INTRODUCTION
Plaque psoriasis is a chronic, inflammatory skin disorder spanning a patient's lifetime and hence requires long-term management.1 Psoriasis is a multisystem disease that remarkably impacts patients' physical health and is associated with an increased incidence of comorbid conditions, including cardiovascular disease, Crohn's disease, type 2 diabetes, obesity, and lymphoma.1-3 Psoriasis and its symptoms also have a considerable impact on patients' quality of life.2
Interleukin (IL)-23 is a key pro-inflammatory cytokine mediating psoriatic inflammation and tissue damage and is thus a target of plaque psoriasis therapy.4,5 The p19 subunit of IL-23 is unique to this cytokine, while the p40 subunit is also present in IL-12.4 Tildrakizumab, a high affinity, anti–IL-23 p19 monoclonal antibody, selectively binds to the p19 subunit, blocking its interaction with the IL-23 receptor. It is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.6,7
The efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis were assessed in 2 Phase 3, multinational, randomized clinical trials, reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754).7-9 In the 64-week reSURFACE 1 trial, patients received a subcutaneous injection of tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo at baseline, week 4, and every 12 weeks thereafter. In the 52-week reSURFACE 2 trial, patients received a subcutaneous injection of tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo on the same schedule as in reSURFACE 1, with etanercept 50 mg (twice weekly to week 12, then weekly to week 28) as an active comparator. In both trials, at week 12, higher proportions of patients receiving tildrakizumab 100 mg achieved greater than or equal to 75% and greater than or equal to 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (PASI 75 and PASI 90 response, respectively) and Physician Global Assessment (PGA) score of "clear" or "minimal" compared with patients receiving placebo.7 Frequencies of adverse events (AEs) were favorable and similar among tildrakizumab treatment arms in
Interleukin (IL)-23 is a key pro-inflammatory cytokine mediating psoriatic inflammation and tissue damage and is thus a target of plaque psoriasis therapy.4,5 The p19 subunit of IL-23 is unique to this cytokine, while the p40 subunit is also present in IL-12.4 Tildrakizumab, a high affinity, anti–IL-23 p19 monoclonal antibody, selectively binds to the p19 subunit, blocking its interaction with the IL-23 receptor. It is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.6,7
The efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis were assessed in 2 Phase 3, multinational, randomized clinical trials, reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754).7-9 In the 64-week reSURFACE 1 trial, patients received a subcutaneous injection of tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo at baseline, week 4, and every 12 weeks thereafter. In the 52-week reSURFACE 2 trial, patients received a subcutaneous injection of tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo on the same schedule as in reSURFACE 1, with etanercept 50 mg (twice weekly to week 12, then weekly to week 28) as an active comparator. In both trials, at week 12, higher proportions of patients receiving tildrakizumab 100 mg achieved greater than or equal to 75% and greater than or equal to 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (PASI 75 and PASI 90 response, respectively) and Physician Global Assessment (PGA) score of "clear" or "minimal" compared with patients receiving placebo.7 Frequencies of adverse events (AEs) were favorable and similar among tildrakizumab treatment arms in
