Tildrakizumab: A Review in Moderate-to-Severe Plaque Psoriasis

Tildrakizumab (tildrakizumab-asmn in the USA) [Ilumetri^®; Ilumya™] is a humanized monoclonal antibody (mAb) that selectively targets the p19 subunit of interleukin (IL)-23, thereby inhibiting the IL-23/IL-17 axis, the signalling pathway primarily implicated in the immunopathogenesis of psoriasis. Administered subcutaneously, it is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy (e.g. in the EU and Australia) and those who are candidates for systemic therapy or phototherapy (in the USA). In the pivotal phase III reSURFACE 1 and 2 trials, tildrakizumab was superior to placebo and efficacious compared with etanercept, in terms of the proportion of patients achieving a response [≥ 75% improvement from baseline in Psoriasis Area and Severity index score (PASI 75) and a Physician’s Global Assessment score of 0/1] at week 12. Response rates peaked at week 22 and the vast majority of patients achieving PASI 75 at week 28 maintained this response after a total of 3 years of treatment in the reSURFACE trials and their ongoing open-label extension studies. In addition, patients with a partial or no response to etanercept at week 28 benefitted from switching to the highest approved dose of tildrakizumab in the reSURFACE 2 trial and its ongoing extension. Treatment with tildrakizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. Tildrakizumab thus expands the range of useful therapeutic options for patients with moderate-to-severe plaque psoriasis, particularly those with an inadequate response to phototherapy and conventional systemic agents.