Autor: |
Gil Yosipovitch, MD, Brian S. Kim, MD, Shawn G. Kwatra, MD, Nicholas K. Mollanazar, MD, Sonja Ständer, MD, Takahiro Satoh, MD, PhD, Pedro Mendes-Bastos, MD, Tsen-Fang Tsai, MD, Elizabeth Laws, PhD, Michael C. Nivens, PhD, Jennifer Maloney, MD, Genming Shi, PhD, Ashish Bansal, MD, MBA, Ariane Dubost-Brama, MD |
Jazyk: |
angličtina |
Rok vydání: |
2024 |
Předmět: |
|
Zdroj: |
JAAD International, Vol 16, Iss , Pp 163-174 (2024) |
Druh dokumentu: |
article |
ISSN: |
2666-3287 |
DOI: |
10.1016/j.jdin.2024.03.025 |
Popis: |
Background: Phase 3 PRIME/PRIME2 trials independently demonstrated efficacy and an acceptable safety profile of dupilumab adults with moderate-to-severe prurigo nodularis. Objective: To obtain a more precise estimate of onset and magnitude of treatment effect using PRIME/PRIME2 pooled data. Methods: In PRIME/PRIME2, patients were randomized to dupilumab or placebo for 24 weeks. Pooled analysis assessed proportion of patients achieving clinically meaningful improvement in itch, clear/almost-clear skin, or both; at weeks 12 and 24; overall and by demographic subgroups and changes from baseline to week 24 in symptoms, signs, and quality of life. Results: Patients receiving dupilumab (n = 153) vs placebo (n = 158) experienced significant improvements in all tested endpoints. At week 24, 90 (58.8%) dupilumab-treated vs 30 (19.0%) placebo-treated patients achieved clinically meaningful improvement in itch, 71 (46.4%) vs 27 (17.1%) clear/almost clear skin, and 54 (35.3%) vs 14 (8.9%) achieved both (P |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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