An overview on safety of monoclonal antibodies

Current Opinion in Allergy and Clinical Immunology

Volumn 16, Issue 6, 2016, Pages 576-581

  Matucci, Andrea ^a   Nencini, Francesca ^b   Pratesi, Sara ^b   Maggi, Enrico ^b   Vultaggio, Alessandra ^a  

^a CAREGGI UNIVERSITY HOSPITAL   (Italy)

^b UNIVERSITY OF FLORENCE   (Italy)

Author keywords

Biological agents; Hypersensitivity; Immunogenicity; Safety

Indexed keywords

BIOLOGICAL PRODUCT; INTERLEUKIN 13 ANTIBODY; INTERLEUKIN 4 ANTIBODY; INTERLEUKIN 5 ANTIBODY; INTERLEUKIN 5 RECEPTOR ALPHA ANTIBODY; MONOCLONAL ANTIBODY; OMALIZUMAB; TUMOR NECROSIS FACTOR INHIBITOR; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ANAPHYLAXIS; BACTERIURIA; CANCER RISK; CARDIOVASCULAR DISEASE; CHRONIC INFLAMMATION; CHURG STRAUSS SYNDROME; CRYSTALLURIA; CYTOPENIA; DIARRHEA; DIZZINESS; DROWSINESS; DRUG SAFETY; DYSPNEA; HEADACHE; HUMAN; IMMUNOGLOBULIN DEFICIENCY; INFECTION; INFECTION RISK; INFUSION RELATED REACTION; INJECTION SITE IRRITATION; INJECTION SITE REACTION; LYMPHOCYTOPENIA; MALIGNANT NEOPLASM; MORTALITY; NAUSEA; NONHUMAN; NOSE OBSTRUCTION; PARASITOSIS; PHARYNGITIS; PRIORITY JOURNAL; PRURITUS; RASH; REVIEW; RHINITIS; RHINOPHARYNGITIS; SERUM SICKNESS; THORAX PAIN; URINARY TRACT INFECTION; WHEEZING; ANIMAL; HYPERSENSITIVITY; IMMUNE SYSTEM; IMMUNE SYSTEM DISEASES; IMMUNOLOGICAL MONITORING; IMMUNOLOGY; IMMUNOTHERAPY; NEOPLASMS; PROCEDURES; RISK ASSESSMENT;

ANIMALS; ANTIBODIES, MONOCLONAL; HUMANS; HYPERSENSITIVITY; IMMUNE SYSTEM; IMMUNE SYSTEM DISEASES; IMMUNOTHERAPY; MONITORING, IMMUNOLOGIC; NEOPLASMS; RISK ASSESSMENT;

EID: 84991490301     PISSN: 15284050     EISSN: 14736322     Source Type: Journal    
DOI: 10.1097/ACI.0000000000000315     Document Type: Review

References (48)

1. 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: 727-754.
2. Vultaggio A, Nencini F, Pratesi S, et al. Manifestations of antidrug antibodies response: Hypersensitivity and infusion reactions. J Interferon Cytokine Res 2014; 34: 946-952.
3. Hansel TT, Kropsshofer H, Singer T, et al. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov 2010; 9: 325-338.
4. van Schie KA, Wolbink GJ, Rispens T. Cross-reactive and pre-existing antibodies to therapeutic antibodies: Effects on treatment and immunogenicity. MAbs 2015; 7: 662-671.
5. Vultaggio A, Matucci A, Nencini F, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy 2010; 65: 657-661.
6. Doessegger L, Banholzer ML. Clinical development methodology for infusionrelated reactions with monoclonal antibodies. Clin Transl immunol 2015; 4: E39.
7. Finkelman FD, Khodoun MV, Strait R. Human IgE-independent systemic anaphylaxis. J Allergy Clin Immunol 2016; 137: 1674-1680.
8. Beutier H, Gillis CM, Iannascoli B, et al. IgG subclasses determine pathways of anaphylaxis in mice. J Allergy Clin Immunol 2016; 137: 1674-1680.
9. Jonsson F, Mancardi DA, Kita Y, et al. Mouse and human neutrophils induce anaphylaxis. J Clin Invest 2011; 121: 1484-1496.
10. McNeil BD, Pundir P, Meeker S, et al. Identification of a mast-cell-specific receptor crucial for pseudoallergic drug reactions.Nature2015;519: 237-241.
11. Lieberman P, Garvey LH. Mast cells and anaphylaxis. Curr Allergy Asthma Rep 2016; 16: 20-27.
12. Proctor L, Renzulli B, Warren S, Brecher ME. Monoclonal antibody-stimulated serum sickness. Transfusion 2004; 44: 955.
13. Krishna M, Nadler S. Immunogenicity to biotherapeutics: The role of antidrug immune complexes. Front Immunol 2016; 7: 1-13.
14. Williams M, Khalid T, Hughes S, et al. Rituximab-induced cytokine storm in the absence of overt lymphoproliferative disease. J Pediatr Hematol Oncol 2016; 38: 29-31.
15. Wing M. Monoclonal antibody first dose cytokine release syndrome: Mechanisms and prediction. J Immunotoxicol 2008; 5: 11-15.
16. Vultaggio A, Maggi E, Matucci A. Immediate adverse reactions to biological: From pathogenic mechanisms to prophylactic management. Curr Opin Allergy Clin Immunol 2011; 11: 262-268.
17. Bremmer M, Deng A, Gaspari AA. A mechanism-based classification of dermatologic reactions to biologic agents used in the treatment of cutaneous disease: Part 2. Dermatitis 2009; 20: 243-256.
18. Torres MJ, Chaves P, Dona I, et al. T-cell involvement in delayed type hypersensitivity reactions to infliximab. J Allergy Clin Immunol 2011; 128: 1365-1367.
19. Matucci A, Maggi E, Vultaggio A. Cellular and humoral immune responses during tuberculosis infection: Useful knowledge in the era of biological agents. J Rheumatol Suppl 2014; 91: 17-23.
20. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: Long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Ann Rheum Dis 2013; 72: 517-524.
21. Domínguez-Mozo MI, Toledano-Martínez E, Rodríguez-Rodríguez L, et al. JC virus reactivation in patients with autoimmune rheumatic diseases treated with rituximab. Scand J Rheumatol 2016; 11: 1-5.
22. Delbue S, Elia F, Carloni C, et al. JC virus urinary excretion and seroprevalence in natalizumab-treated multiple sclerosis patients. J Neurovirol 2015; 21: 645-652.
23. Ramiro S, Gaujoux-Viala C, Nam JL, et al. Safety of synthetic and biological DMARDs: A systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2014; 73: 529-535.
24. Hauser SL. Multiple lessons for multiple sclerosis. N Engl J Med 2008; 359: 1838-1841.
25. Szebeni J. Complement activation-related pseudoallergy: A stress reaction in blood triggered by nanomedicines and biologicals. Mol Immunol 2014; 61: 163-173.
26. Casale TB, Condemi J, LaForce C, et al., Omalizumab Seasonal Allergic Rhinitis Trial Group. Effect of omalizumab on symptoms of seasonal allergic rhinitis: A randomized controlled trial. JAMA 2001; 286: 2956-2967.
27. Tsabouri S, Tseretopoulou X, Priftis K, Ntzani EE. Omalizumab for the treatment of inadequately controlled allergic rhinitis: A systematic review and meta-analysis of randomized clinical trials. J Allergy Clin Immunol Pract 2014; 2: 332.e1-340.e1.
28. Novelli F, Latorre M, Vergura L, et al. Asthma control in severe asthmatics under treatment with omalizumab: A cross-sectional observational study in Italy. Pulm Pharmacol Ther 2015; 31: 123-129.
29. Cox L, Lieberman P, Wallace D, et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, asthma & immunology omalizumabassociated anaphylaxis Joint Task Force follow-up report. J Allergy Clin Immunol 2011; 128: 210-212.
30. Harrison RG, MacRae M, Karsh J, et al. Anaphylaxis and serum sickness in patients receiving omalizumab: Reviewing the data in light of clinical experience. Ann Allergy Asthma Immunol 2015; 115: 77-78.
31. 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.
32. Busse W, Buhl R, Fernandez Vidaurre C, et al. Omalizumab and the risk of malignancy: Results from a pooled analysis. J Allergy Clin Immunol 2012; 129: 983-989.
33. El-Qutob D. Off-label uses of omalizumab. Clin Rev Allergy Immunol 2016; 50: 84-96.
34. 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: 197-207.
35. Ali AK, Hartzema AG. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting. J Asthma Allergy 2012; 5: 1-9.
36. Varricchi G, Bagnasco D, Borriello F, et al. Interleukin-5 pathway inhibition in the treatment of eosinophilic respiratory disorders: Evidence and unmet needs. Curr Opin Allergy Clin Immunol 2016; 16: 186-200.
37. Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol 2010; 125: 1344-1353.
38. Herndon FJ, Kayes SG. Depletion of eosinophils by anti-IL-5 monoclonal antibody treatment of mice infected with Trichinella spiralis does not alter parasite burden or immunologic resistance to reinfection. J Immunol 1992; 149: 3642-3647.
39. Sher A, Coffman RL, Hieny S, et al. Interleukin 5 is required for the blood and tissue eosinophilia but not granuloma formation induced by infection with Schistosoma mansoni. Proc Natl Acad Sci 1990; 87: 61-65.
40. Sakkal S, Miller S, Apostolopoulos V, Nurgali K. Eosinophils in cancer: Favourable or unfavourable? Curr Med Chem 2016; 23: 650-666.
41. Wenzel S, Wilbraham D, Fuller R, et al. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: Results of two phase 2a studies. Lancet 2007; 370: 1422-1431.
42. Brightling CE, Chanez P, Leigh R, et al. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: A randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med 2015; 3: 692-701.
43. Suzuki A, Leland P, Joshi BH, Puri RF. Targeting of IL-4 and IL-13 receptors for cancer therapy. Cytokine 2015; 75: 79-88.
44. Holgate ST, Noonan M, Chanez P, et al. Efficacy and safety of etanercept in moderate-to-severe asthma: A randomised, controlled trial. Eur Respir J 2011; 37: 1352-1359.
45. Wenzel SE, Barnes PJ, Bleecker ER, et al. A randomized, doubleblind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med 2009; 179: 549-558.
46. Askling J, Fored CM, Brandt L, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Ann Rheum Dis 2005; 64: 1421-1426.
47. Carmona L, Abasolo L, Descalzo MA, et al. Cancer in patients with rheumatic diseases exposed to TNF antagonists. Semin Arthritis Rheum 2011; 41: 71-80.
48. Raaschou P, Simard JF, Neovius M, Askling J. Does cancer that occurs during or after antitumor necrosis factor therapy have a worse prognosis? A national assessment of overall and site-specific cancer survival in rheumatoid arthritis patients treated with biologic agents. Arthr Rheum 2011; 63: 1812-1822.