Efficacy and Safety of Tildrakizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis of the Scalp: Week 52 Results From a Phase 3b, Randomized, Double-Blind, Placebo-Controlled Trial.

Background: In the primary analysis of a Phase 3b, randomized, double-blind, placebo-controlled study in patients with moderate-to-severe plaque psoriasis affecting the scalp (NCT03897088), tildrakizumab, an anti-interleukin-23 p19 antibody, met the primary efficacy endpoint at Week (W)16.

Objective: To evaluate maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis from the W52 full analysis.

Methods: Patients randomized to tildrakizumab continued receiving tildrakizumab 100 mg every 12 weeks; patients randomized to placebo (analyzed separately) switched to tildrakizumab 100 mg at W16. Efficacy endpoints included Investigator Global Assessment modified 2011 (IGA mod 2011; scalp) score of 0 or 1 with ≥2-grade improvement and ≥90% improvement in Psoriasis Scalp Severity Index score (PSSI 90) from baseline. Safety was assessed from adverse events.

Results: In patients originally randomized to tildrakizumab vs placebo, IGA mod 2011 (scalp) and PSSI 90 response rates, respectively, improved from 49.4% vs 7.3% and 60.7% vs 4.9% at W16 to 62.9% vs 56.1% and 65.2% vs 57.3% at W52; >80% of W16 responders to tildrakizumab maintained response. No treatment-related serious adverse events occurred.

Limitations: Results were obtained under controlled clinical conditions.

Conclusion: Efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are sustained long-term.