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《工程(英文)》 >> 2021年 第7卷 第11期 doi: 10.1016/j.eng.2020.06.029

单克隆抗体治疗过敏性疾病的研究现状

Department of Immunology, School of Basic Medical Sciences, Capital Medical University, Beijing 100069, China

收稿日期: 2019-10-31 修回日期: 2020-03-09 录用日期: 2020-06-23 发布日期: 2021-05-27

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摘要

过敏性疾病是常见的慢性疾病之一,由变应原在不同器官上引发变态反应,在临床上以不同器官的疾病为主要表现形式,如哮喘、特应性皮炎、鼻-鼻窦炎等,常累及儿童和成人。由于其在世界范围内的广泛流行和对患者生活质量的影响,采用新型生物疗法治疗过敏性疾病的研究业已成为该领域的热点。已知多种因素可促进或触发Th2 型免疫应答,导致2 型细胞因子和免疫球蛋白E(IgE)的产生并参与过敏性疾病的发生发展,因此,开发针对2 型细胞因子和IgE 的单克隆抗体为治疗过敏性疾病提供了新的策略。此外,一些潜在的靶点,如上皮源性预警素-胸腺基质淋巴细胞生成素(TSLP)和白介素33(IL-33)业已进入临床研究阶段。这些新的和潜在的靶点极大地提高了变应性疾病的治疗机会。本文阐述了目前已开发的针对细胞因子、细胞因子受体和IgE 的单克隆抗体在过敏性疾病治疗中的作用,并对这些抗体的临床效果进行了讨论和分析。

补充材料

参考文献

[ 1 ] Sánchez-Borges M, Martin BL, Muraro AM, Wood RA, Agache IO, Ansotegui IJ, et al. The importance of allergic disease in public health: an iCAALL statement. World Allergy Organ J 2018;11:8. 链接1

[ 2 ] Rolland JM, Prickett S, Gardner LM, O’Hehir RE. T cell targeted strategies for improved efficacy and safety of specific immunotherapy for allergic disease. Antiinflamm Antiallergy Agents Med Chem 2013;12(3):201–22. 链接1

[ 3 ] Platts-Mills TAE, Schuyler AJ, Erwin EA, Commins SP, Woodfolk JA. IgE in the diagnosis and treatment of allergic disease. J Allergy Clin Immunol 2016;137 (6):1662–70. 链接1

[ 4 ] Gasser P, Eggel A. Targeting IgE in allergic disease. Curr Opin Immunol 2018;54:86–92. 链接1

[ 5 ] Bochner B, Saini S. Introduction: anti-IgE. Clin Rev Allergy Immunol 2005;29 (1):1–2. 链接1

[ 6 ] Licari A, Marseglia G, Castagnoli R, Marseglia A, Ciprandi G. The discovery and development of omalizumab for the treatment of asthma. Expert Opin Drug Discov 2015;10(9):1033–42. 链接1

[ 7 ] Tajiri T, Niimi A, Matsumoto H, Ito I, Oguma T, Otsuka K, et al. Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study. Ann Allergy Asthma Immunol 2014;113(4):470–5.e2. 链接1

[ 8 ] Gill MA, Bajwa G, George TA, Dong CC, Dougherty II, Jiang N, et al. Counterregulation between the FceRI pathway and antiviral responses in human plasmacytoid dendritic cells. J Immunol 2010;184(11):5999–6006. 链接1

[ 9 ] Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med 2011;364(11):1005–15. 链接1

[10] Sorkness CA, Wildfire JJ, Calatroni A, Mitchell HE, Busse WW, O’Connor GT, et al. Reassessment of omalizumab-dosing strategies and pharmacodynamics in inner-city children and adolescents. J Allergy Clin Immunol Pract 2013;1 (2):163–71. 链接1

[11] Incorvaia C, Mauro M, Makri E, Leo G, Ridolo E. Two decades with omalizumab: what we still have to learn. Biologics 2018;12:135–42. 链接1

[12] Vickery BP. Can omalizumab monotherapy benefit real-world food allergy patients? Lessons from an observational study. J Allergy Clin Immunol Pract 2019;7(6):1910–1. 链接1

[13] Metz M, Staubach P, Bauer A, Brehler R, Gericke J, Kangas M, et al. Clinical efficacy of omalizumab in chronic spontaneous urticaria is associated with a reduction of FceRI-positive cells in the skin. Theranostics 2017;7(5):1266–76. 链接1

[14] Min TK, Saini SS. Emerging therapies in chronic spontaneous urticaria. Allergy Asthma Immunol Res 2019;11(4):470–81. 链接1

[15] Thaçi D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebocontrolled, dose-ranging phase 2b trial. Lancet 2016;387(10013):40–52. 链接1

[16] Harris JM, Maciuca R, Bradley MS, Cabanski CR, Scheerens H, Lim J, et al. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma. Respir Res 2016;17:29. 链接1

[17] Harris JM, Cabanski CR, Scheerens H, Samineni D, Bradley MS, Cochran C, et al. A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria. J Allergy Clin Immunol 2016;138(6):1730–2. 链接1

[18] Sheldon E, Schwickart M, Li J, Kim K, Crouch S, Parveen S, et al. Pharmacokinetics, pharmacodynamics, and safety of MEDI4212, an anti-IgE monoclonal antibody, in subjects with atopy: a phase I study. Adv Ther 2016;33(2):225–51. 链接1

[19] Bao K, Reinhardt RL. The differential expression of IL-4 and IL-13 and its impact on type-2 immunity. Cytokine 2015;75(1):25–37. 链接1

[20] Hart TK, Blackburn MN, Brigham-Burke M, Dede K, Al-Mahdi N, ZiaAmirhosseini P, et al. Preclinical efficacy and safety of pascolizumab (SB 240683): a humanized anti-interleukin-4 antibody with therapeutic potential in asthma. Clin Exp Immunol 2002;130(1):93–100.

[21] Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011;365 (12):1088–98. 链接1

[22] Korenblat P, Kerwin E, Leshchenko I, Yen K, Holweg CTJ, Anzures-Cabrera J, et al. Efficacy and safety of lebrikizumab in adult patients with mild-tomoderate asthma not receiving inhaled corticosteroids. Respir Med 2018;134:143–9. 链接1

[23] Simpson EL, Flohr C, Eichenfield LF, Bieber T, Sofen H, Taïeb A, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: a randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol 2018;78(5):863–71. 链接1

[24] Brightling CE, Chanez P, Leigh R, O’Byrne PM, Korn S, She D, et al. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med 2015;3(9):692–701. 链接1

[25] Panettieri RA, Sjöbring U, Peterffy A, Wessman P, Bowen K, Piper E, et al. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med 2018;6(7):511–25. 链接1

[26] Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, et al. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol 2019;143(1):135–41. 链接1

[27] Antoniu SA. Pitrakinra, a dual IL-4/IL-13 antagonist for the potential treatment of asthma and eczema. Curr Opin Investig Drugs 2010;11(11):1286–94. 链接1

[28] Strowd LC, Feldman SR. Dupilumab for atopic dermatitis. Lancet 2017;389 (10086):2265–6. 链接1

[29] Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med 2018;378(26):2486–96. 链接1

[30] Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med 2018;378(26):2475–85. 链接1

[31] Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA 2016;315 (5):469–79. 链接1

[32] Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, et al. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol 2018;142(1):171–7. 链接1

[33] Rakowski E, Zhao S, Liu M, Ahuja S, Durmus N, Grunig G, et al. Variability of blood eosinophils in patients in a clinic for severe asthma. Clin Exp Allergy 2019;49(2):163–70. 链接1

[34] Agumadu VC, Ramphul K, Mejias SG, Sonaye R, Sombans S, Lohana P. A review of three new anti-interleukin-5 monoclonal antibody therapies for severe asthma. Cureus 2018;10(8):e3216. 链接1

[35] Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014;371(13):1198–207. 链接1

[36] Emma R, Morjaria JB, Fuochi V, Polosa R, Caruso M. Mepolizumab in the management of severe eosinophilic asthma in adults: current evidence and practical experience. Ther Adv Respir Dis 2018;12:175346661880849.

[37] Montero-Pérez O, Contreras-Rey MB, Sánchez-Gómez E. Effectiveness and safety of mepolizumab in severe refractory eosinophilic asthma: results in clinical practice. Drugs Context 2019;8:1–8. 链接1

[38] Gevaert P, Van Bruaene N, Cattaert T, Van Steen K, Van Zele T, Acke F, et al. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol 2011;128(5):989–95. 链接1

[39] Bachert C, Sousa AR, Lund VJ, Scadding GK, Gevaert P, Nasser S, et al. Reduced need for surgery in severe nasal polyposis with mepolizumab: randomized trial. J Allergy Clin Immunol 2017;140(4):1024–31. 链接1

[40] Cavaliere C, Incorvaia C, Frati F, Messineo D, Ciotti M, Greco A, et al. Recovery of smell sense loss by mepolizumab in a patient allergic to Dermatophagoides and affected by chronic rhinosinusitis with nasal polyps. Clin Mol Allergy 2019;17:3. 链接1

[41] Oldhoff JM, Darsow U, Werfel T, Bihari IC, Katzer K, Laifaoui J, et al. No effect of anti-interleukin-5 therapy (mepolizumab) on the atopy patch test in atopic dermatitis patients. Int Arch Allergy Immunol 2006;141 (3):290–4. 链接1

[42] Murphy K, Jacobs J, Bjermer L, Fahrenholz JM, Shalit Y, Garin M, et al. Longterm safety and efficacy of reslizumab in patients with eosinophilic asthma. J Allergy Clin Immunol Pract 2017;5(6):1572–81. 链接1

[43] Liddament M, Husten J, Estephan T, Laine D, Mabon D, Pukac L, et al. Higher binding affinity and in vitro potency of reslizumab for interleukin-5 compared with mepolizumab. Allergy Asthma Immunol Res 2019;11(2):291–8. 链接1

[44] Kolbeck R, Kozhich A, Koike M, Peng L, Andersson CK, Damschroder MM, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol 2010;125(6):1344–53. 链接1

[45] Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med 2019;7(1):46–59. 链接1

[46] Huang YC, Weng CM, Lee MJ, Lin SM, Wang CH, Kuo HP. Endotypes of severe allergic asthma patients who clinically benefit from anti-IgE therapy. Clin Exp Allergy 2019;49(1):44–53. 链接1

[47] Cianferoni A, Spergel J. The importance of TSLP in allergic disease and its role as a potential therapeutic target. Expert Rev Clin Immunol 2014;10 (11):1463–74. 链接1

[48] Li Y, Wang W, Lv Z, Li Y, Chen Y, Huang K, et al. Elevated expression of IL-33 and TSLP in the airways of human asthmatics in vivo: a potential biomarker of severe refractory disease. J Immunol 2018;200(7):2253–62. 链接1

[49] Gauvreau GM, O’Byrne PM, Boulet LP, Wang Y, Cockcroft D, Bigler J, et al. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med 2014;370(22):2102–10. 链接1

[50] Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med 2017;377(10):936–46. 链接1

[51] Simpson EL, Parnes JR, She D, Crouch S, Rees W, Mo M, et al. Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: a randomized phase 2a clinical trial. J Am Acad Dermatol 2019;80(4):1013–21. 链接1

[52] Parnes JR, Sullivan JT, Chen L, Dias C. Pharmacokinetics, safety, and tolerability of tezepelumab (AMG 157) in healthy and atopic dermatitis adult subjects. Clin Pharmacol Ther 2019;106(2):441–9. 链接1

[53] Venkataramani S, Low S, Weigle B, Dutcher D, Jerath K, Menzenski M, et al. Design and characterization of Zweimab and Doppelmab, high affinity dual antagonistic anti-TSLP/IL13 bispecific antibodies. Biochem Biophys Res Commun 2018;504(1):19–24. 链接1

[54] Johansson K, McSorley HJ. Interleukin-33 in the developing lung—roles in asthma and infection. Pediatr Allergy Immunol 2019;30(5):503–10. 链接1

[55] Nakamura N, Tamagawa-Mineoka R, Yasuike R, Masuda K, Matsunaka H, Murakami Y, et al. Stratum corneum interleukin-33 expressions correlate with the degree of lichenification and pruritus in atopic dermatitis lesions. Clin Immunol 2019;201:1–3. 链接1

[56] Dedaj R, Unsel L. Case study: a combination of mepolizumab and omaluzimab injections for severe asthma. J Asthma 2019;56(5):473–4. 链接1

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