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

来源：

JOURNAL OF DERMATOLOGICAL TREATMENT | 2023年 / 34卷 / 01期

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.

引用

页数：6

共 13 条

[1] Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE)
Blauvelt, Andrew
Guttman-Yassky, Emma
Paller, Amy S.
Simpson, Eric L.
Cork, Michael J.
Weisman, Jamie
Browning, John
Soong, Weily
Sun, Xian
Chen, Zhen
Kosloski, Matthew P.
Kamal, Mohamed A.
Delevry, Dimittri
Chuang, Chien-Chia
O'Malley, John T.
Bansal, Ashish
[J]. AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2022, 23 (03) : 365 - 383
[2] Treatment of children from 6 to 11 years old affected by moderate-severe atopic dermatitis with dupilumab: a first perspective from a single-center real-life experience in Italy
Colonna, C.
Zussino, M.
Monzani, N. A.
Ponziani, A.
Cavalli, R.
[J]. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2022, 36 (06) : E478 - E480
[3] Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study
Cork, M. J.
Thaci, D.
Eichenfield, L. F.
Arkwright, P. D.
Sun, X.
Chen, Z.
Akinlade, B.
Boklage, S.
Guillemin, I.
Kosloski, M. P.
Kamal, M. A.
O'Malley, J. T.
Patel, N.
Graham, N. M. H.
Bansal, A.
[J]. BRITISH JOURNAL OF DERMATOLOGY, 2021, 184 (05) : 857 - 870
[4] Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6-11 years): data from a French multicentre retrospective cohort in daily practice
Lasek, A.
Bellon, N.
Mallet, S.
Puzenat, E.
Bursztejn, A. C.
Abasq, C.
Mazereeuw-Hautier, J.
Chiaverini, C.
Hubiche, T.
Raison Peyron, N.
Du Thanh, A.
Barbarot, S.
Aubert, H.
Reguiai, Z.
Droitcourt, C.
Fievet, C.
Bellissen, A.
Bachelerie, M.
Nosbaum, A.
Leymarie, A.
Armingaud, P.
Masson Regnault, M.
Mahe, E.
[J]. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2022, 36 (12) : 2423 - 2429
[5] Dupilumab Treatment in Children Aged 6-11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
Napolitano, Maddalena
Fabbrocini, Gabriella
Neri, Iria
Stingeni, Luca
Boccaletti, Valeria
Piccolo, Vincenzo
Amoruso, Giuseppe Fabrizio
Malara, Giovanna
De Pasquale, Rocco
Di Brizzi, Eugenia Veronica
Diluvio, Laura
Bianchi, Luca
Chiricozzi, Andrea
Di Guida, Adriana
Del Duca, Elisabetta
Moschese, Viviana
Di Lernia, Vito
Dragoni, Federica
Gruber, Michaela
Hansel, Katharina
Licari, Amelia
Manti, Sara
Leonardi, Salvatore
Mastorino, Luca
Ortoncelli, Michela
Provenzano, Eugenio
Palermo, Antonino
Patella, Vincenzo
Peduto, Tiziana
Pezzolo, Elena
Piras, Viviana
Potestio, Luca
Battista, Teresa
Satta, Rosanna
Termine, Stefania
Palma, Paolo
Zangari, Paola
Patruno, Cataldo
[J]. PEDIATRIC DRUGS, 2022, 24 (06) : 671 - 678
[6] Dupilumab Improves Clinical Scores in Children and Adolescents With Moderate to Severe Atopic Dermatitis: A Real-World, Single-Center Study
Pagan, Angel D.
David, Eden
Ungar, Benjamin
Ghalili, Sabrina
He, Helen
Guttman-Yassky, Emma
[J]. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2022, 10 (09) : 2378 - 2385
[7] Laboratory Safety from a Randomized 16-Week Phase III Study of Dupilumab in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
Paller, Amy S.
Siegfried, Elaine C.
Cork, Michael J.
Wollenberg, Andreas
Arkwright, Peter D.
Gonzalez, Mercedes E.
Lockshin, Benjamin
Chen, Zhen
Bansal, Ashish
Levit, Noah A.
Prescilla, Randy
[J]. PEDIATRIC DRUGS, 2023, 25 (01) : 67 - 77
[8] Paller AS, 2022, LANCET, V400, P908, DOI 10.1016/S0140-6736(22)01539-2
[9] Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial
Paller, Amy S.
Siegfried, Elaine C.
Thaci, Diamant
Wollenberg, Andreas
Cork, Michael J.
Arkwright, Peter D.
Gooderham, Melinda
Beck, Lisa A.
Boguniewicz, Mark
Sher, Lawrence
Weisman, Jamie
O'Malley, John T.
Patel, Naimish
Hardin, Megan
Graham, Neil M. H.
Ruddy, Marcella
Sun, Xian
Davis, John D.
Kamal, Mohamed A.
Khokhar, Faisal A.
Weinreich, David M.
Yancopoulos, George D.
Beazley, Bethany
Bansal, Ashish
Shumel, Brad
[J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2020, 83 (05) : 1282 - 1293
[10] Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study
Patruno, Cataldo
Fabbrocini, Gabriella
Longo, Giuseppe
Argenziano, Giuseppe
Ferrucci, Silvia Mariel
Stingeni, Luca
Peris, Ketty
Ortoncelli, Michela
Offidani, Annamaria
Amoruso, Giuseppe Fabrizio
Talamonti, Marina
Girolomoni, Giampiero
Grieco, Teresa
Iannone, Michela
Nettis, Eustachio
Foti, Caterina
Rongioletti, Franco
Corazza, Monica
Veneri, Michele Delli
Napolitano, Maddalena
[J]. AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2021, 22 (04) : 581 - 586

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