Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials Article Swipe
Gil Yosipovitch
,
Nicholas Mollanazar
,
Sonja Ständer
,
Shawn G. Kwatra
,
Brian Kim
,
Elizabeth Laws
,
Leda Mannent
,
Nikhil Amin
,
Bolanle Akinlade
,
Heribert Staudinger
,
Naimish Patel
,
George D. Yancopoulos
,
David M. Weinreich
,
Sheldon Wang
,
Genming Shi
,
Ashish Bansal
,
John T. O’Malley
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1038/s41591-023-02320-9
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1038/s41591-023-02320-9
Prurigo nodularis (PN) is a chronic inflammatory skin disease with intensely pruritic nodules. The LIBERTY-PN PRIME and PRIME2 phase 3 trials enrolled adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13. Patients were randomized 1:1 to 300 mg dupilumab or placebo subcutaneously every 2 weeks for 24 weeks. The primary endpoint was pruritus improvement, measured by proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included nodule number reduction to ≤5 at week 24. PRIME and PRIME2 enrolled 151 and 160 patients, respectively. Both trials met all the pre-specified primary and key secondary endpoints. A ≥4-point WI-NRS reduction at week 24 in the dupilumab and placebo arms was achieved by 60.0% and 18.4% of patients, respectively, in PRIME (95% confidence interval (CI), 27.8–57.7 for the difference, P < 0.001) and at week 12 by 37.2% and 22.0% of patients, respectively, in PRIME2 (95% CI, 2.3–31.2; P = 0.022). Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN. Safety was consistent with the known dupilumab safety profile. ClinicalTrials.gov identifiers: NCT04183335 and NCT04202679 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1038/s41591-023-02320-9
- https://www.nature.com/articles/s41591-023-02320-9.pdf
- OA Status
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- Cited By
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- References
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- Related Works
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- OpenAlex ID
- https://openalex.org/W4372331318
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4372331318Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1038/s41591-023-02320-9Digital Object Identifier
- Title
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Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trialsWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-05-01Full publication date if available
- Authors
-
Gil Yosipovitch, Nicholas Mollanazar, Sonja Ständer, Shawn G. Kwatra, Brian Kim, Elizabeth Laws, Leda Mannent, Nikhil Amin, Bolanle Akinlade, Heribert Staudinger, Naimish Patel, George D. Yancopoulos, David M. Weinreich, Sheldon Wang, Genming Shi, Ashish Bansal, John T. O’MalleyList of authors in order
- Landing page
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https://doi.org/10.1038/s41591-023-02320-9Publisher landing page
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https://www.nature.com/articles/s41591-023-02320-9.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
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https://www.nature.com/articles/s41591-023-02320-9.pdfDirect OA link when available
- Concepts
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Prurigo nodularis, Dupilumab, Medicine, Placebo, Dermatology, Double blind, Randomized controlled trial, Clinical trial, Internal medicine, Atopic dermatitis, Alternative medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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179Total citation count in OpenAlex
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2025: 80, 2024: 70, 2023: 28Per-year citation counts (last 5 years)
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58Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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