Tofacitinib (7) – Xeljanz®

• Clinical trials
  • Furthermore, no indirect comparisons were presented to address the questions raised in the benefit assessment.

a1) Adults with active ankylosing spondylitis who have responded inadequately to conventional therapy and who are eligible for treatment with tofacitinib

• The additional benefit is not proven.
• In its dossier for the assessment of the additional benefit of tofacitinib, 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.
• On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
• Overall assessment
  • On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.

a2) Adults with active ankylosing spondylitis who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment and who are eligible for treatment with tofacitinib

• An additional benefit is not proven.
• In its dossier for the assessment of the additional benefit of tofacitinib, 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.
• On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
• Overall assessment
  • On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.

Courtesy translation only, please refer to the German original.