Dupilumab for Prurigo Nodularis: Real-World Outcomes Up to 104 Weeks from the DUPItaPN Study

BACKGROUND: Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder that markedly impairs quality of life. Dupilumab, an IL-4Rα antagonist, is approved for moderate-to-severe PN, but long-term real-world evidence remains limited. OBJECTIVES: To evaluate the long-term effectiveness and safety of dupilumab in adults with PN, including those with multiple comorbidities, in a real-world multicenter setting. METHODS: Clinical data were collected from 26 Italian dermatology centers. Adults with PN refractory to topical therapies and/or phototherapy, and/or prior systemic treatments who received dupilumab for a minimum treatment duration of 12 weeks were included. Outcomes routinely assessed in practice-Worst Itch Numeric Rating Scale (WI-NRS), Investigator Global Assessment for PN-Stage (IGA PN-S), Sleep NRS, Skin Pain NRS, and Dermatology Life Quality Index (DLQI)-were analyzed at baseline and weeks 12, 24, 52, 76, and 104. Main endpoints were ≥4-point WI-NRS reduction and IGA PN-S 0/1 status. Predictors of response and safety were also evaluated. RESULTS: A total of 543 patients (mean age 65.7 years; 63.7% female) were included. Dupilumab induced rapid and sustained improvements: mean WI-NRS decreased from 8.7 to 2.7 at week 24 and to 1.7 at week 104 (p < 0.001); ≥4-point WI-NRS reduction was achieved by 86.4% and by 86.8% of patients at 24 and 104 weeks, respectively; IGA PN-S 0/1 by 62.8% and by 81.2% of patients at 24 and 104 weeks. DLQI improved from 17.4 to 2.6 (p < 0.001). Higher baseline WI-NRS predicted better outcomes, while psychiatric comorbidities and prior tricyclic antidepressant use predicted lower response. Dupilumab was well tolerated; discontinuation due to adverse events occurred in 2.9%, with no cancer progression or viral reactivation. CONCLUSIONS: Dupilumab provided sustained, clinically meaningful benefits and a favourable safety profile over 104 weeks, supporting its role as a long-term treatment for moderate-to-severe PN, including in elderly and comorbid patients.

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Journal
Clinical and Experimental Dermatology
Published
2026-04-11
DOI
https://doi.org/10.1093/ced/llag164
Primary Topic
Dermatology and Skin Diseases
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article
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article

Dupilumab for Prurigo Nodularis: Real-World Outcomes Up to 104 Weeks from the DUPItaPN Study

Gabriele Biondi, Martina Maurelli, Filomena Russo, Donatella Sordi et al.
Clinical and Experimental Dermatology
Dermatology and Skin Diseases
article

Dupilumab for Prurigo Nodularis: Real-World Outcomes Up to 104 Weeks from the DUPItaPN Study

Gabriele Biondi, Martina Maurelli, Filomena Russo, Donatella Sordi, Elia Esposto, Edoardo Mortato, Maria Esposito, Luigi Gargiulo, Rosanna Satta, Lina Maria Magnanimi, Laura Calabrese, Claudia Paganini, Ginevra Pertusi, Laura Lazzeri, Maddalena Nicoletti, Annunziata Raimondo, Roberto Maglie, Luca Stingeni, Ilaria Trave, Marika Del Gaudio, Maria MARIANO, Anna Belloni Fortina, Barbara Cocuroccia, Paolo Amerio, Marco Galluzzo, Stefano Caccavale, Luciano Ibba, Giorgia Sbarra, Elena Pezzolo, Cataldo Patruno, Martina Zussino, Andrea Carugno, Natale Schettini, Federica Veronese, Silvia Mariel Ferrucci, Alessandra Narcisi, Katharina Hansel, Benedetta Tirone, Edvige Morea, Maria Letizia Musumeci, Rossana Tiberio, Alessia Loda, Marina Talamonti, Mariateresa Rossi, Anna Balato, Monica Corazza, Francesca Caroppo, Maddalena Napolitano, Serena Lembo, Ketty Peris, Alessandra D’Amore, Giuseppe Micali, Giampiero Girolomoni, Luca Bianchi, Paola Savoia, Maria Concetta Fargnoli, Alessandro Borghi, Angelo Valerio Marzano, Caterina Foti, Erica Stevan, Antonio Costanzo, Niccolò Gori, Emiliano Antiga, Nicola Zerbinati, Emanuele Cozzani
article en

Abstract

BACKGROUND: Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder that markedly impairs quality of life. Dupilumab, an IL-4Rα antagonist, is approved for moderate-to-severe PN, but long-term real-world evidence remains limited. OBJECTIVES: To evaluate the long-term effectiveness and safety of dupilumab in adults with PN, including those with multiple comorbidities, in a real-world multicenter setting. METHODS: Clinical data were collected from 26 Italian dermatology centers. Adults with PN refractory to topical therapies and/or phototherapy, and/or prior systemic treatments who received dupilumab for a minimum treatment duration of 12 weeks were included. Outcomes routinely assessed in practice-Worst Itch Numeric Rating Scale (WI-NRS), Investigator Global Assessment for PN-Stage (IGA PN-S), Sleep NRS, Skin Pain NRS, and Dermatology Life Quality Index (DLQI)-were analyzed at baseline and weeks 12, 24, 52, 76, and 104. Main endpoints were ≥4-point WI-NRS reduction and IGA PN-S 0/1 status. Predictors of response and safety were also evaluated. RESULTS: A total of 543 patients (mean age 65.7 years; 63.7% female) were included. Dupilumab induced rapid and sustained improvements: mean WI-NRS decreased from 8.7 to 2.7 at week 24 and to 1.7 at week 104 (p < 0.001); ≥4-point WI-NRS reduction was achieved by 86.4% and by 86.8% of patients at 24 and 104 weeks, respectively; IGA PN-S 0/1 by 62.8% and by 81.2% of patients at 24 and 104 weeks. DLQI improved from 17.4 to 2.6 (p < 0.001). Higher baseline WI-NRS predicted better outcomes, while psychiatric comorbidities and prior tricyclic antidepressant use predicted lower response. Dupilumab was well tolerated; discontinuation due to adverse events occurred in 2.9%, with no cancer progression or viral reactivation. CONCLUSIONS: Dupilumab provided sustained, clinically meaningful benefits and a favourable safety profile over 104 weeks, supporting its role as a long-term treatment for moderate-to-severe PN, including in elderly and comorbid patients.

Clinical and Experimental Dermatology
University of Siena (IT), University of Insubria (IT), University of Rome Tor Vergata (IT), University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Molise (IT), University of Salerno (IT), Humanitas University (IT), University of Padua (IT), University of Sassari (IT), University of Milan (IT), University of Ferrara (IT), University of L'Aquila (IT), University of Perugia (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), University of Chieti-Pescara (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Istituto Dermopatico dell'Immacolata (IT), Veria General Hospital (GR), University of Campania "Luigi Vanvitelli" (IT), Policlinico Universitario di Catania (IT), Policlinico Tor Vergata (IT), San Gallicano Hospital (IT), Azienda Ospedaliera Ospedale Maggiore (IT), Ospedale Policlinico San Martino (IT), University of the Sacred Heart (JP), Ospedale San Bortolo (IT), IRCCS Humanitas Research Hospital (IT), University of Florence (IT), University of Bari Aldo Moro (IT), University of Naples Federico II (IT), University of Brescia (IT)
Good health and well-being
Openalex Percentile: Top 20%
Dermatology and Skin Diseases
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