Display options
Cite
Agache I, Akdis CA, Akdis M, et al. EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17 years old. Allergy. 2021;77(1):17-38doi: 10.1111/all.15030.
Agache, I., Akdis, C. A., Akdis, M., Brockow, K., Chivato, T., Del Giacco, S., Eiwegger, T., Eyerich, K., Giménez-Arnau, A., Gutermuth, J., Guttman-Yassky, E., Maurer, M., Ogg, G., Ong, P. Y., O'Mahony, L., Schwarze, J., Warner, A., Werfel, T., Palomares, O., & Jutel, M. (2022). EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17 years old. Allergy, 77(1), 17-38. https://doi.org/10.1111/all.15030
Agache, Ioana, et al. "EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17 years old." Allergy vol. 77,1 (2022): 17-38. doi: https://doi.org/10.1111/all.15030
Agache I, Akdis CA, Akdis M, Brockow K, Chivato T, Del Giacco S, Eiwegger T, Eyerich K, Giménez-Arnau A, Gutermuth J, Guttman-Yassky E, Maurer M, Ogg G, Ong PY, O'Mahony L, Schwarze J, Warner A, Werfel T, Palomares O, Jutel M. EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17 years old. Allergy. 2022 Jan;77(1):17-38. doi: 10.1111/all.15030. Epub 2021 Aug 08. PMID: 34324716.
Copy Download .nbib Format: NLM
Share it on

Allergy. 2022 Jan;77(1):17-38. doi: 10.1111/all.15030. Epub 2021 Aug 08.

EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17 years old.

Allergy

Ioana Agache, Cezmi A Akdis, Mubeccel Akdis, Knut Brockow, Tomas Chivato, Stefano Del Giacco, Thomas Eiwegger, Kilian Eyerich, Ana Giménez-Arnau, Jan Gutermuth, Emma Guttman-Yassky, Marcus Maurer, Graham Ogg, Peck Y Ong, Liam O'Mahony, Jürgen Schwarze, Amena Warner, Thomas Werfel, Oscar Palomares, Marek Jutel

Affiliations

  1. Faculty of Medicine, Transylvania University, Brasov, Romania.
  2. Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland.
  3. Christine-Kühne-Center for Allergy Research and Education (CK-CARE, Davos, Switzerland.
  4. Department of Dermatology and Allergology Biederstein, School of Medicine, Technical University of Munich, Munich, Germany.
  5. School of Medicine, University CEU San Pablo, Madrid, Spain.
  6. Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
  7. Translational Medicine Program, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.
  8. Department of Immunology, University of Toronto, Toronto, ON, Canada.
  9. Karl Landsteiner University of Health Sciences, Krems, Austria.
  10. Department of Paediatrics, University Hospital St. Pölten, Pölten, Austria.
  11. Department of Dermatology and Allergy Biederstein, Technical University of Munich, Munich, Germany.
  12. Department of Dermatology, Hospital del Mar- Institut Mar d'Investigacions Mèdiques, Universitat Autònoma de Barcelona, Barcelona, Spain.
  13. Department of Dermatology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB, Brussels, Belgium.
  14. Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  15. Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  16. MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, Oxford NIHR Biomedical Research Centre, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
  17. Division of Clinical Immunology & Allergy, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  18. Departments of Medicine and Microbiology, APC Microbiome Ireland, University College Cork, Cork, Ireland.
  19. Centre for Inflammation Research, Child Life and Health, The University of Edinburgh, Edinburgh, UK.
  20. Allergy UK, Kent, UK.
  21. Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.
  22. Department of Biochemistry and Molecular Biology, Chemistry School, Complutense University of Madrid, Madrid, Spain.
  23. Department of Clinical Immunology, Wroc?aw Medical University, Wroclaw, Poland.
  24. All-MED Medical Research Institute, Wroclaw, Poland.

PMID: 34324716 DOI: 10.1111/all.15030

Abstract

Chronic spontaneous urticaria (CSU) imposes a significant burden on patients, families and healthcare systems. Management is difficult, due to disease heterogeneity and insufficient efficacy of classical drugs such as H

© 2021 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Keywords: GRADE; chronic spontaneous urticaria; guidelines; omalizumab

References

  1. Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy 2018;73(7):1393-1414. - PubMed
  2. Fricke J, Ávila G, Keller T, et al. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy 2020;75(2):423-432. - PubMed
  3. Weller K, Giménez-Arnau A, Grattan C, et al. The Chronic Urticaria Registry: rationale, methods and initial implementation. J Eur Acad Dermatol Venereol 2021;35(3):721-729. - PubMed
  4. Maurer M, Abuzakouk M, Bérard F, et al. The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU. Allergy 2017;72(12):2005-2016. - PubMed
  5. Gonçalo M, Gimenéz-Arnau A, Al-Ahmad M, et al. The global burden of chronic urticaria for the patient and society. Br J Dermatol 2021;184(2):226-236. - PubMed
  6. Church MK, Kolkhir P, Metz M, Maurer M. The role and relevance of mast cells in urticaria. Immunol Rev 2018;282(1):232-247. - PubMed
  7. Deza G, March-Rodríguez A, Sánchez S, et al. Relevance of the Basophil high-affinity IgE receptor in chronic urticaria: clinical experience from a Tertiary Care Institution. J Allergy Clin Immunol Pract. 2019;7(5):1619-1626. - PubMed
  8. Turner H, Kinet JP. Signalling through the high-affinity IgE receptor Fc epsilonRI. Nature 1999;402(6760 Suppl.):B24-30. - PubMed
  9. Rossi AB, Herlaar E, Braselmann S, et al. Identification of the Syk kinase inhibitor R112 by a human mast cell screen. J Allergy Clin Immunol 2006;118:749-755. - PubMed
  10. Saini SS, Paterniti M, Vasagar K, et al. Cultured peripheral blood mast cells from chronic idiopathic urticaria patients spontaneously degranulate upon IgE sensitization: relationship to expression of Syk and SHIP-2. Clin Immunol 2009;132:342-348. - PubMed
  11. MacGlashan D. Auto-antibodies to IgE and FceRI and the natural variability of SYK expression in basophils. J Allergy Clin Immunol 2018;143:1100-1107. - PubMed
  12. Eggel A, Baravalle G, Hobi G, et al. Accelerated dissociation of IgE-FcεRI complexes by disruptive inhibitors actively desensitizes allergic effector cells. J Allergy Clin Immunol 2014;133:1709-1719. - PubMed
  13. Davies AM, Allan EG, Keeble AH, et al. Allosteric mechanism of action of the therapeutic anti-IgE antibody omalizumab. J Biol Chem 2017;292:9975-9987. - PubMed
  14. Kaplan AP, Giménez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy 2017;72(4):519-533. - PubMed
  15. Maurer M, Giménez-Arnau AM, Sussman G, et al. Ligelizumab for chronic spontaneous urticaria. N Engl J Med 2019;381:1321-1332. - PubMed
  16. Baumann MJ, Eggel A, Amstutz P, Stadler BM, Vogel M. DARPins against a functional IgE epitope. Immunol Lett 2010;133:78-84. - PubMed
  17. Eggel A, Buschor P, Baumann MJ, et al. Inhibition of ongoing allergic reactions using a novel anti-IgE DARPin-Fc fusion protein. Allergy 2011;66:961-968. - PubMed
  18. Zellweger F, Gasser P, Brigger D, et al. A novel bispecific DARPin targeting FcγRIIB and FcεRI-bound IgE inhibits allergic responses. Allergy 2017;72:1174-1183. - PubMed
  19. Maurer M, Eyerich K, Eyerich S, et al. Urticaria: Collegium Internationale Allergologicum (CIA) Update 2020. Int Arch Allergy Immunol 2020;181(5):321-333. - PubMed
  20. Konstantinou GN, Asero R, Ferrer M, et al. EAACI taskforce position paper: evidence for autoimmune urticaria and proposal for defining diagnostic criteria. Allergy 2013;68:27-36. - PubMed
  21. Schoepke N, Asero R, Ellrich A, et al. Biomarkers and clinical characteristics of autoimmune chronic spontaneous urticaria: Results of the PURIST Study. Allergy 2019;74(12):2427-2436. - PubMed
  22. Kolkhir P, Metz M, Altrichter S, Maurer M. Comorbidity of chronic spontaneous urticaria and autoimmune thyroid diseases: A systematic review. Allergy 2017;72(10):1440-1460. - PubMed
  23. Asero R, Marzano AV, Ferrucci S, et al. Co-occurrence of IgE and IgG autoantibodies in patients with chronic spontaneous urticaria. Clin Exp Immunol 2020;200(3):242-249. - PubMed
  24. Baumann K, Marcelino J, Skov PS, et al. Autologous serum skin test reactions in chronic spontaneous urticaria differ from heterologous cell reactions. J Eur Acad Dermatol Venereol 2021;35(6):1338-1345. https://doi.org/10.1111/jdv.17131. - PubMed
  25. Gericke J, Metz M, Ohanyan T, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol 2017;139(3):1059-1061. - PubMed
  26. Schmetzer O, Lakin E, Topal FA, et al. IL-24 is a common and specific autoantigen of IgE in patients with chronic spontaneous urticaria. J Allergy Clin Immunol 2018;142:876-882. - PubMed
  27. Yu L, Buttgereit T, Stahl Skov P, et al. Immunological effects and potential mechanisms of action of autologous serum therapy in chronic spontaneous urticaria. J Eur Acad Dermatol Venereol 2019;33(9):1747-1754. - PubMed
  28. Kay AB, Clark P, Maurer M, Ying S. Elevations in T-helper-2-initiating cytokines (interleukin-33, interleukin-25 and thymic stromal lymphopoietin) in lesional skin from chronic spontaneous (‘idiopathic’) urticaria. Br J Dermatol 2015;172(5):1294-1330. - PubMed
  29. Ochi H, De Jesus NH, Hsieh FH, Austen KF, Boyce JA. IL-4 and -5 prime human mast cells for different profiles of IgE-dependent cytokine production. Proc Natl Acad Sci U S A. 2000;97(19):10509-10513. - PubMed
  30. Soruri A, Grigat J, Kiafard Z, Zwirner J. Mast cell activation is characterized by upregulation of a functional anaphylatoxin C5a receptor. BMC Immunol 2008;9:29. - PubMed
  31. Elieh Ali Komi D, Shafaghat F, Kovanen PT, Meri S. Mast cells and complement system: Ancient interactions between components of innate immunity. Allergy 2020;75(11):2818-2828. - PubMed
  32. Fujisawa D, Kashiwakura J, Kita H, et al. Expression of Mas-related gene X2 on mast cells is upregulated in the skin of patients with severe chronic urticaria. J Allergy Clin Immunol 2014;134(3):622-633. - PubMed
  33. Shtessel M, Limjunyawong N, Oliver ET, et al. MRGPRX2 activation causes increased skin reactivity in patients with chronic spontaneous urticaria. J Invest Dermatol 2021;141(3):678-768. - PubMed
  34. Kühn H, Kolkhir P, Babina M, et al. Mas-related G protein-coupled receptor X2 and its activators in dermatologic allergies. J Allergy Clin Immunol 2021;147(2):456-469. - PubMed
  35. Youngblood BA, Leung J, Falahati R, et al. Discovery, function, and therapeutic targeting of Siglec-8. Cell 2021;10(1):19. - PubMed
  36. Zhang S, Cherwinski H, Sedgwick JD, Phillips JH. Molecular mechanisms of CD200 inhibition of mast cell activation. J Immunol 2004;173(11):6786-6793. - PubMed
  37. Mostmans Y, De Smedt K, Richert B, et al. Markers for the involvement of endothelial cells and the coagulation system in chronic urticaria: A systematic review. Allergy 2021;76:2998 -3016. https://doi.org/10.1111/all.14828. - PubMed
  38. Altrichter S, Frischbutter S, Fok JS, et al. The role of eosinophils in chronic spontaneous urticaria. J Allergy Clin Immunol 2020;145(6):1510-1516. - PubMed
  39. Boyman O, Kaegi C, Akdis M, et al. EAACI IG Biologicals task force paper on the use of biologic agents in allergic disorders. Allergy 2015;70(7):727-754. - PubMed
  40. Serrano-Candelas E, Martinez-Aranguren R, Valero A, et al. Comparable actions of omalizumab on mast cells and basophils. Clin Exp Allergy 2016;46(1):92-102. - PubMed
  41. Gasser P, Tarchevskaya SS, Guntern P, et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab. Nat Commun 2020;11(1):165. - PubMed
  42. Hollis K, Proctor C, McBride D, et al. Comparison of urticaria activity score over 7 days (UAS7) values obtained from once-daily and twice-daily versions: results from the ASSURE-CSU Study. Am J Clin Dermatol 2018;19(2):267-274. - PubMed
  43. Hawro T, Ohanyan T, Schoepke N, et al. The urticaria activity score-validity, reliability, and responsiveness. J Allergy Clin Immunol Pract. 2018;6(4):1185-1190. - PubMed
  44. Stull D, McBride D, Tian H, et al. Analysis of disease activity categories in chronic spontaneous/idiopathic urticaria. Br J Dermatol 2017;177(4):1093-1101. - PubMed
  45. Mathias SD, Crosby RD, Rosén KE, Zazzali JL. The minimal important difference for measures of urticaria disease activity: Updated findings. Allergy Asthma Proc. 2015;36(5):394-398. - PubMed
  46. Mathias SD, Crosby RD, Zazzali JL, Maurer M, Saini SS. Evaluating the minimally important difference of the urticaria activity score and other measures of disease activity in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol 2012;108(1):20-24. - PubMed
  47. Hawro T, Ohanyan T, Schoepke N, et al. Comparison and interpretability of the available urticaria activity scores. Allergy 2018;73:251-255. - PubMed
  48. Shikiar R, Harding G, Leahy M, Lennox RD. Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria. Health Qual Life Outcomes 2005;3:36. - PubMed
  49. Agache I, Rocha C, Pereira A, et al. Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines. Allergy 2021;76(1):59-70. - PubMed
  50. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924. - PubMed
  51. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64(4):383-394. - PubMed
  52. Santesso N, Glenton C, Dahm P, et al., GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions. J Clin Epidemiol 2020;26:126-135. https://doi.org/10.1016/j.jclinepi.2019.10.014 - PubMed
  53. https://apps.who.int/iris/bitstream/handle/10665/75146/9789241548441_eng.pdf;jsessionid=CA74A1F992AE5574F7B899567C721BC1?sequence=1; Accessed 05 May, 2021. - PubMed
  54. Maurer M, Altrichter S, Bieber T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol 2011;128(1):202-209. - PubMed
  55. Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013;368(10):924-935. https://doi.org/10.1056/NEJMoa1215372 - PubMed
  56. Saini S, Rosen KE, Hsieh HJ, et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol 2011;128(3):567-573. - PubMed
  57. Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H 1 antihistamines: a randomized, placebo-controlled study. Journal of Investigative Dermatology 2015;135(1):67-75. https://doi.org/10.1038/jid.2014.306 - PubMed
  58. Staubach P, Metz M, Chapman-Rothe N, et al. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial [published correction appears in Allergy. 2017;72 (9):1430]. Allergy 2016;71(8):1135-1144. - PubMed
  59. Metz M, Staubach P, Bauer A, et al. Clinical efficacy of omalizumab in chronic spontaneous urticaria is associated with a reduction of FcεRI-positive cells in the skin. Theranostics. 2017;7(5):1266-1276. - PubMed
  60. Jörg L, Pecaric-Petkovic T, Reichenbach S, et al. Double-blind placebo-controlled trial of the effect of omalizumab on basophils in chronic urticaria patients. Clin Exp Allergy 2018;48(2):196-204. - PubMed
  61. Hide M, Park HS, Igarashi A, et al. Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria. J Dermatol Sci 2017;87(1):70-78. - PubMed
  62. Maurer M, Kaplan A, Rosén K, et al. The XTEND-CIU study: Long-term use of omalizumab in chronic idiopathic urticaria. J Allergy Clin Immunol 2018;141(3):1138-1139. - PubMed
  63. Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019;7(7):2487-2490. - PubMed
  64. Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol 2013;132(1):101-109. - PubMed
  65. Deza G, Bertolin-Colilla M, Sanchez S, et al. Basophil FcɛRI expression is linked to time to omalizumab response in chronic spontaneous urticaria. J Allergy Clin Immunol 2018;141:2313-2316. - PubMed
  66. Weller K, Ohanyan T, Hawro T, et al. Total IgE levels are linked to the response of chronic spontaneous urticaria patients to omalizumab. Allergy 2018;73:2406-2408. - PubMed
  67. Ertas R, Ozyurt K, Atasoy M, Hawro T, Maurer M. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy 2018;73:705-712. - PubMed
  68. de Montjoye L, Darrigade AS, Gimenez-Arnau A, et al. Correlations between disease activity, autoimmunity and biological parameters in patients with chronic spontaneous urticaria. Eur Ann Allergy. Clin Immunol 2021;53(02):55. - PubMed
  69. Altrichter S, Fok JS, Jiao Q, et al. Total IgE as a marker for chronic spontaneous urticaria. Allergy Asthma Immunol Res. 2021;13(2):206-218. - PubMed
  70. Weller K, Groffik A, Church MK, et al. Development and validation of the urticaria control test: a patient-reported outcome instrument for assessing urticaria control. J Allergy Clin Immunol 2014;133(5):1365-1372. - PubMed
  71. Weller K, Church MK, Metz M, et al. The response to treatment in chronic spontaneous urticaria depends on how it is measured. J Allergy Clin Immunol Pract. 2019;7(6):2055-2056. - PubMed
  72. Metz M, Vadasz Z, Kocatürk E, Giménez-Arnau AM. Omalizumab updosing in chronic spontaneous urticaria: an overview of real-world evidence. Clin Rev Allergy Immunol 2020;59(1):38-45. - PubMed
  73. Ferrer M, Giménez-Arnau A, Saldana D, et al. Predicting chronic spontaneous urticaria symptom return after omalizumab treatment discontinuation: exploratory analysis. J Allergy Clin Immunol Pract. 2018;6(4):1191-1197. - PubMed
  74. Khan DA. Hypersensitivity and immunologic reactions to biologics: opportunities for the allergist. Ann Allergy Asthma Immunol 2016;117(2):pp. 115-20.4. - PubMed
  75. 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 2007c;120(6):1378-1381. - PubMed
  76. Price KS, Hamilton RG. Anaphylactoid reactions in two patients after omalizumab administration after successful long-term therapy. Allergy Asthma Proc. 2007;28(3):313-319. - PubMed
  77. Macglashan DW Jr, Saini SS. Omalizumab increases the intrinsic sensitivity of human basophils to IgE-mediated stimulation. J Allergy Clin Immunol 2013;132(4):906-911. - PubMed
  78. Balbino B, Herviou P, Godon O, et al. The anti-IgE mAb omalizumab induces adverse reactions by engaging Fcγ receptors. J Clin Invest 2020;130(3):1330-1335. - PubMed
  79. Bergmann KC, Maurer M, Church MK, Zuberbier T. Anaphylaxis to mepolizumab and omalizumab in a single patient: is polysorbate the culprit? J Investig Allergol Clin Immunol 2020;30(4):285-287. - PubMed
  80. Lieberman PL, Umetsu DT, Carrigan GJ, Rahmaoui A. Anaphylactic reactions associated with omalizumab administration: Analysis of a case-control study. J Allergy Clin Immunol 2016;138(3):913-915. - PubMed
  81. Baker DL, Nakamura GR, Lowman HB, Fischer SK. Evaluation of IgE antibodies to omalizumab (Xolair®) and their potential correlation to anaphylaxis. AAPS J 2016;18(1):115-123. - PubMed
  82. Ferastraoaru D, Bax HJ, Bergmann C, et al. AllergoOncology: ultra-low IgE, a potential novel biomarker in cancer-a Position Paper of the European Academy of Allergy and Clinical Immunology (EAACI). Clin Transl Allergy. 2020;10:32. - PubMed
  83. Long A, Rahmaoui A, Rothman KJ, et al. Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. J Allergy Clin Immunol 2014;134:560-567. - PubMed
  84. Johnston A, Smith C, Zheng C, et al. Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta-analysis. Clin Exp Allergy 2019;49(10):1291-1305. - PubMed
  85. Iribarren C, Rahmaoui A, Long AA, et al. Cardiovascular and cerebrovascular events among patients receiving omalizumab: Results from EXCELS, a prospective cohort study in moderate to severe asthma. J Allergy Clin Immunol 2017;139(5):1489-1495. - PubMed
  86. Gill MA, Liu AH, Calatroni A, et al. Enhanced plasmacytoid dendritic cell antiviral responses after omalizumab. J Allergy Clin Immunol 2018;141:1735-1743. - PubMed
  87. Teach SJ, Gill MA, Togias 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):1476-1485. - PubMed
  88. Tomomatsu K, Oguma T, Baba T, et al. Japan ABPM Research Program. Effectiveness and safety of omalizumab in patients with allergic bronchopulmonary aspergillosis complicated by chronic bacterial infection in the airways. Int Arch Allergy Immunol 2020;181(7):499-506. - PubMed
  89. Cruz AA, Lima F, Sarinho E, 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. - PubMed
  90. Winthrop KL, Mariette X, Silva JT, et al. ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [II]: agents targeting interleukins, immunoglobulins and complement factors). Clin Microbiol Infect 2018;24(Suppl 2):S21-S40. - PubMed
  91. Brightbill HD, Lin YL, Lin Z, et al. Quilizumab is an afucosylated humanized anti-M1 prime therapeutic antibody. Clin AntiInflam AntiAllergy Drugs. 2014;1:24-31. - PubMed
  92. Harris JM, Cabanski CR, Scheerens H, et al. A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria. J Allergy Clin Immunol 2016;138:1730-1732. - PubMed
  93. Harris JM, Maciuca R, Bradley MS, et al. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma. Respir Res 2016;17:29. - PubMed
  94. http://gi-innovation.com/en/images/content/GI-301_PDF.pdf; Accessed 07 May 2021. - PubMed
  95. Shiung YY, Chiang CY, Chen JB, et al. An anti-IgE monoclonal antibody that binds to IgE on CD23 but not on high-affinity IgE.fc receptors. Immunobiology 2012;217(7):676-683. - PubMed
  96. Chen JB, Ramadani F, Pang MOY, et al. Structural basis for selective inhibition of immunoglobulin E-receptor interactions by an anti-IgE antibody. Sci Rep 2018;8(1):11548. - PubMed
  97. Lee JK, Simpson RS. Dupilumab as a novel therapy for difficult to treat chronic spontaneous urticaria. J Allergy Clin Immunol Pract. 2019;7(5):1659-1661. - PubMed
  98. Magerl M, Terhorst D, Metz M, et al. Benefit of mepolizumab treatment in a patient with chronic spontaneous urticaria. J Dtsch Dermatol Ges. 2018;16(4):477-478. - PubMed
  99. Maurer M, Altrichter S, Metz M, et al. Benefit from reslizumab treatment in a patient with chronic spontaneous urticaria and cold urticaria. J Eur Acad Dermatol Venereol 2018;32(3):e112-e113. - PubMed
  100. Bernstein JA, Singh U, Rao MB, et al. Benralizumab for Chronic Spontaneous Urticaria. N Engl J Med 2020;383(14):1389-1391. - PubMed
  101. Bernstein JA, Singh U, Rao MB, et al. Treatment of chronic spontaneous urticaria with benralizumab: Report of primary endpoint per-protocol analysis and exploratory endpoints. Allergy 2021;76(4):1277-1280. - PubMed
  102. Altrichter S, Staubach P, Pasha M, et al. Efficacy and safety data of AK002, an anti-siglec-8 monoclonal antibody, in patients with multiple forms of uncontrolled chronic urticaria (CU): Results from an open-label phase 2a study. Allergy 2020;74:120. - PubMed
  103. Dellon ES, Peterson KA, Murray JA, et al. Anti-Siglec-8 antibody for eosinophilic gastritis and duodenitis. N Engl J Med 2020;383:1624-1634. - PubMed
  104. Maurer M, Crew L, Murphy M, et al. CDX-0159, an anti-KIT monoclonal antibody, demonstrates dose-dependent reductions in serum tryptase and a favorable safety profile in a phase 1a healthy volunteer study. Allergy 2020;75:280. - PubMed
  105. Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol 2014;133(5):1270-1277. - PubMed
  106. Caffarelli C, Paravati F, El Hachem M, et al. Management of chronic urticaria in children: a clinical guideline. Ital J Pediatr. 2019;45(1):101. - PubMed
  107. Choi JH, Lee DH, Song WJ, et al. The KAAACI/KDA evidence-based practice guidelines for chronic spontaneous Urticaria in Korean adults and children: Part 2. management of H1-antihistamine-refractory chronic urticaria. Allergy Asthma Immunol Res. 2020;12(5):750-770. - PubMed
  108. Metz M, Altrichter S, Buttgereit T, et al. The Diagnostic Workup in chronic spontaneous urticaria-what to test and why. J Allergy Clin Immunol Pract. 2021;S2213-2198(21):00435-439. - PubMed
  109. Fok JS, Kolkhir P, Church MK, Maurer M. Predictors of treatment response in chronic spontaneous urticaria. Allergy 2021;76:2965-2981. https://doi.org/10.1111/all.14757. - PubMed
  110. Breiteneder H, Peng YQ, Agache I, et al. Biomarkers for diagnosis and prediction of therapy responses in allergic diseases and asthma. Allergy 2020;75(12):3039-3068. - PubMed
  111. 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. - PubMed
  112. Eyerich S, Metz M, Bossios A, Eyerich K. New biological treatments for asthma and skin allergies. Allergy 2020;75(3):546-560. - PubMed
  113. Metz M, Maurer M. Use of biologics in chronic spontaneous urticaria - beyond omalizumab therapy? Allergol Select. 2021;5:89-95. - PubMed
  114. Mansur AH, Srivastava S, Mitchell V, Sullivan J, Kasujee I. Long-term clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety. Respir Med 2017;124:36-43. - PubMed
  115. Nieto García A, Garriga-Baraut T, Plaza Martín AM, et al. Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma. Pediatr Allergy Immunol 2021;32(5):980-991. https://doi.org/10.1111/pai.13484 - PubMed
  116. Nakamura N, Kashitani Y, Yoshisue H, Nagasaki M, Sasajima T. Real-life long-term safety and effectiveness of omalizumab in Japanese pediatric patients with severe allergic asthma: A post-marketing surveillance. Allergol Int. 2021;70(3):319-326. - PubMed
  117. Asero R, Casalone R, AIemoli E. Extraordinary response to omalizumab in a child with severe chronic urticaria. Eur Ann Allergy Clin Immunol 2014;46:41. - PubMed
  118. Netchiporouk E, Nguyen CH, Thuraisingham T, et al. Management of pediatric chronic spontaneous and physical urticaria patients with omalizumab: case series. Pediatr Allergy Immunol 2015;26:585-588. - PubMed
  119. Kanters TA, Thio HB, Hakkaart L. Cost-effectiveness of omalizumab for the treatment of chronic spontaneous urticaria. Br J Dermatol 2018;179(3):702-708. - PubMed
  120. Graham J, McBride D, Stull D, et al. Cost utility of omalizumab compared with standard of care for the treatment of chronic spontaneous urticaria. Pharmacoeconomics 2016;34(8):815-827. - PubMed

Publication Types