Real-World Effectiveness and Safety of Tildrakizumab in Patients With Moderate-to-Severe Psoriasis: Week 28 Interim Analysis of a Phase 4 Study.

BACKGROUND

Tildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis. This analysis evaluated real-world effectiveness and safety of tildrakizumab for 28 weeks.

METHODS

In this Phase 4 study (NCT03718299), adults with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg subcutaneously at week 0, week 4, and every 12 weeks thereafter. Clinical improvement was assessed from Psoriasis Area and Severity Index (PASI) score change from baseline; disease activity from body surface area (BSA) percentage affected, static Physician's Global Assessment (sPGA), and sPGA x BSA; and safety from adverse events (AEs).

RESULTS

At week 28, 52/55 enrolled patients were assessed. Mean (standard deviation [SD]) PASI score decreased significantly (P<0.001) from 11.6 (7.1) at baseline to 1.8 (3.0; 82.1% improvement) at week 28; 55.8% of patients achieved PASI 90 response. From baseline to week 28, mean (SD) BSA decreased significantly from 14.5% (11.5%) to 2.9% (6.4%), sPGA from 3.2 (0.6) to 1.2 (0.9), and BSA x sPGA from 47.0 (41.5) to 6.8 (20.3; all P<0.001). Serious AEs were infrequent. No treatment-emergent AEs were considered related to tildrakizumab. Conclusions: Real-world tildrakizumab treatment significantly improved clinical status and reduced disease activity, with no new safety concerns. Heim J, Gabriel Vasquez J, Schenkel B, et al. Real-world effectiveness and safety of tildrakizumab in patients with moderate- to-severe psoriasis: week 28 interim analysis of a phase 4 study. J Drugs Dermatol. 2023;22(8):754-760. doi:10.36849/JDD.7471.