Dupilumab for prurigo nodularis: real-world outcomes up to 104 weeks from the Dupilumab Italian Prurigo Nodularis (DUPItaPN) study.
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Talamonti Marina, Mortato Edoardo, Narcisi Alessandra, Ferrucci Silvia Mariel, Gargiulo Luigi, Marzano Angelo Valerio, Napolitano Maddalena, Patruno Cataldo, Rossi Mariateresa, Balato Anna, Gori Niccolò, Foti Caterina, Tiberio Rossana, Corazza Monica, Carugno Andrea, Calabrese Laura, Pezzolo Elena, Esposito Maria, Antiga Emiliano, Trave Ilaria, Savoia Paola, Caroppo Francesca, Maurelli Martina, Musumeci Maria Letizia, Amerio Paolo, Stingeni Luca, Lembo Serena, Satta Rosanna Rita, Russo Filomena, Mariano Maria, Paganini Claudia, Costanzo Antonio, Zussino Martina, Del Gaudio Marika, Stevan Erica, Caccavale Stefano, D'Amore Alessandra, Tirone Benedetta, Pertusi Ginevra, Borghi Alessandro, Lazzeri Laura, Magnanimi Lina Maria, Maglie Roberto, Cozzani Emanuele, Veronese Federica, Belloni Fortina Anna, Girolomoni Giampiero, Micali Giuseppe, Morea Edvige, Hansel Katharina, Raimondo Annunziata, Biondi Gabriele, Sordi Donatella, Ibba Luciano, Nicoletti Maddalena, Peris Ketty, Sbarra Giorgia, Schettini Natale, Loda Alessia, Esposto Elia, Cocuroccia Barbara, Fargnoli Maria Concetta, Zerbinati Nicola, Bianchi Luca, Galluzzo Marco
Аннотация
OBJECTIVES: To evaluate the long-term effectiveness and safety of dupilumab in adults with PN, including those with multiple comorbidities, in a real-world multicentre setting.
METHODS: Clinical data were collected from 26 Italian dermatology centres [the Dupilumab Italian Prurigo Nodularis (DUPItaPN) study]. 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 (WI) Numeric Rating Scale (NRS) (WI-NRS), Investigator Global Assessment for PN-Stage (IGA PN-S), Sleep-NRS, Skin Pain-NRS and Dermatology Life Quality Index (DLQI) - were analysed 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: In total, 543 patients [mean age 65.7 (SD 15.8) years; 63.7% (346/543) female] were included. Dupilumab induced rapid and sustained improvements: mean WI-NRS decreased from 8.69 (SD 1.41) to 2.67 (SD 2.59) at week 24 and to 1.72 (SD 2.44) at week 104 (P < 0.001); ≥ 4-point WI-NRS reduction was achieved by 78.6% (408/519) and by 86.9% (258/297) of patients at 24 and 104 weeks, respectively; and IGA PN-S 0/1 achieved by 62.8% (326/519) and 81.1% (241/297) of patients at 24 and 104 weeks. DLQI improved from 17.40 (SD 6.94) to 2.57 (SD 4.89) (P < 0.001). Higher baseline WI-NRS predicted better outcomes, whereas psychiatric comorbidities and prior tricyclic antidepressant use predicted lower response. Dupilumab was well tolerated; discontinuation because of adverse events occurred in 2.9% (16/543), 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 older adults and patients with comorbidities.