The following is a summary of “Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study,” published in the July 2024 issue of Dermatology by Gebauer, et al.
Scalp psoriasis is a prevalent condition known for its challenging management. For a study, researchers sought to assess the effectiveness and safety of tildrakizumab in treating scalp psoriasis.
Conducted as a Phase 3b, randomized, double-blind, placebo-controlled trial, the study enrolled patients with moderate-to-severe plaque psoriasis affecting the scalp (defined as Investigator Global Assessment modified [IGA mod] 2011 [scalp] score ≥3, Psoriasis Scalp Severity Index [PSSI] ≥12, and ≥30% scalp surface area affected). Participants received either tildrakizumab 100 mg or placebo at Weeks 0 and 4. The primary endpoint was the proportion of patients achieving an IGA mod 2011 (scalp) score of “clear” or “almost clear” with at least a 2-point reduction from baseline at Week 16 (IGA mod 2011 [scalp] response). Key secondary endpoints included PSSI 90 response rates at Weeks 12 and 16, and IGA mod 2011 (scalp) response rates at Week 12. Safety assessments were based on adverse event reports.
Among patients treated with tildrakizumab (n = 89) versus placebo (n = 82), significantly more achieved the primary endpoint at Week 16 (49.4% vs. 7.3%) and Week 12 (46.1% vs. 4.9%). Similarly, more patients achieved a PSSI 90 response at Week 16 (60.7% vs. 4.9%) and Week 12 (48.3% vs. 2.4%) with tildrakizumab compared to placebo (all P < .00001). No serious treatment-related adverse events were reported during the study period. The study presented only short-term data, warranting further investigation into the long-term safety and efficacy of tildrakizumab for scalp psoriasis treatment.
Tildrakizumab demonstrated significant efficacy in treating scalp psoriasis, achieving high response rates according to both primary and secondary endpoints. No new safety concerns were identified.
Reference: sciencedirect.com/science/article/pii/S019096222400536X