Tildrakizumab eases itch, improves life quality in scalp psoriasis

Treatment with tildrakizumab in patients with moderate-to-severe scalp psoriasis helps reduce scalp itch and improve quality of life when compared with placebo, with no new safety signals, as shown in a phase IIIb study.

“[T]ildrakizumab was superior to placebo for the treatment of moderate-to-severe plaque psoriasis of the scalp,” said lead author Dr Kurt Gebauer from Fremantle Dermatology, Fremantle, Western Australia, Australia. [J Am Acad Dermatol 2024;91:91-99]

“[T]ildrakizumab was significantly more effective vs placebo based on two scalp-specific measures, the Investigator's Global Assessment (IGA) mod 2011 (scalp) and Psoriasis Scalp Severity Index (PSSI) 90 response,” he added.

Gebauer and his team conducted this randomized, double-blind, placebo-controlled study in patients with moderate-to-severe plaque psoriasis affecting the scalp (IGA mod 2011 ≥3, PSSI ≥12, ≥30-percent scalp surface area affected) who received either tildrakizumab 100 mg (n=89) or placebo (n=82) at week 0 and week 4.

The primary endpoint was IGA mod 2011 score of “clear” or “almost clear” with ≥2-point reduction from baseline at week 16, while secondary ones were PSSI 90 response at week 12 and week 16 and IGA mod 2011 response at week 12. Adverse events (AEs) were assessed to analyse the safety of the study drug.

Significantly more patients in the tildrakizumab arm achieved IGA mod 2011 (scalp) response at week 12 (46.1 percent vs 4.9 percent) and at week 16 (49.4 percent vs 7.3 percent), as well as PSSI 90 response at week 12 (48.3 percent vs 2.4 percent) and week 16 (60.7 percent vs 4.9 percent; p<0.00001 for all), than those in the placebo group. In addition, serious treatment-related AEs did not occur.

Related studies

Only two published trials so far have assessed the efficacy and safety of biologics for the treatment of scalp psoriasis, according to Gebauer and colleagues.

The first study found etanercept to be efficacious for the treatment of moderate-to-severe plaque psoriasis with scalp involvement through week 24. In the second study, secukinumab was superior to placebo in patients with moderate-to-severe scalp psoriasis. [J Am Acad Dermatol 2012;67:86-92; J Am Acad Dermatol 2017;77:667-674]

“Most evidence favouring biologic treatment of scalp psoriasis is from subgroup analyses of patients with scalp involvement in phase III trials (guselkumab, VOYAGE 1 and VOYAGE 2; ixekizumab, UNCOVER-1, UNCOVER-2, and UNCOVER-3; bimekizumab, BE SURE, and BE VIVID),” Gebauer said. [JAMA Dermatol 2018;154:676-683; J Dermatolog Treat 2017;28:282-287; EADV Congress 2019 and 2020]

These studies reported encouraging results, but the methodological differences (ie, inconsistencies in enrolment criteria, baseline scalp severity assessment, concomitant medications allowed during the study, assessment tools, and time points) confound direct comparisons, said Gebauer.

Scalp psoriasis is significantly associated with pruritus, scaling, and erythema. Additionally, it can lead to psychological and social distress. [Acta Derm Venereol 2014;94:411-414; J Am Acad Dermatol 2009;60:962-971; Psoriasis (Auckl) 2016;6:33-40; Malays Fam Physician 2022;17:84-88]

“Topical therapy, typically the first line of psoriasis treatment, is challenging on the scalp because of the presence of hair,” Gebauer said. “The joint American Academy of Dermatology–National Psoriasis Foundation guidelines endorse use of biologics in patients with scalp psoriasis.” [J Am Acad Dermatol 2019;80:1029-1072; J Am Acad Dermatol 2009;60:962-971; Psoriasis (Auckl) 2016;6:33-40]