The potential risk of infections during (prolonged) rituximab therapy in rheumatoid arthritis

Expert Opinion on Drug Safety

Volumn 10, Issue 5, 2011, Pages 715-726

  Brinkman, Ithamar Heber ^a   Van De Laar, Mart A F J ^b   Jansen, Tim L ^c   Van Roon, Eric N ^a,d  

^a MEDICAL CENTER LEEUWARDEN   (Netherlands)

^b MEDISCH SPECTRUM TWENTE   (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

immunoglobulin; infection; rheumatoid arthritis; rituximab; serious infection

Indexed keywords

ABATACEPT; ADALIMUMAB; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; METHOTREXATE; METHYLPREDNISOLONE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PREDNISOLONE; PREDNISONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; TOCILIZUMAB;

B LYMPHOCYTE; BACTERIAL INFECTION; DRUG MEGADOSE; DRUG SAFETY; EMBASE; FOLLOW UP; HUMAN; HUMORAL IMMUNITY; IMMUNOGLOBULIN DEFICIENCY; IMMUNOSUPPRESSIVE TREATMENT; INFECTION RATE; INFECTION RISK; LONG TERM CARE; LOW DRUG DOSE; LYMPHOCYTE DEPLETION; MEDLINE; META ANALYSIS (TOPIC); PNEUMONIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; SIDE EFFECT; SKIN INFECTION;

ANIMALS; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; B-LYMPHOCYTES; CLINICAL TRIALS AS TOPIC; HUMANS; INFECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 80051975598     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2011.562188     Document Type: Review

References (54)

1. Bijlsma JWJ, Burmester GR, da Silva JAP, et al. Eular Compendium on Rheumatic Diseases. BMJ Books; May 2009
2. Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: An American college of rheumatology/European league against rheumatism collaborative initiative. Arthritis Rheum 2010;62(9):2569-81
3. Prevoo ML, van Gastel AM, van't Hof MA, et al. Remission in a prospective study of patients with rheumatoid arthritis. American rheumatism association preliminary remission criteria in relation to the disease activity score. Br J Rheumatol 1996;35:1101-5
4. Saag KG, Gim GT, Nivedita M, et al. "American college of rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis". Arthritis Rheum 2008;59(6):762-84
5. Askling J, van Vollenhoven RF, Granath F, et al. Cancer risk in patients with rheumatoid arthritis treated with anti-tumor necrosis factor alpha therapies: Does the risk change with the time since start of treatment? Arthritis Rheum 2009;60(11):3180-9
6. Doran MF, Crowson CS, O'Fallon WM, et al. Frequency of infection in patients with rheumatoid arthritis compared with controls: A population-based study. Arthritis Rheum 2002;46:2287-93
7. McLean-Tooke A, Aldridge C, Waugh S, et al. Methotrexate, rheumatoid arthritis and infection risk - what is the evidence? Rheumatology 2009;48:867-71
8. Ruyssen-Witrand A, Fautrel B, Saraux A, et al. Infections induced by low-dose corticosteroids in rheumatoid arthritis: A systematic literature review. Joint Bone Spine 2010;77(3):246-51
9. Lacaille D, Guh DP, Abrahamowicz M, et al. Use of nonbiologic disease-modifying antirheumatic drugs and risk of infection in patients with rheumatoid arthritis. Arthritis Rheum 2008;59:1074-81
10. Bongartz T, Sutton AJ, Sweeting MJ, Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies - systematic review and met-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275
11. Dixon WG, Symmons DPM, Lunt M, et al. Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis - lessons from interpreting data from observational studies. Arthritis Rheum 2007;56:2896-904
12. Bernatsky S, Habel Y, Rahme E. Observational studies of infections in rheumatoid arthritis: A meta-analysis of tumor necrosis factor antagonists. J Rheumatol 2010;37:5
13. Genovese MC, Schiff M, Luggen M, 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(4):547-54
14. Kremer JM, Genant HK, Moreland LW, et al. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum 2008;58(4):953-63
15. Mertens M, Singh JA. A nakinra for rheumatoid arthritis: A systematic review. J Rheumatol 2009;36(6):1118-25
16. Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis:meta- analyses of randomised placebo-controlled trials. Ann Rheum Dis 2009;68(1):25-32
17. Nishimoto N, Takagi N. Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: Meta-analysis of six initial trials and five lon-term axtensions. Mod Rheumatol 2010;2(3):222-32
18. Product characteristics of Mabthera-, May 2008, Roche. Available from: Http://eudrapharm.eu/eudrapharm/ showDocument?documentId= 7002782083304205782 [Last accessed on 16 April 2010]
19. Smolen JS, Keystone EC, Emery P, et al. The working group on the rituximab consensus statement. consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66:143-50
20. Furst DE, Keystone EC, Kirkham B, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases. Ann Rheum Dis 2008;67(Suppl 3):iii2-25
21. Takahashi Y. Memory B cells in systemic and mucosal immune response: Implications for successful vaccination, Biosci Biotechnol Biochem 2007;71(10):2358-66
22. Manz RA, Thiel A, Radbruch A. Lifetime of plasma cells in the bone marrow. Nature 1997;388:133-4
23. Popa C, Leandro MJ, Cambridge G, Edwards JC. Repeated B lymphocyte depletion with rituxmab in rheumatoid arthritis over 7 yrs. Rheumatology 2007;46:626-30
24. van Assen S, Holvast A, Benne CA, et al. Humoral responses after influenza vaccination are severly reduced in patients with rheumatoid arthritis treated with rituximab. Arthritis Rheum 2010;62:75-81
25. Bingham CO III, Looney RJ, Deodhar A, et al. Immunization responses in rheumatoid arthritis patients treated with rituximab. Arthritis Rheum 2010;62:64-74
26. Gottenberg JE, Ravaud P, Bardin T, et al. autoimmunity and rituximab registry and french society of rheumatology.risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum 2010;62(9):2625-32
27. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. DANCER study group. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 2006;54(5):1390-400
28. Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE). Ann Rheum Dis 2010;69(9):1629-35
29. Rubbert-Roth A, Tak PP, Zerbini C, et al. MIRROR trial investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: Results of a Phase III randomized study (MIRROR). Rheumatology (Oxford) 2010;49(9):1683-93
30. Keystone E, Fleischmann R, Emery P, 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(12):3896-908
31. van Vollenhoven RF, Emery P, Bingham CO III, et al. Longterm safety of patients recieving rituximab in rheumatoid arthritis clinical trials. J Rheumatol 2010;37:3
32. Furst DE. Serum immunoglobulins and risk of infection; how low can you go? Semin Arthritis Rheum 2009;39(1):18-29
33. Pourpak Z, Aghamohammadi A, Sedighipour L, et al. Effect of regular intravenous immunoglobulin therapy on prevention of pneumonia in patients with common variable immunodeficiency. J Microbiol Immunol Infect 2006;39(2):114-20
34. Winkelstein JA, Marino MC, Lederman HM, et al. X-linked agammaglobulinemia: Report on a United States registry of 201 patients. Medicine 2006;85(4):193-202
35. EijkhoutHW, van Der Meer JW, Kallenberg CG, et al. Inter-university working party for the study of immune deficiencies.The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Ann Intern Med 2001;135(3):165-74
36. Bayrakci B, Ersoy F, Sanal O, et al. The efficacy of immunoglobulin replacement therapy in the long-term follow-up of the B-cell deficiencies (XLA, HIM, CVID). Turk J Pediatr 2005;47(3):239-46
37. Copson ER, Ellis BA, Westwood NB, Majumdar G. IgG subclass levels in patients with B cell chronic lymphocytic leukaemia. Leuk Lymphoma 1994;14(5-6):471-3
38. Rituximab FDA labelling text. Available from: Http://www.accessdata.fda. gov/drugsatfda-docs/label/2010/ 103705s5311lbl.pdf [Last accessed on 19 January 2011]
39. Dudler J, Finckh A, Kyburz D, et al. Swiss consensus statement: Recommendations for optimising re-treatment with MabThera (rituximab) in rheumatoid arthritis. Swiss Med Wkly 2010;140:w13073
40. Cohen SB, Emery P, Greenwald MW, et al. REFLEX trial group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006;54(9):2793-806
41. Mease PJ, Cohen S, Gaylis NB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: Results from the SUNRISE trial. J Rheumatol 2010;37(5):917-27
42. Common terminology criteria for adverse events 2.0. Available from: Http://www. eortc.be/services/doc/ctc/default.htm [Last accessed 29 July 2010]
43. Common terminology criteria for adverse events 3.0. Available from: Http://www. eortc.be/services/doc/ctc/default.htm [Last accessed 29 July 2010]
44. Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004;350(25):2572-81
45. Ramos-Casals M, Soto MJ, Cuadrado MJ, Khamashta MA. Rituximab in systemic lupus erythematosus - A systematic review of off-label use in 188 cases. Lupus 2009;18767-76
46. Fleischmann RM. Progressive multifocal leukoencephalopathy following rituximab treatment in a patient with rheumatoid arthritis. Arthritis Rheum 2009;60(11):3225-8
47. Carson KR, Evens AM, Richey EA, 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(20):4834-40
48. Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy in patients with rheumatic diseases: Are patients with systemic lupus erythematosus at particular risk? Autoimmun Rev 2008;8(2):144-6
49. Buch MH. Sequential use of biologic therapy in rheumatoid arthritis. Curr Opin Rheumatol 2010;22(3):321-9
50. Arad U, Tzadok S, Amir S, et al. The cellular immune response to influenza vaccination is preserved in rheumatoid arthritis patients treated with rituximab. Vaccine 2011;29(8):1643-8
51. St.Clair EW. Good and bad memories following rituximab therapy, editorial. Arthritis Rheuam 2010;62:1-5
52. Ostergaard M, Baslund B, et al. Ofatumumab, a human anti-CD20 monocolonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs. Arthritis Rheum 2010;62:2227-38
53. Genovese MC, Kaine JL, Lowenstein MB, et al. ACTION study group. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum 2008;58(9):2652-61
54. Press release by Roche. Avialable from: Http://www.fiercebiotech.com/ pressreleases/ roche-and-biogen-idecannounce- their-decision- discontinueocrelizumab- clinical-develo [Last accessed 8 October 2010]