Clinical development methodology for infusion-related reactions with monoclonal antibodies

Clinical and Translational Immunology

Volumn 4, Issue , 2015, Pages

  Doessegger, Lucette ^a   Banholzer, Maria Longauer ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN E ANTIBODY; MONOCLONAL ANTIBODY;

ANAPHYLAXIS; COMPLEMENT ACTIVATION; COMPLEMENT ACTIVATION RELATED PSEUDOALLERGY; CROSS REACTION; CYTOKINE RELEASE; CYTOKINE RELEASE SYNDROME; DRUG SAFETY; HUMAN; IMMUNOGENICITY; IMMUNOGLOBULIN BLOOD LEVEL; INCIDENCE; INFUSION RELATED REACTION; PRACTICE GUIDELINE; PREDICTIVE VALUE; PRICK TEST; PRIORITY JOURNAL; REVIEW; RISK MANAGEMENT; SKIN TEST;

EID: 85048755741     PISSN: None     EISSN: 20500068     Source Type: Journal    
DOI: 10.1038/cti.2015.14     Document Type: Review

References (48)

1. Kang SP, Saif MW. Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer-identification, prevention, and management. J Support Oncol 2007; 5: 451-457.
2. Coombs RRA, Gell PGH. Classification of allergic reactions responsible for clinical hypersensitivity and disease (eds Gell PGH, Coombs RRA, LPJ) Clinical Aspects of Immunology. 3rd edn. Blackwell Scientific Publications: Oxford, 1975, pp 761-781.
3. Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy et al. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol 2010; 105: 259-273.
4. Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF et al. Revised nomenclature for allergy for global use: report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol 2004; 113: 832-836.
5. Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr., Bock SA, Branum A et al. Second symposium on the definition and management of anaphylaxis: summary report- Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol 2006; 117: 391-397.
6. Joint Task Force on Practice Parameters, American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy et al. The diagnosis and management of anaphylaxis: an updated practice parameter. J Allergy Clin Immunol 2005; 115: S483-S523.
7. Lieberman P, Nicklas RA, Oppenheimer J, Kemp SF, Lang DM, Bernstein DI et al. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol 2010; 126: 477-480 e471-442.
8. Muraro A, Roberts G, Worm M, Bilo MB, Brockow K, Fernandez Rivas M et al. Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy 2014; 69: 1026-1045.
9. Abbas AK, AH L, Pillai S. Humoral immune responses. Basic Immunology: Functions and Disorders of the Immune System. 4th edn Saunders/Elsevier: Philadelphia (PA): 2014; 131-150.
10. Bonilla FA UpToDate: The humoral immune response. 2015 [cited]; Available at http://www.uptodate.com/contents/the-humoral-immune-response?topicKey=ALLRG%2F3975&elapsedTimeMs=4&source=search-result&searchTerm=IgM&selectedTitle=3%7E150+-+H22&view=print&displayedView=full.
11. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004; 93: 2645-2668.
12. Sudowe S, Rademaekers A, Kolsch E. Antigen dose-dependent predominance of either direct or sequential switch in IgE antibody responses. Immunology 1997; 91: 464-472.
13. Xiong H, Dolpady J, Wabl M, Curotto de Lafaille MA, Lafaille JJ. Sequential class switching is required for the generation of high affinity IgE antibodies. J Exp Med 2012; 209: 353-364.
14. Johansson SG, Hourihane JO, Bousquet J, Bruijnzeel-Koomen C, Dreborg S, Haahtela T et al. A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force. Allergy 2001; 56: 813-824.
15. Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity. Toxicology 2005; 216: 106-121.
16. Szebeni J, Muggia F, Gabizon A, Barenholz Y. Activation of complement by therapeutic liposomes and other lipid excipient-based therapeutic products: prediction and prevention. Adv Drug Deliv Rev 2011; 63: 1020-1030.
17. Szebeni J. Hemocompatibility testing for nanomedicines and biologicals: Predictive assays for complement mediated infusion reactions. Eur J Nanomed 2012; 4: 33-53.
18. Szebeni J. Complement activation-related pseudoallergy: a stress reaction in blood triggered by nanomedicines and biologicals. Mol Immunol 2014; 61: 163-173.
19. Gaston RS, Deierhoi MH, Patterson T, Prasthofer E, Julian BA, Barber WH et al. OKT3 first-dose reaction: association with T cell subsets and cytokine release. Kidney Int 1991; 39: 141-148.
20. Jeyarajah DR, Thistlethwaite JR Jr. General aspects of cytokine-release syndrome: timing and incidence of symptoms. Transplant Proc 1993; 25: 16-20.
21. Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355: 1018-1028.
22. Winkler U, Jensen M, Manzke O, Schulz H, Diehl V, Engert A. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood 1999; 94: 2217-2224.
23. Walker M, Makropoulos D, Achuthanandam R, Bugelski PJ. Recent advances in the understanding of drug-mediated infusion reactions and cytokine release syndrome. Curr Opin Drug Discov Devel 2010; 13: 124-135.
24. Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 2014; 124: 188-195.
25. Bugelski PJ, Achuthanandam R, Capocasale RJ, Treacy G, Bouman-Thio E. Monoclonal antibody-induced cytokine-release syndrome. Expert Rev Clin Immunol 2009; 5: 499-521.
26. National Cancer Insitute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. 2006 [cited]; Available at http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf.
27. National Cancer Insitute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. 2010 [cited]; Available at http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-8.5x11.pdf.
28. Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A et al. Anticetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs 2011; 3: 396-401.
29. 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: 1109-1117.
30. Arnold DF, Misbah SA. Cetuximab-induced anaphylaxis and IgE specific for galactosealpha- 1,3-galactose. N Engl J Med 2008; 358: 2735 author reply 2735-2736.
31. European Medicines Agency, Committe for Medicinal Products for Human Use (CHMP) Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (EMEA/CHMP/BMWP/14327/2006). 2007 [cited]; Available at http://www.ema.europa. eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003946.pdf.
32. Food and Drug Administration (FDA)Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Immunogenicity Assessment for Therapeutic Protein Products. 2014 [cited]; Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf.
33. Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D et al. 'Cytokine storm' in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2007; 179: 3325-3331.
34. Stebbings R, Eastwood D, Poole S, Thorpe R. After TGN1412: recent developments in cytokine release assays. J Immunotoxicol 2013; 10: 75-82.
35. Remicade (infliximab). FDA Drug Approval Package, Approval Date: August 1998. 1998 [cited]; Available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093327.htm.
36. Arzerra (ofatumumab), FDA Drug Approval Package; Approval Date: October 2009. 2009 [cited]; Available at http://www.accessdata.fda.gov/drugsatfda-docs/nda/2009-/125326s000TOC.cfm.
37. Vectibix (panitumumab injectable), FDA Drug Approval Package, Approval Date: September 2006. 2007 [cited]; Available at http://www.accessdata.fda.gov/drugsatfda- docs/nda/2006/125147s0000TOC.cfm.
38. Erbitux (cetuximab), FDA Approval Package, Approval Date: February 2004. 2004 [cited]; Available from http://www.accessdata.fda.gov/drugsatfda-docs/bla/2004-/125084-erbitux-toc.cfm.
39. Tysabri (natalizumab), FDA Approval Package, Approval Date: November 2004. 2005 [cited]; Available at http://www.accessdata.fda.gov/drugsatfda-docs/nda/2004-/125104s000-Natalizumab.cfm.
40. FDA Arthritis Advisory Committee Meeting Briefing Document for the 16 November 2010 Meeting, Benlysta (belimumab), Human Genome Sciences, Inc.; Treatment of Systemic Lupus Erythematosus; BLA 125370, 13 October 2010. 2010 [cited]; Available from: www.fda.gov/../advisorycommittees/committeesmeetingmaterials/../arth.
41. Valent P. Mast cell activation syndromes: definition and classification. Allergy 2013; 68: 417-424.
42. Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 2008; 13: 725-732.
43. Valent P, Akin C, Arock M, Brockow K, Butterfield JH, Carter MC et al. Definitions, criteria and global classification of mast cell disorders with special reference to mast cell activation syndromes: a consensus proposal. Int Arch Allergy Immunol 2012; 157: 215-225.
44. Sala-Cunill A, Cardona V, Labrador-Horrillo M, Luengo O, Esteso O, Garriga T et al. Usefulness and limitations of sequential serum tryptase for the diagnosis of anaphylaxis in 102 patients. Int Arch Allergy Immunol 2013; 160: 192-199.
45. Simons FE, Ardusso LR, Dimov V, Ebisawa M, El-Gamal YM, Lockey RF et al. World Allergy Organization Anaphylaxis Guidelines: 2013 update of the evidence base. Int Arch Allergy Immunol 2013; 162: 193-204.
46. Duff G, Lechler R, Borysiewicz L, Inglis S, Parry V, Walport M et al. Expert scientific group on phase one clinical trials; final report. 2006 [cited]; Available at http://webarchive.nationalarchives.gov.uk/+/dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh-63117.
47. European Medicines Agency, Committe for Medicinal Products for Human Use (CHMP) Guideline on strategies to identify and mitigate risks for first-in human clinical trials with investigational medicinal products (EMA/CHMP/SWP/28367/07). 2007 [cited]; Available at http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002988.pdf.
48. Vidal JM, Kawabata TT, Thorpe R, Silva-Lima B, Cederbrant K, Poole S et al. In vitro cytokine release assays for predicting cytokine release syndrome: the current state-ofthe- science. Report of a European Medicines Agency Workshop. Cytokine 2010; 51: 213-215.