Acute infusion reactions induced by monoclonal antibody therapy

Expert Review of Clinical Immunology

Volumn 7, Issue 1, 2011, Pages 55-63

  Maggi, Enrico ^a   Vultaggio, Alessandra ^b   Matucci, Andrea ^b  

^a UNIVERSITY OF FLORENCE   (Italy)

^b Immunoallergology Unit   (Italy)

Author keywords

anaphylaxis; anti TNF antibody; biological agents; drug allergy; infliximab; mAbs; monoclonal antibodies

Indexed keywords

ANTIGEN; ANTIHISTAMINIC AGENT; AZATHIOPRINE; BIOLOGICAL MARKER; CETUXIMAB; CORTICOSTEROID; CYTOKINE; HYDROCORTISONE; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E ANTIBODY; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; NATALIZUMAB; OMALIZUMAB; PARACETAMOL; RITUXIMAB; TRASTUZUMAB;

ADVERSE DRUG REACTION; ANAPHYLAXIS; ANKYLOSING SPONDYLITIS; ASTHMA; CROHN DISEASE; CYTOKINE RELEASE; CYTOKINE RELEASE SYNDROME; DISEASE SEVERITY; DRUG ANTIGENICITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG INFUSION REACTION; DRUG MEGADOSE; DRUG SAFETY; DRUG SOLUBILITY; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; EPIDEMIOLOGICAL DATA; HUMAN; IMMUNE DEFICIENCY; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOGLOBULIN DEFICIENCY; IMMUNOSUPPRESSIVE TREATMENT; IN VITRO STUDY; IN VIVO STUDY; LEISHMANIN SKIN TEST; MEDIATOR; MULTIPLE SCLEROSIS; NEOPLASM; NONHODGKIN LYMPHOMA; NONHUMAN; PATHOGENESIS; PRICK TEST; PSORIASIS; REVIEW; RHEUMATOID ARTHRITIS; RISK FACTOR; SIGNAL TRANSDUCTION; SKIN TEST; SPONDYLOARTHROPATHY; SYSTEMATIC DESENSITIZATION; TREATMENT INDICATION; VASCULITIS;

ANAPHYLAXIS; ANTIBODIES, MONOCLONAL; DRUG HYPERSENSITIVITY; HUMANS; IMMUNOGLOBULIN E; IMMUNOLOGIC FACTORS; INCIDENCE; INFUSIONS, INTRAVENOUS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 78650578346     PISSN: 1744666X     EISSN: None     Source Type: Journal    
DOI: 10.1586/eci.10.90     Document Type: Review

References (84)

1. Leape LL, Brennan TA, Laird N et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N. Engl. J. Med. 324, 77-84 (1991).
2. Pichler WJ. Adverse side-effects to biological agents. Allergy 61, 912-920 (2006).
3. Schaible TF. Long term safety of infliximab. Can. J. Gastroenterol. 14, 29C-32C (2000).
4. Fleischmann R, Yocum D. Does safety make a difference in selecting the right TNF antagonist? Arthritis Res. Ther. 6 (Suppl. 2), S12-S18 (2004).
5. Colombel JF, Loftus Jr EV, Treimane WJ et al. The safety profile of infliximab inpatients with Crohns disease: the Mayo clinic experience in 500 patients. Gastroenterology 126, 19-31 (2004).
6. Reich K, Nestle FO, Papp K et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a Phase III, multicentre, double-blind trial. Lancet 366, 1367-1374 (2005).
7. Baert F, Noman M, Vermeire S et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohns disease. N. Engl. J. Med. 348, 601-608 (2003).
8. Cohen RD, Tsang JF, Hanauer SB. Infliximab in Crohns disease: first anniversary clinical experience. Am. J. Gastroenterol. 95, 3469-3477 (2000).
9. Ricart E, Panaccione R, Loftus EV et al. Infliximab for Crohns disease in clinical practice at the Mayo Clinic: the first 100 patients. Am. J. Gastroenterol. 96, 722-729 (2001).
10. Farrel RJ, Shah SA, Lodhavia PJ et al. Clinical experience with infliximab therapy in 100 patients with Crohn disease. Am. J. Gastroenterol. 5, 3490-3497 (2000).
11. Vultaggio A, Matucci A, Parronchi P et al. Safety and tolerability of infliximab therapy: suggestions and criticisms based on wide clinical experience. Int. J. Immunopathol. Pharmacol. 21, 367-374 (2008).
12. Plosker GL, Figgitt DP. Rituximab: a review of its use in non-Hodgkins lymphoma and chronic lymphocytic leukemia. Drugs 63, 803-843 (2003).
13. 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. Blood 94, 2217-2224 (1999).
14. Sobrero AF, Maurel J, Fehrenbacher L et al. EPIC: Phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J. Clin. Oncol. 26, 2311-2319 (2008).
15. Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N. Engl. J. Med. 354, 567-578 (2006).
16. Cunningan D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irotecan-refractory metastatic colorectal cancer. N. Engl. J. Med. 351, 337-345 (2004).
17. Lenz H-J. Cetuximab in the management of colo-rectal cancer. Biologics 1, 77-91 (2007).
18. Dillman RO. Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy. Cancer Metastasis Rev. 18, 465-471 (1999).
19. Ransohoff RM. Natalizumab for multiple sclerosis. N. Engl. J. Med. 356, 2622-2629 (2007).
20. Calabresi PA, Giovannoni G, Confavreux C et al. The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL. Neurology 69, 1391-1403 (2007).
21. Cox LS, Platts-Mills TAE, Finegold I et al. American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force report on omalizumab-associated anaphylaxis. J. Allergy Clin. Immunol. 120, 1373-1377 (2007).
22. Presta LG. Engineering of therapeutic antibodies to minimize immunogenicity and optimize function. Adv. Drug Deliv. Rev. 58, 640-656 (2006).
23. Hansel TT, Kropshofer H, Singer T et al. The safety and side effects of monoclonal antibodies. Nat. Rev. Drug Discov. 9, 325-338 (2010).
24. Sandborn WJ, Colombel JF, Enns R et al. International efficacy of natalizumab as active Crohons therapy (ENACT-1) trial group; evaluation of natalizuamb as continuous therapy (ENACT-1) trial group. Natalizumab induction and maintenance therapy for Crohons disease. N. Engl. J. Med. 353, 1912-1925 (2005).
25. Kress A. Adalimumab for use in the treatment of rheumatoid arthritis: clinical review. Abbott laboratories biologic licensing application. Office of Therapeutic Research and Review, Division of Clinical Trial Design and Analysis; Immunology and Infectious Diseases Branch. Food and Drug Administration, Rockville, MD, USA, 1-136 (2002).
26. Weiblatt ME, Keystone EC, Furst DE et al. Adalimumab a fully human anti-tumor necrosis factor monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant metotrexate. The ARMANDA trial. Arthritis Rheum. 45, 35-45 (2003).
27. Anderson PJ. Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles. Semin. Arthritis Rheum. 34(S1), 19-22 (2005).
28. Haraoui B, Cameron L, Ouellet M et al. Anti-infliximab antibodies in patients with rheumatoid arthritis who require higher doses of infliximab to achieve or maintain a clinical response. J. Rheumatol. 33, 31-36 (2006).
29. Wolbink GJ, Vis M, Lems W et al. Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 54, 711-715 (2006).
30. Svenson M, Geborek P, Saxne T et al. Monitoring patients treated with anti- TNF-a biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology 46, 1828-1834 (2007).
31. van der Bijl AE, Breedveld FC, Antoni CE et al. An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status. Clin. Rheumatol. 27, 1021-1028 (2007).
32. van den Bemt BJ, den Broeder AA, Snijders GF et al. Sustained effect after lowering high-dose infliximab in patients with rheumatoid arthritis: a prospective dose titration study. Ann. Rheum. Dis. 67, 1697-1701 (2008).
33. Bendtzen K, Geborek P, Svenson M et al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor a inhibitor infliximab. Arthritis Rheum. 54, 3782-3789 (2006).
34. Hanauer SB, Wagner CL, Bala M et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohns disease. Clin. Gastroenterol. Hepatol. 2, 542-553 (2004).
35. Wasserman MJ, Weber DA, Guthrie JA et al. Infusion-related reactions to infliximab in patients with rheumatoid arthritis in a clinical practice setting: relationship to dose, antihistamine pretreatment, and infusion number. J. Rheumatol. 31, 1912-1917 (2004).
36. Vultaggio A, Matucci A, Nencini F et al. Anti-infliximab IgE and non IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy 65, 657-661 (2010).
37. Berger W, Gupta N, McArlary M et al. Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. Ann. Allergy Asthma Immunol. 91, 182-188 (2003).
38. Fahy JV, Cockcroft DW, Boulet LP et al. Effect of aerosolized anti-IgE (E25) on airway responses to inhaled allergen in asthmatic subjects. Am. J. Respir. Crit. Care Med. 160, 1023-1027 (1999).
39. Gould HJ, Sutton BJ, Beavil AJ et al. The biology of IgE and the basis for allergic disease. Annu. Rev. Immunol. 21, 579-628 (2003).
40. Prussin C, Metcalfe DD. IgE, mast cells, basophils, and eosinophils. J. Allergy Clin. Immunol. 117, S450-S456 (2006).
41. Lenz HJ. Management and prepardenees for infusion and hypersensitivity reactions. Oncologist 12, 601-609 (2007).
42. Chung CH, Mirakhur B, Chan E et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-a-1,3-galactose. N. Engl. J. Med. 358, 1109-1117 (2008).
43. Brennan PJ, Bouza TR, Hsu FI et al. Hypersensitivity reactions to mAbs: 105 desensitizations in 23 patients, from evaluation to treatment. J. Allergy Clin. Immunol. 124, 1259-1266 (2009).
44. Price KS, Hamilton RG. Anaphylactoid reactions in two patients after omalizumab administration after successful long-term therapy. Allergy Asthma Proc. 28, 313-319 (2007).
45. Steele RH, Limaye S, Cleland B et al. Hypersensitivity reactions to the polysorbate contained in recombinant erythropoietin and darbepoietin. Nephrology 10, 317-320 (2005).
46. Chavez-Lopez MA, Delgado-Villafana J, Gallaga A et al. Severe anaphylactic reaction during the second infusion of infliximab in a patient with psoriatic arthritis. Allergol. Immunopathol. 33, 291-292 (2005).
47. Soykan I, Ertan C, Ozden A. Severe anaphylactic reaction to infliximab: report of a case. Am. J. Gastroenterol. 95, 2395-2396 (2000).
48. Kolho KL, Ruuska T, Savilahti E. Severe adverse reaction to infliximab therapy are common in young children with inflammatory bowel disease. Acta Paediatr. 96, 128-130 (2007).
49. Diamanti A, Castro M, Papadatou B, Ferretti F, Gambarara M. Severe anaphylactic reaction to infliximab in pediatric patients with Crohns disease. J. Pediatr. 140, 636-637 (2002).
50. Puchner TC, Kugathasan S, Kelly KJ, Binion DG. Successful desensitization and therapeutic use of infliximab in adult and pediatric Crohns disease patients with prior anaphylactic reaction. Inflamm. Bowel Dis. 7, 34-37 (2001).
51. Sany J, Kaiser MJ, Jorgensen C et al. Study of the tolerance of infliximab infusions with or without betamethasone premedication in patients with active rheumatoid arthritis. Ann. Rheum. Dis. 1647-1649 (2005).
52. Cheifetz A, Smedley M, Martin S et al. The incidence and management of infusion reactions to infliximab: a large center experience. Am. J. Gastroenterol. 98, 1315-1324 (2003).
53. Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N. Engl. J. Med. 327, 380-384 (1992).
54. Finkelman FD. Anaphylaxis: lessons from mouse model. J. Allergy Clin. Immunol. 120, 506-515 (2007).
55. Vadas P, Gold M, Perelman B et al. Platelet-activating factor, PAF acetylhydrolase, and severe anaphylaxis. N. Engl. J. Med. 358, 28-35 (2008).
56. Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clin. J. Oncol. Nursing 14, E10-E21 (2010).
57. Winkler U, Jensen M, Manzke O et al. 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 94, 2217-2224 (1999).
58. Looney RJ. B cells as a therapeutic target in autoimmune diseases other than rheumatoid arthritis. Rheumatology 44(Suppl. 2), 13-17 (2005).
59. Hainsworth JD. Safety of rituximab in the treatment of B cell malignancies: implications for rheumatoid arthritis. Arthritis Res. Ther. 5(Suppl. 4), S12-S16 (2003).
60. Breslin S. Cytokine-release syndrome: overview and nursing implications. Clin. J. Oncol. Nursing 11(Suppl. 1), 37-42 (2007).
61. Kimby E. Tolerability and safety of rituximab (Mabthera). Cancer Treat. Rev. 31,456-473 (2005).
62. Moss AC, Fernandez-Becker N, Jo Kim K et al. The impact of infliximab infusion reactions on long-term outcomes in patients with Crohns disease. Aliment. Pharmacol. Ther. 28, 221-227 (2008).
63. Sandborn WJ, Hanauer SB. Infliximab in the treatment of Crohns disease: a users guide for clinicians. Am. J. Gastroenterol. 97, 2962-2972 (2002).
64. Farrell RJ, Alsahli M, Jeen YT et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohns disease: a randomized controlled trial. Gastroenterology 124, 917-924 (2003).
65. Lecluse LLA, Piskin G, Mekkes JR, Boss JD, de Rie MA. Review and expert opinion on prevention and treatment of infliximab-related infusion reactions. Br. J. Dermatol. 159, 527-536 (2008).
66. Pan SM, Dehler S, Ciurea A et al. Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis. Arthritis Rheum. 61, 560-568 (2009).
67. Kugathasan S, Levy MB, Saeinan K et al. Infliximab retreatment in adults and children with Crohns disease: risk factors for the development of delayed of severe systemic reaction. Am. J. Gastroenterol. 97, 1408-1414 (2002).
68. Sands BE, Anderson FH, Bernstein CN et al. Infliximab maintenance therapy for fistulizing Crohns disease. N. Engl. J. Med. 350, 876-885 (2004).
69. Rutgeerts P, Feagan BG, Lichtenstein GR et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohns disease. Gastroenterology 126, 402-413 (2004).
70. Colombel JF, Sandborn WJ, Rutgeerts P et al. Adalimumab for maintenance of clinical response and remission in patients with Crohns disease: the CHARM trial. Gastroenterology 132, 52-65 (2007).
71. Candon S, Mosca A, Ruemmele F et al. Clinical and biological consequences of immunization to infliximab in pediatric Crohns disease. Clin. Immunol. 118, 11-19 (2006).
72. Rutgeerts V, Van Assche G, Vermeire S. Review article: inflximab therapy for inflammatory bowel disease-seven years on. Aliment. Pharmacol. Ther. 23, 451-463 (2006).
73. Domènech E, Zabana Y, Maosa M, Garcia-Planella E, Cabre E, Gassull MA. Infliximab reintroduction is not associated to a higher rate of immune-related adverse effects in patients with inflammatory bowel disease initially treated with a three-infusion induction regimen. J. Clin. Gastroenterol. 44, 34-37 (2010).
74. Baraliakos X, Listing J, Rudwaleit M et al. Safety and efficacy of readministration of infliximab after longterm continuous therapy and withdrawal in patients with ankylosing spondylitis. J. Rheumatol. 34, 510-515 (2007).
75. Bourdage JS, Lee TN, Taylor JM et al. Effect of double antigen bridging immuneassay format on antigen coating concentration dependence and implications for designing immunogenicity assays for monoclonal antibodies. J. Pharm. Biomed. Anal. 39, 685-690 (2005).
76. Robert F, Ezekiel MP, Spencer SA et al. Phase I study of anti-epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J. Clin. Oncol. 19, 3234-3243 (2001).
77. Milowsky MI, Nanus DM, Kostakoglu L et al. Phase I trial of yttrium-90-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for androgen-independent prostate cancer. J. Clin. Oncol. 22, 2522-2531 (2004).
78. Ritter G, Cohen LS, Williams C Jr et al. Serological analysis of human anti-human antibody responses in colon cancer patients treated with repeated doses of humanized monoclonal antibody A33. Cancer Res. 61, 6851-6859 (2001).
79. Poter S. Human immune response to recombinant human proteins. J. Pharm. Sci. 90, 1-11 (2001).
80. Ryff JC. Clinical investigation of the immunogenicity of interferon-a 2a. J. Interferon Cytokine Res. 17(Suppl. 1), S29-S33 (1997).
81. Hanauer SB, Faegan BG, Lichtestein GR et al. Maintenance infliximab for Crohns disease: the ACCENT I randomised trial. Lancet 359, 1541-1549 (2002).
82. Patton A, Mullenix MC, Swanson SJ et al. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J. Immunol. Methods 304, 189-195 (2005).
83. Georgitis JW, Browning MC, Steiner D, Lorentz WB. Anaphylaxis and desensitization to the murine monoclonal antibody used for renal graft rejection. Ann. Allergy 66, 343-347 (1991).
84. Munoz-Cano R, Carnes J, Sanchez-Lopez J et al. Biological agents: new drugs, old problems. J. Allergy Clin. Immunol. 126, 394-395 (2010).