B-cell-targeted therapy for systemic lupus erythematosus

Drugs

Volumn 66, Issue 15, 2006, Pages 1933-1948

  Sabahi, Ramin ^a   Anolik, Jennifer H ^a  

^a UNIVERSITY OF ROCHESTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BELIMUMAB; CD20 ANTIGEN; CYCLOPHOSPHAMIDE; CYTOKINE; RITUXIMAB;

AUTOIMMUNITY; B LYMPHOCYTE; BODY SURFACE; BRONCHOSPASM; CLINICAL TRIAL; DRUG APPROVAL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPOTENSION; IMMUNE SYSTEM; IN VITRO STUDY; INFECTION; LUPUS ERYTHEMATOSUS; NONHUMAN; PATHOGENESIS; PRURITUS; RASH; REMISSION; REVIEW; RHEUMATOID ARTHRITIS; TREATMENT RESPONSE;

ANIMALS; ANTIBODIES, MONOCLONAL; B-LYMPHOCYTES; HUMANS; LEUKOCYTE REDUCTION PROCEDURES; LUPUS ERYTHEMATOSUS, SYSTEMIC;

EID: 33751095383     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200666150-00004     Document Type: Review

References (94)

1. Petri M. Epidemiology of systemic lupus erythematosus. Best Pract Res Clin Rheumatol 2002; 16: 847-58
2. Bongu A, Chang E, Ramsey-Goldman R. Can morbidity and mortality of SLE be improved? Best Pract Res Clin Rheumatol 2002; 16: 313-32
3. Chan OT, Madaio MP, Shlomchik MJ. The central and multiple roles of B cells in lupus pathogenesis. Immunol Rev 1999; 169: 107-21
4. Mamula MJ, Fatenejad S, Craft J. B cells process and present lupus autoantigens that initiate autoimmune T cell responses. J Immunol 1994; 152: 1453-61
5. Linton PJ, Harbertson J, Bradley LM. A critical role for B cells in the development of memory CD4 cells. J Immunol 2000; 165: 5558-65
6. Chan OT, Hannum LG, Haberman AM, et al. A novel mouse with B cells but lacking serum antibody reveals an antibody-independent role for B cells in murine lupus. J Exp Med 1999; 189: 1639-48
7. Shlomchik MJ, Madaio MP, Ni D, et al. The role of B cells in lpr/lpr-induced autoimmunity. J Exp Med 1994; 180: 1295-306
8. O'Keefe TL, Williams GT, Batista FD, et al. Deficiency in CD22, a B cell-specific inhibitory receptor, is sufficient to predispose to development of high affinity autoantibodies. J Exp Med 1999; 189: 1307-3
9. Gross J, Johnston J, Mudri S. TACI and BCMA are receptors for a TNF homologue implicated in B cell autoimmune disease. Nature 2000; 404: 995-9
10. Cohen PL, Caricchio R, Abraham V, et al. Delayed apoptotic cell clearance and lupus-like autoimmunity in mice lacking the c-mer membrane tyrosine kinase. J Exp Med 2002; 196: 135-40
11. Grammer A, Lipsky PE. B cell abnormalities in systemic lupus erythematosus. Arthritis Res Ther 2003; 5 Suppl. 4: S22-7
12. Odendahl M, Jacobi A, Hansen A, et al. Disturbed peripheral B lymphocyte homeostasis in systemic lupus erythematosus. J Immunol 2000; 165: 5970-9
13. Anolik J, Barnard J, Cappione A, et al. Rituximab improves peripheral B cell abnormalities in human systemic lupus erythematosus. Arthritis Rheum 2004; 50: 3580-90
14. Zhang J, Roschke V, Baker KP, et al. Cutting edge: a role for B lymphocyte stimulator in systemic lupus erythematosus. J Immunol 2001; 166: 6-10
15. Ronnblom L, Eloranta ML, Alm GV. The type I interferon system in systemic lupus erythematosus. Arthritis Rheum 2006; 54: 408-20
16. Arbuckle M, McClain M, Rubertone M, et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med 2003; 349: 1526-33
17. Martin F, Chan AC. B cell immunobiology in disease: evolving concepts from the clinic. Ann Rev Immunol 2006; 24: 467-96
18. Leadbetter EA, Rifkin IR, Hohlbaum AM, et al. Chromatin-IgG complexes activate B cells by dual engagement of IgM and toll-like receptors. Nature 2002; 416: 603-7
19. Viglianti GA, Lau CM, Hanley TM, et al. Activation of autoreactive B cells by CpG dsDNA. Immunity 2003; 19: 837-47
20. Boule MW, Broughton C, Mackay F, et al. Toll-like receptor 9-dependent and -independent dendritic cell activation by chromatin-immunoglobulin G complexes. J Exp Med 2004; 199: 1631-40
21. Bave U, Alm GV, Ronnblom L. The combination of apoptotic U937 cells and lupus IgG is a potent IFN-alpha inducer. J Immunol 2000; 165: 3519-26
22. Bave U, Magnusson M, Eloranta M, et al. Fc gamma RIIa is expressed on natural IFN-alpha producing cells (plasmacytoid dendritic cells) and is required for the IFN-alpha production induced by apoptotic cells combined with lupus IgG. J Immunol 2003; 171: 3296-302
23. Means TK, Latz E, Hayashi F, et al. Human lupus autoantibody-DNA complexes activate DCs through cooperation of CD32 and TLR9. J Clin Invest 2005; 115: 407-17
24. Ronnblom L, Alm GV. A pivotal role for the natural interferon alpha-producing cells (plasmacytoid dendritic cells) in the pathogenesis of lupus [comment]. J Exp Med 2001; 194 Suppl. 12: F59-63
25. Manz R, Arce S, Cassese G, et al. Humoral immunity and long-lived plasma cells. Curr Opin Immunol 2002; 14: 517-21
26. Hoyer B, Moser K, Hauser A, et al. Short-lived plasmablasts and long-lived plasma cells contribute to chronic humoral autoimmunity in NZB/W mice. J Exp Med 2004; 199: 1577
27. Tedder TF, Engel P. CD20: a regulator of cell-cycle progression of B lymphocytes. Immunol Today 1994; 15: 450-4
28. Reff ME, Carner K, Chambers KS, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood 1994; 83: 435-45
29. Maloney DG, Smith B, Rose A. Rituximab: mechanism of action and resistance. Semin Oncol 2002; 29: 2-9
30. Gong Q, Ou Q, Ye S, et al. Importance of cellular microenvironment and circulatory dynamics in B cell immunotherapy. J Immunol 2005; 174: 817-26
31. Cartron G, Dacheux L, Salles G, et al. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcγRIIIa. Blood 2002; 99: 754-8
32. Anolik JH, Campbell D, Felgar R, et al. The relationship of FcãRIIIa genotype to degree of B cell depletion by rituximab in the treatment of SLE. Arthritis Rheum 2003; 48: 455-9
33. Kneitz C, Wilhelm M, Tony HP. Effective B cell depletion with rituximab in the treatment of autoimmune diseases. Immunobiology 2002; 206: 519-27
34. Leandro MJ, Cooper N, Cambridge G, et al. Bone marrow B-lineage cells in patients with rheumatoid arthritis following rituximab therapy. Rheumatology (Oxford) 2006 May 30, (Epub ahead of print)
35. Kimby E. Tolerability and safety of rituximab (MabTher®). Cancer Treat Rev 2005; 31: 456-73
36. Looney RJ. B cell-targeted therapy in diseases other than rheumatoid arthritis. J Rheumatol Suppl 2005; 73: 25-8; discussion 29-30
37. Looney J. B cell-targeted therapy for rheumatoid arthritis. Drugs 2006; 66 (5): 625-39
38. 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: 2572-81
39. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment. Arthritis Rheum 2006; 54: 1390-400
40. Tobinai K, Kobayashi Y, Narabayashi M, et al. Feasibility and pharmacokinetic study of a chimeric anti-CD20 monoclonal antibody (IDEC-C2B8, rituximab) in relapsed B-cell lymphoma: The IDEC-C2B8 Study Group. Ann Oncol 1998; 9: 527-34
41. Pescovitz MD. Rituximab, an anti-CD20 monoclonal antibody: history and mechanism of action. Am J Transplant 2006; 6: 859-66
42. Ng CM, Bruno R, Combs D, et al. Population pharmacokinetics of rituximab (anti-CD20 monoclonal antibody) in rheumatoid arthritis patients during a phase II clinical trial. J Clin Pharmacol 2005; 45: 792-801
43. McLaughlin P, Grillo-Lopez A, Link B, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998; 16: 2825-33
44. Vieira CA, Agarwal A, Book BK, et al. Rituximab for reduction of anti-HLA antibodies in patients awaiting renal transplantation: 1. Safety, pharmacodynamics, and pharmacokinetics. Transplantation 2004; 77: 542-8
45. Edwards JC, Leandro MJ, Cambridge G. B lymphocyte depletion therapy with rituximab in rheumatoid arthritis. Rheum Dis Clin North Am 2004; 30: 393-403
46. Looney RJ, Anolik JH, Campbell D, et al. B cell depletion as a novel treatment for systemic lupus erythematosus: a phase I/II dose-escalation trial of rituximab. Arthritis Rheum 2004; 50: 2580-9
47. Eisenberg R. Update on rituximab. Ann Rheum Dis 2005; 64 Suppl. 4: iv55-7
48. Leandro M, Edwards J, Cambridge G, et al. An open study of B lymphocyte depletion in systemic lupus erythematosus. Arthritis Rheum 2002; 46: 2673-7
49. Sfikakis PP, Boletis JN, Lionaki S, et al. Remission of proliferative lupus nephritis following B cell depletion therapy is preceded by down-regulation of the T cell costimulatory molecule CD40 ligand: an open-label trial. Arthritis Rheum 2005; 52: 501-3
50. Sfikakis PP, Boletis JN, Tsokos GC. Rituximab anti-B-cell therapy in systemic lupus erythematosus: pointing to the future. Curr Opin Rheumatol 2005; 17: 550-7
51. Leandro MJ, Cambridge G, Edwards JC, et al. B-cell depletion in the treatment of patients with systemic lupus erythematosus: a longitudinal analysis of 24 patients. Rheumatology 2005; 44: 1542-5
52. Vigna-Perez M, Hernandez-Castro B, Paredes-Saharopulos O, et al. Clinical and immunologic effects of rituximab in patients with lupus nephritis refractory to conventional therapy: a pilot study. Arthritis Res Ther 2006; 3 (8): R83
53. Albert D, Khan S, Stansberry J, et al. A phase I trial of rituximab (anti-CD20) for treatment of systemic lupus erythematosus [abstract]. Arthritis Rheum 2004; 9: S446
54. Marks SD, Patey S, Brogan PA, et al. B lymphocyte depletion therapy in children with refractory systemic lupus erythematosus. Arthritis Rheum 2005; 52: 3168-74
55. Tokunaga M, Fujii K, Saito K, et al. Down-regulation of CD40 and CD80 on B cells in patients with life-threatening systemic lupus erythematosus after successful treatment with rituximab. Rheumatology 2005; 44: 176-82
56. Smith KGC, Jones RB, Burns SM, et al. Long-term comparison of rituximab treatment for referactory systemic lupus erythematosus and vasculitis: remission, relapse, and re-treatment. Arthritis Rheum 2006 Sep; 54 (9): 2970-82
57. Willems M, Haddad E, Niaudet P, et al. Rituximab therapy for childhood-onset systemic lupus erythematosus. J Pediatr 2006; 148: 623-7
58. US National Institutes of Health. A study to evaluate the efficacy and safety of rituximab in patients with severe systemic lupus erythematosus (SLE) [online]. Available from URL: http://www.clinicaltrials.gov/ct/show/NCT00137969? order=2 [Accessed 2006 Sep 27]
59. US National Institutes of Health. A study to evaluate the efficacy and safety of rituximab in subjects with ISN/RPS class III or IV lupus nephritis [online]. Available from URL: http://www.clinicaltrials.gov/ct/show/NCT00282347? order=1 [Accessed 2006 Oct 6]
60. Edwards JC, Cambridge G. B-cell targeting in rheumatoid arthritis and other autoimmune diseases. Nature Rev Immunol 2006; 6: 394-403
61. Leandro MJ, Cambridge G, Ehrenstein MR, et al. Reconstitution of peripheral blood B cells after depletion with rituximab in patients with rheumatoid arthritis. Arthritis Rheum 2006; 54: 613-20
62. Hainsworth JD. Prolonging remission with rituximab maintenance therapy. Semin Oncol 2004; 31: 17-21
63. Byrd JC, Murphy T, Howard RS, et al. Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol 2001; 19: 2153-64
64. Byrd JC, Peterson BL, Morrison VA, et al. Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood 2003; 101: 6-4
65. Maini R, St Clair E, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomized phase III trial. ATTRACT Study Group. Lancet 1999; 354 (9194): 1932-9
66. Maeda T, Yamada Y, Tawara M, et al. Successful treatment with a chimeric anti-CD20 monoclonal antibody for a patient with relapsed mantle cell lymphoma who developed a human anti-chimeric antibody. Int J Hematol 2001; 74: 70-5
67. D'Arcy C, Mannik M. Serum sickness secondary to treatment with the murine human chimeric antibody IDEC-C2B8. Arhritis Rheum 2001; 44: 1717-8
68. Herishanu Y. Rituximab induced serum sickness. Am J Hematol 2002; 70 (4): 329
69. Cambridge G, Leandro MJ, Edwards JC, et al. Serologic changes following B lymphocyte depletion therapy for rheumatoid arthritis. Arthritis Rheum 2003; 48: 2146-54
70. Ghielmini M, Schmitz SF, Cogliatti S, et al. Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol 2005; 23: 705-11
71. Ghielmini M, Schmitz SF, Cogliatti SB, et al. Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly x 4 schedule. Blood 2004; 103: 4416-23
72. Ng K, Leandro MJ, Edwards JC, et al. Repeated B cell depletion in treatment of refractory systemic lupus erythematosus. Ann Rheum Dis 2006; 65: 942-5
73. Gonzalez-Stawinski GV, Yu PB, Love SD, et al. Hapten-induced primary and memory humoral responses are inhibited by the infusion of anti-CD20 monoclonal antibody (IDEC-C2B8, rituximab). Clin Immunol 2001 Feb; 98 (2): 175-9
74. Van der Kolk L, Baars J, Prins M, et al. Rituximab treatment results in impaired secondary humoral immune responsiveness. Blood 2002; 100: 2257-9
75. Bearden CM, Agarwal A, Book BK, et al. Rituximab inhibits the in vivo primary and secondary antibody response to a neoantigen, bacteriophage phiX174. Am J Transplant 2005; 5: 50-7
76. Cuss A, Avery D, Cannons J, et al. Expansion of functionally immature transitional B cells is associated with human immunodeficient states characterized by impaired humoral immunity. J Immunol 2006; 176: 1506-16
77. Stein R, Qu Z, Chen S, et al. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res 2004; 10: 2868-78
78. Teeling JL, French RR, Cragg MS, et al. Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood 2004; 104: 1793-800
79. Dorner T, Kaufmann J, Wegener W, et al. Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus. Arthritis Res Ther 2006; 3 (8): R74
80. Furie R. Abetimus sodium (riquent) for the prevention of nephritic flares in patients with systemic lupus erythematosus. Rheum Dis Clin North Am 2006; 32: 149-56
81. Wang X, Huang W, Schiffer LE, et al. Effects of anti-CD154 treatment on B cells in murine systemic lupus erythematosus. Arthritis Rheum 2003; 48: 495-506
82. Kalunian KC, Davis JC, Merrill JT, et al. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002; 46: 3251-8
83. Boumpas DT, Furie R, Manzi S, et al. A short course of BG9588 (anti-CD40 ligand antibody) improves serologic activity and decreases hematuria in patients with proliferative lupus glomerulonephritis. Arthritis Rheum 2003; 48: 719-27
84. Huang W, Sinha J, Newman J, et al. The effect of anti-CD40 ligand antibody on B cells in human systemic lupus erythematosus. Arthritis Rheum 2002; 46: 1554-62
85. Grammer A, Slota R, Fischer R, et al. Abnormal germinal center reactions in systemic lupus erythematosus demonstrated by blockade of CD154-CD40 interactions. J Clin Invest 2003; 112: 1506-20
86. Daikh DI, Wofsy D. Cutting edge: reversal of murine lupus nephritis with CTLA4Ig and cyclophosphamide. J Immunol 2001; 166: 2913-6
87. Abrams JR, Lebwohl MG, Guzzo CA, et al. CTLA4Ig-mediated blockade of T-cell costimulation in patients with psoriasis vulgaris. J Clin Invest 1999; 103: 1243-52
88. Kremer JM, Westhovens R, Leon M, et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003; 349: 1907-5
89. Lesley R, Xu Y, Kalled SL, et al. Reduced competitiveness of autoantigen-engaged B cells due to increased dependence on BAFF. Immunity 2004; 20: 441-53
90. Mackay F, Woodcock S, Lawton P, et al. Mice transgenic for BAFF develop lymphocytic disorders along with autoimmune manifestations. J Exp Med 1999; 190: 1697-710
91. Stohl W, Metyas S, Tan SM, et al. B lymphocyte stimulator overexpression in patients with systemic lupus erythematosus: longitudinal observations. Arthritis Rheum 2003; 48: 3475-86
92. Furie R, Stohl W, Ginzler E, et al. Safety, pharmacokinetic and pharmacodynamic results of a phase I single and double dose-escalation study of lymphoStat-B (human monoclonal antibody to BLyS) in SLE patients [abstract]. Arthritis Rheum 2003; 48 (9): S377
93. Wallace DJ, Lisse J, Stohl W, et al. Belimumab (LymphoStat-B) shows bioactivity and reduces SLE disease activity [oral presentation]. European Congress of Rheumatology; 2006 Jun 21-23; Amsterdam
94. Furie R, Lisse J, Merrill JT, et al. Multiple SLE disease activity measures in a multi-center phase 2 SLE trial demonstrate bilimumab improves or stabilizes SLE activity in serologically active SLE patients [oral presentation]. European Congress of Rheumatology; 2006 Jun 21-23; Amsterdam