Adalimumab Biosimilar Efficacy and Safety in a 5-Year-Old Patient with Severe Plaque Psoriasis During SARS-CoV-2 Pandemic Outbreak

Lucia Gallo; Gianmarco Capasso; Francesca Nastro; Gabriella Fabbrocini; Matteo Megna

doi:10.3889/oamjms.2022.7575

Authors

Lucia Gallo Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
Gianmarco Capasso Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy https://orcid.org/0000-0002-0076-4575
Francesca Nastro Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
Gabriella Fabbrocini Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
Matteo Megna Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy https://orcid.org/0000-0003-1803-2046

DOI:

https://doi.org/10.3889/oamjms.2022.7575

Keywords:

Pediatric dermatology, Psoriasis treatment, COVID-19, Biologic therapy, Teledermatology

Abstract

BACKGROUND: Psoriasis is a chronic inflammatory disease that affects 2% of population. About 0.5–2% of psoriatic cases develop during pediatric age. In most cases, the condition is responsive to topical treatment. However, a small percentage of children require systemic treatment with conventional systemic drugs or biological agents, such as anti-tumor necrosis factor (TNF)-α. Adalimumab (ADA) is an anti-TNF-α recently approved for pediatric psoriasis in the European Union (from 4 years of age, 2015).

CASE PRESENTATION: We describe our experience treating a 5-year-old female patient affected by severe plaque psoriasis with ADA biosimilar during SARS-CoV-2 pandemic outbreak also using teledermatology.

CONCLUSION: The case reported in this article highlights the safety and the effectiveness of ADA biosimilar MSB11022 (Idacio®) in the treatment of a 5-year-old female affected by plaque psoriasis and paves the way to bigger trials for a more extensive use of TNF-α inhibitor biosimilars for psoriasis in pediatric population.

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References

Hansel K, Marietti R, Tramontana M, Bianchi L, Romita P, Giuffrida R, et al. Childhood generalized pustular psoriasis: Successful long-term treatment with adalimumab. Dermatol Ther. 2020;33(3):e13294. https://doi.org/10.1111/dth.13294 DOI: https://doi.org/10.1111/dth.13294

Wang Z, Xiang X, Chen Y, Zhao X, Liu Y, Xu Z, et al. Treating paediatric acrodermatitis continua of hallopeau with adalimumab: A case series. Clin Exp Dermatol. 2022;47(1):195-6. https://doi.org/10.1111/ced.14890 PMid:34559906 DOI: https://doi.org/10.1111/ced.14890

Chang MH, Shantha JG, Fondriest JJ, Lo MS, Angeles-Han ST. Uveitis in children and adolescents. Rheum Dis Clin North Am. 2021;47(4):619-41. https://doi.org/10.1016/j.rdc.2021.07.005 PMid:34635295 DOI: https://doi.org/10.1016/j.rdc.2021.07.005

Fotiadou C, Lazaridou E, Ioannides D. Management of psoriasis in adolescence. Adolesc Health Med Ther. 2014;5:25-34. https://doi.org/10.2147/AHMT.S36672 PMid:24729738 DOI: https://doi.org/10.2147/AHMT.S36672

Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(2):205-12. https://doi.org/10.1111/jdv.13854 PMid:27573025 DOI: https://doi.org/10.1111/jdv.13854

Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Voorhees AS, et al. Psoriasis and comorbid diseases: Epidemiology. J Am Acad Dermatol. 2017;76(3):377-90. https://doi.org/10.1016/j.jaad.2016.07.064 PMid:28212759 DOI: https://doi.org/10.1016/j.jaad.2016.07.064

Megna M, Balato A, Napolitano M, Gallo L, Caso F, Costa L, et al. Psoriatic disease treatment nowadays: Unmet needs among the “jungle of biologic drugs and small molecules”. Clin Rheumatol. 2018;37(7):1739-41. https://doi.org/10.1007/s10067-018-4090-6 PMid:29644570 DOI: https://doi.org/10.1007/s10067-018-4090-6

Talamonti M, Galluzzo M, Chiricozzi A, Quaglino P, Fabbrocini G, Gisondi P, et al. Management of biological therapies for chronic plaque psoriasis during COVID-19 emergency in Italy. J Eur Acad Dermatol Venereol. 2020;34(12):e770-2. https://doi.org/10.1111/jdv.16841 PMid:32735716 DOI: https://doi.org/10.1111/jdv.16841

Prison R, Soroodian B, Fiorillo L. Psoriasis in children. Psoriasis (Auckl). 2016;6:121-9. https://doi.org/10.2147/PTT.S87650 PMid:29387599 DOI: https://doi.org/10.2147/PTT.S87650

Klufas DM, Wald JM, Strober BE. Treatment of moderate to severe pediatric psoriasis: A retrospective case series. Pediatric Dermatol. 2016;33(2):142-9. https://doi.org/10.1111/pde.12782 PMid:26871417 DOI: https://doi.org/10.1111/pde.12782

Megna M, Napolitano M, Balato A, Scalvenzi M, Cirillo T, Gallo L, et al. Psoriasis in children: A review. Curr Pediatr Rev. 2015;11(1):10-26. https://doi.org/10.2174/1573400511666150504125456 PMid:25938378 DOI: https://doi.org/10.2174/1573400511666150504125456

Napolitano M, Megna M, Balato A, Ayala F, Lembo S, Villani A, et al. Systemic treatment of pediatric psoriasis: A review. Dermatol Ther (Heidelb). 2016;6(2):125-42. https://doi.org/10.1007/s13555-016-0117-6 PMid:27085539 DOI: https://doi.org/10.1007/s13555-016-0117-6

Zangrilli A, Bavetta M, Bianchi L. Adalimumab in children and adolescents with severe plaque psoriasis: A safety evaluation. Expert Opin Drug Saf. 2020;19(4):433-8. https://doi.org/10.1080/14740338.2020.1752659 DOI: https://doi.org/10.1080/14740338.2020.1752659

Hansel K, Bianchi L, Lanza F, Bini V, Stingeni L. Adalimumab dose tapering in psoriasis: Predictive factors for maintenance of complete clearance. Acta Derm Venereol. 2017;97(3):346-50. https://doi.org/10.2340/00015555-2571 PMid:27868145 DOI: https://doi.org/10.2340/00015555-2571

Papp K, Thaçi D, Marcoux D, Weibel L, Philipp S, Ghislain PD, et al. Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: A randomised, doubleblind, phase 3 trial. Lancet. 2017;390(10089):40-9. https://doi.org/10.1016/S0140-6736(17)31189-3 PMid:28478975 DOI: https://doi.org/10.1016/S0140-6736(17)31189-3

Cohen AD, Wu JJ, Puig L, Chimenti S, Vender R, Rajagopalan M, et al. Biosimilars for psoriasis: Worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. Br J Dermatol. 2017;177(6):1495-502. https://doi.org/10.1111/bjd.15756 DOI: https://doi.org/10.1111/bjd.15756

Carrascosa J, Jacobs I, Petersel D, Strohal R. Biosimilar drugs for psoriasis: Principles, present, and near future. Dermatol Ther (Heidelb). 2018;8(2):173-94. https://doi.org/10.1007/s13555-018-0230-9 PMid:29549597 DOI: https://doi.org/10.1007/s13555-018-0230-9

Radtke MA, Augustin M. Biosimilars in psoriasis: What can we expect? Biosimilars in psoriasis. J Dtsch Dermatol Ges. 2014;12(4):306-12. DOI: https://doi.org/10.1111/ddg.12294

Generics and Biosimilars Initiative (GaBI). Biosimilars Approved in Europe. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe [Last accessed on 2021 Oct 12].

Generics and Biosimilars Initiative (GaBI). Biosimilars approved in the US. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US [Last accessed on 2021 Oct 12].

Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017;76:1093-102. DOI: https://doi.org/10.1016/j.jaad.2016.12.014

Reynolds KA, Pithadia DJ, Lee EB, Liao W, Wu JJ. Safety and effectiveness of anti-tumor necrosis factor-alpha biosimilar agents in the treatment of psoriasis. Am J Clin Dermatol. 2020;21(4):483-91. https://doi.org/10.1007/s40257-020-00507-1 PMid:32048187 DOI: https://doi.org/10.1007/s40257-020-00507-1

Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: A randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020;182(2):316-26. https://doi.org/10.1111/bjd.18220 PMid:31206593 DOI: https://doi.org/10.1111/bjd.18220

Megna M, Fabbrocini G, Costa C, Ferrillo M. A case of pediatric acrodermatitis continua of Hallopeau successfully treated with adalimumab biosimilar. Dermatol Ther. 2020;33(3):e13327. DOI: https://doi.org/10.1111/dth.13327