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:2
|
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
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
收藏
页码:1561 / 1572
页数:12
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