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

• Published in: Journal of the American Academy of Dermatology 2024-12
• Main Authors: Sofen, Howard L., Gebauer, Kurt, Spelman, Lynda, Yamauchi, Paul S., Yao, Siu-Long, Nishandar, Tushar, Kopeloff, Iris, Crane, Michael, Gogineni, Ranga, Kothekar, Mudgal, Bagel, Jerry
• Format: Article
• Language: English
• Subjects: efficacy; itch; psoriasis; safety; scalp; tildrakizumab
• ISSN: 0190-9622; 1097-6787; 1097-6787
• DOI: 10.1016/j.jaad.2024.12.018

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. To evaluate maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis from the W52 full analysis. 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. 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. Results were obtained under controlled clinical conditions. Efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are sustained long-term.