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Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).
Bagel, J; Blauvelt, A; Nia, J; Hashim, P; Patekar, M; de Vera, A; Ahmad, K; Paguet, B; Xia, S; Muscianisi, E; Lebwohl, M.
Afiliação
  • Bagel J; Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.
  • Blauvelt A; Oregon Medical Research Center, Portland, OR, USA.
  • Nia J; Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Hashim P; Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Patekar M; Novartis Pharma AG, Basel, Switzerland.
  • de Vera A; Novartis Pharma AG, Basel, Switzerland.
  • Ahmad K; Novartis Healthcare Pvt Ltd, Hyderabad, India.
  • Paguet B; Novartis Pharma AG, Basel, Switzerland.
  • Xia S; Beijing Novartis Pharma Co, Ltd, Shanghai, China.
  • Muscianisi E; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
  • Lebwohl M; Icahn School of Medicine at Mount Sinai, New York, NY, USA.
J Eur Acad Dermatol Venereol ; 35(1): 135-142, 2021 Jan.
Article em En | MEDLINE | ID: mdl-32365251
BACKGROUND: Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study. OBJECTIVE: To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY. METHODS: Analysis of 52-week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label. RESULTS: At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < 0.0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms. CONCLUSIONS: This second head-to-head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials. Clinicaltrials.gov identifier: NCT02826603.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Psoríase / Fármacos Dermatológicos Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Psoríase / Fármacos Dermatológicos Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article