Infections associated with monoclonal antibody and fusion protein therapy in humans

mAbs

Volumn 3, Issue 5, 2011, Pages 461-466

  Uettwiller, Florence ^a   Rigal, Emilie ^a   Hoarau, Cyrille ^a  

^a UNIVERSITÉ DE TOURS   (France)

Author keywords

Complication; Human; Infections; Monoclonal antibodies

Indexed keywords

ABATACEPT; ADALIMUMAB; ALEMTUZUMAB; BELATACEPT; CD20 ANTIGEN; CD52 ANTIGEN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; EFALIZUMAB; ETANERCEPT; HYBRID PROTEIN; INFLIXIMAB; LYMPHOCYTE FUNCTION ASSOCIATED ANTIGEN 1; MONOCLONAL ANTIBODY; NATALIZUMAB; PLACEBO; RITUXIMAB; TUMOR NECROSIS FACTOR; VERY LATE ACTIVATION ANTIGEN 4;

BRONCHITIS; CANDIDIASIS; DRUG SURVEILLANCE PROGRAM; HUMAN; INFECTION; INFECTION COMPLICATION; OPPORTUNISTIC INFECTION; RESPIRATORY TRACT INFECTION; REVIEW; RHINOPHARYNGITIS; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION;

ANTIBODIES, MONOCLONAL; ANTIGENS, SURFACE; HUMANS; IMMUNE SYSTEM; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOTHERAPY; INFECTION; PHARMACOVIGILANCE; RECOMBINANT FUSION PROTEINS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 80052586179     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.3.5.16553     Document Type: Review

References (54)

1. Fontoura P. Monoclonal antibody therapy in multiple sclerosis: Paradigm shifts and emerging challenges. mAbs 2010; 2:670-81.
2. Riechmann L, Clark M, Waldmann H, Winter G. Reshaping human antibodies for therapy. Nature 1988; 332:323-7.
3. Nückel H, Frey UH, Röth A, Dührsen U, Siffert W. Alemtuzumab induces enhanced apoptosis in vitro in B-cells from patients with chronic lymphocytic leukemia by antibody-dependent cellular cytotoxicity. Eur J Pharmacol 2005; 514:217-24.
4. Osterborg A, Dyer MJ, Bunjes D, Pangalis GA, Bastion Y, Catovsky D, et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol 1997; 15:1567-74.
5. Rai KR, Freter CE, Mercier RJ, Cooper MR, Mitchell BS, Stadtmauer EA, et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol 2002; 20:3891-7.
6. Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood 2002; 99:3554-61.
7. Martin SI, Marty FM, Fiumara K, Treon SP, Gribben JG, Baden LR. Infectious complications associated with alemtuzumab use for lymphoproliferative disorders. Clin Infect Dis 2006; 43:16-24.
8. Peleg AY, Husain S, Kwak EJ, Silveira FP, Ndirangu M, Tran J, et al. Opportunistic infections in 547 organ transplant recipients receiving alemtuzumab, a humanized monoclonal CD-52 antibody. Clin Infect Dis 2007; 44:204-12.
9. Reddy KS, Devarapalli Y, Mazur M, Hamawi K, Chakkera H, Moss A, et al. Alemtuzumab with rapid steroid taper in simultaneous kidney and pancreas transplantation: comparison to induction with antithymocyte globulin. Transplant Proc 2010; 42:2006-8.
10. Osterborg A, Karlsson C, Lundin J, Kimby E, Mellstedt H. Strategies in the management of alemtuzumabrelated side effects. Semin Oncol 2006; 33:29-35.
11. Osterborg A, Foà R, Bezares RF, Dearden C, Dyer MJS, Geisler C, et al. Management guidelines for the use of alemtuzumab in chronic lymphocytic leukemia. Leukemia 2009; 23:1980-8.
12. Schulz H, Bohlius JF, Trelle S, Skoetz N, Reiser M, Kober T, et al. Immunochemotherapy with rituximab and overall survival in patients with indolent or mantle cell lymphoma: a systematic review and meta-analysis. J Natl Cancer Inst 2007; 99:706-14.
13. Kaplan LD, Lee JY, Ambinder RF, Sparano JA, Cesarman E, Chadburn A, et al. Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010. Blood 2005; 106:1538-43.
14. Boué F, Gabarre J, Gisselbrecht C, Reynes J, Cheret A, Bonnet F, et al. Phase II trial of CHOP plus rituximab in patients with HIV-associated non-Hodgkin's lymphoma. J Clin Oncol 2006; 24:4123-8.
15. Goldberg SL, Pecora AL, Alter RS, Kroll MS, Rowley SD, Waintraub SE, et al. Unusual viral infections (progressive multifocal leukoencephalopathy and cytomegalovirus disease) after high-dose chemotherapy with autologous blood stem cell rescue and peritransplantation rituximab. Blood 2002; 99:1486-8.
16. Suzan F, Ammor M, Ribrag V. Fatal reactivation of cytomegalovirus infection after use of rituximab for a post-transplantation lymphoproliferative disorder. N Engl J Med 2001; 345:1000.
17. Vallet S, Tempescul A, Tran A, Legrand-Quillien MC, Narbonne V, Berthou C. Cytomegalovirus-associated meningoradiculoneuritis after treatment of mantle cell lymphoma with a combination of chemotherapy and rituximab. Ann Hematol 2005; 84:545-7.
18. Carson KR, Evens AM, Richey EA, Habermann TM, Focosi D, Seymour JF, et al. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project. Blood 2009; 113:4834-40.
19. Niscola P, Del Principe MI, Maurillo L, Venditti A, Buccisano F, Piccioni D, et al. Fulminant B hepatitis in a surface antigen-negative patient with B-cell chronic lymphocytic leukaemia after rituximab therapy. Leukemia 2005; 19:1840-1.
20. Perceau G, Diris N, Estines O, Derancourt C, Lévy S, Bernard P. Late lethal hepatitis B virus reactivation after rituximab treatment of low-grade cutaneous B-cell lymphoma. Br J Dermatol 2006; 155:1053-6.
21. Dervite I, Hober D, Morel P. Acute hepatitis B in a patient with antibodies to hepatitis B surface antigen who was receiving rituximab. N Engl J Med 2001; 344:68-9.
22. Tsutsumi Y, Tanaka J, Kawamura T, Miura T, Kanamori H, Obara S, et al. Possible efficacy of lamivudine treatment to prevent hepatitis B virus reactivation due to rituximab therapy in a patient with non-Hodgkin's lymphoma. Ann Hematol 2004; 83:58-60.
23. Aksoy S, Harputluoglu H, Kilickap S, Dede DS, Dizdar O, Altundag K, et al. Rituximab-related viral infections in lymphoma patients. Leuk Lymphoma 2007; 48:1307-12.
24. Kamar N, Milioto O, Puissant-Lubrano B, Esposito L, Pierre MC, Mohamed AO, et al. Incidence and predictive factors for infectious disease after rituximab therapy in kidney-transplant patients. Am J Transplant 2010; 10:89-98.
25. Brinkman IH, van de Laar MA, Jansen TL, van Roon EN. The potential risk of infections during (prolonged) rituximab therapy in rheumatoid arthritis. Expert Opin Drug Saf [Internet]. 2011; Available from: http://www. ncbi.nlm.nih.gov/pubmed/21401437.
26. Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, et al. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum 2007; 56:3896-908.
27. Nam JL, Winthrop KL, van Vollenhoven RF, Pavelka K, Valesini G, Hensor EMA, et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis 2010; 69:976-86.
28. Aggarwal BB. Signalling pathways of the TNF superfamily: a double-edged sword. Nat Rev Immunol 2003; 3:745-56.
29. Di Sabatino A, Ciccocioppo R, Cinque B, Millimaggi D, Morera R, Ricevuti L, et al. Defective mucosal T cell death is sustainably reverted by infliximab in a caspase dependent pathway in Crohn's disease. Gut 2004; 53:70-7.
30. Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients. Arthritis Rheum 2004; 50:1740-51.
31. Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006; 65:889-94.
32. Gómez-Reino JJ, Carmona L, Angel Descalzo M. Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection. Arthritis Rheum 2007; 57:756-61.
33. Dixon WG, Hyrich KL, Watson KD, Lunt M, Galloway J, Ustianowski A, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 2010; 69:522-8.
34. Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology 2011; 50:124-31.
35. Winthrop KL, Chang E, Yamashita S, Iademarco MF, LoBue PA. Nontuberculous mycobacteria infections and anti-tumor necrosis factor-alpha therapy. Emerging Infect Dis 2009; 15:1556-61.
36. Kim YJ, Bae SC, Sung YK, Kim TH, Jun JB, Yoo DH, et al. Possible reactivation of potential hepatitis B virus occult infection by tumor necrosis factor-alpha blocker in the treatment of rheumatic diseases. J Rheumatol 2010; 37:346-50.
37. Vassilopoulos D, Apostolopoulou A, Hadziyannis E, Papatheodoridis GV, Manolakopoulos S, Koskinas J, et al. Long-term safety of anti-TNF treatment in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection. Ann Rheum Dis 2010; 69:1352-5.
38. Van Assche G, Van Ranst M, Sciot R, Dubois B, Vermeire S, Noman M, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med 2005; 353:362-8.
39. Langer-Gould A, Atlas SW, Green AJ, Bollen AW, Pelletier D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med 2005; 353:375-81.
40. Clifford DB, De Luca A, DeLuca A, Simpson DM, Arendt G, Giovannoni G, et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol 2010; 9:438-46.
41. Carson KR, Focosi D, Major EO, Petrini M, Richey EA, West DP, et al. Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab and efalizumab: a Review from the Research on Adverse Drug Events and Reports (RADAR) Project Lancet Oncol 2009; 10:816-24.
42. Berger JR. Progressive multifocal leukoencephalopathy and newer biological agents. Drug Saf 2010; 33:969-83.
43. Tan P, Anasetti C, Hansen JA, Melrose J, Brunvand M, Bradshaw J, et al. Induction of alloantigen-specific hyporesponsiveness in human T lymphocytes by blocking interaction of CD28 with its natural ligand B7/ BB1. J Exp Med 1993; 177:165-73.
44. Moreland LW, Alten R, Van den Bosch F, Appelboom T, Leon M, Emery P, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002; 46:1470-9.
45. Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005; 52:2263-71.
46. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005; 353:1114-23.
47. Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, et al. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis 2008; 67:547-54.
48. Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006; 144:865-76.
49. Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: A one-year randomized, placebo-controlled study. Arthritis Rheum 2006; 54:2807-16.
50. Simon TA, Askling J, Lacaille D, Franklin J, Wolfe F, Covucci A, et al. Infections requiring hospitalization in the abatacept clinical development program: an epidemiological assessment. Arthritis Res Ther 2010; 12:67.
51. Snanoudj R, Zuber J, Legendre C. Co-stimulation blockade as a new strategy in kidney transplantation: benefits and limits. Drugs 2010; 70:2121-31.
52. Tesfa1 D, Ajeganova S, Hägglund1 H, Sander B, Fadeel B, Hafström I, et al. Late-onset neutropenia following rituximab therapy in rheumatic diseases: Association with B-lymphocyte depletion and infections. Arthritis Rheum 2011; Available from: http://www.ncbi.nlm. nih.gov/pubmed/ 21560117.
53. Fontoura P. Roles of B lymphocytes in multiple sclerosis: diversifying beyond the antibody response. Immunotherapy 2009; 1:181-5.
54. Robak T, Robak E. New anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoid malignancies. BioDrugs 2011; 25:13-25.