Биологические препараты в терапии атопического дерматита и бронхиальной астмы: фокус на дупилумаб

Ревякина В.А., Геппе Н.А., Малахов А.Б., Калюжин О.В., Астафьева Н.Г., Колосова Н.Г., Малахова-Капанадзе М.А. Биологические препараты в терапии атопического дерматита и бронхиальной астмы: фокус на дупилумаб. Педиатрия. Consilium Medicum. 2021; 2: 129–137. DOI: 10.26442/26586630.2021.2.201053

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Reviakina VA, Geppe NA, Malakhov AB, Kaliuzhin OV, Astaf'eva NG, Kolosova NG, Malakhova-Kapanadze MA. Biological drugs in the therapy of atopic dermatitis and bronchial asthma: focus on dupilumab. Pediatrics. Consilium Medicum. 2021; 2: 129–137. DOI: 10.26442/26586630.2021.2.201053

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Аннотация

За последнее десятилетие был достигнут значительный прогресс в лечении аллергических заболеваний, таких как атопический дерматит и бронхиальная астма. Дупилумаб, блокирующий передачу сигналов от ИЛ-4 и ИЛ-13, стал инновационным методом таргетной терапии. Иммунобиологическая терапия ингибитором IL-4Rα показана пациентам со среднетяжелым и тяжелым неконтролируемым атопическим дерматитом, среднетяжелым и тяжелым эозинофильным фенотипом некотролируемой бронхиальной астмы и плохо контролируемым тяжелым хроническим полипозным риносинуситом. Представлены клинический случай и последние данные о применении дупилумаба для лечения Т2-ассоциированных воспалительных заболеваний и обсуждаются перспективы применения препарата.

Ключевые слова: атопический дерматит, бронхиальная астма, аллергический ринит, дети, дупилумаб, иммунобиологическая терапия, ингибитор интерлейкина

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Significant progress has been made over the past decade in the treatment of allergic diseases such as atopic dermatitis and bronchial asthma. Dupilumab, which targets interleukin IL-4 and IL-13, has become an innovative targeted therapy. Immunobiologic therapy with the interleukin inhibitor is indicated for patients with moderate to severe uncontrolled atopic dermatitis, moderate to severe eosinophilic phenotype of uncontrolled Bronchial asthma and patients with poorly controlled severe chronic polyposis rhinosinusitis. A clinical case and recent data on the use of dupilumab for the treatment of type 2 inflammatory disease and prospects for its use are discussed.

Keywords: atopic dermatitis, bronchial asthma, allergic rhinitis, children, dupilumab, immunobiological therapy, interleukin inhibitor

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Список литературы

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26. Beck LA, Thaçi D, Deleuran M, et al. 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. Am J Clin Dermatol. 2020;21(4):567-77. DOI:10.1007/s40257-020-00527-x. PMID: 32557382. PMCID: PMC7371647.
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________________________________________________

1. Pefoyo AJ, Bronskill SE, Gruneir A, et al. The increasing burden and complexity of multimorbidity. BMC Public Health. 2015;15:415. DOI:10.1186/s12889-015-1733-2. PMID: 25903064. PMCID: PMC4415224.
2. Brunner PM, Silverberg JI, Guttman-Yassky E, et al. Councilors of the International Eczema Council. Increasing Comorbidities Suggest that Atopic Dermatitis Is a Systemic Disorder. J Invest Dermatol. 2017;137(1):18-25. DOI: 10.1016/j.jid.2016.08.022. PMID: 27771048.
3. Harrison C, Fortin M, van den Akker M, et al. Comorbidity versus multimorbidity: Why it matters. J Comorb. 2021;11:2633556521993993. DOI:10.1177/2633556521993993. PMID: 33718251. PMCID: PMC7930649.
4. Gandhi NA, Bennett BL, Graham NM, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50. DOI:10.1038/nrd4624. PMID: 26471366.
5. Palomares O, Akdis M, Martín-Fontecha M, Akdis CA. Mechanisms of immune regulation in allergic diseases: the role of regulatory T and B cells. Immunol Rev. 2017;278(1):219-36. DOI:10.1111/imr.12555. PMID: 28658547.
6. Stone KD, Prussin C, Metcalfe DD. IgE, mast cells, basophils, and eosinophils. J Allergy Clin Immunol. 2010;125(2 Suppl. 2):S73-80. DOI:10.1016/j.jaci.2009.11.017. PMID: 20176269. PMCID: PMC2847274.
7. Burleson SCM, Fick RB, Mannie MD, et al. The Immune Basis of Allergic Lung Disease, Ed.: Richard A. Parent, Comparative Biology of the Normal Lung (Second Edition), Academic Press, 2015; p. 683-719.
8. Abdelaziz MH, Abdelwahab SF, Wan J, et al. Alternatively activated macrophages; a double-edged sword in allergic asthma. J Transl Med. 2020;18(1):58. DOI:10.1186/s12967-020-02251-w. PMID: 32024540. PMCID: PMC7003359.
9. Zhu L, Ciaccio CE, Casale TB. Potential new targets for drug development in severe asthma. World Allergy Organ J. 2018;11(1):30. DOI:10.1186/s40413-018-0208-1. PMID: 30386455. PMCID: PMC6203275.
10. Atopic dermatitis. Clinical guidelines. All-Russian public organization “Russian Society of Dermatovenereologists and Cosmetologists”, All-Russian Public Organization “Russian Association of Allergists and Clinical Immunologists”, All-Russian Public Organization “Union of Pediatricians of Russia”. Available at: https://raaci.ru/dat/pdf/KR/atopic_dermatitis_2020.pdf. Accessed: 15.06.2021 (in Russian)
11. Harmonising Outcome Measures for Eczema (HOME). Available at: http://www.homeforeczema.org/ Accessed: 15.06.2021.
12. Бронхиальная астма. Клинические рекомендации. Режим доступа: https://cr.minzdrav.gov.ru/schema/359_2. Ссылка активна на 15.06.2021 [Bronchial asthma. Clinical guidelines. Available at: https://cr.minzdrav.gov.ru/schema/359_2. Accessed: 15.06.2021 (in Russian)].
13. Hynes GM, Hinks TSC. The role of interleukin-17 in asthma: a protective response? ERJ Open Res. 2020;6(2):00364-2019. DOI:10.1183/23120541.00364-2019. PMID: 32494573. PMCID: PMC7248344.
14. Halwani R, Al-Muhsen S, Al-Jahdali H, Hamid Q. Role of transforming growth factor-β in airway remodeling in asthma. Am J Respir Cell Mol Biol. 2011;44(2):127-33.
DOI:10.1165/rcmb.2010-0027TR. PMID:20525803.
15. Hauber H-P, Hamid Q. The Role of Interleukin-9 in Asthma. Allergol Int. 2005;54(Issue 1):71‑8. DOI:10.2332/allergolint.54.71
16. Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704. DOI:10.1038/nm.2755. PMID: 22561833; PMCID: PMC3597223.
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18. Global Initiative for Asthma (GINA) 2021. Available at: https://ginasthma.org/gina-reports/ Accessed: 15.06.2021.
19. Castro M, Corren J, Pavord ID, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018;378(26):2486-96. DOI:10.1056/NEJMoa1804092. PMID: 29782217.
20. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020;156(1):44-56. DOI:10.1001/jamadermatol.2019.3336. PMID: 31693077. PMCID: PMC6865265.
21. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. Journal of the American Academy of Dermatology. 2020;83(5):1282-93.
22. Worm M, Simpson EL, Thaçi D, et al. Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020;156(2):131-43. DOI:10.1001/jamadermatol.2019.3617. PMID: 31876900. PMCID: PMC6990756.
23. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. 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;389(10086):2287-303.
DOI:10.1016/S0140-6736(17)31191-1. PMID: 28478972.
24. de Bruin-Weller M, Thaçi D, Smith CH, et al. 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;178(5):1083-101. DOI:10.1111/bjd.16156. PMID: 29193016.
25. Ariëns, LFM, van der Schaft, J, Bakker, DS, et al. 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;75:116-26. DOI:10.1111/all.14080
26. Beck LA, Thaçi D, Deleuran M, et al. 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. Am J Clin Dermatol. 2020;21(4):567-77. DOI:10.1007/s40257-020-00527-x. PMID: 32557382. PMCID: PMC7371647.
27. NCT03346434. Available at: https://clinicaltrials.gov/ct2/show/NCT03346434. Accessed: 15.06.2021.
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DOI:10.1111/bjd.18476. PMID: 31595499. PMCID: PMC6972638.
32. Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-85.
DOI:10.1056/NEJMoa1804093. PMID: 29782224.
33. Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31-44. DOI:10.1016/S0140-6736(16)30307-5
34. FDA: Highlights of Prescribing Information (Dupilumab). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s020lbl.pdf. Accessed: 15.06.2021.

Авторы

В.А. Ревякина1, Н.А. Геппе2, А.Б. Малахов2,3, О.В. Калюжин2, Н.Г. Астафьева4, Н.Г. Колосова*2, М.А. Малахова-Капанадзе5

1 ФГБУН «Федеральный исследовательский центр питания и биотехнологии», Москва, Россия;
2 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
3 ГБУЗ «Морозовская детская городская клиническая больница» Департамента здравоохранения г. Москвы, Москва, Россия;
4 ФГБОУ ВО «Саратовский государственный медицинский университет им. В.И. Разумовского», Саратов, Россия;
5 ГБУЗ МО «Коломенская центральная районная больница», Коломна, Россия
*kolosovan@mail.ru

________________________________________________

Vera A. Reviakina1, Natalia A. Geppe2, Aleksandr B. Malakhov2,3, Oleg V. Kaliuzhin2, Natalia G. Astaf'eva4, Natalia G. Kolosova*2, Mariia A. Malakhova-Kapanadze5

1 Federal Research Center for Nutrition and Biotechnology, Moscow, Russia;
2 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
3 Morozov Children's City Clinical Hospital, Moscow, Russia;
4 Razumovsky Saratov State Medical University, Saratov, Russia;
5 Kolomna Central District Hospital, Kolomna, Russia
*kolosovan@mail.ru

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