Evidence map›Paper›PMID 37142763›Full record

Trial reportNature medicine2023

Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials.

Gil Yosipovitch, Nicholas Mollanazar, Sonja Ständer, Shawn G Kwatra, Brian S Kim, Elizabeth Laws, Leda P Mannent, Nikhil Amin, Bolanle Akinlade, Heribert W Staudinger and 7 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 123 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 3 pooled it
57.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04183335 phase3completednot on this map

A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

TypeinterventionalSponsorSanofiRan2019 to 2022Enrolled151ConditionsNeurodermatitisArmsDupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
NCT04202679 phase3completednot on this map

A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

TypeinterventionalSponsorSanofiRan2020 to 2021Enrolled160ConditionsNeurodermatitisArmsDupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 3 syntheses or guidelines pooled it, 204 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025
    Guideline
  4. Trial
  5. Trial
  6. Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Emerging Paediatric Uses of Dupilumab Beyond Approvals.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Immunopathogenesis of itch: an integrative framework for chronic pruritus.JID innovations : skin science from molecules to population health · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Observational

63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 3 countries.

Gil YosipovitchUniversity of Miami, Miami, FL, USA.
Nicholas MollanazarPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Sonja StänderUniversity Hospital Münster, Mϋnster, Germany.ORCID http://orcid.org/0000-0003-3612-7786
Shawn G KwatraJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Brian S KimIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Elizabeth LawsSanofi, Bridgewater, NJ, USA.
Leda P MannentSanofi, Chilly-Mazarin, France.
Nikhil AminRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Bolanle AkinladeRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Heribert W StaudingerSanofi, Bridgewater, NJ, USA.
Naimish PatelSanofi, Cambridge, MA, USA.
George D YancopoulosRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
David M WeinreichRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Sheldon WangSanofi, Bridgewater, NJ, USA.
Genming ShiSanofi, Bridgewater, NJ, USA.
Ashish BansalRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
John T O'MalleySanofi, Cambridge, MA, USA. john.o'malley2@sanofi.com.ORCID http://orcid.org/0000-0002-9968-1517
Sanofi (United States) · USRegeneron (United States) · USIcahn School of Medicine at Mount Sinai · USJohns Hopkins University · USSanofi (France) · FRUniversity Hospital Münster · DEUniversity of Miami · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 .

Indexed as

PrurigoAdultAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodHumansInjections, SubcutaneousPruritusSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID37142763
PMCPMC10202800
OpenAlexW4372331318

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.