NSAIDs was not indicated or suitable.
  • Patients were randomised in a 1:1 ratio to receive either upadacitinib 15 mg once daily or placebo.

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 non-non-steroidal anti-inflammatory drugs (NSAIDs)

• An additional benefit is not proven.
• In its dossier for the assessment of the additional benefit of upadacitinib, the pharmaceutical manufacturer does not present any suitable direct comparative study against the appropriate comparator therapy.
• Furthermore, no indirect comparisons were provided to address the issues raised in the benefit assessment.
• In the placebo-controlled registration trial SELECT-AXIS 2, the appropriate comparator therapy was not implemented; consequently, no suitable data are available from this trial for the early benefit assessment.
• Overall assessment
  • In summary, for adult patients 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 non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of upadacitinib compared with the appropriate comparator therapy is not proven.

b) 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 prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment

• An additional benefit is not proven.
• In its dossier for the assessment of the additional benefit of upadacitinib, the pharmaceutical manufacturer has not provided any suitable direct comparative study against the appropriate comparator therapy.
• Furthermore, no indirect comparisons were provided to address the issues raised in the benefit assessment.
• In the placebo-controlled registration trial SELECT-AXIS 2, the appropriate comparator therapy was not implemented; consequently, no suitable data are available from this trial for the early benefit assessment.
• Overall assessment
  • Overall, for adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or confirmed by magnetic resonance imaging (MRI), who have responded inadequately to prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment, the additional benefit of upadacitinib over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.