Immunotoxicity of monoclonal antibodies

mAbs

Volumn 1, Issue 2, 2009, Pages 104-111

  Descotes, Jacques ^a  

^a Poison Center   (France)

Author keywords

Immunological safety evaluation; Immunotoxicology; Monoclonal antibodies

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; CERTOLIZUMAB PEGOL; CETUXIMAB; CYTOCHROME P450; ETANERCEPT; IBUPROFEN; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; NATALIZUMAB; OKT 3; OMALIZUMAB; PALIVIZUMAB; PANITUMUMAB; PARACETAMOL; RECOMBINANT INTERFERON; RECOMBINANT INTERLEUKIN 2; RITUXIMAB; TGN 1412; TRASTUZUMAB; TUMOR NECROSIS FACTOR INHIBITOR;

ANAPHYLAXIS; ARTHRALGIA; ASPERGILLOSIS; AUTOIMMUNE DISEASE; B CELL LYMPHOMA; BACTERIAL INFECTION; BIOTRANSFORMATION; BLOOD PRESSURE; BONE INFECTION; BREAST CANCER; CANDIDIASIS; CENTRAL NERVOUS SYSTEM INFECTION; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL FEATURE; COCCIDIOIDOMYCOSIS; CONFUSION; CROHN DISEASE; CYTOKINE RELEASE; DIARRHEA; DRUG FATALITY; FLU LIKE SYNDROME; HEART MUSCLE ISCHEMIA; HISTOPLASMOSIS; HUMAN; HYPERPYREXIA; HYPOTENSION; IMMUNOGENICITY; IMMUNOSTIMULATION; IMMUNOTOXICITY; INFECTION COMPLICATION; INFECTIOUS ARTHRITIS; INFECTIOUS COMPLICATION; INJECTION SITE REACTION; LISTERIOSIS; LYMPHOPROLIFERATIVE DISEASE; MULTIPLE SCLEROSIS; MYCOSIS; NAUSEA; NAUSEAS; NEUROLOGIC DISEASE; NONHUMAN; OBNUBILATION; PNEUMOCYSTIS PNEUMONIA; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RESPIRATORY TRACT INFECTION; REVIEW; RHEUMATOID ARTHRITIS; RIGOR; SEIZURE; SERUM SICKNESS; SHOCK; SIDE EFFECT; SKIN INFECTION; TREMOR; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; URINARY TRACT INFECTION; VIRUS CARCINOGENESIS; VIRUS INFECTION; VOMITING;

ANIMALS; ANTIBODIES, MONOCLONAL; AUTOIMMUNITY; DRUG EVALUATION, PRECLINICAL; DRUG HYPERSENSITIVITY; HUMANS; IMMUNIZATION; IMMUNOSUPPRESSION; RATS; SAFETY;

EID: 77953677314     PISSN: 19420862     EISSN: None     Source Type: Journal    
DOI: 10.4161/mabs.1.2.7909     Document Type: Review

References (54)

1. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256:495-497
2. Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2008; 84:548-558
3. Descotes J, Gouraud A. Clinical immunotoxicity of therapeutic proteins. Exp Opin Drug Metab Toxicol 2008; 4:1537-1549
4. Descotes J. Health consequences of immunotoxic effects. In: Immunotoxicology of Drugs and Chemicals. An Experimental and Clinical Approach. Vol.1 Principles and Methods of Immunotoxicology. Descotes J, ed. Amsterdam: Elsevier Science 2004; 55-126.
5. Vial T, Descotes J. Immunosuppressive drugs and cancer. Toxicology 2003; 185: 229-240
6. Rychly DJ, Dipiro JT. Infections associated with tumor necrosis factor-alpha antagonists. Pharmacotherapy 2005; 25:1181-1192 (Pubitemid 41242578)
7. Strangfeld A, Listing J. Infection and musculoskeletal conditions: bacterial and opportunistic infections during anti-TNF therapy. Best Pract Res Clin Rheumatol 2006; 20:1181-1195
8. Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001; 345:1098-1104 (Pubitemid 34940777)
9. Theis VS, Rhodes JM. Minimizing tuberculosis during anti-tumour necrosis factor-alpha treatment of inflammatory bowel disease. Aliment Pharmacol Ther 2008; 7:19-30. (Pubitemid 350212629)
10. Slifman NR, Gershon SK, Lee JH, Edwards ET, Braun MM. Listeria monocytogenes infection as a complication of treatment with tumor necrosis factor alpha-neutralizing agents. Arthritis Rheum 2003; 48:319-324 (Pubitemid 36277998)
11. Kaur N, Mahl TC. Pneumocystis jiroveci (carinii) pneumonia after infliximab therapy: a review of 84 cases. Dig Dis Sci 2007; 52:1481-1484 (Pubitemid 46776482)
12. Tsiodras S, Samonis G, Boumpas DT, Kontoyiannis DP. Fungal infections complicating tumor necrosis factor alpha blockade therapy. Mayo Clin Proc 2008; 83:181-194 (Pubitemid 351303102)
13. Rafailidis PI, Kakisi OK, Vardakas K, Falagas ME. Infectious complications of monoclonal antibodies used in cancer therapy: a systematic review of the evidence from randomized controlled trials. Cancer 2007; 109:2182-2189 (Pubitemid 46805005)
14. Kimby E. Tolerability and safety of rituximab (MabThera). Cancer Treat Rev 2005; 31:456-473
15. Fraser G, Smith CA, Imrie K, Meyer R and the Hematology Disease Site Group of Cancer Care Ontario's Program in Evidence-Based Care. Alemtuzumab in chronic lymphocytic leukemia. Curr Oncol 2007; 14:96-109.
16. Berger JR. Natalizumab and progressive multifocal leucoencephalopathy. Ann Rheum Dis 2006; 65:48-53.
17. Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study. Arthritis Rheum 2007; 56: 2886-2895 (Pubitemid 47502734)
18. Carmona L, Descalzo MA, Perez-Pampin E, Ruiz-Montesinos D, Erra A, Cobo T, Gómez-Reino JJ and the BIOBADASER and EMECAR Groups. All-cause and causespecific mortality in rheumatoid arthritis are not greater than expected when treated with tumour necrosis factor antagonists. Ann Rheum Dis 2007; 66:880-885
19. 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 (Pubitemid 44343545)
20. Descotes J, Vial T. Flu-like syndromes and cytokines. In: Cytokines in Human Health: Immunotoxicology, Pathology and Therapeutic Applications, House RV, Descotes J, eds. Totowa NJ: Humana Press 2007; 193-204.
21. Wing M. Monoclonal antibody first dose cytokine release syndromes-mechanisms and prediction. J Immunotoxicol 2008; 5:11-15
22. Sgro C. Side-effects of a monoclonal antibody, muromonab CD3/orthoclone OKT3: bibliographic review. Toxicology 1995; 105:23-29 (Pubitemid 126738973)
23. Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 2008; 13:725-732 (Pubitemid 351904917)
24. Van Der Kolk LE, Grillo-Lopez AJ, Baars JW, Hack CE, Van Oers MH. Complement activation plays a key role in the side-effects of rituximab treatment. Br J Haematol 2001; 115:807-811 (Pubitemid 34042897)
25. Costa MF, Said NR, Zimmermann B. Drug-induced lupus due to anti-tumor necrosis factor alpha agents. Semin Arthritis Rheum 2008; 37:381-387 (Pubitemid 351734520)
26. Jakobovits A, Amado RG, Yang X, Roskos L, schwab G. From XenoMouse technology to panitumumab, the first fully human antibody product from transgenic mice. Nat Biotechnol 2007; 25:1134-1143
27. Mukovozov I, Sabljic T, Hortelano G, Ofosu FA. Factors that contribute to the immmunogenicity of therapeutic recombinant human proteins. Thromb Haemost 2008; 99:874-882 (Pubitemid 351705303)
28. De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol 2007; 28:482-490
29. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 2008; 333:1-9.
30. Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, et al. Recommendations for the design, optimization and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods 2007; 321:1-18. (Pubitemid 46454303)
31. 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
32. Chávez-López MA, Delgado-Villafaña J, Gallaga A, Huerta-Yáñez G. Severe anaphylactic reaction during the second infusion of infliximab in a patient with psoriatic arthritis. Allergol Immunopathol (Madr) 2005; 33:291-292 (Pubitemid 41769450)
33. Stallmach A, Giese T, Schmidt C, Meuer SC, Zeuzem SS. Severe anaphylactic reaction to infliximab: successful treatment with adalimumab-report of a case. Eur J Gastroenterol Hepatol 2004; 16:627-630 (Pubitemid 38703873)
34. Baudouin V, Crusiaux A, Haddad E, Schandene L, Goldman M, Loirat C, Abramowicz D. Anaphylactic shock caused by immunoglobulin E sensitization after retreatment with the chimeric anti-interleukin-2 receptor monoclonal antibody basiliximab. Transplantation 2003; 76:459-463 (Pubitemid 37013247)
35. Pharand C, Palisaitis DA, Hamel D. Potential anaphylactic shock with abciximab readministration. Pharmacotherapy 2002; 22:380-383 (Pubitemid 34205174)
36. Riegert-Johnson DL, Godfrey JA, Myers JL, Hubmayr RD, Sandborn WJ, Loftus EV Jr. Delayed hypersensitivity reaction and acute respiratory distress syndrome following infliximab infusion. Inflamm Bowel Dis 2002; 8:186-191 (Pubitemid 34546045)
37. Dempster AM. Nonclinical safety evaluation of biotechnologically derived pharmaceuticals. Biotechnol Annu Rev 2000; 5:221-258 (Pubitemid 41081548)
38. Cavagnaro JA. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat Rev Drug Discov 2002; 1:469-475 (Pubitemid 37361490)
39. Brennan FR, Shaw L, Wing MG, Robinson C. Preclinical safety testing of biotechnology- derived pharmaceuticals: understanding the issues and addressing the challenges. Mol Biotechnol 2004; 27:59-74. (Pubitemid 41490606)
40. Chapman K, Pullen N, Graham M, Ragan I. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov 2007; 6:120-126 (Pubitemid 46745340)
41. Weiner LM. Fully human therapeutic monoclonal antibodies. J Immunother 2006; 29:1-9. (Pubitemid 43756076)
42. ICH guideline S6: Preclinical safety evaluation of biotechnology-derived pharmaceuticals 1997; document available at http://www.ich.org/LOB/media/ MEDIA503.pdf.
43. ICH guideline S8: Immunotoxicity studies for human pharmaceuticals 2005; document available at http://www.ich.org/LOB/media/MEDIA1706.pdf.
44. Descotes J. Methods of evaluating immunotoxicity. Expert Opin Drug Metab Toxicol 2006; 2:249-259
45. Dean JH, Padarathsingh ML, Jerrells TR. Assessment of immunobiological effects induced by chemicals, drugs and food additives I. Tier testing and screening approach. Drug Chem Toxicol 1979; 2:5-17.
46. Herzyk DJ, Holsapple M. Immunotoxicity evaluation by immune function tests: focus on the T-dependent antibody response (TDAR). J Immunotoxicol 2007; 4:143-147
47. Ladics GS. Primary immune response to sheep red blood cells (SRBC) as the conventional t-cell dependent antibody response (TDAR) test. J Immunotoxicol 2007; 4:149-152 (Pubitemid 46897811)
48. Bugelski PJ, Kim C. T-dependent antigen response (TDAR) tests: meta-analysis of results generated across multiple laboratories. J Immunotoxicol 2007; 4:159-164 (Pubitemid 46897805)
49. Descotes J, Ravel G. Role of NK cells in immunotoxicity: an update. Exp Rev Clin Immunol 2005; 1:605-610
50. Ponce R. Adverse consequences of immunostimulation. J Immunotoxicol 2008; 5:33-41.
51. St. Clair EW. The calm after the cytokine storm: lessons from the TGN1412 trial. J Clin Invest 2008; 118:1344-1347
52. EMEA: Guideline on the immunogenicity assessment of biotechnology-derived therapeutic proteins 2007; document available at: http://www.emea.europa.eu/ pdfs/human/ biosimilar/1432706en.pdf.
53. Gourley I, Descotes J. Bridging immunotoxicology to clinical drug development. In: Immunotoxicology Strategies for Pharmaceutical Safety Assessment. Herzyk D, Bussiere J, Eds. New York: John Wiley & Sons 2008; 375-384
54. O'Gorman MRG, Donnenberg AD. Handbook of Human Immunology, 2nd edition. Boca Raton: CRC Press 2008.