Analysis of a case series of adult patients with severe atopic dermatitis treated with dupilumab in Argentina
DOI:
https://doi.org/10.31053/1853.0605.v77.n2.27845Keywords:
dermatitis, atopic, biological products, antibodies, monoclonalAbstract
Introduction: Severe atopic dermatitis (AD) treatment is an unmet need, given the limited efficacy and safety of classical systemic treatments (CSTs). Dupilumab is a monoclonal antibody that blocks the signaling of the interleukins that mediate the inflammatory response involved in AD. Methods: the clinical response of a group of patients from Argentina with severe AD and insufficient response and/or toxicity to CSTs who were treated with dupilumab before commercial availability was analyzed. EASI, SCORAD, DLQI scales and analog visual scales of pruritus and sleep were evaluated, during a median follow-up of 189 days. In addition, the incidence of adverse events was analyzed. Results: 20 patients (13 male) were included; median age: 37.5 years; median AD evolution: 20 years; atopic comorbidity: 70%. 100% had received systemic corticosteroids (serious complications: 20%). Main reasons for discontinuation of CSTs were lack of efficacy and occurrence of adverse events. All scores were significantly and steadily reduced, with identifiable clinical response at the second month of treatment. At the end of the follow-up, only 3 patients required concomitant systemic immunosuppressive treatment. Dupilumab was well tolerated, with mild and controllable adverse events. Discussion: Dupilumab is the only biological agent with high efficacy demonstrated in clinical and observational studies. In this case series, its effectiveness was confirmed in difficult-to-treat patients with severe AD and inadequate response to CSTs. The safety profile was favorable and consistent.
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Sociedad Argentina de Dermatología. Consenso Nacional de Dermatitis Atópica, 2004 [Internet]. Buenos Aires: Sociedad Argentina de Dermatología; 2004 [citado 1 de agosto de 2019]. Disponible en: http://www.dermatolarg.org.ar/index.php/dermatolarg/article/viewFile/379/189
David Boothe W, Tarbox JA, Tarbox MB. Atopic Dermatitis: Pathophysiology. Adv Exp Med Biol. 2017;1027:21-37. doi: 10.1007/978-3-319-64804-0_3.
Renert-Yuval Y, Guttman-Yassky E. Systemic therapies in atopic dermatitis: The pipeline. Clin Dermatol. 2017 Jul-Aug;35(4):387-397. doi: 10.1016/j.clindermatol.2017.03.012.
Silvestre Salvador JF, Romero-Pérez D, Encabo-Durán B. Atopic Dermatitis in Adults: A Diagnostic Challenge. J Investig Allergol Clin Immunol. 2017;27(2):78-88. doi: 10.18176/jiaci.0138.
Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suárez-Fariñas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020.
Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemény L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. 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. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1.
de Bruin-Weller M, Thaçi D, Smith CH, Reich K, Cork MJ, Radin A, Zhang Q, Akinlade B, Gadkari A, Eckert L, Hultsch T, Chen Z, Pirozzi G, Graham NMH, Shumel B. 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 CAFÉ). Br J Dermatol. 2018 May;178(5):1083-1101. doi: 10.1111/bjd.16156.
Ruiz-Villaverde R, Dominguez-Cruz J, Armario-Hita JC, Martinez-Pilar L, Alcantara-Luna S, Pereyra-Rodriguez JJ. Fifty-two week follow-up safety and effectiveness results of dupilumab treatment of moderate-to-severe atopic dermatitis from a retrospective, multicentric series. Dermatol Ther. 2019 Jul;32(4):e12931. doi: 10.1111/dth.12931.
Wang C, Kraus CN, Patel KG, Ganesan AK, Grando SA. Real-world experience of dupilumab treatment for atopic dermatitis in adults: a retrospective analysis of patients' records. Int J Dermatol. 2020 Feb;59(2):253-256. doi: 10.1111/ijd.14573.
Uchida H, Kamata M, Mizukawa I, Watanabe A, Agematsu A, Nagata M, Fukaya S, Hayashi K, Fukuyasu A, Tanaka T, Ishikawa T, Ohnishi T, Tada Y. Real-world effectiveness and safety of dupilumab for the treatment of atopic dermatitis in Japanese patients: a single-centre retrospective study. Br J Dermatol. 2019 Nov;181(5):1083-1085. doi: 10.1111/bjd.18163.
Ariëns LFM, van der Schaft J, Bakker DS, Balak D, Romeijn MLE, Kouwenhoven T, Kamsteeg M, Giovannone B, Drylewicz J, van Amerongen CCA, Delemarre EM, Knol EF, van Wijk F, Nierkens S, Thijs JL, Schuttelaar MLA, de Bruin-Weller MS. 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. Allergy. 2020 Jan;75(1):116-126. doi: 10.1111/all.14080.
de Wijs LEM, Bosma AL, Erler NS, Hollestein LM, Gerbens LAA, Middelkamp-Hup MA, Kunkeler ACM, Nijsten TEC, Spuls PI, Hijnen DJ. Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. Br J Dermatol. 2020 Feb;182(2):418-426. doi: 10.1111/bjd.18179.
Armario-Hita JC, Pereyra-Rodriguez J, Silvestre JF, Ruiz-Villaverde R, Valero A, Izu-Belloso R, Jáuregui-Presa I, Curto-Barredo L, Figueras-Nart I, Herranz-Pinto P, Herraez-Herrera L, Ortiz-de-Frutos FJ, Martinez-Pilar L, Sastre J, Serra-Baldrich E. Treatment of moderate-to-severe atopic dermatitis with dupilumab in real clinical practice: a multicentre, retrospective case series. Br J Dermatol. 2019 Nov;181(5):1072-1074. doi: 10.1111/bjd.18041.
Fargnoli MC, Esposito M, Ferrucci S, Girolomoni G, Offidani A, Patrizi A, Peris K, Costanzo A, Malara G, Pellacani G, Romanelli M, Amerio P, Cristaudo A, Flori ML, Motolese A, Betto P, Patruno C, Pigatto P, Sirna R, Stinco G, Zalaudek I, Bianchi L, Boccaletti V, Cannavò SP, Cusano F, Lembo S, Mozzillo R, Gallo R, Potenza C, Rongioletti F, Tiberio R, Grieco T, Micali G, Persechino S, Pettinato M, Pucci S, Savi E, Stingeni L, Romano A, Argenziano G; Dupilumab Italian National Access Program (Dup-INAP group). Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2019 Oct 28:1-7. doi: 10.1080/09546634.2019.1682503.
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Referencia: Solicitud de importación de medicamentos bajo el régimen de acceso de excepción [Internet]. Disposición 2017-10874. Disponible en: http://bit.ly/2kqPW7H
Wollenberg A, Oranje A, Deleuran M, Simon D, Szalai Z, Kunz B, Svensson A, Barbarot S, von Kobyletzki L, Taieb A, de Bruin-Weller M, Werfel T, Trzeciak M, Vestergard C, Ring J, Darsow U; European Task Force on Atopic Dermatitis/EADV Eczema Task Force. ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients. J Eur Acad Dermatol Venereol. 2016 May;30(5):729-47. doi: 10.1111/jdv.13599.
Seegräber M, Srour J, Walter A, Knop M, Wollenberg A. Dupilumab for treatment of atopic dermatitis. Expert Rev Clin Pharmacol. 2018 May;11(5):467-474. doi: 10.1080/17512433.2018.1449642.
Snast I, Reiter O, Hodak E, Friedland R, Mimouni D, Leshem YA. Are Biologics Efficacious in Atopic Dermatitis? A Systematic Review and Meta-Analysis. Am J Clin Dermatol. 2018 Apr;19(2):145-165. doi: 10.1007/s40257-017-0324-7.
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