Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis: a real-world multicentre Italian study of 2576 patients

被引：7

作者：

Ferrucci, Silvia ^{[1
]}

Tavecchio, Simona ^{[1
]}

Maronese, Carlo Alberto ^{[1
,2
]}

Balato, Anna

Di Brizzi, Eugenia Veronica ^{[3
]}

Ortoncelli, Michela ^{[4
]}

Ribero, Simone ^{[4
]}

Girolomoni, Giampiero ^{[5
]}

Maurelli, Martina ^{[5
]}

Fortina, Anna Belloni ^{[6
]}

Caroppo, Francesca ^{[6
]}

Naldi, Luigi ^{[7
,8
]}

Pezzolo, Elena ^{[8
]}

Nettis, Eustachio ^{[9
]}

Pugliese, Francesco ^{[9
]}

Stingeni, Luca ^{[10
]}

Hansel, Katharina ^{[10
]}

Rubegni, Giovanni ^{[11
]}

Calabrese, Laura ^{[12
]}

Russo, Filomena ^{[13
]}

Gola, Massimo ^{[14
]}

Magnaterra, Elisabetta ^{[14
]}

Rongioletti, Franco ^{[15
]}

Mercuri, Santo Raffaele ^{[15
]}

Paolino, Giovanni ^{[15
]}

Savoia, Paola ^{[16
,17
]}

Veronese, Federica ^{[17
]}

Foti, Caterina ^{[18
]}

Ambrogio, Francesca ^{[19
]}

Scalvenzi, Massimiliano ^{[20
]}

Napolitano, Maddalena

Patruno, Cataldo ^{[21
]}

Dastoli, Stefano ^{[21
]}

Corazza, Monica ^{[22
]}

Borghi, Alessandro ^{[22
]}

Calzavara-Pinton, Pier Giacomo ^{[23
]}

Rossi, Mariateresa ^{[23
]}

Offidani, Annamaria ^{[24
]}

Radi, Giulia ^{[24
]}

Bonzano, Laura ^{[25
]}

Ferreli, Caterina ^{[26
]}

Piras, Viviana ^{[26
]}

Satta, Rosanna ^{[27
]}

Sucato, Federica ^{[27
]}

Malagoli, Piergiorgio ^{[28
]}

Gaiani, Francesca ^{[28
]}

Micali, Giuseppe ^{[29
]}

Musumeci, Maria Letizia ^{[29
]}

Fargnoli, Maria Concetta ^{[30
]}

Esposito, Maria ^{[31
]}

机构：

[1] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dermatol Unit, Milan, Italy

[2] Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy

[3] Univ Campania Luigi Vanvitelli, Dermatol Unit, Naples, Italy

[4] Univ Turin, Med Sci Dept, Dermatol Clin, Turin, Italy

[5] Univ Verona, Dept Med, Sect Dermatol, Verona, Italy

[6] Univ Padua, Dept Women & Children Hlth, Padua, Italy

[7] Italian Grp Epidemiol Res Dermatol, Study Ctr, Bergamo, Italy

[8] San Bortolo Hosp Vicenza, Dept Dermatol, Vicenza, Italy

[9] Univ Bari, Sch & Chair Allergol & Clin Immunol, Dept Emergency & Organ Transplantat, Bari, Italy

[10] Univ Perugia, Dept Med, Sect Dermatol, Perugia, Italy

[11] Univ Siena, Dept Ophthalmol, Siena, Italy

[12] Univ Siena, Dept Med Sci Surg & Neurosci, Sect Dermatol, Siena, Italy

[13] IDI IRCCS, Ist Dermopat Immacolata, Rome, Italy

[14] Azienda Sanit & Univ Florence, Piero Palagi Hosp, Sect Dermatol, Viale Michelangiolo, Florence, Italy

[15] IRCCS San Raffaele Hosp, Dermatol Clin, Milan, Italy

[16] Univ Piemonte Orientale, Dept Hlth Sci, Novara, Italy

[17] AOU Maggiore della Carita Novara, Novara, Italy

[18] Univ Bari, Dept Dermatol, Dipartimento Sci Biomed & Oncol Umana, Bari, Puglia, Italy

[19] Univ Bari, Dept Precis & Regenerat Med & Ionian Area DiMePRe, Sect Dermatol & Venereol, Bari, Italy

[20] Univ Naples Federico II, Dept Clin Med & Surg, Sect Dermatol, Naples, Italy

[21] Magna Graecia Univ Catanzaro, Catanzaro, Calabria, Italy

[22] Univ Ferrara, Dept Med Sci, Sect Dermatol, Ferrara, Emilia Romagna, Italy

[23] Univ Brescia, Dermatol Dept, Brescia, Italy

[24] Univ Politecn Marche, Dept Clin & Surg Specialties, Fac Med & Chirurg, Ancona, Marche, Italy

[25] AUSL Modena, Allergol Serv, Modena, Italy

[26] Univ Cagliari, Dept Med Sci & Publ Hlth, Unit Dermatol, Cagliari, Italy

[27] Univ Sassari, Dept Med Surg & Expt Sci, Dermatol Unit, Sassari, Italy

[28] Ist Policlin San Donato, Milan, Italy

[29] Univ Catania, Catania, Italy

[30] Univ Aquila, Dept Dermatol, Laquila, Italy

[31] Univ Aquila, Dept Biotechnol & Appl Clin Sci, Laquila, Italy

[32] Univ Rome Sapienza, Dermatol Unit, Rome, Italy

[33] Univ Milan, Dept Clin Sci & Community Hlth, Milan, Italy

来源：

CLINICAL AND EXPERIMENTAL DERMATOLOGY | 2024年 / 49卷 / 12期

关键词：

EUROPEAN GUIDELINES; ADULTS; MANAGEMENT; PLACEBO;

D O I：

10.1093/ced/llae208

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

Background The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long-term treatment outcomes is currently available to inform clinical decisions. Objectives To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. Methods A multicentre, retrospective, dynamic cohort study was conducted to assess long-term effectiveness and safety of dupilumab in patients with moderate-to-severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria [defined as the simultaneous achievement of a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score <= 1, sleep-NRS score <= 1 and Dermatology Life Quality Index <= 1] were investigated. Results In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AEs led to treatment discontinuation in < 1% of patients during the evaluated time periods. Conclusions The high long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate-to-severe AD, regardless of clinical phenotype and course (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.

引用

页码：1561 / 1572

页数：12

共 30 条

[1]

Agenzia Italiana Del Farmaco, DUPIXENT 300MG

[2] Conjunctivitis in dupilumab clinical trials [J].

Akinlade, B. ;

Guttman-Yassky, E. ;

de Bruin-Weller, M. ;

Simpson, E. L. ;

Blauvelt, A. ;

Cork, M. J. ;

Prens, E. ;

Asbell, P. ;

Akpek, E. ;

Corren, J. ;

Bachert, C. ;

Hirano, I. ;

Weyne, J. ;

Korotzer, A. ;

Chen, Z. ;

Hultsch, T. ;

Zhu, X. ;

Davis, J. D. ;

Mannent, L. ;

Hamilton, J. D. ;

Teper, A. ;

Staudinger, H. ;

Rizova, E. ;

Pirozzi, G. ;

Graham, N. M. H. ;

Shumel, B. ;

Ardeleanu, M. ;

Wollenberg, A. .

BRITISH JOURNAL OF DERMATOLOGY, 2019, 181 (03) :459-473

[3] Dupilumab is very effective in a large cohort of difficult-to-treat adult atopic dermatitis patients: First clinical and biomarker results from the BioDay registry [J].

Ariens, Lieneke F. M. ;

van der Schaft, Jorien ;

Bakker, Daphne S. ;

Balak, Deepak ;

Romeijn, Margreet L. E. ;

Kouwenhoven, Tessa ;

Kamsteeg, Marijke ;

Giovannone, Barbara ;

Drylewicz, Julia ;

van Amerongen, Cynthia Catalina Aurora ;

Delemarre, Evelien M. ;

Knol, Edward F. ;

van Wijk, Femke ;

Nierkens, Stefan ;

Thijs, Judith L. ;

Schuttelaar, Marie L. A. ;

de Bruin-Weller, Marjolein S. .

ALLERGY, 2020, 75 (01) :116-126

[4] Epidemiology of atopic dermatitis in adults: Results from an international survey [J].

Barbarot, S. ;

Auziere, S. ;

Gadkari, A. ;

Girolomoni, G. ;

Puig, L. ;

Simpson, E. L. ;

Margolis, D. J. ;

de Bruin-Weller, M. ;

Eckert, L. .

ALLERGY, 2018, 73 (06) :1284-1293

[5] Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis [J].

Beck, Lisa A. ;

Deleuran, Mette ;

Bissonnette, Robert ;

de Bruin-Weller, Marjolein ;

Galus, Ryszard ;

Nakahara, Takeshi ;

Seo, Seong Jun ;

Khokhar, Faisal A. ;

Vakil, Jignesh ;

Xiao, Jing ;

Marco, Ainara Rodriguez ;

Levit, Noah A. ;

O'Malley, John T. ;

Shabbir, Arsalan .

AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2022, 23 (03) :393-408

[6] Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis [J].

Beck, Lisa A. ;

Thaci, Diamant ;

Deleuran, Mette ;

Blauvelt, Andrew ;

Bissonnette, Robert ;

de Bruin-Weller, Marjolein ;

Hide, Michihiro ;

Sher, Lawrence ;

Hussain, Iftikhar ;

Chen, Zhen ;

Khokhar, Faisal A. ;

Beazley, Bethany ;

Ruddy, Marcella ;

Patel, Naimish ;

Graham, Neil M. H. ;

Ardeleanu, Marius ;

Shumel, Brad .

AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2020, 21 (04) :567-577

[7] Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [J].

Blauvelt, Andrew ;

de Bruin-Weller, Marjolein ;

Gooderham, Melinda ;

Cather, Jennifer C. ;

Weisman, Jamie ;

Pariser, David ;

Simpson, Eric L. ;

Papp, Kim A. ;

Hong, H. Chih-Ho ;

Rubel, Diana ;

Foley, Peter ;

Prens, Errol ;

Griffiths, Christopher E. M. ;

Etoh, Takafumi ;

Pinto, Pedro Herranz ;

Pujol, Ramon M. ;

Szepietowski, Jacek C. ;

Ettler, Karel ;

Kemeny, Lajos ;

Zhu, Xiaoping ;

Akinlade, Bolanle ;

Hultsch, Thomas ;

Mastey, Vera ;

Gadkari, Abhijit ;

Eckert, Laurent ;

Amin, Nikhil ;

Graham, Neil M. H. ;

Pirozzi, Gianluca ;

Stahl, Neil ;

Yancopoulos, George D. ;

Shumel, Brad .

LANCET, 2017, 389 (10086) :2287-2303

[8] Expert Perspectives on Management of Moderate-to-Severe Atopic Dermatitis: A Multidisciplinary Consensus Addressing Current and Emerging Therapies [J].

Boguniewicz, Mark ;

Alexis, Andrew F. ;

Beck, Lisa A. ;

Block, Julie ;

Eichenfield, Lawrence F. ;

Fonacier, Luz ;

Guttman-Yassky, Emma ;

Paller, Amy S. ;

Pariser, David ;

Silverberg, Jonathan I. ;

Lebwohl, Mark .

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2017, 5 (06) :1519-1531

[9] New insights on ocular surface disease in patients with atopic dermatitis treated with dupilumab [J].

Bortoluzzi, P. ;

Ferrucci, S. ;

Galimberti, D. ;

Garavelli, F. ;

Pozzo Giuffrida, F. ;

Pizzati, A. ;

Marzano, A. V. ;

Mapelli, C. .

BRITISH JOURNAL OF DERMATOLOGY, 2022, 186 (01) :186-187

[10] Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFE) [J].

de Bruin-Weller, M. ;

Thaci, D. ;

Smith, C. H. ;

Reich, K. ;

Cork, M. J. ;

Radin, A. ;

Zhang, Q. ;

Akinlade, B. ;

Gadkari, A. ;

Eckert, L. ;

Hultsch, T. ;

Chen, Z. ;

Pirozzi, G. ;

Graham, N. M. H. ;

Shumel, B. .

BRITISH JOURNAL OF DERMATOLOGY, 2018, 178 (05) :1083-1101

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