In a phase 3b, randomized, double-blind, placebo-controlled trial tildrakizumab showed sustained efficacy and safety for moderate-to-severe scalp psoriasis through 52 weeks.
Researchers analyzed the long-term effects of the interleukin-23 p19 inhibitor in 231 patients (117 tildrakizumab; 114 placebo).
Patients receiving tildrakizumab 100 mg every 12 weeks maintained an improved response rate from week 16 to week 52. The proportion achieving an Investigator Global Assessment modified 2011 scalp response increased from 49.4% to 62.9%, with 81.8% of week 16 patients maintaining response.
Psoriasis Scalp Severity Index (PSSI 90) response improved from 60.7% to 65.2%, with 81.5% maintaining response, reported Howard L. Sofen, MD, from the Division of Dermatology, David Geffen School of Medicine at UCLA, and colleagues.
Placebo crossover patients saw marked improvement after switching to tildrakizumab at week 16, with IGA mod 2011 response rising from 7.3% to 56.1% and PSSI 90 response from 4.9% to 57.3% by week 52.
Tildrakizumab also reduced mean PSSI scores (5.9 to 2.9), Scalp Itch Numeric Rating Scale scores (3.4 to 2.3), and scalp surface area involvement (13.5% to 6.1%). Quality of life, as measured by the Dermatology Life Quality Index, improved from 4.8 to 2.9 in the tildrakizumab group and from 12.6 to 2.8 in the crossover group, according to data published in the Journal of the American Academy of Dermatology.
"Key strengths of this study are that it was designed as a dedicated, long-term trial for the treatment of scalp psoriasis with stringent and clinically meaningful outcome measures," noted Dr. Sofen and colleagues.
Adverse events occurred in 53% of tildrakizumab-treated patients and 51.8% of crossover patients, with serious adverse events reported in 2.6% and 3.5%, respectively. Common events included nasopharyngitis, headache, and hypertension. Major adverse cardiovascular events occurred in two patients per group, all with relevant medical histories.
While the findings support tildrakizumab as a long-term treatment option, the study was conducted under controlled conditions and excluded patients with minimal whole-body psoriasis, potentially limiting real-world applicability. Further studies are needed to validate the results in broader clinical practice, noted investigators.
Disclosures are available in the published study.