nach oben

Erschienen in:

24.06.2020 | Urtikaria | Übersicht

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

verfasst von: Askin Gülsen, Prof. Dr. med. Bettina Wedi, Prof. Dr. med. Uta Jappe

Erschienen in: Allergo Journal | Ausgabe 4/2020

Einloggen, um Zugang zu erhalten

Abstract

Purpose: Biotechnological substances (BSs) are strongly relied upon to prevent rejection of transplanted organs, and to treat oncological, allergological, and other inflammatory diseases. Allergic reactions to partly foreign biologics can occur due to their potential immunogenicity. The severity of an immune response to a biological drug may range from no clinical significance to a severe, life-threatening anaphylactic reaction.

Methods: Detailed searches were performed on Pubmed, Web of Science, and Google Scholar to include all available publications. In addition, the Food and Drug Administration, the European Medicines Agency, and British Columbia Cancer Agency Drug Manual databases were screened for hypersensitivity reaction (HSR), infusion reaction, injection site reaction, urticaria, and anaphylaxis for individual BSs.

Results: Treatment with BSs can cause various types of HSR. These are mentioned in the literature with definitions such as allergic reactions, anaphylactoid reactions, anaphylaxis, HSR, infusion reactions, injection site reactions, cytokine release syndrome, and urticaria. Due to the overlap in signs and symptoms in the reported descriptions, it is not always possible to differentiate these reactions properly according to their pathomechanism. Similarly, many data reported as anaphylaxis actually describe severe anaphylactic reactions (grades III or IV).

Conclusion: There is an urgent need for a simpler symptom- or system-based classification and scoring system to create an awareness for HSRs to BSs. A better understanding of the pathophysiology of HSRs and increased clinical experience in the treatment of side effects will provide timely control of unexpected reactions. As a result, immunotherapy with BSs will become safer in the future.

Cite this as Gülsen A, Wedi B, Jappe U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events. Allergo J Int 2020; 29:97-125

https://doi.org/10.1007/s40629-020-00126-6

Scherer K, Spoerl D, Bircher AJ. Adverse drug reactions to biologics. JDtschDermatolGes. 2010;8(6):411-26

Doessegger L, Banholzer ML. Clinical development methodology for infusion-related reactions with monoclonal antibodies. Clin Transl Immunology. 2015;4(7):e39

Sociedad Española de Reumatología. Informe Anual Biobadaser 2018. Registro Español de acontecimientos adversos de terapia biológica en enfermedades reumáticas. 2018. https://biobadaser.ser.es/docs/2BIOBADASER %20Informe%20Web%202018.pdf. Accessed 5Aug 2019

Castro M, Wenzel SE, Bleecker ER, Pizzichini E, Kuna P, Busse WW. Benralizumab, an anti-interleukin 5 receptor α monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. LancetRespirMed. 2014;2:879-90

5. US Food and Drug Administration. FDA labels for benralizumab. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000SumR.pdf. Accessed 1May 2018

Park HS, Lee SH, Lee SY, KimMK, Lee BJ, Werkström V, et al. Efficacy and safety of benralizumab for Korean patients with severe, uncontrolled eosinophilic asthma. Allergy Asthma ImmunolRes. 2019;11:508-18

Pelaia C, Busceti MT, Vatrella A, Rago GF, Crimi C, Terracciano R, et al. Real-life rapidity of benralizumab effects in patients with severe allergic eosinophilic asthma: assessment of blood eosinophils, symptom control,lung function and oral corticosteroid intake after the first drug dose. Pulm PharmacolTher. 2019;58:101830. https://doi.org/10.1016/j.pupt.2019.101830

Liu W, Ma X, Zhou W. Adverse events of benralizumab in moderate to severe eosinophilic asthma: a meta-analysis. Medicine (Baltimore). 2019;98:e15868. https://doi.org/10.1097/MD.0000000000015868.

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-controlledstudies. Thorax. 2015;70:748-56

10.

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

11.

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

12.

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 moderateto-severe atopic dermatitis inadequately controlled by topical corticosteroids: a randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78:863-71

13.

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

14.

US Food and Drug Administration. FDA labels for mepolizumab (Nucala®). 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000 SumR.pdf. Accessed 9 Aug 2019

15.

Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, et al. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058-2070.e1. https://doi.org/10.1016/j.clinthera.2016.07.010

16.

Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143:1742-51

17.

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

18.

US Food and Drug Administration. FDA labels for reslizumab (Cinqair®). 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761033Orig1s000SumR.pdf. Accessed 9Aug 2019

19.

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

20.

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;7:2277-83

21.

Cox L, Platts-Mills TA, Finegold I, Schwartz LB, Simons FE, Wallace DV. 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.

22.

Di Bona D, Fiorino I, Taurino M, Frisenda F, Minenna E, Pasculli C, et al. Long-term "real-life" safety of omalizumab in patients with severe uncontrolled asthma: a nine-year study. RespirMed. 2017;130:55-60

23.

Cox L, Lieberman P, Wallace D, Simons FE, Finegold I, Platts-Mills T, et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma & Immunology Omalizumab-Associated Anaphylaxis Joint Task Force follow-up report. J Allergy Clin Immunol. 2011;128:210-2

24.

US Food and Drug Administration. FDA labels for omalizumab (Xolair®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103976s5234lbl.pdf. Accessed 12Aug 2019

25.

Therapeutic Goods Administration. Australian public assessment report fornintedanib esilate. Proprietaryproduct name: Ofev and Vargatef. 2016. https://www.tga.gov.au/sites/default/files/auspar-nintedanib-esilate-160208. pdf. Accessed 13 Aug 2019

26.

US Food and Drug Administration. FDA labels for nintedanib (OFEV®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf. Accessed 13 Aug 2019

27.

Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377(9779):1760-9

28.

US Food and Drug Administration. FDA labels for pirfenidone (Esbriet®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022535s012,208780s002lbl.pdf. Accessed 13 Aug 2019

29.

Sehgal VN, Pandhi D, Khurana A. Biologics in dermatology: an integrated review. Indian J Dermatol. 2014;59:425- 41

30.

Graves JE, Nunley K, Heffernan MP. Off-label uses of biologics in dermatology: rituximab, omalizumab, infliximab, etanercept, adalimumab, efalizumab, and alefacept (part 2 of 2). JAmAcadDermatol. 2007;56:55-79

31.

US Food and Drug Administration. FDA labels for alefacept (AMEVIVE®). 2012. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125036s0144lbl.pdf. Accessed 13 Aug 2019

32.

Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N, et al. Efalizumab Study Group. Efalizumab for patients with moderate to severe plaque psoriasis: a randomizedcontrolled trial. JAMA. 2003;290:3073-80

33.

US Food and Drug Administration. FDA labels for efalizumab (RAPTIVA®). 2009. https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM143346.pdf. Accessed 13 Aug 2019

34.

Brunasso AM, Puntoni M, Salvini C, Delfino C, Curcic P, Gulia A, et al. Tolerability and safety of biological therapies for psoriasis in daily clinical practice: a study of 103 Italianpatients. ActaDermVenereol. 2011;91:44-9

35.

US Food and Drug Administration. FDA labels for ixekizumab (TALTZ®). 2017. https://www.accessdata.fda.gov/ drugsatfda_docs/label/2017/125521s004lbl.pdf. Accessed 14Aug 2019

36.

Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R, et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76:432-40

37.

European Medicines Agency. Assessment report of secukinumab (COSENTYX®). 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/003729/WC500199574.pdf. Accessed 14Aug 2019

38.

Schwensen JF, Clemmensen A, SandC, Gniadecki R, Skov L, Zachariae C, et al. Effectiveness and safety of secukinumab in 69 patients with moderate to severe plaque psoriasis: a retrospective multicenter study. Dermatol Ther. 2017;30:e12550

39.

US Food and Drug Administration. FDA labels for secukinumab (COSENTYX®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf. Accessed 15 Aug 2019

40.

Deodhar A, Mease PJ, McInnes IB, Baraliakos X, Reich K, Blauvelt A, et al. Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data. ArthritisResTher. 2019;21:111

41.

European Medicines Agency. Assessment report of ustekinumab (STELARA®). 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000958/WC500217159.pdf. Accessed 15Aug 2019

42.

US Food and Drug Administration. FDA labels for ustekinumab (STELARA®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf. Accessed 15Aug 2019

43.

Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, et al. Correction to: Ustekinumab safety in psoriasis, psoriatic arthritis, and Crohn's disease: an integrated analysis of phase II/III clinical development programs. Drug Saf. 2019;42:809

44.

US Food and Drug Administration. FDA labels for dupilumab (DUPIXENT®). 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf. Accessed 16Aug 2019

45.

Ou Z, Chen C, Chen A, Yang Y, Zhou W. Adverse events of dupilumab in adults with moderate-to-severe atopic dermatitis: a meta-analysis. Int Immunopharmacol. 2018;54:303-10

46.

European Medicines Agency. Assessment report of dupilumab (DUPIXENT®). 2019. https://www.ema.europa.eu/en/documents/variation-report/dupixent-hc-4390-x-0004-g-epar-assessment-report-extension_en. pdf. Accessed 04May 2020

47.

Maurer M, Giménez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, et al. Ligelizumab for chronic spontaneousurticaria. NEngl JMed. 2019;381(14):1321-32

48.

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 inadequatelycontrolled allergic asthma. RespirRes. 2016;17:29

49.

European Medicines Agency. Assessment report of aflibercept (ZALTRAP®). 2019. https://www.ema.europa.eu/en/documents/product-information/zaltrap-epar-productinformation_en.pdf. Accessed 17 Feb 2020

50.

US Food and Drug Administration. FDA labels for aflibercept (ZALTRAP®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125418s045lbl.pdf. Accessed 17 Feb 2020

51.

Nagai N, Ibuki M, Shinoda H, Kameyama K, Tsubota K, Ozawa Y. Maculopapular rash after intravitreal injection of an antivascular endothelial growth factor, aflibercept, for treating age-related macular degeneration: a case report. Medicine (Baltimore). 2017;96(21):e6965.

52.

European Medicines Agency. Assessment report of alemtuzumab (LEMTRADA®). 2013. https://www.ema.europa.eu/documents/assessment-report/lemtrada-epar-publicassessment-report_en.pdf. Accessed 17Aug 2019

53.

BC Cancer Agency. Cancer drug manual, drug name: alemtuzumab. 2015. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Alemtuzumab_Monograph_1May2015.pdf. Accessed 17 Aug 2019

54.

US Food and Drug Administration. FDA labels for alemtuzumab (LEMTRADA®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5172lbl.pdf. Accessed 17Aug 2019

55.

Frau J,Coghe G,Lorefice L,FenuG,Musu L,Cocco E. Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis. J Neurol. 2019;266:1405-11

56.

US Food and Drug Administration. FDA labels for atezolizumab (TECENTRIQ®). 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s 000lbl.pdf. Accessed 17 Feb 2020

57.

European Medicines Agency. Assessment report of atezolizumab (TECENTRIQ®). 2019. https://www.ema.europa.eu/en/documents/product-information/ tecentriq-epar-product-information_en.pdf. Accessed 17 Feb 2020

58.

BC Cancer Agency. Cancer drug manual, drug name: atezolizumab. 2019. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Atezolizumab_Monograph.pdf. Accessed 17 Feb 2020

59.

BC Cancer Agency. Cancer drug manual, drug name: bevacizumab. 2016. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Bevacizumab_monograph.pdf. Accessed 04 May 2020

60.

European Medicines Agency. Assessment report bevacizumab (ZIRABEV®). 2018. https://www.ema.europa.eu/en/documents/assessment-report/zirabev-epar-publicassessment-report_en.pdf. Accessed 17Aug 2019

61.

US Food and Drug Administration. FDA labels for bevacizumab (AVASTIN®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125085s331lbl.pdf. Accessed 17Aug 2019

62.

BC Cancer Agency. Cancer drug manual, drug name: blinatumomab. 2017. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Blinatumomab_monograph.pdf. Accessed 17 Aug 2019

63.

European Medicines Agency. Assessment report of blinatumomab (BLINCYTO®). 2018. https://www.ema.europa.eu/documents/variation-report/blincyto-h-c-3731-ii0018-epar-assessment-report-variation_en.pdf. Accessed 17Aug 2019

64.

US Food and Drug Administration. FDA labels for blinatumomab (BLINCYTO®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf. Accessed 17Aug 2019

65.

Maggi E, Vultaggio A, Matucci A. Acute infusion reactions induced by monoclonal antibody therapy. Expert Rev Clin Immunol. 2011;7:55-63

66.

Pichler WJ. Adverse side-effects to biological agents. Allergy. 2006;61:912-20

67.

Needle MN. Safety experience with IMC-C225, an antiepidermal growth factor receptor antibody. Semin Oncol. 2002;29:55-60

68.

Galvão VR, Castells MC. Hypersensitivity to biological agents-updated diagnosis, management, and treatment. J Allergy Clin Immunol Pract. 2015;3:175-85

69.

US Food and Drug Administration. FDA labels for cetuximab (ERBITUX®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125084s273lbl.pdf. Accessed 18 Aug 2019.

70.

Commins SP, Platts-Mills TA. Allergenicity of carbohydrates and their role in anaphylactic events. Curr Allergy Asthma Rep. 2010;10:29-33

71.

Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008;358:1109-17

72.

Commins SP, James HR, Kelly LA, Pochan SL, Workman LJ, Perzanowski MS, et al. The relevance of tick bites to the production of IgE antibodies to the mammalian oligosaccharide galactose-α-1,3-galactose. J Allergy Clin Immunol. 2011;127:1286-93

73.

Wedi B. Alpha-Gal in therapeutics: more relevant than thought? Hautarzt. 2017;68:246-7

74.

Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, et al. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs. 2011;3:396-401

75.

US Food and Drug Administration. FDA labels for durvalumab (IMFINZI®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761069s013lbl.pdf. Accessed 04 May 2020

76.

EuropeanMedicines Agency. Assessment report of durvalumab (IMFINZI®). 2020. https://www.ema.europa.eu/en/documents/product-information/imfizi-epar-productinformation_en.pdf. Accessed 18 Feb 2020

77.

BC Cancer Agency. Cancer drug manual, drug name: durvalumab. 2020. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Durvalumab_monograph.pdf. Accessed 18 Feb 2020

78.

US Food and Drug Administration. FDA labels for gemtuzumab (MYLOTARG®). 2006. https://www.accessdata. fda.gov/drugsatfda_docs/label/2006/021174s020lbl.pdf. Accessed 19Aug 2019

79.

European Medicines Agency. Assessment report of gemtuzumab (MYLOTARG®). 2018. https://www.ema. europa.eu/en/documents/assessment-report/mylotargepar-public-assessment-report_en.pdf. Accessed 19 Aug 2019

80.

Hanbali A, Wollner I, Neme K, Ulreich C. Fatal hypersensitivity reaction to gemtuzumab ozogamicin associated with platelet transfusion. Am J Health Syst Pharm. 2007;64:1401-2

81.

US Food and Drug Administration. FDA labels for ibritumomab (ZEVALIN®). 2002. https://www.accessdata.fda. gov/drugsatfda_docs/label/2002/ibriide021902lb.pdf. Accessed 19 Aug 2019

82.

European Medicines Agency. Assessment report of ibritumomab (ZEVALIN®). 2017. https://www.ema.europa.eu/en/documents/product-information/zevalin-eparproduct-information_en.pdf. Accessed 19 Aug 2019

83.

BC Cancer Agency. Cancer drug manual, drug name: ibritumomab. 2016. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Ibritumomab_interim%20 monograph.pdf. Accessed 19Aug 2019

84.

Mukherjee S, Ayanambakkam A, Ibrahimi S, Schmidt S, Charkrabarty JH, Khawandanah M. Ibritumomab tiuxetan (Zevalin) and elevated serum human anti-murine antibody (HAMA). Hematol Oncol Stem Cell Ther. 2018;11:187-8

85.

US Food and Drug Administration. FDA labels for imatinib (GLEEVEC®). 2001. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf. Accessed 19 Aug 2019

86.

BC Cancer Agency. Cancer drug manual, drug name: imatinib. 2017. http://www.bccancer.bc.ca/drug-databasesite/Drug%20Index/Imatinib_Monograph_1Mar2017.pdf. Accessed 19Aug 2019

87.

US Food and Drug Administration. FDA labels for ipilimumab (YERVOY®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s104lbl.pdf. Accessed 18 Feb 2020

88.

European Medicines Agency. Assessment report of ipilimumab (YERVOY®). 2020. https://www.ema.europa.eu/en/documents/product-information/yervoy-eparproduct-information_en.pdf. Accessed 18 Feb 2020

89.

BC Cancer Agency. Cancer drug manual, drug name: ipilimumab. 2020. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Ipilimumab_monograph. pdf. Accessed 18 Feb 2020

90.

Ludlow SP, Kay N. Delayed dermatologic hypersensitivity reaction secondary to ipilimumab. J Immunother. 2015;38(4):165-6

91.

US Food and Drug Administration. FDA labels for necitumumab (PORTRAZZA®). 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf. Accessed 18 Feb 2020

92.

European Medicines Agency. Assessment report of necitumumab (PORTRAZZA®). 2016. https://www.ema.europa.eu/en/documents/product-information/portrazza-eparproduct-information_en.pdf. Accessed 18 Feb 2020

93.

US Food and Drug Administration. FDA labels for nivolumab (OPDIVO®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s075lbl.pdf. Accessed 18 Feb 2020

94.

European Medicines Agency. Assessment report of nivolumab (OPDIVO®). 2020. https://www.ema.europa.eu/en/documents/product-information/opdivo-eparproduct-information_en.pdf. Accessed 18 Feb 2020

95.

BC Cancer Agency. Cancer drug manual, drug name: nivolumab. 2020. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Nivolumab_monograph.pdf. Accessed 18 Feb 2020

96.

Sáenz de Santa María García M, Noguerado-Mellado B, Rojas-Pérez-Ezquerra P, Prieto-García A, Bartolomé-Zavala B, Tornero P. First case of allergy to nivolumab. J Allergy Clin Immunol Pract. 2017;5:1140-1

97.

Oda H, Ishihara M, Miyahara Y, Nakamura J, Kozuka Y, Iwasa M et al. First case of cytokine release syndrome after nivolumab for gastric cancer. Case Rep Oncol. 2019;12:147-56

98.

Choi B, McBride A, Scott AJ. Treatment with pembrolizumab after hypersensitivity reaction to nivolumab in a patient with hepatocellular carcinoma. Am J Health Syst Pharm. 2019;76:1749-52

99.

Caponetto P, Biedermann T, Yazdi AS, Fischer J. Panitumumab: a safe option for oncologic patients sensitized to galactose-α-1,3-galactose. J Allergy Clin Immunol Pract. 2015;3:982-3.

100.

US Food and Drug Administration. FDA labels for panitumumab (VECTIBIX®). 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf. Accessed 19 Aug 2019.

101.

BC Cancer Agency. Cancer drug manual, drug name: panitumumab. 2020. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Panitumumab%20monograph.pdf. Accessed 04May 2020

102.

Mersin SS, Bulut I, Yakut T, Örçen C, Tepetam FM. Successful desensitization with panitumumab; a case report. Allergy. 2019;74:741-2

103.

European Medicines Agency. Assessment report of pembrolizumab (KEYTRUDA®). 2019. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Accessed 18 Feb 2020

104.

BC Cancer Agency. Cancer drug manual, drug name: pembrolizumab. 2019. http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Pembrolizumab_monograph.pdf. Accessed 18 Feb 2020.

105.

US Food and Drug Administration. FDA labels for pembrolizumab (KEYTRUDA®). 2020. https://www. accessdata.fda.gov/drugsatfda_docs/label/2020/125514 s067lbl.pdf. Accessed 18 Feb 2020

106.

van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, et al. Immunogenicity of pembrolizumab in patients with advanced tumors. J ImmunotherCancer. 2019;7:212

107.

BC Cancer Agency. Cancer drug manual, drug name: pertuzumab. 2014. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Pertuzumab_monograph_1Jan2014.pdf. Accessed 19 Feb 2020

108.

European Medicines Agency. Assessment report of pertuzumab (PERJETA®). 2019. https://www.ema.europa.eu/en/documents/product-information/perjeta-eparproduct-information_en.pdf. Accessed 19 Feb 2020

109.

US Food and Drug Administration. FDA labels for pertuzumab (PERJETA®). 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Accessed 19 Feb 2020

110.

BC Cancer Agency. Cancer drug manual, drug name: ramucirumab. 2017. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Ramucirumab_monograph_1May2017.pdf. Accessed 19 Feb 2020

111.

European Medicines Agency. Assessment report of ramucirumab (CYRAMZA®). 2019. https://www.ema.europa. eu/en/documents/product-information/cyramza-eparproduct-information_en.pdf. Accessed 19 Feb 2020

112.

112. US Food and Drug Administration. FDA labels for ramucirumab (CYRAMZA®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf. Accessed 19 Feb 2020

113.

BC Cancer Agency. Cancer drug manual, drug name: trastuzumab. 2020. http://www.bccancer.bc.ca/drugdatabase-site/Drug%20Index/Trastuzumab_monograph.pdf. Accessed 04 May 2020

114.

European Medicines Agency. Assessment report of trastuzumab (TRAZIMERA®). 2018. https://www.ema.europa.eu/en/documents/assessment-report/trazimeraepar-public-assessment-report_en.pdf. Accessed 06 May 2020

115.

US Food and Drug Administration. FDA labels for trastuzumab (KADCYLA®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf. Accessed 19 Aug 2019

116.

Puxeddu I, Giori L, Rocchi V, Bazzichi L, Bombardieri S, Tavoni A, et al. Hypersensitivity reactions during treatment with infliximab, etanercept, and adalimumab. Ann Allergy Asthma Immunol. 2012;108:123-4

117.

Tarkiainen M, Tynjälä P, Vähäsalo P, Lahdenne P. Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting. Rheumatology (Oxford). 2015;54:1170-6

118.

US Food and Drug Administration. FDA labels for TNF inhibitors: adalimumab (HUMIRA®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 125057s410lbl.pdf. Accessed 19 Aug 2019

119.

European Medicines Agency. Summary of product characteristic. Anakinra (KINERET®). 2014. https://ec.europa.eu/health/documents/community-register/2014/20140627128993/anx_128993_en.pdf. Accessed 28 Oct 2019

120.

US Food and Drug Administration. FDA labels for anakinra (KINERET®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf. Accessed 04May 2020

121.

Desai D, Goldbach-Mansky R, Milner JD, Rabin RL, Hull K, Pucino F. Anaphylactic reaction to anakinra in a rheumatoid arthritis patient intolerant to multiple nonbiologic and biologic disease-modifying antirheumatic drugs. Ann Pharmacother. 2009;43:967-72

122.

Aguiar CL, Pan N, Adams A, Barinstein L, Lehman TJ. Anaphylaxis to anakinra in a pediatric patient with systemic juvenile idiopathic arthritis successfully treated with canakinumab: a case-based review. Clin Rheumatol. 2015;34:1821-4

123.

Soyyigit S, Kendirlinan R, Aydın O, Çelik GE. Successful ˘ desensitization with anakinra in a case with immediate hypersensitivity reaction. Ann Allergy Asthma Immunol. 2014;113:325-6

124.

European Medicines Agency. Assessment report of belimumab (BENLYSTA®). 2018. https://www.ema.europa.eu/en/documents/product-information/benlysta-eparproduct-information_en.pdf. Accessed 21 Aug 2019

125.

US Food and Drug Administration. FDA labels for belimumab (BENLYSTA®). 2019. http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf. Accessed 21 Aug 2019

126.

US Food and Drug Administration. FDA labels for canakinumab (ILARIS®). 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf. Accessed 29Oct 2019

127.

Bettiol A, Lopalco G, Emmi G, Cantarini L, Urban ML, Vitale A et al. Unveiling the efficacy, safety, and tolerability of anti-interleukin-1 treatment in monogenic and multifactorial autoinflammatory diseases. Int J Mol Sci. 2019;20(8):1898

128.

US Food and Drug Administration. FDA labels for etanercept (ENBREL®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5569lbl.pdf. Accessed 20Aug 2019

129.

Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Mack M, et al. Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Ann Rheum Dis. 2015;74:538-46

130.

US Food and Drug Administration. FDA labels for TNF inhibitors: golimumab (SIMPONI®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf. Accessed 20Aug 2019

131.

US Food and Drug Administration. FDA labels for TNF inhibitors: infliximab (RENFLEXIS®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf. Accessed 20 Aug 2019

132.

Vultaggio A, Matucci A, Nencini F, Pratesi S, Parronchi P, Rossi O, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010;65:657-61

133.

Vultaggio A, Matucci A, Nencini F, Pratesi S, Maggi E. Skin testing and infliximab-specific antibodies detection as a combined strategy for preventing infusion reaction. Intern Emerg Med. 2012;7:77-9

134.

European Medicines Agency. Assessment report of certolizumab (CIMZIA®). 2015. https://www.ema.europa.eu/en/documents/variation-report/cimzia-h-c-1037-ii0045-epar-assessment-report-variation_en.pdf. Accessed 20 Aug 2019

135.

US Food and Drug Administration. FDA labels for certolizumab (CIMZIA®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf. Accessed 20Aug 2019

136.

Bykerk VP, Cush J, Winthrop K, Calabrese L, Lortholary O, de Longueville M, et al. Update on the safety profile of certolizumab pegol in rheumatoid arthritis: an integrated analysis from clinical trials. Ann Rheum Dis. 2015;74:96-103

137.

US Food and Drug Administration. FDA labels for rituximab (RITUXAN HYCELA®). 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf. Accessed 20Aug 2019

138.

US Food and Drug Administration. FDA labels for rituximab (RITUXAN®). 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf. Accessed 20 Aug 2019

139.

BC Cancer Agency. Cancer drug manual, drug name: rituximab. 2018. http://www.bccancer.bc.ca/drug-databasesite/Drug%20Index/Rituximab_monograph.pdf. Accessed 20 Aug 2019

140.

Schmidt E, Hennig K, Mengede C, Zillikens D, Kromminga A. Immunogenicity of rituximab in patients with severe pemphigus. Clin Immunol. 2009;132:334-41

141.

Vultaggio A, Matucci A, Nencini F, Pratesi S, Petroni G, Cammelli D, et al. Drug-specific Th2 cells and IgE antibodies in a patient with anaphylaxis to rituximab. Int Arch Allergy Immunol. 2012;159:321-6

142.

US Food and Drug Administration. FDA labels for basiliximab (SIMULECT®). 2001. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf. Accessed 21 Aug 2019

143.

Erickson AL, Roberts K, Malek SK, Chandraker AK, Tullius SG, Gabardi S. Analysis of infusion-site reactions in renal transplant recipients receiving peripherally administered rabbit antithymocyte globulin as compared with basiliximab. Transpl Int. 2010;23:636-40

144.

Baudouin V, Crusiaux A, Haddad E, Schandene L, Goldman M, Loirat C, et al. Anaphylactic shock caused by immunoglobulin E sensitization after retreatment with the chimeric anti-interleukin-2 receptor monoclonal antibodybasiliximab. Transplantation. 2003;76:459-63

145.

BC Transplant. Clinical guidelines for transplant medications. Section: Basiliximab. 2018. http://www.transplant.bc.ca/Documents/Health%20Professionals/Clinical%20guidelines/Clinical%20Guidelines%20for %20Transplant%20Medications%20-%20June%202018.pdf. Accessed 20 Aug 2019, p 8-12

146.

US Food and Drug Administration. FDA labels for belatacept (NULOJIX®). 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf. Accessed 21 Aug 2019

147.

European Medicines Agency. Assessment report of belatacept (NULOJIX®). 2019. https://www.ema.europa.eu/en/documents/product-information/nulojix-epar-productinformation_en.pdf. Accessed 29 Nov 2019

148.

Becker H, Reichert JM. Muromonab-CD3 (orthoclone OKT3). In: Dübel S, Reichert JM, editors. Handbook of therapeutic antibodies. 2014. pp. 1663-4. https://doi.org/10.1002/9783527682423.ch60

149.

Boden EK, Canavan JB, Moran CJ, McCann K, Dunn WA, Farraye FA, et al. Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis. Crohns Colitis 360. 2019;1(2):otz9. https://doi.org/10. 1093/crocol/otz009

150.

Dery JP, Braden GA, Lincoff AM, Kereiakes DJ, Browne K, Little T, et al. ReoPro readministration registry investigators. Final results of the ReoPro readministration registry. Am JCardiol. 2004;93:979-84

151.

Iakovou Y, Manginas A, Melissari E, Cokkinos DV. Acute profound thrombocytopenia associated with anaphylactic reaction after abciximab therapy during percutaneous coronary angioplasty. Cardiology. 2001;95:215-6

152.

US Food and Drug Administration. FDA labels for abciximab (REOPRO®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103575s5318lbl.pdf. Accessed 21 Aug 2019

153.

US Food and Drug Administration. FDA labels for eculizumab (SOLIRIS®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf. Accessed 20 Feb 2020

154.

European Medicines Agency. Assessment report of eculizumab (SOLIRIS®). 2019. https://www.ema.europa.eu/en/documents/product-information/solirisepar-product-information_en.pdf. Accessed 20 Feb 2020

155.

Wedi B. Lanadelumab to treat hereditary angioedema. Drugs Today. 2019;55:439-48

156.

Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, et al. HELP investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomizedclinical trial. JAMA. 2018;320:2108-21

157.

European Medicines Agency. Summary of product characteristic. Lanadelumab (TAKHZYRO®). 2018. https://www.ema.europa.eu/en/documents/assessment-report/takhzyro-epar-public-assessment-report_en.pdf. Accessed 29 Oct 2019

158.

European Medicines Agency. Assessment report of natalizumab (TYSABRI®). 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Tysabri_20/European_Commission_final_decision/WC500202392.pdf. Accessed 21 Aug 2019

159.

US Food and Drug Administration. FDA labels for natalizumab (TYSABRI®). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125104s966lbl.pdf. Accessed 21 Aug 2019

160.

US Food and Drug Administration. FDA labels for palivizumab (SYNAGIS®). 2009. https://www.accessdata.fda.gov/drugsatfda_docs/bla/2003/103770orig1s5033.pdf. Accessed 22 Aug 2019

161.

Chen JJ, Chan P, Paes B, Mitchell I, Li A, Lanctôt KL, et al. Serious adverse events in the Canadian registry of children receiving palivizumab (CARESS) for respiratory syncytial virusprevention. PLoSOne. 2015;10:e134711

162.

Resch B. Product review on the monoclonal antibody palivizumab for prevention of respiratory syncytial virus infection. Hum Vaccin Immunother. 2017;13:2138-49

163.

Jappe U. Allergic reactions to oncology biologics. Immunology Section of EAACI Congress; Munich, Germany. 2018. BM Task Force forAllergoOncology

164.

Vultaggio A, Petroni G, Pratesi S, Nencini F, Cammelli D, Ferraro A, et al. How the immune system responds to therapeutic biological agents. J Int Med Res. 2016;44:38-42

165.

Lenz HJ. Management and preparedness for infusion and hypersensitivity reactions. Oncologist. 2007;12:601-9

166.

Ring J, Beyer K, Biedermann T, Bircher A, Duda D, Fischer J, et al. Guideline for acute therapy and management of anaphylaxis. S2 guideline of DGAKI, AeDA, GPA, DAAU, BVKJ, ÖGAI, SGAI, DGAI, DGP, DGPM, AGATE and DAAB. Allergo J Int. 2014; 23:96-112.

167.

Shimabukuro-Vornhagen A, Gödel P, Subklewe M, Stemmler HJ, Schlößer HA, Schlaak M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6:56

Titel: Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*
verfasst von: Askin Gülsen
Prof. Dr. med. Bettina Wedi
Prof. Dr. med. Uta Jappe
Publikationsdatum: 24.06.2020
Verlag: Springer Medizin
Schlagwörter: Urtikaria
Angioödem
Anaphylaxie
Anaphylaxie
Erschienen in: Allergo Journal / Ausgabe 4/2020
Print ISSN: 0941-8849
Elektronische ISSN: 2195-6405
DOI: https://doi.org/10.1007/s15007-020-2550-1

Passend zum Thema

Anaphylaxie

Es wäre so einfach, ein Leben zu retten – Wenn man nur daran denkt…

Anaphylaxie ist eine akute schwere allergische Reaktion und somit die schwerste Komplikation in der Allergologie. Darauf sollten Ärztinnen und Ärzte vorbereitet sein.

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 4/2020

Schulterschluss zwischen Wissenschaft und Praxis

Hypersensitivitätsreaktionen gegen Biologika

Vermeintliche Penizillinallergie schnell enttarnen

Anaphylaxie: durchwachsene Leitlinienadhärenz

Allergie auf Pollen des Götterbaumes in Deutschland: Nachweis mittels positiver nasaler Provokation

EAACI-definierte Pollenflugsaison korreliert gut mit Rhinitissymptomatik

Passend zum Thema

Es wäre so einfach, ein Leben zu retten – Wenn man nur daran denkt…