Tildrakizumab (1) – Ilumetri®

• Clinical trials
  • For patient population b), the pharmaceutical manufacturer presents the randomised, double-blind, active- and placebo-controlled trial P011.

a) Adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their initial systemic treatment.

• For adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their first-line systemic treatment, the additional benefit is not proven.
• The pharmaceutical manufacturer was unable to provide a direct comparative study of tildrakizumab versus the appropriate comparator therapy for patient population a).
• Overall, the pharmaceutical manufacturer has therefore not provided suitable data for assessing the additional benefit of tildrakizumab compared with the appropriate comparator therapy.
• Overall assessment
  • On balance, therefore, an additional benefit is not proven.

b) Adult patients with moderate to severe plaque psoriasis who have responded inadequately to, or are intolerant of, systemic therapy.

• For adult patients with moderate to severe plaque psoriasis who have responded inadequately to, or are unable to tolerate, systemic therapy, the additional benefit is not proven.
• Overall, the pharmaceutical manufacturer has therefore not provided suitable data to assess the additional benefit of tildrakizumab compared with the appropriate comparator therapy.
• Overall assessment
  • On balance, therefore, no additional benefit is proven.

Courtesy translation only, please refer to the German original.