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.
J Am Acad Dermatol
; 91(1): 91-99, 2024 Jul.
Article
en En
| MEDLINE
| ID: mdl-38554938
ABSTRACT
BACKGROUND:
Scalp psoriasis is common and difficult to treat.OBJECTIVE:
To evaluate efficacy and safety of tildrakizumab for the treatment of scalp psoriasis.METHODS:
In this Phase 3b, randomized, double-blind, placebo (PBO)-controlled study (NCT03897088), patients with moderate-to-severe plaque psoriasis affecting the scalp (Investigator Global Assessment modified [IGA mod] 2011 [scalp] ≥3, Psoriasis Scalp Severity Index [PSSI] ≥12, ≥30% scalp surface area affected) received tildrakizumab 100 mg or PBO at W0 and W4. The primary endpoint was IGA mod 2011 (scalp) score of "clear" or "almost clear" with ≥2-point reduction from baseline at W16 (IGA mod 2011 [scalp] response). Key secondary endpoints were PSSI 90 response at W12 and W16 and IGA mod 2011 (scalp) response at W12. Safety was assessed from adverse events.RESULTS:
Of patients treated with tildrakizumab (n = 89) vs PBO (n = 82), 49.4% vs 7.3% achieved IGA mod 2011 (scalp) response at W16 (primary endpoint) and 46.1% vs 4.9% at W12; 60.7% vs 4.9% achieved PSSI 90 response at W16 and 48.3% vs 2.4% at W12 (all P < .00001). No serious treatment-related adverse events occurred.LIMITATIONS:
Only short-term data are presented.CONCLUSION:
Tildrakizumab was efficacious for the treatment of scalp psoriasis with no new safety signals.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Psoriasis
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Dermatosis del Cuero Cabelludo
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Índice de Severidad de la Enfermedad
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Anticuerpos Monoclonales Humanizados
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2024
Tipo del documento:
Article