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

Abstract

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 16.

Objective: To evaluate maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis from the week 52 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 week 16. Efficacy endpoints included Investigator Global Assessment modified 2011 (scalp) score of 0 or 1 with ≥2-grade improvement and ≥90% improvement in Psoriasis Scalp Severity Index score from baseline. Safety was assessed from adverse events.

Results: In patients originally randomized to tildrakizumab versus placebo, Investigator Global Assessment modified 2011 (scalp) and ≥90% improvement in Psoriasis Scalp Severity Index score response rates, respectively, improved from 49.4% versus 7.3% and 60.7% versus 4.9% at week 16 to 62.9% versus 56.1% and 65.2% versus 57.3% at week 52; >80% of week 16 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.

Keywords: efficacy; itch; psoriasis; safety; scalp; tildrakizumab.