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Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS.
Silverberg, Jonathan I; Yosipovitch, Gil; Simpson, Eric L; Kim, Brian S; Wu, Jashin J; Eckert, Laurent; Guillemin, Isabelle; Chen, Zhen; Ardeleanu, Marius; Bansal, Ashish; Kaur, Mandeep; Rossi, Ana B; Graham, Neil M H; Patel, Naimish; Gadkari, Abhijit.
Afiliación
  • Silverberg JI; Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: jonathanisilverberg@gmail.com.
  • Yosipovitch G; Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, Florida.
  • Simpson EL; Department of Dermatology, Oregon Health and Science University, Portland, Oregon.
  • Kim BS; Division of Dermatology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.
  • Wu JJ; Dermatology Research and Education Foundation, Irvine, California.
  • Eckert L; Sanofi, Chilly-Mazarin, France.
  • Guillemin I; Sanofi, Lyon, France.
  • Chen Z; Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
  • Ardeleanu M; Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
  • Bansal A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
  • Kaur M; Sanofi Genzyme, Cambridge, Massachusetts.
  • Rossi AB; Sanofi Genzyme, Cambridge, Massachusetts.
  • Graham NMH; Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
  • Patel N; Sanofi, Cambridge, Massachusetts.
  • Gadkari A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
J Am Acad Dermatol ; 82(6): 1328-1336, 2020 Jun.
Article en En | MEDLINE | ID: mdl-32135208
BACKGROUND: Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). OBJECTIVE: To evaluate the timing and effect of dupilumab on itch. METHODS: Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428). RESULTS: Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all). LIMITATIONS: Short duration of monotherapy trials (16 weeks). CONCLUSION: Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prurito / Dermatitis Atópica / Fármacos Dermatológicos / Anticuerpos Monoclonales Humanizados Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adolescent / Adult / Humans Idioma: En Revista: J Am Acad Dermatol Año: 2020 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prurito / Dermatitis Atópica / Fármacos Dermatológicos / Anticuerpos Monoclonales Humanizados Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adolescent / Adult / Humans Idioma: En Revista: J Am Acad Dermatol Año: 2020 Tipo del documento: Article Pais de publicación: Estados Unidos