1. Gross CP, Sepkowitz KA. The myth of the medical breakthrough: smallpox, vaccination, and Jenner reconsidered. Int J Infect Dis. 1998;3(1):54-60.

2. Lewiecki EM. Biological therapy: chronicling 15 years of progress. Expert Opin Biol Ther. 2015;15(5):619-21.

3. Finco O, Rappuoli R. Designing vaccines for the twenty-first century society. Front Immunol. 2014;5:12.

4. Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256(5517):495-7.

5. Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7(1):9-14.

6. Gaughan CL. The present state of the art in expression, production and characterization of monoclonal antibodies. Mol Divers. 2016;20(1):255‑70.

7. Medzhitov R, Janeway C. Innate immunity. N Engl J Med. 2000;343(5):338-44.

8. Parren PWHI, Carter PJ, Plückthun A. Changes to International Nonproprietary Names for antibody therapeutics 2017 and beyond: of mice, men and more. MAbs. 2017;9(6):898-906.

9. Flanagan SE, Haapaniemi E, Russell MA, Caswell R, AllenHL, De Franco E, et al. Activating germline mutations in STAT3 cause early-onset multi-organ autoimmune disease. Nat Genet. 2014;46(8):812-4.10. Kuehn HS, Ouyang W, Lo B, Deenick EK, Niemela JE, Avery DT, et al. Immune dysregulation in human subjects with heterozygous germline mutations in CTLA4. Science. 2014;345(6204):1623-7.

11. Sebastiani GD, Scirocco C, Galeazzi M. Rheumatic immune related adverse events in patients treated with checkpoint inhibitors for immunotherapy of cancer. Autoimmun Rev. 2019 Aug;18(8):805‑13.

12 Clark EA, Ledbetter JA. How does B cell depletion therapy work, and how can it be improved? Ann Rheum Dis. 2005;64 Suppl 4:iv77‑80.

13. Browne SK, Zaman R, Sampaio EP, Jutivorakool K, Rosen LB, Ding L, et al. Anti-CD20 (rituximab) therapy for anti-IFN-γ autoantibodyassociated nontuberculous mycobacterial infection. Blood. 2012;119(17):3933-9.

14. Chase NM, Verbsky JW, Hintermeyer MK, Waukau JK, Tomita-Mitchell A, Casper JT, et al. Use of combination chemotherapy for treatment of granulomatous and lymphocytic interstitial lung disease (GLILD) in patients with common variable immunodeficiency (CVID). J Clin Immunol. 2013;33(1):30-9.

15. Gobert D, Bussel JB, Cunningham-Rundles C, Galicier L, Dechartres A, Berezne A, et al. Efficacy and safety of rituximab in common variable immunodeficiency-associated immune cytopenias: a retrospective multicentre study on 33 patients. Br J Haematol. 2011;155(4):498‑508.

16. Easthope S, Jarvis B. Omalizumab. Drugs. 2001;61(2):253-60.

17. Holgate ST, Polosa R. Treatment strategies for allergy and asthma. Nat Rev Immunol. 2008;8(3):218‑30.

18. Djukanovi R, Wilson SJ, Kraft M, Jarjour NN, Steel M, Chung KF, et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med. 2004;170(6):583‑93.

19. Belliveau PP. Omalizumab: a monoclonal anti-IgE antibody. Med Gen Med. 2005;7(1):27.

20. Genentech. Xolair (omalizumab) for subcutaneous use prescribing information. South San Francisco, CA; 2014 sep. Revised 05/2019. Disponível em: https://www.gene.com/download/pdf/xolair_prescribing. pdf. Acessado em junho de 2019.

21. Johansson SG, Haahtela T, O’Byrne PM. Omalizumab and the immune system: an overview of preclinical and clinical data. Ann Allergy Asthma Immunol. 2002;89:132-8.

22. Oliver J, Tarleton C, Gilmartin L, Archibeque T, Qualls C, Diehl L, et al. Reduced FcepsilonRI-mediated release of asthma-promoting cytokines and chemokines from human basophils during omalizumab therapy. Int Arch Allergy Immunol. 2010;151(4):275‑84.

23. MacGlashan DW, Bochner BS, Adelman DC, Jardieu PM, Togias A, McKenzie-White J, et al. Down-regulation of Fc(épsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol. 1997;158:1438‑45.

24. Beck LA, Marcotte GV, MacGlashan Jr D, Togias A, Saini S. Omalizumab-induced reductions in mast cell FcεRI expression and function. J Allergy Clin Immunol. 2004,114(3):527-30.

25. Chanez P, Contin-Bordes CC, Garcia G, Verkindre C, Didier A, De Blay Fdr, et al. Omalizumab-induced decrease of FcεRI expression in patients with severe allergic asthma. Respir Med. 2010;104(11):1608‑17.

26. Shields RL, Whether WR, Zioncheck K, O'Connell L, Fendly B, Presta LG, et al. Inhibition of Allergic Reactions with Antibodies to IgE. Int Arch Allergy Immunol. 1995;107(1-3):308‑12.

27. Hamilton RG. Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (omalizumab). J Allergy Clin Immunol. 2006;117:759.

28. Massanari M, Holgate ST, Busse WW, Jimenez P, Kianifard F, Zeldin R. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Resp Med. 2009;104(2):188‑96.

29. Van Rensen ELJ, Evertse CE, Van Schadewijk WAAM, Van Wijngaarden S, Ayre G, Mauad T, et al. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment. Allergy. 2009;64(1):72‑80.

30. Lin H, Boesel KM, Griffith DT, Prussin C, Foster B, Romero FA, et al. Omalizumab rapidly decreases nasal allergic response and FcepsilonRI on basophils. J Allergy Clin Immunol. 2004;113(2):297‑302.

31. Hochhaus G, Brookman L, Fox H, Johnson C, Matthews J, Ren S, et al. Pharmacodynamics of omalizumab: implications for optimized dosing strategies and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin. 2003;19:491‑8.

32. Solèr M, Matz J, Townley R, Buhl R, O'Brien J, Fox H, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254‑61.

33. Corren J, Wood RA, Patel D, Zhu J, Yegin A, Dhillon G, et al. Effects of omalizumab on changes in pulmonary function induced by controlled cat room challenge. J Allergy Clin Immunol. 2011;127(2):398‑405.

34. Nopp A, Johansson SG, Adedoyin J, Ankerst J, Palmqvist M, Oman H. After 6 years with Xolair: a 3-year withdrawal follow-up. Allergy. 2010;65:56-60.

35. Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy. 2009;39:788-97.

36. Cox L, Platts-Mills TA, Finegold I, Schwartz LB, Simons FE, Wallace DV, et al. American Academy of Allergy, Asthma & Immunology/ American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol. 2007;120:1373-7.

37 Tan LD, Bratt JM, Godor D, Louie S, Kenyon NJ. Benralizumab: a unique IL-5 inhibitor for severe asthma. J Asthma Allergy. 2016;9:71‑81.

38. Markham A. Benralizumab: First Global Approval. Drugs. 2018;78(4):505-11.

39. FASENRATM benralizumabe – Bula profissional disponível em https:// www.astrazeneca.com.br/content/dam/az-br/Medicine/InfoFasenra/ Fasenra_Bula_Profissional%20-%20FSN003.pdf. Acesso em junho de 2019.

40. Smith DA, Minthorn EA, Beerahee M. Pharmacokinetics and pharmacodynamics of mepolizumab, an anti-interleukin-5 monoclonal antibody. Clin Pharmacokinet. 2011;50(4):215-27.

41. Krings JG, McGregor MC, Bacharier LB, Castro M. Biologics for severe asthma: treatment-specific effects are important in choosing a specific agent. J Allergy Clin Immunol Pract. 2019;7(5):1379-92.

42. Gnanakumaran G, Babu KS. Technology evaluation: mepolizumab, GlaxoSmithKline. Curr Opin Mol Ther. 2003;5(3):321-5.

43. Molfino NA, Gossage D, Kolbeck R, Parker JM, Geba GP. Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor. Clin Exp Allergy. 2012;42(5):712-37.

44. Ortega HG, Yancey SW, Mayer B, Gunsoy NB, Keene ON, Bleecker ER, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4(7):549‑56.

45. Cardet JC, Israel E. Update on reslizumab for eosinophilic asthma. Expert Opin Biol Ther. 2015;15:1531-9.

46. Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343-73.

47. Nucala (mepolizumabe) - Nova indicação. Disponível em: http://portal.anvisa.gov.br/informacoes-tecnicas13?p_p_id=101_INSTANCE_WvKKx2fhdjM2&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_WvKKx2fhdjM2_groupId=219201&_101_INSTANCE_WvKKx2fhdjM2_urlTitle=nucala-mepolizumabe-&_101_INSTANCE_WvKKx2fhdjM2_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_WvKKx2fhdjM2_assetEntryId=5584341&_101_INSTANCE_WvKKx2fhdjM2_type=content . Acesso em agosto de 2019.

48. 125526 Mepolizumab Statistical PREA – FDA. Disponível em: www.fda.gov/media/95129/download. Acesso em junho de 2019.

49. Pouliquen IJ, Kornmann O, Barton SV, Price JA, Ortega HG. Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab. Int J Clin Pharmacol Ther. 2015;53(12):1015‑27.

50. Matucci A, Vultaggio A, Danesi R. The use of intravenous versus subcutaneous monoclonal antibodies in the treatment of severe asthma: a review. Respir Res. 2018;19:154.

51. 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;371:1198-207.

52. Busse WW. Biological treatments for severe asthma: A major advance in asthma care. Allergol Int. 2019; Feb 18. [Epub ahead of print].

53. Sulaiman I, Lim JCW, Soo HL, Stanslas J. Molecularly targeted therapies for asthma: Current development, challenges and potential clinical translation. Pulm Pharmacol Ther. 2016;40:52-68.

54. Lieberman P, Patterson R, Kunske R. Complications of long-term steroid therapy for asthma. J Allergy Clin Immunol. 1972;49:329‑36.

55. Take Action With DUPIXENT® (dupilumab). Disponível em: https://www.dupixent.com/ . Acesso em junho de 2019.

56. CINQAERO, INN-reslizumab - European Medicines Agency - europa. eu. Disponível em: https://www.ema.europa.eu/en/documents/product-information/cinqaero-epar-product-information_en.pdf. Acesso em junho de 2019.

57. Verstraete K, Peelman F, Braun H. Structure and antagonism of the receptor complex mediated by human TSLP in allergy and asthma. Nat Commun. 2017;8:14937.

58. 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;377:936‑46.

59. Ziegler SF, Artis D. Sensing the outside world: TSLP regulates barrier immunity. Nat Immunol. 2010;11:289-93.

60. Kato A, Favoreto S Jr, Avila PC, Schleimer RP. TLR3- and Th2 cytokine dependent production of thymic stromal lymphopoietin in human airway epithelial cells. J Immunol. 2007;179:1080. 61 .Allakhverdi Z, Comeau MR, Jessup HK, Yoon BR, Brewer A, Chartier S, et al. Thymic stromal lymphopoietin is released by human epithelial cells in response to microbes, trauma, or inflammation and potently activates mast cells. J Exp Med. 2007;204(2):253-8.

62. Shikotra A, Choy DF, Ohri CM, Doran E, Butler C, Hargadon B, et al. Increased expression of immunoreactive thymic stromal lymphopoietin in patients with severe asthma. J Allergy Clin Immunol. 2012;129:104‑11.

63. He JQ, Hallstrand TS, Knight D, Chan-Yeung M, Sandford A, Tripp B, et al. A thymic stromal lymphopoietin gene variant is associated with asthma and airway hyperresponsiveness. J Allergy Clin Immunol. 2009;124:222-9.

64. 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;370:2102-10.

65. 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;Feb 19. doi:

10.1002/cpt.1401.

66. Tezepelumab granted Breakthrough Therapy Designation by US FDA. Disponível em: https://www.astrazeneca.com/media-centre/press-releases/2018/tezepelumab-granted-breakthrough-therapydesignation-by-us-fda-07092018.html. Acesso em julho de 2019.

67. Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (DIRECTION). Disponível em: https://clinicaltrials.gov/ct2/show/study/NCT03927157. Acesso em julho de 2019.

68. Fichtner-Feigl S, Strober W, Kawakami K, Puri RK, Kitani A. IL-13 signaling through the IL-13alpha2 receptor is involved in induction of TGF-beta1 production and fibrosis. Nat Med. 2006;12:99‑106.

69. O’Dwyer DN, Moore BB. The role of periostin in lung fibrosis and airway remodeling. Cell Mol Life Sci. 2017;74:4305‑14.

70. Matsumoto H. Serum periostin: a novel biomarker for asthma management. Allergol Int. 2014;63:153‑60.

71. Li H, Wang K, Huang H, Cheng W, Liu X. A meta-analysis of antiinterleukin-13 monoclonal antibodies for uncontrolled asthma. PLoS ONE 14(1):e0211790.

72. Liu Y, Zhang S, Chen R, Wei J, Guan G, Zhou M, et al. Meta-analysis of randomized controlled trials for the efficacy and safety of antiinterleukin-13 therapy with lebrikizumab in patients with uncontrolled asthma. Allergy Asthma Proc. 2018;39(5):332-7.

73. Steinke JW. Anti-interleukin-4 therapy. Immunol Allergy Clin North Am. 2004;24:599-614.

74. Pelaia G, Vatrella A, Maselli R. The potential of biologics for the treatment of asthma. Nat Rev Drug Discov. 2012;11:958-72.

75. Kao CC, Parulekar AD. Spotlight on fevipiprant and its potential in the treatment of asthma: evidence to date. J Asthma Allergy. 2019;12:1-5.

76. Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, et al. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017;50(2). pii: 1700670.

77. Kuna P, Bjermer L, Tornling G. Two Phase II randomized trials on the CRTh2 antagonist AZD1981 in adults with asthma. Drug Des Devel Ther. 2016;10:2759‑70.

78. Zhu L, Ciaccio CE, Casale TB. Potential new targets for drug development in severe asthma. World Allergy Organ J. 2018;11(1):30.

79. Darveaux J, Busse WW. Biologics in asthma – the next step toward personalized treatment. J Allergy Clin Immunol Pract. 2015;3:152‑60.

80. Manka LA, Wechsler ME. New biologics for allergic diseases. Expert Rev Clin Immunol. 2018;14:285-96.

81. Vignesh P, Rawat A, Singh S. An Update on the Use of Immunomodulators in Primary Immunodeficiencies. Clin Rev Allergy Immunol. 2017;52:287-303.

82. Israel E, Reddel HK. Severe and difficult-to-treat asthma in adults. N Engl J Med. 2017;377:965‑76.

83. Olin JT, Wechsler ME. Asthma: pathogenesis and novel drugs for treatment. BMJ. 2014;349:g5517.

84. Gonem S, Berair R, Singapuri A, Hartley R, Laurencin MFM, Bacher G, et al. Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2016;4:699‑707.

85. Desai M, Oppenheimer J, Lang DM. Immunomodulators and Biologics. Beyond stepped-care therapy. Clin Chest Med. 2019;40:179-92.

86. Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-90.

87. Humbert M, Beasley R, Ayres J, Slavin R, Hébert J, Bousquet J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005;60(3):309-16.

88. Chan MA, Gigliotti NM, Dotson AL, Rosenwasser LJ. Omalizumab may decrease IgE synthesis by targeting membrane IgE+ human B cells. Clin Transl Allergy. 2013;3(1):29.

89. Teach SJ, Gill MA, Togias A, Sorkness CA, Arbes SJ Jr, Calatroni A, et al. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol. 2015;136(6):1476-85.

90. Global Initiative for Asthma – update 2019. Disponível em: ginasthma.org/wp-content/uploads/2019/04/GINA-2019-mainPocket-Guide-wms.pdf. Acesso em abril de 2019.

91. Carvalho-Pinto RM, Agondi RC, Giavina-Bianchi P, Cukier A, Stelmach R. Omalizumab in patients with severe uncontrolled asthma: well-defined eligibility criteria to promote asthma control. J Bras Pneumol. 2017;43(6):487-9.

92. Karpel J, Massanari M, Geba GP, Kianifard F, Inhaber N, Zeldin RK. Effectiveness of omalizumab in reducing corticosteroid burden in patients with moderate to severe persistent allergic asthma. Ann Allergy Asthma Immunol. 2010;105(6):465-70.

93. Bhutani M, Yang WH, Hébert J, de Takacsy F, Stril JL. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX Observational study. PLoS One. 2017;12(8):e0183869.

94. Bousquet J, Cabrera P, Berkman N, Buhl R, Holgate S, Wenzel S, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy. 2005 Mar;60(3):302-8.

95. Lai T, Wang S, Xu Z, Zhang C, Zhao Y, Hu Y, et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015;5:8191.

96. Normansell R, Walker S, Milan SJ, Walters EH, Nair P. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev. 2014;(1):CD003559.

97. Pitrez PM, de Souza RG, Roncada C, Heinzmann-Filho JP, Santos G, Pinto LA, et al. Impact of omalizumab in children from a middle-income country with severe therapy-resistant asthma: A real-life study. Pediatr Pulmonol. 2017;52(11):1408-13.

98. Fahy JV, Fleming HE, Wong HH, Liu JT, Su JQ, Reimann J, et al. The effect of an anti-IgE monoclonal antibody on the early- and late-phase responses to allergen inhalation in asthmatic subjects. Am J Respir Crit Care Med. 1997;155(6):1828-34.

99. Jones J, Shepherd J, Hartwell D, Harris P, Cooper K, Takeda A, et al. Omalizumab for the treatment of severe persistent allergic asthma. Health Technol Assess. 2009;13 Suppl 2:31-9.

100. Casale TB, Luskin AT, Busse W, Zeiger RS, Trzaskoma B, Yang M, et al. Omalizumab effectiveness by biomarker status in patients with asthma: Evidence from PROSPERO, a prospective real-world study. J Allergy Clin Immunol Pract. 2019;7(1):156-164.e1.

101. Limb SL, Starke PR, Lee CE, Chowdhury BA. Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. J Allergy Clin Immunol. 2007;120(6):1378-81.

102. Cruz AA, Lima F, Sarinho E, Ayre G, Martin C, Fox H, et al. Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. Clin Exp Allergy. 2007;37(2):197‑207.

103. Giavina-Bianchi P, Giavina-Bianchi M, Agondi R, Kalil J. Administration of anti-IgE to a Churg-Strauss syndrome patient. Int Arch Allergy Immunol. 2007;144(2):155-8.

104. Rambasek T, Kavuru MS. Omalizumab dosing via the recommended card versus use of the published formula. J Allergy Clin Immunol. 2006;117(3):708-9.

105. FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, et al. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a multicenter, double-blind, placebocontrolled phase 3 trial. Lancet. 2016;388:2128‑41.

106. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a multicenter, placebocontrolled phase 3 trial. Lancet. 2016;388:2115-27.

107. Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-58.

108. Sehmi R, Lim HF, Mukherjee M, Huang C, Radford K, Newbold P, et al. Benralizumab attenuates airway eosinophilia in prednisonedependent asthma. J Allergy Clin Immunol. 2018;141:1529‑32e8.

109. Fasenra® Bula. Disponível em: https://www.astrazeneca.com.br/content/dam/az-br/Medicine/InfoFasenra/Fasenra_Bula_Profissional%20-%20FSN003.pdf. Acesso em março de 2019.

110. Hermosa JL, Sanchez CB, Rubio MC, Minguez MM, Walther JL. Factors associated with the control of severe asthma. J Asthma. 2010;47:124-30.

111. Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 study of reslizumab in patients with poorly controlled asthma: effects across a broad range of eosinophil counts. Chest. 2016;150:799‑810.

112. 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;378:2486-96.

113. Menzella F, Montanari G. Clinical usefulness of mepolizumab in severe eosinophilic asthma. Ther Clin Risk Manag. 2016:907‑16.

114. Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371:1189-97.

115. Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med. 2009;360:973-84.

116. Haldar P, Brightling CE, Singapuri A, Hargadon B, Gupta S, Monteiro W, et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol. 2014;133:921-3.

117. Shimoda T, Odajima H, Okamasa A, Kawase M, Komatsubara M, Mayer B, et al. Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma. Allergol Int. 2017;66:445‑51.

118. Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, et al. Longterm efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38: 2058-2070.e1.

119. Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, et al. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016;71:1335-44.

120. Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380:651-9.

121. Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5:390-400.

122. Farne HA, Wilson A, Powell C, Bax L, Milan SJ. Anti-IL5 therapies for asthma. Cochrane Database Syst Rev. 2017;9:CD010834.

123. Tsukamoto N, Takahashi N, Itoh H, Pouliquen I. Pharmacokinetics and pharmacodynamics of mepolizumab, an anti-interleukin 5 monoclonal antibody, in healthy Japanese male subjects. Clin Pharmacol Drug Dev. 2016;5:102-8.

124. Flood-Page PT, Menzies-Gow AN, Kay AB, Robinson DS. Eosinophil's role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med. 2003;167:199-204.

125. Galkin D, Liu MC, Chipps BE, Chapman KR, Muñoz X, Bergna MA, et al. Efficacy and safety of mepolizumab in uncontrolled patients with severe eosinophilic asthma following a switch from omalizumab (OSMO study): exacerbation and safety outcomes. J Allergy Clin Immunol. 2018;141:AB409.

126. 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;378:2475-85.

127. Zayed Y, Kheiri B, Banifadel M, Hicks M, Aburahma A, Hamid K, et al. Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and meta-analysis of randomized clinical trials. J Asthma. 2018 Oct 1:1-10. [Epub ahead of print].

128. Passalacqua G, Matucci A, Vultaggio A, Bagnasco D, Mincarini M, Maggi E, et al. The safety of monoclonal antibodies in asthma. Expert Opin Drug Saf. 2016;15:1087-95.

129. Bochner BS, Klunk DA, Sterbinsky SA, Coffman RL, Schleimer RP. IL13 selectively induces vascular cell adhesion molecule-1 expression in human endothelial cells. J Immunol. 1995;154:799‑803.

130. Conroy DM, Williams TJ. Eotaxin and the attraction of eosinophils to the asthmatic lung. Respir Res. 2001;2:150-6.

131. Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebocontrolled study. Am J Respir Crit Care Med. 2011;184:1125‑32.

132. Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3:355-66.

133. Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016;150:789-98.

134. Mukherjee M, Aleman Paramo F, Kjarsgaard M, Salter B, Nair G, LaVigne N, et al. Weight-adjusted intravenous reslizumab in severe asthma with inadequate response to fixed-dose subcutaneous mepolizumab. Am J Respir Crit Care Med. 2018;197:38-46.

135. Henriksen DP, Bodtger U, Sidenius K, Maltbaek N, Pedersen L, Madsen H, et al. Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma - a systematic review and meta-analysis. Eur Clin Respir J. 2018;5(1):1536097.

136. Pérez de Llano LA, Cosío BG, Domingo C, Urrutia I, Bobolea I, Valero A, et al. Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study. J Allergy Clin Immunol Pract.

2019 Jan 21. pii: S2213-2198(19)30069-8. [Epub ahead of print].

137. Bateman ED, Zangrilli J, Germinaro M, Castro M. Association between early improvements in lung function and asthma control with reslizumab and the annual rate of asthma exacerbations. Am J Respir Crit Care Med. 2016;193:A7782.

138. Teva announces top-line results from phase III studies of subcutaneously administered reslizumab in patients with severe eosinophilic asthma; 2018. Available from: http://www.tevapharm. com/news/teva_announces_top_line_ results_from_phase_ iii_studies_of_subcutaneously_administered_reslizumab_ in_ patients_with_severe_eosinophilic_asthma_01_18.aspx. Acessado em março de 2019.

139. Murphy K, Jacobs J, Bjermer L, Fahrenholz JM, Shalit Y, Garin M, et al. Long-term safety and efficacy of reslizumab in patients with eosinophilic asthma. J Allergy Clin Immunol Pract. 2017;5:1572‑81 e3.

140. Bula CIQ-40891 CINQAIR Full PI v003 and Patient Information

8.5x11 eletronic.indd Disponível em: https://www.cinqair.com/ globalassets/cinqair/prescribinginformation.pdf. Acesso em maio de 2019.

141. Korenblat P, Kerwin E, Leshchenko I, Yen K, Holweg CTJ, AnzuresCabrera J, et al. Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids. Respir Med. 2018;134:143-9.

142. Trial NCT02104674 at http://www.clinicaltrials.gov.

143. Ziegler SF. The role of thymic stromal lymphopoietin (TSLP) in allergic disorders. Curr Opin Immunol. 2010; 22(6):795‑9.

144. Study NCT03347279. ClinicalTrials.gov website.

145. Study NCT03406078. ClinicalTrials.gov website.

146. Study NCT03706079. ClinicalTrials.gov website.

147. Study NCT03688074. ClinicalTrials.gov website.

148. Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003;361:151‑60.

149. Seguchi T, Cui CY, Kusuda S, Takahashi M, Aisu K, Tezuka T. Decreased expression of filaggrin in atopic skin. Arch Dermatol Res. 1996;288:442-6.

150. Howell MD, Parker ML, Mustelin T, Ranade K. Past, present, and future for biologic intervention in atopic dermatitis. Allergy. 2015;70:887‑96.

151. Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, et al. Anti-interleukin-31 receptor A antibody for atopic dermatitis. N Engl J Med. 2017;376:826-35.

152. Deleanu D, Nedelea I. Biological therapies for atopic dermatitis: An update. Exp Ther Med. 2019;17:1061-7.

153. Romano C, Sellitto A, De Fanis U, Balestrieri A, Savoia A, Abbadessa S, et al. Omalizumab for difficult-to-treat dermatological conditions: Clinical and immunological features from a retrospective real-life experience. Clin Drug Investig. 2015;35:159-68.

154. Wang HH, Li YC, Huang YC: Efficacy of omalizumab in patients with atopic dermatitis: A systematic review and meta-analysis. J Allergy Clin Immunol. 2016;138:1719-22.

155. Iyengar SR, Hoyte EG, Loza A, Bonaccorso S, Chiang D, Umetsu DT, et al. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: A randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol.2013;162:89-93.

156. Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014;371:130-9.

157. Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335‑48.

158. Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, et al. Long-term management of moderate-tosevere atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, doubleblinded, placebo-controlled, phase 3 trial. Lancet (London, England). 2017;389:2287‑303.

159. 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. 2019 Jul 8. doi: 10.1111/ijd.14573. [Epub ahead of print].

160. He JQ, Chan-Yeung M, Becker AB, Dimich-Ward H, Ferguson AC, Manfreda J, et al. Genetic variants of the IL13 and IL4 genes and atopic diseases in at-risk children. Genes Immun. 2003;4:385‑9.

161. Tazawa T, Sugiura H, Sugiura Y, Uehara M. Relative importance of IL-4 and IL-13 in lesional skin of atopic dermatitis. Arch Dermatol Res. 2004;295:459‑64.

162. Kim BE, Leung DY, Boguniewicz M, Howell MD. Loricrin and involucrin expression is down-regulated by Th2 cytokines through STAT-6. Clin Immunol. 2008;126:332‑7.

163. Khattri S, Shemer A, Rozenblit M, Dhingra N, Czarnowicki T, Finney R, et al. Cyclosporine in patients with atopic dermatitis modulates activated inflammatory pathways and reverses epidermal pathology. J Allergy Clin Immunol. 2014;133:1626‑34.

164. Ultsch M, Bevers J, Nakamura G, Vandlen R, Kelley RF, Wu LC, et al. Structural basis of signaling blockade by anti-IL-13 antibody lebrikizumab. J Mol Biol. 2013;425:1330‑9.

165. Hanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, et al. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015;70:748‑56.

166. Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, et al. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016;4:781‑96.

167. 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 (TREBE). J Am Acad Dermatol. 2018;78(5):863-71.

168. May RD, Monk PD, Cohen ES, Manuel D, Dempsey F, Davis NH, et al. Preclinical development of CAT-354, an IL-13 neutralizing antibody, for the treatment of severe uncontrolled asthma. Br J Pharmacol. 2012;166:177‑93.

169. 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.

170. Bilsborough J, Leung DY, Maurer M, Howell M, Boguniewicz M, Yao L, et al. IL-31 is associated with cutaneous lymphocyte antigenpositive skin homing T cells in patients with atopic dermatitis. J Allergy Clin Immunol. 2006;117:418‑25.

171. Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, et al. Nemolizumab in patients with moderate-to-severe atopic dermatitis: randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018;142:1121‑30.

172. Mihara R, Kabashima K, Furue M, Nakano M, Ruzicka T. Nemolizumab in moderate to severe atopic dermatitis: n exploratory analysis of workproductivity and activity impairment in a randomized phase II study. J Dermatol. 2019 Jun 5, doi: 10.1111/1346-8138.14934. [Epub ahead of print].

173. Peng W, Novak N. Recent developments in atopic dermatitis. Curr Opin Allergy Clin. 2014;14:417‑22.

174. Guttman-Yassky E, Brunner PM, Neumann AU, Khattri S, Pavel AB, Malik K, et al. Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to severe atopic dermatitis inadequately controlled by conventional treatments: a randomized, double-blind, phase 2a trial. J Am Acad Dermatol. 2018;78:872‑81.

175. Khattri S, Brunner PM, Garcet S, Finney R, Cohen SR, Oliva M, et al. Efficacy and safety of ustekinumab treatment in adults with moderateto-severe atopic dermatitis. Exp Dermatol. 2017;26:28‑35.

176. Fernández-Antón Martínez MC, Alfageme Roldán F, Ciudad Blanco C, Suárez Fernández R. Ustekinumab in the treatment of severe atopic dermatitis: A preliminary report of our experience with 4 patients. Actas Dermosifiliogr. 2014;105:312‑3.

177. Shroff A, Guttman-Yassky E. Successful use of ustekinumab therapy in refractory severe atopic dermatitis. JAAD Case Rep. 2014;1:25-6.

178. Saeki H, Kabashima K, Tokura Y, Murata Y, Shiraishi A, Tamamura R, et al. Efficacy and safety of ustekinumab in Japanese patients with severe atopic dermatitis: a randomized, double-blind, placebocontrolled, phase II study. Br J Dermatol. 2017;177:419‑27.

179. 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.

180. Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, BallmerWeber B, et al. The EAACI/GA2 LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. The 2017 revision and update. Allergy. 2018;73:1145‑6.

181. Kocatürk E, Zuberbier T. New biologics in the treatment of urticaria. Curr Opin Allergy Clin Immunol. 2018;18:425-31.

182. Maurer M, Altrichter S, Bieber T, Biedermann T, Bräutigam M, Seyfried S, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128:202‑5.

183. Maurer M, Rosén K, Hsieh H-J, Saini S, Grattan C, Gimenéz-Arnau A, et al. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. N Engl J Med. 2013;368:924‑35.

184. Saini SS, Bindslev-Jensen C, Maurer M, Grob J-J, Bülbül Baskan E, Bradley MS, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:67‑75.

185. Kaplan A, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, et al. Omalizumab in patients with symptomatic chronic idiopathic/ spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132:101‑9.

186. Ensina LF, Valle SOR, Juliani AP, Galeane M, Vieira dos Santos R, Arruda LK, et al. Omalizumab in Chronic Spontaneous Urticaria: A Brazilian Real-Life Experience. Int Arch Allergy Immunol. 2016;169:121‑4.

187. Tharp MD, Bernstein JA, Kavati A, Ortiz B, MacDonald K, Denhaerynck K, et al. Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of “Real-world” Evidence. JAMA Dermatol. 2019;155:29-38.

188. Har D, Patel S, Khan DA. Outcomes of using omalizumab for more than 1 year in refractory chronic urticaria. Ann Allergy Asthma Immunol. 2015;115:126‑9.

189. Ensina LF, de Lacerda AE, Machado LM de O, Camelo-Nunes I, Sole D. Long-term omalizumab therapy for refractory chronic spontaneous urticaria: a real-life experience. Ann Allergy Asthma Immunol. 2015;115:536.

190. Ensina LF, Cusato-Ensina AP, Camelo-Nunes IC, Sole D. Omalizumab as Third-Line Therapy for Urticaria During Pregnancy. J Investig Allergol Clin Immunol. 2017;27:326‑7.

191. Gericke J, Metz M, Ohanyan T, Weller K, Altrichter S, Skov PS, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;139:1059‑61.

192. Maurer M, Metz M, Brehler R, Hillen U, Jakob T, Mahler V, et al. Omalizumab treatment in patients with chronic inducible urticaria: A systematic review of published evidence. J Allergy Clin Immunol. 2018;141:638‑49.

193. Arm JP, Bottoli I, Skerjanec A, Floch D, Groenewegen A, Maahs S, et al. Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects. Clin Exp Allergy. 2014;44(11):1371‑85.

194. Maurer M, Gimenez-Arnau A, Sussman G, Loeffler J, Barve A, Severin T, et al. Ligelizumab as add on therapy for patients with H1 antihistamine refractory chronic spontaneous urticaria: Primary results of a placebo and active controlled phase 2b dose finding study. Allergy. 2018;73(S105):837.

195. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Disponível em: https://clinicaltrials.gov/ct2/results?term=ligelizumab&cond=Urticaria. Acessado em março de 2019.

196. 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.

197. 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;138:1730-2.

198. Bangsgaard N, Skov L, Zachariae C. Treatment of Refractory Chronic Spontaneous Urticaria with Adalimumab. Acta DermatoVenereologica. 2017;97:524‑5.

199. Wilson LH, Eliason MJ, Leiferman KM, Hull CM, Powell DL. Treatment of refractory chronic urticaria with tumor necrosis factoralfa inhibitors. J Am Acad Dermatol. 2011;64:1221‑2.

200. Magerl M, Philipp S, Manasterski M, Friedrich M, Maurer M. Successful treatment of delayed pressure urticaria with anti‑TNF-α. J Allergy Clin Immunol. 2007;119:752‑4.

201. Virkud VY, Wang J, Shreffler WG. Enhancing the Safety and Efficacy of Food Allergy Immunotherapy: a Review of Adjunctive Therapies. Clin Rev Allergy Immunol. 2018;55:172‑89.

202. Burk CM, Dellon ES, Steele PH, Virkud YV, Kulis M, Burks AW, et al. Eosinophilic esophagitis during peanut oral immunotherapy with omalizumab. J Allergy Clin Immunol Pract. 2017;5(2):498-501.

203. Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, et al. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016;137(4):1103-1110 e11.

204. Frischmeyer-Guerrerio PA, Masilamani M, Gu W, Brittain E, Wood R, Kim J, Nadeau K, et al. Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy. J Allergy Clin Immunol. 2017;140(4):1043‑53.e8.

205. Hill DA, Grundmeier RW, Ramos M, Spergel JM. Eosinophilic Esophagitis Is a Late Manifestation of the Allergic March. J Allergy Clin Immunol Pract. 2018; 6:1528-33.

206. Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, et al. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018;155:1022-33.

207. Ko E, Chehade M. Biological Therapies for Eosinophilic Esophagitis: Where Do We Stand? Clin Rev Allergy Immunol. 2018; 55:205‑16.

208. Krause K, Metz M, Makris M, Zuberbier T, Maurer M. The role of interleukin-1 in allergy-related disordes. Curr Opin Allergy Clin Immunol. 2012;12:477-84.

209. Rothenberg ME, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, et al. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2015;135(2):500-7.

210. Sastre J, Davila I. Dupilumab: A New Paradigm for the Treatment of Allergic Diseases. J Investig Allergol Clin Immunol. 2018;28(3):139‑50.

211. Simons FE, Ardusso LR, Bilò MB, El-Gamal YM, Ledford DK, Ring J, et al. World allergy organization guidelines for the assessment and management of anaphylaxis. World Allergy Organ J. 2011;4:13‑37.

212. Castells M. Diagnosis and management of anaphylaxis in precision medicine. J Allergy Clin Immunol. 2017;140:321-3.

213. Bernd LA, Sá AB, Watanabe AS, Castro AP, Solé D, Castro FM, et al. Practical guide to the management of anaphylaxis – 2012. Rev Bras Alerg Imunopatol. 2012;35:53-70.

214. Lombardi C, Canonica GW, Passalacqua G. Allergen immunotherapy as add-on to biologic agents. Curr Opin Allergy Clin Immunol. 2018;502-8.

215. Galera C, Soohun N, Zankar N, Caimmi S, Gallen C, Demoly P. Severe anaphylaxis to bee venom immunotherapy: efficacy of pretreatment and concurrent treatment with omalizumab. J Investig Allergol Clin Immunol. 2009;19:225-9.

216. Palgan K, Bartuzi Z, Gotz-Zbikowska M. Treatment with a combination of omalizumab and specific immunotherapy for severe anaphylaxis after a wasp sting. Int J Immunopathol Pharmacol. 2014;27:109‑12.

217. Christensen MJ, Bindslev-Jensen C. Successful treatment with omalizumab in challenge confirmed exercise-induced anaphylaxis. J Allergy Clin Immunol Pract. 2017;5:204-6.

218. Ojaimi S, Harnett PR, Fulcher DA. Successfull carboplatin desensitization by using omalizumab and paradoxical diminution of total IgE levels. J Allergy Clin Immunol Pract. 2014;2:105-6.

219. Burguete-Cabanas MT, Fajardo-Ramirez OR, Yesaki R, EstradaMaganas R, Salazar-Meza S, Rios-Chavez O, et al. Omalizumab for hypersensitive reaction to seminal plasma: a case report. Allergol Int. 2018;67:278-9.

220. Solé D, Silva LR, Cocco RR, Ferreira CT, Sarni RO, Oliveira LC, et al. Consenso Brasileiro sobre alergia alimentar: 2018-Parte 2-Diagnóstico, tratamento e prevenção. Arq Asma Alerg Immunol. 2018;2:39-82.

221. Bégin P, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, et al. Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab. Allergy Asthma Clin Immunol. 2014;10:7.

222. Casale TB. Status of immunotherapy: current and future. J Allergy Clin Immunol. 2004;113:1036-9.

223. Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, et al. Omalizumab pretreatment decreases acute reactions after rush immuntherapy for ragweed-induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2006;117:134‑40.

224. Stelmach I, Majak P, Jerzynska J, Bojo M, Cichalewski L, Smejda K. Children with severe asthma can start allergen immunotherapy after controlling asthma with omalizumab: a case series from Poland. Arch Med Sci. 2015;11:901‑4.

225. Broesby-Olsen S, Vestergaard H, Mortz CG, Jensen B, Havelund T, Hermann AP, et al. Omalizumab prevents anaphylaxis and improves symptoms in systemic mastocytosis; efficacy and safety observations. Allergy. 2018;73:230‑8.

226. Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012: a summary for otorhinolaryngologists. Rhinology. 2012;50:1‑12.

227. Liao B, Liu J-X, Li Z-Y, Zhen Z, Cao P-P, et al. Multidimensional endotypes of chronic rhinosinusitis and their association with treatment outcomes. Allergy. 2018;73:1459-69.

228. Cho SH, Bachert C, Lockey RF. Chronic rhinosinusitis phenotypes: an approach to better medical care for chronic rhinosinusitis. J Allergy Clin Immunol Pract. 2016;4:639-42.

229. Cho SW, Kim DW, Kim J-W, Lee CH, Rhee C-S. Classification of chronic rhinosinusitis according to a nasal polyp and tissue eosinophilia: limitation of current classification system for Asian population. Asia Pac Allergy. 2017;7:121-30.

230. Zhang Y, Gevaert E, Lou H, Wang X, Zhang L, Bachert C, Zhang N. Chronic rhinosinusitis in Asia. J Allergy Clin Immunol. 2017;140:1230-9.

231. Smith KA, Pulsipher A, Grabrielsen DA, Alt JA. Biologics in Chronic Rhinosinusitis: an update and thoughts for future directions. Am J Rhinol Allergy. 2018;32(5):412-23.

232. Kim DW, Cho SH. Emerging endotypes of chronic rhinosinusitis and its application to precision medicine. Allergy Asthma Immunol Res. 2017;9(4):299-306.

233. Schleimer RP. Immunopathogenesis of chronic rhinosinusitis and nasal polyposis. Annu Rev Pathol. 2017;12:331-57.

234. Poposki JA, Klinger AI, Tan BK, Soroosh P, Banie H, Lewis G, et al. Group 2 innate lymphoid cells are elevated and activated in chronic rhinosinusitis with nasal polyps. Immun Inflamm Dis. 2017;5(3):233‑43.

235. Gurrola II J, Borish L. Chronic rhinosinusitis: endotypes, biomarkers, and treatment response. J Allergy Clin Immunol. 2017;140:1499‑508.

236. Bachert C, Gevaert P, Hellings P. Biotherapeutics in chronic rhinosinusitis with and without nasal polyps. J Allergy Clin Immunol Pract. 2017;5(6):1512-6.

237. Pinto JM, Mehta N, DiTineo M, Wang J, Baroody FM, et al. A randomized, double blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010;48:318-24.

238. Gevaert P, Calus L, Zele TV, Blomme K, De Ruyck N, Bauters W, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol 2013;131:110-6.

239. Bidder T, Sahota J, Rennie C, Lund VJ, Robinson DS, Kariyawasam HH. Omalizumab treats chronic rhinosinusitis with nasal polyps and asthma together – a real life study. Rhinology. 2018;56:42-5.

240. Massachusetts General Hospital and Genentech, Inc. Subcutaneous omalizumab for treatment of chronic rhinosinusitis with nasal polyps. ClinicalTrials.gov website. Disponível em: https://clinicaltrials.gov/ct2/show/NCT01066104. Acesso em abril de 2019.

241. Hoffmann-La Roche. A clinical trial of omalizumab in participants with chronic rhinosinusitis with nasal polyps (POLYP 1). ClinicalTrials. gov website. Disponível em: https://clinicaltrials.gov/ct2/show/ NCT03280550. Acesso em abril de 2019.

242. Hoffmann-La Roche. A clinical trial of omalizumab in participants with chronic rhinosinusitis with nasal polyps (POLYP 2). ClinicalTrials. gov website. Disponível em: https://clinicaltrials.gov/ct2/show/NCT03280537. Acesso em abril de 2019.

243. Hoffmann-La Roche. An extension study of omalizumab in participants with chronic rhinosinusitis with nasal polyps. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/ NCT03478930. Acesso em abril de 2019.

244. Para AJ, Clayton E, Peters AT. Management of rhinosinusitis: an evidence based approach. Curr Opin Allergy Clin Immunol. 2016;16(4):383‑9.

245. Gevaert P, Lang-Loidolt D, Lackner A, Stammberger H, Staudinger H, Van Zele T, et al. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol. 2006;118;1133-41.

246. Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, et al. Effects of reslizumab on asthma outcomes in a subgroup of eosinophilic asthma patients with self-reported chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract. 2019;7:589-96.

247. Tuttle KL, Buchheit KM, Laidlaw TM, Cahill KN. A retrospective analysis of mepolizumab in subjects with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2018;6(3):1045-7.

248. 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;140:1024-1031.e14.

249. Hagin D, Shacham Y, Kivity S, Benor S. Mepolizumab for the treatment of aspirin-exacerbated respiratory disease associated with coronary spasm. J Allergy Clin Immunol Pract. 2019;7(3):1076-7.

250. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936.

251. Kyowa Hakko Kirin. Study of benralizumab (KHK4563) in patients with eosinophilic chronic rhinosinusitis. ClinicalTrials.gov website. Disponível em: https://clinicaltrials.gov/ct2/show/NCT02772419. Acesso abril de 2019.

252. AstraZeneca. Efficacy and safety study of benralizumab for patients with severe nasal polyposis (OSTRO). ClinicalTrials.gov website. Disponível em: https://clinicaltrials.gov/ct2/show/NCT03401229. Acesso em abril de 2019.

253. Chanez P, McDonald M, Garin M, Murphy K. Early decreases in blood eosinophil levels with reslizumab. J Allergy Clin Immunol. 2019;143:1653-5.

254. Pham T-H, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-9.

255. Flood-Page P, Swenson C, Faiferman I, Matthews J, Williams M, Brannick L, et al, A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma. Am J Respir Crit Care Med. 2007;176:1062-107.

256. US Food and Drugs Administration. FDA approves first treatment for chronic rhinosinusitis with nasal polyps. Disponível em: www.fda.gov/news-events/press-announcements/fda-approves-firsttreatment-chronic-rhinosinusitis-nasal-polyps. Acesso em junho de 2019.

257. 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;315:469-79.

258. Bachert C, Hellings PW, Mullol J, Naclerio RM, Chao J, Amin N, et al. Dupilumab improves patient reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma. J Allergy Clin Immunol. 2019;doi: https://doi.org/10.1016/j.jaip.2019.03.023.

259. Jonstam K, Swanson BN, Mannent LP, Cardell L-O, Tian N, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy. 2019;74:743‑52.

260. Liao B, Cao P-P, Zeng M, Zhen Z, Wang H, Zhang YN, et al. Interation of thymic stromal lymphopoietin, IL-33, and their receptors in epithelial cells in eosinophilic chronic rhinosinusitis with nasal polyps. Allergy. 2015;70:1169-80.

261. AnaptysBio, Inc. Etokimab in adults patients with chronic rhinosinusitis with nasal polyps (CRSwNP). ClinicalTrials.gov website. Disponível em: https://clinicaltrials.gov/ct2/show/NCT03614923. Acesso em abril de 2019.

262. Picard C, Bobby Gaspar H, Al-Herz W, Bousfiha A, Casanova JL, Chatila T, et al. International Union of Immunological Societies:

2017 Primary Immunodeficiency Diseases Committee Report on Inborn Errors of Immunity. J Clin Immunol. 2018;38:96-128.

263. Kilic SS, Kilicbay F. Interferon-alpha treatment of molluscum contagiosum in a patient with hyperimmunoglobulin E syndrome, Pediatrics. 2006;117:e1253-1255.

264. Al-Zahrani D, Raddadi A, Massaad M, Keles S, Jabara HH, Chatila TA, et al. Successful interferon-alpha 2b therapy for unremitting warts in a patient with DOCK8 deficiency, Clin Immunol. 2014:153:104‑8.

265. Böhm M, Luger TA, Bonsmann G. "Disseminated giant molluscum contagiosum in a patient with idiopathic CD4+ lymphocytopenia. Dermatology. 2008;217(3):196‑8.

266. Lafaille FG, Pessach IM, Zhang SY, Ciancanelli MJ, Herman M, Abhyankar A, et al. Impaired intrinsic immunity to HSV-1 in human iPSC-derived TLR3-deficient CNS cells. Nature. 2012;491:769‑73.

267. International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med.1991;324(8):509‑16.

268. Alangari AA, Al-Zamil F, Al-Mazrou A, Al-Muhsen S, Boisson-Dupuis S, Awadallah S, et al. Treatment of disseminated mycobacterial infection with high-dose IFN-gamma in a patient with IL-12Rbeta1 deficiency, Clin Dev Immunol. 2011;2011:691956.

269. Remiszewski P, Roszkowska-Sliz B, Winek J, Chapgier A, Feinberg J, Langfort R, et al. Disseminated Mycobacterium avium infection in a 20-year-old female with partial recessive IFNgammaR1 deficiency, Respiration. 2006; 73:375-8.

270. Marchand, I, Mahe E, Clerici T, Saiag P, Chevallier B. Disseminated BCG infection revealing X-linked severe combined immunodeficiency, Ann Dermatol Venereol. 2008;135:587‑90.

271. Orange JS, Roy-Ghanta S, Mace EM, Maru S, Rak GD, Sanborn KB, et al. IL-2 induces a WAVE2-dependent pathway for actin reorganization that enables WASp-independent human NK cell function, J Clin Invest. 2011;121:1535‑48.

272. Cunningham-Rundles C, Bodian C, Ochs HD, Martin S, ReiterWong M, Zhuo Z. Long-term low-dose IL-2 enhances immune function in common variable immunodeficiency, Clin Immunol. 2001;100:181‑90.

273. Regent A, Autran B, Carcelain G, Cheynier R, Terrier B, CharmeteauDe Muylder B, et al. French Idiopathic CD4 T Lymphocytopenia Study Group, Idiopathic CD4 lymphocytopenia: clinical and immunologic characteristics and follow-up of 40 patients. Medicine (Baltimore). 2014;93:61-72.

274. Orange JS, Brodeur SR, Jain A, Bonilla FA, Schneider LC, Kretschmer R, et al. Deficient natural killer cell cytotoxicity in patients with IKKgamma/NEMO mutations. J Clin Invest. 2012;109:1501‑9.

275. Chase NM, Verbsky JW, Hintermeyer MK, Waukau JK, TomitaMitchell A, Casper JT, et al. Use of combination chemotherapy for treatment of granulomatous and lymphocytic interstitial lung disease (GLILD) in patients with common variable immunodeficiency (CVID). J Clin Immunol. 2013;33:30‑9.

276. Hennig C, Baumann U, Ilginus C, Horneff G, Foell J, Hansen G. Successful treatment of autoimmune and lymphoproliferative complications of patients with intrinsic B-cell immunodeficiencies with Rituximab. Br J Haematol. 2010;148:445‑8.

277. Milone MC, Tsai DE, Hodinka RL, Silverman LB, Malbran A, Wasik MA, et al. Treatment of primary Epstein-Barr virus infection in patients with X-linked lymphoproliferative disease using B-cell-directed therapy. Blood. 2005; 105:994‑6.

278. Pathak S, McDermott MF, Savic S. Autoinflammatory diseases: update on classification diagnosis and management. J Clin Pathol. 2017;70:1-8.

279. Havnaer A, Han G. Autoinflammatory disorders: a review and update on pathogenesis and treatment. Am J Clin Dermatol. 2019;20(4):539‑64.

280. Lo B, Zhang K, Lu W, Zheng L, Zhang Q, Kanellopoulou C, et al. Autoimmune Disease. Patients with LRBA deficiency show CTLA4 loss and immune dysregulation responsive to abatacept therapy. Science. 2015;349:436‑40.

281. Milner JD, Vogel TP, Forbes L, Ma CA, Stray-Pedersen A, Niemela JE, et al. Early-onset lymphoproliferation and autoimmunity caused by germline STAT3 gain-of function mutations. Blood. 2015;125:591‑9.

282. Forbes LR, Vogel TP, Cooper MA, Castro-Wagner J, Schussler E, Weinacht KG, et al. Jakinibs for the treatment of immune dysregulation in patients with gain-of-function signal transducer and activator of transcription 1 (STAT1) or STAT3 mutations. J Allergy Clin Immunol. 2018;142:1665-9.

283. Moutsopoulos NM, Zerbe CS, Wild T, Dutzan N, Brenchley L, DiPasquale G, et al. Interleukin-12 and interleukin-23 blockade in leukocyte adhesion deficiency type 1. N Engl J Med. 2017;37(12):1141‑6.

284. Seidel MG, Kindle G, Gathmann B, Quinti I, Buckland M, van Montfrans J, et al. The European Society for Immunodeficiencies (ESID) Registry Working Definitions for the Clinical Diagnosis of Inborn Errors of Immunity. J Allergy Clin Immunol Pract. 2019;7(6):1763‑70.

285. Goudouris ES, Rego Silva AM, Ouricuri AL, Grumach AS, CondinoNeto A, Costa-Carvalho BT, et al. II Brazilian Consensus on the use of human immunoglobulin in patients with primaryimmunodeficiencies. Einstein (Sao Paulo). 2017;15(1):1‑16.

286. Condino-Neto A, Costa-Carvalho BT, Grumach AS, King A, Bezrodnik L, Oleastro M, et al. Guidelines for the use of human immunoglobulin therapy in patients with primary immunodeficiencies in Latin America. Allergol Immunopathol (Madr). 2014;42(3):245-60.

287. Wasserman RL. Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases. Immunotherapy. 2017;9(12):1035‑50.

288. Wasserman RL, Melamed I, Kobrynski L, Puck J, Gupta S, Doralt J, et al. Recombinant human hyaluronidase facilitated subcutaneous immunoglobulin treatment in pediatric patients with primary immunodeficiencies: long-term efficacy, safety and tolerability. Immunotherapy. 2016;8(10):1175-86.

289. Wasserman RL, Melamed IR, Stein MR, Jolles S, Norton M, Moy JN, et al. Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency. J Clin Immunol. 2017;37(3):301‑10.

290. Wasserman RL, Melamed I, Stein MR, Engl W, Sharkhawy M, Leibl H, et al. Long-term tolerability, safety, and efficacy of recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulin for primary immunodeficiency. J Clin Immunol.

291. Costa-Carvalho BT, Grumach AS, Franco JL, Espinosa-Rosales FJ, Leiva LE, King A, et al. Attending to warning signs of primary immunodeficiency diseases across the range of clinical practice. J Clin Immunol. 2014;34(1):10-22.

292. Giavina-Bianchi P, Arruda LK, Aun MV, Campos RA, Chong-Neto HJ, Constantino-Silva RN, et al. Brazilian Guidelines for Hereditary Angioedema Management - 2017 Update Part 1: Definition, Classification and Diagnosis. Clinics. 2018;73:e310.

293. Zuraw BL. Hereditary angioedema with normal C1 inhibitor: four types and counting. J Allergy Clin Immunol. 2018;141:884-5.

294. Germenis AE, Speletas M. Genetics of hereditary angioedema revisited. Clin Rev Allergy Immunol. 2016;51:170-82.

295. Kaplan AP, Joseph K. Complement, kinins, and hereditary angioedema: mechanisms of plasma instability when C1 inhibitor is absent. Clin Rev Allergy Immunol. 2016;51:207-15.

296. Maurer M, Magerl M, Ansotegui I, Aygören-Pürsün E, Betschel S, Bork K, et al. The international WAO/EAACI guideline for the management of hereditary angioedema - The 2017 revision and update. Allergy. 2018;73:1575-96.

297. Perego F, Wu MA, Valerieva A, Caccia S, Suffritti C, Zanichelli A, et al. Expert Opin Biol Ther. 2019 Mar 26:1-10. doi: 10.1080/14712598.2019.1595581 [Epub ahead of print].

298. Giavina-Bianchi P, Arruda LK, Aun MV, Campos RA, Solé D, Grumach AS, et al. Diretrizes Brasileiras para o diagnóstico e tratamento do angioedema hereditário – 2017. Arq Asma Alerg Imunol. 2017;1:23‑48.

299. Craig T, Zuraw B, Longhurst H, Cicardi M, Bork K, Grattan C, et al. Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks. J Allergy Clin Immunol Pract. 2019 Feb 15. pii: S2213-2198(19)30163-1.

300. Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, et al. Effect of Lanadelumab compared with placebo on prevention of hereditary angioedema attacks, a randomized clinical trial. JAMA. 2018;320(20):2108-21.

301. Cicardi M, Banerji A, Bracho F, Malbrán A, Rosenkranz B, Riedl M, et al. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010;363:532-41.

302. Malbran A, Riedl M, Ritchie B, Smith WB, Yang W, Banerji A, et al. Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial. Clin Exp Immunol. 2014;177:544-53.

303. Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, et al. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011;107:529-37.

304. Maurer M, Aberer W, Bouillet L, Caballero T, Fabien V, Kanny G, et al. hereditary angioedema attacks resolve faster and are shorter after early icatibant treatment. PLoS ONE. 2013; 8 e53773.

305. Farkas H, Reshef A, Aberer W, Caballero T, McCarthy L, Hao J, et al. Treatment effect and safety of icatibant in pediatric patients with hereditary angioedema. J Allergy Clin Immunol Pract. 2017;5:1671-8.

306. Otani IM, Lumry WR, Hurwitz S, Li HH, Craig TJ, Holtzman NS, et al. Subcutaneous icatibant for the treatment of hereditary angioedema attacks: comparison of home self-administration with administration at a medical facility. J Allergy Clin Immunol Pract. 2017;5:442-7.

307. Craig TJ, Levy RJ, Wasserman RL, Bewtra AK, Hurewitz D, Obtulowicz K, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol. 2009;124:801-8.

308. Craig TJ, Bewtra AK, Bahna SL, Hurewitz D, Schneider LC, Levy RJ, et al. C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - final results of the I.M.P.A.C.T.2 study. Allergy. 2011;66:1604-11.

309. Zuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010;363:513-22.

310. Zanichelli A, Azin GM, Cristina F, Vacchini R, Caballero T. Safety, effectiveness, and impact on quality of life of self-administration with plasma-derived nanofiltered C1 inhibitor (Berinert(R)) in patients with hereditary angioedema: the SABHA study. Orphanet J Rare Dis. 2018;13(1):51.

311. Longhurst H, Cicardi M, Craig T, Bork K, Grattan C, Baker J, et al. Prevention of hereditary angioedema attacks with a subcutaneous C1 inhibitor. N Engl J Med. 2017;376:1131-40.

312. Zuraw B, Cicardi M, Levy RJ, Nuijens JH, Relan A, Visscher S, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol. 2010;126:821-7.

313. Riedl MA, Bernstein JA, Li H, Reshef A, Lumry W, Moldovan D, et al. Recombinant human C1-esterase inhibitor relieves symptoms of hereditary angioedema attacks: phase 3, randomized, placebocontrolled trial. Ann Allergy Asthma Immunol. 2014;112:163-9.

314. Reshef A, Moldovan D, Obtulowicz K, Leibovich I, Mihaly E, Visscher S, et al. Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: a pilot study. Allergy. 2013;68(1):118‑24.

315. Riedl MA, Grivcheva-Panovska V, Moldovan D, Baker J, Yang WH, Giannetti BM, et al. Recombinant human C1 esterase inhibitor for prophylaxis of hereditary angio-oedema: a phase 2, multicentre, randomised, double-blind, placebo-controlled crossover trial. Lancet. 2017;390(10102):1595‑602.

316. Li HH, Moldovan D, Bernstein JA, Reshef A, Porebski G, Stobiecki M, et al. Recombinant human-c1 inhibitor is effective and safe for repeat hereditary angioedema attacks. J Allergy Clin Immunol Pract. 2015;3(3):417‑23.

317. Cicardi M, Levy RJ, McNeil DL, Li HH, Sheffer AL, Campion M, et al. Ecallantide for the treatment of acute attacks in hereditary angioedema. N Engl J Med. 2010;363:523-31.

318. Sheffer AL, Campion M, Levy RJ, Li HH, Horn PT, Pullman WE. Ecallantide (DX-88) for acute hereditary angioedema attacks: integrated analysis of 2 double-blind, phase 3 studies. J Allergy Clin Immunol. 2011;128:153-4.

319. Roth-Walter F, Adcock IA, Benito-Villalvilla C, Bianchini R, Bjermer L, Caramori G, Cari L, et al. Comparing biologicals and small molecule drug therapies for chronic respiratory diseases: An EAACI Taskforce on Immunopharmacology position paper. Allergy. 2019;74:432‑48.

320. Mauger D, Apter AJ. Indirect treatment comparisons and biologics. J Allergy Clin Immunol. 2019;143:84-6.

321. Bauer RN, Monohar M, Singh AM, Jay DC, Nadeau KC. The Future of Biologics: Application for food allergy. J Allergy Clin Immunol. 2015;135:312‑23.

322. Makris M, Papadavid E, Zuberbier T. The use of biologicals in cutaneous allergies - present and future. Curr Opin Allergy Clin Immunol. 2014;14:409-16.

323. Joly P, Mouquet H, Roujeau JC, D’Incan M, Gilbert D, Jacquot S, et al. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007;357:545-52.

324. MabThera® (rituximabe) – Roche – Bula. Disponível em: http://www.anvisa.gov.br/datavisa/fila_bula/frmVisualizarBula.asp?pNuTransacao=19730032016&pIdAnexo=3645535. Acesso em junho 2019.

325. Arkwright PD. Anti-CD20 or anti-IgE therapy for severe chronic autoimmune urticarial. J Allergy Clin Immunol. 2009;123:510-1.

326 Chakaravarty SD, Yee AF, Paget SA. Rituximab successfully treats refractory chronic autoimmune urticarial causes by IgE receptor autoantibodies. J Allergy Clin Immunol. 2011;128:1354-5.

327. Combalia A, Losno RA, Prieto-González S, Mascaró JM. Rituximab in Refractory Chronic Spontaneous Urticaria: an encouraging therapeutic approach. Skin Pharmacol Physiol. 2018;31:184‑7.

328. Mallipeddi R, Grattan CE. Lack of response of severe steroiddependent chronic urticarial to rituximab. Clin Exp Dermatol. 2007;32:333-4.

329. Kocatürk E, Maurer M, Metz M, Grattan C. Looking forward to new targeted treatments for chronic spontaneous urticarial. Clin Transl Allergy. 2017;7:1.

330. Gery I, Gershon RK, Waksman BH. Potentation of T-lymphocyte response to mitogens I. The responding cell. J Exp Med. 1972;136:128‑42.

331. Gery I, Waksman BH. Potentation of T-lymphocyte response to mitogens II. The cellular source of potentating mediator(s). J Exp Med. 1972;136:143‑55.

332. Dinarello CA, Renfer L, Wolff SM. Human leukocytic pyrogen:purification and development of a radioimmunoassay. Proc Nati Acad Sci USA. 1977;74:4624-7.

333. Dinarello CA. Immunological and inflammatory functions of the interleukin-1 family. Annu Rev Immunol. 2009;27:519-50.

334. Kineret, INN-anakinra - Europa EU – Bula. Disponível em: https://ec.europa.eu/health/documents/communityregister/2016/20160602135155/anx_135155_pt.pdf. Acesso em junho de 2019.

335. Mitroulis I, Papadopoulos VP, Kostantinidis T, Ritis K. Anakinra supresses familial Mediterranean fever crises in a colchicineresistant patient. Neth J Med. 2008;66:489-91.

336. de Koning HD, Bodar EJ, Simon A, van der Hilst JC, Netea MG, van der Meer JW. Beneficial response to anakinra and thalidomide in Schnitzler’s syndrome. Ann Rheum Dis. 2006;65:542-4.

337. Bodar EJ, van der Hilst JC, Drenth JP, van der Meer JW, Simon A. Effect of etarnecept and anakinra on inflammatory attacks in the hyper-IgD syndrome: introducing a vaccination provocation model. Neth J Med. 2005;63:260-4.

338. Simon A, Bodar EJ, van der Hilst JC, van der Meer JW, Fiselier TJ, Cuppen MP, et al. Beneficial response to interleukin 1 receptor antagonist in traps. Am J Med. 2004;117:208-10.

339. Bodar EJ, Simon A, Visser M, van der Meer JW. Complete remission of severe idiopathic cold urticarial on intrleukin-I receptor antagonist (anakinra). Neth J Med. 2009;67:302-5.

340. Hsu LC, Ali SR, Mc Gillivay S, Tseng PH, Mariathasan S, Humke EW, et al. A NOD2-NALP1 complex mediates caspase-1-dependent IL-1beta secretion in response to Bacillus anthracis infection and muramyl dipeptide. Proc Nat Acad Sci USA. 2008;105:7803‑8.

341. Gross O, Poeck H, Bscheider M, Dostert C, Hannesschläger N, Endres S, et al. Syk kinase signalling couples to the NIrp3 inflamasome for antifungal host defence. Nature. 2009;459:433‑6.

342. Kanneganti TD, Body-Malapel M, Amer A, Park JH, Whitfield J, Franchi L, et al. Critical role for Cryopyrin/Nalp3 in activation of caspase-1 in response to viral infection and double-stranded RNA. J Biol Chem. 2006;281:36560-8.

343. Ilaris – Anvisa – Bula. Disponível em: http://www.anvisa.gov.br/datavisa/fila_bula/frmVisualizarBula.asp?pNuTransacao=17991412017&pIdAnexo=9080022. Acesso em junho de 2019.

344. Lenormand C, Lispker D. Efficiency of interleukin-1 blockade in refractory delayed-pressure urticarial. Ann Intern Med. 2012;157:599-600.

345. Rilonacept (Professional Patient Advice) - Drugs.com – Bula. Disponível em: https://www.drugs.com/ppa/rilonacept.html. Acesso em junho de 2019.

346. Liu L, Okada S, Kong X-F, Kreins AY, Cypowyj S, Abhyankar A, et al. Gain-of-function human STAT1 mutations impair IL-17 immunity and underlie chronic mucocutaneous candidiasis. J Exp Med. 2011; 208:1635‑48.

347. Vargas-Hernández A, Mace EM, Zimmerman O, Zerbe CS, Freeman AF, Rosenzweig S, et al. Ruxolitinib partially reverses functional natural killer cell deficiency in patients with signal transducer and activator of transcription 1 (STAT1) gain-of-function mutations. J Allergy Clin Immunol. 2018;141:2142-55.

348. Clinical Trials: NIH: U.S. National Library of Medicine Disponível em: http://www.clinicaltrials.gov. Acesso em maio de 2019.

349. O’Callaghan J, Barry SP, Bermingham M, Morris JM, Griffin BT. Regulation of biosimilar medicines and current perspectives on interchangeability and policy. Eur J Clin Pharmacol. 2019;75:1‑11.

350. Daller J. Biosimilars: a consideration of the regulation in the United States and European Union. Regul Toxicol Pharmacol. 2016;76:199‑208.

351. Bonovas S, Peyrin-Biroulet L, Danese S. Clinical development of biologicals and biosimilars – safey concerns. Exp Rev Clin Pharmacol. 2017;10:567‑9.

352. Ferrando M, Bagnasco D, Braido F, Varricchi G, Canonica GW. Biosimlars in allergic diseases. Curr Opin Allergy Clin Immunol. 2016;16:68-73.

353 European Medicines Agency (EMA). Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. Disponível em: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Acesso em maio de 2019.

354. Food and Drug Administration (FDA). Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product, guidance for industry. Disponível em: http://www.fda.downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Acesso em maio de 2019.

355. Bui LA, Hurst S, Finch GL, Ingram B, Jacobs IA, Kirchhoff CF, et al. Key considerations in the preclinical development of biosimilars. Drug Discov Today. 2015; 20(Suppl 1):3.

356. European Medicines Agency (EMA). Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non clinical and clinical issues. Disponível em: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Acesso em maio de 2019.

357. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111‑7.

358. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124:3191‑6.

359. World Health Organization Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009. Disponível em: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Acesso em maio de 2019.

360. ICH Harmonised Tripartite Guideline. Specifications: test procedures and acceptance criteria for biotechnological/biological products Q6B. 1999. Disponível em: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002824.pdf. Acesso em maio de 2019.

361. Cauchi R. State laws and legislation related to biologics medications and substitution of biosimilars (2018). Disponível em: http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologicmedications-and-substitution-of-biosimilars.aspx. Acesso em maio /2019.

362. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78:463‑78.

363. European Medicines Agency (EMA) Press release: European Medicines Agency recommends approval of first two monoclonal antibody biosimilars (2013). Disponível em: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144941.pdf. Acesso em maio de 2019.

364. Food and Drug Administration (FDA) FDA News Release: FDA approves Inflectra, a biosimilar to Remicade (2016). Disponível em: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm494227.htm. Acesso em maio de 2019.

365. Boone NW, Liu L, Romberg-Camps MJ, Duijsens L, Houwen C, van der Kuy PHM, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74:655‑61.

366. Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304‑16.