Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis

被引：76

作者：

Fargnoli, M. C. ^{[1
]}

Esposito, M. ^{[43
,1
]}

Ferrucci, S. ^{[2
]}

Girolomoni, G. ^{[3
]}

Offidani, A. ^{[4
]}

Patrizi, A. ^{[5
]}

Peris, K. ^{[6
,7
]}

Costanzo, A. ^{[8
,9
]}

Malara, G. ^{[10
]}

Pellacani, G. ^{[11
]}

Romanelli, M. ^{[12
]}

Amerio, P. ^{[13
]}

Cristaudo, A. ^{[14
]}

Flori, M. L. ^{[15
]}

Motolese, A. ^{[16
]}

Betto, P. ^{[17
]}

Patruno, C. ^{[18
]}

Pigatto, P. ^{[19
]}

Sirna, R. ^{[20
]}

Stinco, G. ^{[21
]}

Zalaudek, I. ^{[22
]}

Bianchi, L. ^{[23
]}

Boccaletti, V. ^{[24
]}

Cannavo, S. P. ^{[25
]}

Cusano, F. ^{[26
]}

Lembo, S. ^{[27
]}

Mozzillo, R. ^{[28
]}

Gallo, R. ^{[29
]}

Potenza, C. ^{[30
]}

Rongioletti, F. ^{[31
]}

Tiberio, R. ^{[32
]}

Grieco, T. ^{[33
]}

Micali, G. ^{[34
]}

Persechino, S. ^{[35
]}

Pettinato, M. ^{[36
]}

Pucci, S. ^{[37
]}

Savi, E. ^{[38
]}

Stingeni, L. ^{[39
]}

Romano, A. ^{[40
]}

Argenziano, G. ^{[41
]}

Calabrese, Giulia

Campanati, Anna

Caruso, Cristiano

Chello, Camilla

De Pasquale, Tiziana

Di Costanzo, Luisa

Dini, Valentina

De Pasquale, Rocco

Del Giglio, Micol

Fracassi, Giovanna

机构：

[1] Univ Aquila, Dept Biotechnol & Appl Clin Sci, Dermatol Unit, Laquila, Italy

[2] Fdn IRCCS Ca Grande Osped Maggiore Policlin, Unit Dermatol, Milan, Italy

[3] Univ Verona, Dept Med, Sect Dermatol & Venereol, Verona, Italy

[4] Polytech Marche Univ, Dept Clin & Mol Sci, Dermatol Unit, Ancona, Italy

[5] Univ Bologna, Dept Expt Diagnost & Specialty Med, Dermatol Unit, Bologna, Italy

[6] Catholic Univ, Inst Dermatol, Rome, Italy

[7] Fdn Policlin Univ A Gemelli IRCCS, Rome, Italy

[8] Humanitas Univ, Dept Biomed Sci, Dermatol Unit, Rozzano, Italy

[9] Humanitas Clin & Res Ctr, Rozzano, Italy

[10] Grande Osped Metropolitano, Bianchi Melacrino Morelli, Dermatol Dept, Reggio Di Calabria, Italy

[11] Univ Modena & Reggio Emilia, Dept Dermatol, Modena, Italy

[12] Univ Pisa, Dept Clin & Expt Med, Dermatol Unit, Pisa, Italy

[13] Univ G dAnnunzio, Dermatol Clin, Dept Med & Aging Sci, Chieti, Italy

[14] San Gallicano Dermatol Inst IRCCS, Unit Dermatol, Rome, Italy

[15] Univ Siena, Hosp S Maria Scotte, Dept Clin Med & Immunol Sci, Dermatol Sect, Siena, Italy

[16] Macchi Hosp, Dept Dermatol, Varese, Italy

[17] ULSS8 Berica, Osped San Bortolo, Dept Dermatol, Vicenza, Italy

[18] Magna Graecia Univ Catanzaro, Dept Hlth Sci, Catanzaro, Italy

[19] Univ Milan, IRCCS Galeazzi Orthopaed Inst, Clin Dermatol, Dept Biomed Surg & Dent Sci, Milan, Italy

[20] Osped Misericordia, Unit Dermatol, Grosseto, Italy

[21] Univ Udine, Inst Dermatol, Dept Med, Udine, Italy

[22] Hosp Maggiore Trieste, Dermatol Clin, Trieste, Italy

[23] Univ Tor Vergata, Dept Dermatol, Rome, Italy

[24] Univ Hosp, Dept Clin & Expt Med, Sect Dermatol, Parma, Italy

[25] Univ Messina, Dept Clin & Expt Med, Dermatol, Messina, Italy

[26] Gaetano Rummo Hosp Benevento, Dermatol Unit, Benevento, Italy

[27] Univ Hosp San Giovanni Dio & Ruggi Salerno, Hosp Santa Maria Incoronata Olmo, Unit Dermatol, Salerno, Italy

[28] San Gennaro Hosp, Dermatol & Venereol, Naples, Italy

[29] Univ Genoa, Polyclin Hosp San Martino, Dept Hlth Sci, Dermatol Sect, Genoa, Italy

[30] Sapienza Univ Rome Polo Pontino, Dept Med & Surg Sci & Biotechnol, Dermatol Unit, Rome, Italy

[31] Univ Cagliari, Dept Med Sci & Publ Hlth, Sect Dermatol, Cagliari, Italy

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

[33] Sapienza Univ Rome, Dermatol Clin Umberto 1, Rome, Italy

[34] Univ Catania, Dermatol Clin, Catania, Italy

[35] Sapienza Univ Rome, NESMOS Dept, St Andrea Hosp, Dermatol Unit, Rome, Italy

[36] Policlin Vittorio Emanuele, Univ Hosp, Unit Dermatol, Catania, Italy

[37] Hosp Civitanova Marche, Allergol, Marche, Italy

[38] Hosp Guglielmo Saliceto, Unit Dermatol, Piacenza, Italy

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

[40] Catholic Univ, Fdn Policlin Univ A Gemelli IRCCS, Columbus Presidium, Allergol Unit, Rome, Italy

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

来源：

JOURNAL OF DERMATOLOGICAL TREATMENT | 2021年 / 32卷 / 05期

关键词：

Atopic dermatitis; dupilumab; real-life; ECZEMA; RELIABILITY; PLACEBO;

D O I：

10.1080/09546634.2019.1682503

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.

引用

页码：507 / 513

页数：7

共 21 条

[1] 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

[2] Dupilumab in atopic dermatitis: rationale, latest evidence and place in therapy [J].

Ariens, Lieneke F. M. ;

Bakker, Daphne S. ;

van der Schaft, Jorien ;

Garritsen, Floor M. ;

Thijs, Judith L. ;

de Bruin-Weller, Marjolein S. .

THERAPEUTIC ADVANCES IN CHRONIC DISEASE, 2018, 9 (09) :159-170

[3] Treatment of moderate-to-severe atopic dermatitis with dupilumab in real clinical practice: a multicentre, retrospective case series [J].

Armario-Hita, J. C. ;

Pereyra-Rodriguez, J. ;

Silvestre, J. F. ;

Ruiz-Villaverde, R. ;

Valero, A. ;

Izu-Belloso, R. ;

Jauregui-Presa, I. ;

Curto-Barredo, L. ;

Figueras-Nart, I. ;

Herranz-Pinto, P. ;

Herraez-Herrera, L. ;

Ortiz-de-Frutos, F. J. ;

Martinez-Pilar, L. ;

Sastre, J. ;

Serra-Baldrich, E. .

BRITISH JOURNAL OF DERMATOLOGY, 2019, 181 (05) :1072-1074

[4]

Badia X, 1999, BRIT J DERMATOL, V141, P698

[5] Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis [J].

Beck, Lisa A. ;

Thaci, Diamant ;

Hamilton, Jennifer D. ;

Graham, Neil M. ;

Bieber, Thomas ;

Rocklin, Ross ;

Ming, Jeffrey E. ;

Ren, Haobo ;

Kao, Richard ;

Simpson, Eric ;

Ardeleanu, Marius ;

Weinstein, Steven P. ;

Pirozzi, Gianluca ;

Guttman-Yassky, Emma ;

Suarez-Farinas, Mayte ;

Hager, Melissa D. ;

Stahl, Neil ;

Yancopoulos, George D. ;

Radin, Allen R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (02) :130-139

[6] 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

[7] 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

[8] Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data [J].

de Wijs, L. E. M. ;

Bosma, A. L. ;

Erler, N. S. ;

Hollestein, L. M. ;

Gerbens, L. A. A. ;

Middelkamp-Hup, M. A. ;

Kunkeler, A. C. M. ;

Nijsten, T. E. C. ;

Spuls, P. I. ;

Hijnen, D. J. .

BRITISH JOURNAL OF DERMATOLOGY, 2020, 182 (02) :418-426

[9] Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort [J].

Faiz, Sarah ;

Giovannelli, Jonathan ;

Podevin, Celine ;

Jachiet, Marie ;

Bouaziz, Jean-David ;

Reguiai, Ziad ;

Nosbaum, Audrey ;

Lasek, Audrey ;

le Bouedec, Marie-Christine Ferrier ;

Aurelie Du Thah ;

Raison-Peyron, Nadia ;

Tetart, Florence ;

Duval-Modeste, Anne-Benedicte ;

Misery, Laurent ;

Aubin, Francois ;

Dompmartin, Anne ;

Morice, Cecile ;

Droitcourt, Catherine ;

Soria, Angele ;

Arnault, Jean-Philippe ;

Delaunay, Juliette ;

Mahe, Emmanuel ;

Richard, Marie-Aleth ;

Schoeffler, Amelie ;

Lacour, Jean-Philippe ;

Begon, Edouard ;

Walter-Lepage, Amelie ;

Dillies, Anne-Sophie ;

Rappelle-Duruy, Sandrine ;

Barete, Stephane ;

Bellon, Nathalia ;

Beneton, Nathalie ;

Valois, Aude ;

Barbarot, Sebastien ;

Senechal, Julien ;

Staumont-Salle, Delphine .

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 81 (01) :143-151

[10] The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis [J].

Hanifin, JM ;

Thurston, M ;

Omoto, M ;

Cherill, R ;

Tofte, SJ ;

Graeber, M .

EXPERIMENTAL DERMATOLOGY, 2001, 10 (01) :11-18

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