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The following is a summary of “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 the December 2024 issue of Dermatology by Sofen et al.
A Phase 3b, randomized, double-blind, placebo-controlled study (NCT03897088) previously demonstrated that tildrakizumab, an anti–interleukin-23 p19 antibody, met the primary efficacy endpoint at Week (W) 16 in patients with moderate-to-severe plaque psoriasis affecting the scalp.
Researchers conducted a retrospective study to assess the maintenance of tildrakizumab efficacy and safety for treating scalp psoriasis from the W 52 full analysis.
They randomized patients to continue receiving tildrakizumab 100 mg every 12 weeks or, for those on placebo (analyzed separately), switch to tildrakizumab 100 mg at W16. Efficacy endpoints included an Investigator Global Assessment modified 2011 (IGA mod 2011; scalp) score of 0 or 1 with a ≥2-grade improvement and ≥90% improvement in Psoriasis Scalp Severity Index score (PSSI 90) from baseline. Safety was evaluated based on adverse events.
The results showed that in patients initially randomized to tildrakizumab vs placebo, the IGA mod 2011 (scalp) and PSSI 90 response rates 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, respectively. More than 80% of responders at W16 to tildrakizumab maintained the response. No serious adverse events related to treatment were reported.
Investigators concluded that tildrakizumab demonstrated sustained long-term efficacy and safety in treating scalp psoriasis.
Source: jaad.org/article/S0190-9622(24)03393-0/fulltext
