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A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years
被引:8
|作者:
Patruno, Cataldo
[1
]
Fabbrocini, Gabriella
[2
]
Lauletta, Giuseppe
[2
]
Boccaletti, Valeria
[3
]
Colonna, Cristiana
[4
]
Cavalli, Riccardo
[4
]
Neri, Iria
[5
]
Ortoncelli, Michela
[6
]
Schena, Donatella
[7
]
Stingeni, Luca
[8
]
Hansel, Katharina
[8
]
Piccolo, Vincenzo
[9
]
Di Brizzi, Veronica
[9
]
Potenza, Concetta
[10
]
Tolino, Ersilia
[10
]
Bianchi, Luca
[11
]
Manti, Sara
[11
]
De Pasquale, Rocco
[12
]
Di Lernia, Vito
[13
]
Caminiti, Lucia
[14
]
Galli, Elena
[15
]
Coppo, Paola
[16
]
Chiricozzi, Andrea
[17
,18
]
De Simone, Clara
[17
,18
]
Guerriero, Cristina
[17
]
Amoruso, Fabrizio Giuseppe
[19
]
Provenzano, Eugenio
[19
]
Leonardi, Salvatore
[20
]
Licari, Amelia
[21
]
Marseglia, Gian Luigi
[21
]
Palermo, Antonino
[22
]
Di Pillo, Sabrina
[23
]
Russo, Daniele
[23
]
Moschese, Viviana
[24
]
Patella, Vincenzo
[25
]
Peduto, Tiziana
[25
]
Ferreli, Caterina
[26
]
Zangari, Paola
[27
]
Veronese, Federica
[28
]
Berti, Samantha Federica
[29
]
Gruber, Michaela
[30
]
Pezzolo, Elena
[31
]
Termine, Stefania
[32
]
Satta, Rosanna
[33
]
Dragoni, Federica
[34
]
Esposito, Maria
[35
]
Fargnoli, Maria Concetta
[35
]
Chiodini, Paolo
[9
]
Vallone, Ylenia
[2
]
di Vico, Francesca
[2
]
机构:
[1] Magna Graecia Univ Catanzaro, Dept Hlth Sci, Catanzaro, Italy
[2] Univ Naples Federico II, Dept Clin Med & Surg, Sect Dermatol, Naples, Italy
[3] Univ Brescia, Dept Med, Sect Dermatol, Brescia, Italy
[4] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dept Clin Sci & Community Hlth, Pediat Dermatol Unit, Milan, Italy
[5] Univ Bologna, Unit Dermatol, IRCCS AOU Policlin S Orsola, Bologna, Italy
[6] Univ Turin, Dept Med Sci, Div Dermatol, Turin, Italy
[7] Univ Verona, Dept Med, Sect Dermatol & Venereol, Verona, Italy
[8] Univ Perugia, Dept Med & Surg, Dermatol Sect, Perugia, Italy
[9] Univ Campania Luigi Vanvitelli, Dermatol Unit, Caserta, Italy
[10] Sapienza Univ Rome, Dept Med Surg Sci & Biotechnol, Dermatol Unit Daniele Innocenzi, Polo Pontino, Latina, Italy
[11] Univ Tor Vergata, Syst Med Dept, Dermatol Unit, Policlin Tor Vergata, Rome, Italy
[12] Osped San Marco, UO Dermatol, Catania, Italy
[13] Azienda USL IRCCS Reggio Emilia, Dermatol Unit, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy
[14] Univ Messina, Policlin Hosp, Messina, Italy
[15] Osped San Pietro Fatebenefratelli, UOS Immuno Allergol Eta evolut, Rome, Italy
[16] Regina Margher Childrens Hosp Citta Salute & Sci T, Pediat Endocrinol Unit, Turin, Italy
[17] Fdn Policlin Univ A Gemelli IRCCS, Dipartimento Sci Med & Chirurg, Dermatol, Rome, Italy
[18] Univ Cattolica Sacro Cuore, Dipartimento Univ Med & Chirurg Traslazionale, Dermatol, Rome, Italy
[19] Azienda Osped Cosenza, Dermatol Unit, Cosenza, Italy
[20] Univ Catania, San Marco Hosp, Dept Clin & Expt Med, Pediat Resp Unit, Catania, Italy
[21] Univ Pavia, Fdn IRCCS Policlin San Matteo, Dept Pediat, Pediat Clin, Pavia, Italy
[22] Garibaldi Hosp, Dept Pediat, Catania, Italy
[23] Univ G dAnnunzio, Dept Pediat, Pediat Allergy & Pulmonol Unit, Chieti, Italy
[24] Univ Roma Tor Vergata, Pediat Allergol & Immunol Unit, Policlin Tor Vergata, Rome, Italy
[25] Santa Maria Speranza Hosp, Dept Med, Div Allergy & Clin Immunol, Battipaglia, SA, Italy
[26] Univ Cagliari, Dept Med Sci & Publ Hlth, Dermatol Clin, Cagliari, Italy
[27] Bambino Gesu Pediat Hosp, Acad Dept Pediat DPUO, Res Unit Clin Immunol & Vaccinol, IRCCS, Rome, Italy
[28] AOU Maggiore Car Hosp, Dermatol Clin, Novara, Italy
[29] Univ Florence, Dept Surg & Translat Med, Dermatol Unit, Florence, Italy
[30] Cent Hosp Bolzano, Dept Pediat, Bolzano, Italy
[31] Osped San Bortolo, Dermatol Unit, Vicenza, Italy
[32] Santa Chiara Hosp, Div Dermatol, Trento, Italy
[33] Univ Sassari, Dipartimento Sci Med Chirurg & Sperimentali, Sassari, Italy
[34] UOC Dermatol Osped San Donato, Arezzo, Italy
[35] Univ Aquila, Dept Biotechnol & Appl Clin Sci, Dermatol, Laquila, Italy
关键词:
Atopic dermatitis;
children;
dupilumab;
real-world data;
D O I:
10.1080/09546634.2023.2246602
中图分类号:
R75 [皮肤病学与性病学];
学科分类号:
100206 ;
摘要:
Background: Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years. Methods: All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled. Results: Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52. Conclusions: Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.
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