Biologics in the treatment of systemic lupus erythematosus

Current Opinion in Rheumatology

Volumn 22, Issue 5, 2010, Pages 504-509

  Lateef, Aisha ^a,b   Petri, Michelle ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

Author keywords

B cell depletion; belimumab; rituximab; systemic lupus erythematosus

Indexed keywords

ABATACEPT; ACETYLCYSTEINE; AZATHIOPRINE; BELIMUMAB; BIOLOGICAL PRODUCT; CYCLOPHOSPHAMIDE; EPRATUZUMAB; ETANERCEPT; GLUCOCORTICOID; INFLIXIMAB; INTERFERON MONOCLONAL ANTIBODY; METHOTREXATE; MONOCLONAL ANTIBODY; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PROTEIN KINASE SYK INHIBITOR; R 788; RAPAMYCIN; RITUXIMAB; TOCILIZUMAB; TUMOR NECROSIS FACTOR INHIBITOR; UNCLASSIFIED DRUG; CYTOKINE;

CLINICAL TRIAL; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; HUMAN; INFECTION; NEUTROPENIA; NONHUMAN; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; REVIEW; RHEUMATOID ARTHRITIS; SYSTEMIC LUPUS ERYTHEMATOSUS; T LYMPHOCYTE; TREATMENT OUTCOME; ANTAGONISTS AND INHIBITORS; LUPUS ERYTHEMATOSUS, SYSTEMIC;

ANTIBODIES, MONOCLONAL; CYTOKINES; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; TREATMENT OUTCOME;

EID: 77955173179     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/BOR.0b013e32833b475e     Document Type: Review

References (64)

1. Anolik JH. B cell biology and dysfunction in SLE. Bull NYU Hosp Jt Dis 2007; 65:182-186.
2. Garcia-Carrasco M, Mendoza-Pinto C, Sandoval-Cruz M, et al. Anti-CD20 therapy in patients with refractory systemic lupus erythematosus: a longitudinal analysis of 52 Hispanic patients. Lupus. Feb; 19:213-219.
3. JonsdottirT, Gunnarsson I, RisseladaA, etal. Treatment of refractory SLE with rituximab plus cyclophosphamide: clinical effects, serological changes, and predictors of response. Ann Rheum Dis 2008; 67:330-334.
4. JonsdottirT, Sundelin B, Zickert A, etal. Long-term renal outcome in rituximab-treated patients with lupus nephritis: a biopsy/rebiopsy study. Ann Rheum Dis 2008; 67 (Suppl II):54.
5. Lateef A, Lahiri M, Teng GG, Vasoo S. Use of rituximab in the treatment of refractory systemic lupus erythematosus: Singapore experience. Lupus 2010; 19 (6):765-770; Epub 2010 Jan 29.
6. Lindholm C, Borjesson-Asp K, Zendjanchi K, et al. Longterm clinical and immunological effects of anti-CD20 treatment in patients with refractory systemic lupus erythematosus. J Rheumatol 2008; 35:826-833.
7. Lu TY, Ng KP, Cambridge G, et al. A retrospective seven-year analysis of the use of B cell depletion therapy in systemic lupus erythematosus at university college London hospital: the first fifty patients. Arthritis Rheum 2009; 61:482-487.
8. Pepper R, Griffith M, Kirwan C, et al. Rituximab is an effective treatment for lupus nephritis and allows a reduction in maintenance steroids. Nephrol Dial Transplant 2009; 24(12):3717-3723. Epub 2009 Jul 17.
9. Reynolds JA, Toescu V, Yee CS, et al. Effects of rituximab on resistant SLE disease including lung involvement. Lupus 2009; 18:67-73.
10. Furie R, Looney RJ, Rovin B, et al. Efficacy and safety of rituximab in subjects with active proliferative lupus nephritis (LN): results from the randomized, double-blind phase III Lunar study. Arthritis Rheum 2009; 60 (Suppl 1):S429.
11. Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase ii/iii systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum 2010; 62:222-233.
12. Tenbrock K, Juang YT, Kyttaris VC, Tsokos GC. Altered signal transduction in SLE T cells. Rheumatology (Oxford) 2007; 46:1525-1530.
13. Merrill JT, Burgos-Vargas R, Westhovens R, et al. Activity of abatacept in SLE: results of a 12-month phase II exploratory study. Ann Rheum Dis 2009; 68 (Suppl 3):70.
14. Perl A, Fernandez DR, Telarico T, et al. T-cell and B-cell signaling biomarkers and treatment targets in lupus. Curr Opin Rheumatol 2009; 21:454-464.
15. Yao Y, Richman L, Higgs BW, etal. Neutralization of interferon-alpha/ beta-inducible genes and downstream effect in a phase I trial of an antiinterferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum 2009; 60:1785-1796.
16. Hughes G. Rituximab in lupus and beyond: the state of the art. Lupus 2009; 18:639-644.
17. Sabahi R, Anolik JH. B-cell-targeted therapy for systemic lupus erythematosus. Drugs 2006; 66:1933-1948.
18. Favas C, Isenberg DA. B-cell-depletion therapy in SLE: what are the current prospects for its acceptance? Nat Rev Rheumatol 2009; 5:711-716.
19. 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; 18:767-776.
20. Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy in patients with rheumatic diseases: are patients with systemic lupus erythematosus at particular risk? Autoimmun Rev 2008; 8:144-146.
21. F.D.A. Unites States Food and Drug Administration: information for healthcare professionals: rituximab available at http://wwwfdagov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm12651 9htm. Accessed February 20, 2010.
22. Merrill JT, Wallace DJ, Latinis KM, et al. Treatment of systemic lupus erythematosus (SLE) with rituximab: 78-week safety data from the phase II/III EXPLORER trial. American College of Rheumatology National Meeting 2009; Abstract 2070.
23. Wallace DJ, Hobbs K, Houssiau F, et al. Randomized controlled trials of epratuzumab (anti-CD-22MAB targeting B cells) reveal clinically meaningful reductions in corticosteroid use with favorable safety profile in moderate and severe flaring SLE patients. Ann Rheum Dis 2008; 67 (Suppl II):212.
24. Petri MA, Hobbs K, Gordon C, et al. Randomized controlled trials of epratuzumab (anti-CD-22MAB targeting B cells) reveal clinically meaningful improvements in patients with moderate and severe SLE flares. Ann Rheum Dis 2008; 67 (Suppl II):53
25. ClinicalTrials.gov. Study of epratuzumab in serologically-positive systemic lupus erythematosus patients with active disease (NCT00624351). http://clinicaltrialsgov/ct2/show/NCT00624351?term=EPRATUZUMAB+AND+ SLE&rank=8. Accessed February 20, 2010
26. ClinicalTrials.gov. Open-label study of epratuzumab in serologically-positive systemic lupus erythematosus patients with active disease (NCT00660881). http://clinicaltrialsgov/ct2/show/NCT00660881?term=EPRATUZUMAB+ AND+SLE&rank=7. Accessed February 20, 2010.
27. Cancro MP, D'Cruz DP, Khamashta MA. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Invest 2009; 119:1066-1073.
28. Petri M, Stohl W, Chatham W, et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum 2008; 58:2453-2459.
29. Wallace DJ, Stohl W, Furie RA, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 2009; 61:1168-1178
30. Petri MA, Furie R, Merrill JT, etal. Four year experience of belimumab, a BLyS-specific inhibitor, in systemic lupus erythematosus (SLE). American College of Rheumatology National Meeting 2009; Abstract 2069
31. TM in systemic lupus erythematosus. http://wwwhgsicom/latest/human-genome-sciences-and- glaxosmithkline-announce-positive-results-in-second-of-two-phase-3-trials-of- benlysta-in-systemic-lupus-erythema-5html. Accessed February 20, 2010
32. TM in systemic lupus erythematosus. http://wwwhgsicom/latest/human-genome-sciences- and-glaxosmithkline-announce-full-presentation-at-acr-of-positive-phase-3-study- results-for-benlysta-in-systemic-lupus-erythema-5html. Accessed February 20, 2010.
33. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009; 61:1143-1151.
34. Davidson A, Wang X, Mihara M, et al. Co-stimulatory blockade in the treatment of murine systemic lupus erythematosus (SLE). Ann N Y Acad Sci 2003; 987:188-198. (Pubitemid 36584022)
35. Merrill JT, Burgos-Vargas R, Westhovens R, et al. The efficacy and safety of abatacept in SLE: results of a 12 month exploratory study. American College of Rheumatology National Meeting 2008; Abstract L15
36. ClinicalTrials.gov. Efficacy and safety of abatacept to treat lupus nephritis (NCT0043067). http://clinicaltrialsgov/ct2/show/NCT00430677?term= abatacept+AND+SLE&rank=2. Accessed February 16, 2010.
37. ClinicalTrials.gov. Abatacept and cyclophosphamide combination therapy for lupus nephritis (ACCESS) (NCT00774852). http://clinicaltrialsgov/ct2/show/ NCT00774852?term=abatacept+AND+SLE&rank=4. Accessed February 16, 2010.
38. Gergely PJr, Grossman C, Niland B, etal. Mitochondrial hyperpolarization and ATP depletion in patients with systemic lupus erythematosus. Arthritis Rheum 2002; 46:175-190.
39. Suwannaroj S, Lagoo A, Keisler D, McMurray RW. Antioxidants suppress mortality in the female NZB × NZW F1 mouse model of systemic lupus erythematosus (SLE). Lupus 2001; 10:258-265
40. ClinicalTrials.gov. Treatment of systemic lupus erythematosus with N-acety lcysteine (NCT00775476). http://clinicaltrialsgov/ct2/show/NCT00775476? term=NAC+AND+SLE&rank=1. Accessed 1 April 2010.
41. Fernandez DR, Telarico T, Bonilla E, et al. Activation of mammalian target of rapamycin controls the loss of TCRzeta in lupus T cells through HRES-1/Rab4-regulated lysosomal degradation. J Immunol 2009; 182:2063-2073.
42. Perl A. Systems biology of lupus: mapping the impact of genomic and environmental factors on gene expression signatures, cellular signaling, metabolic pathways, hormonal and cytokine imbalance, and selecting targets for treatment. Autoimmunity Feb; 43:32-47.
43. Warner LM, Adams LM, Sehgal SN. Rapamycin prolongs survival and arrests pathophysiologic changes in murine systemic lupus erythematosus. Arthritis Rheum 1994; 37:289-297.
44. Fernandez D, Bonilla E, MirzaN, etal. Rapamycin reduces disease activity and normalizes T cell activation-induced calcium fluxing in patients with systemic lupus erythematosus. Arthritis Rheum 2006; 54:2983-2988
45. ClinicalTrials.gov. Prospective study of rapamycin for the treatment of SLE (NCT00779194). http://clinicaltrialsgov/ct2/show/NCT00779194?term= rapamycin+and+SLE&rank=1. Accessed 1 April 2010.
46. Ghosh D, Tsokos GC. Spleen tyrosine kinase: an Src family of nonreceptor kinase has multiple functions and represents a valuable therapeutic target in the treatment of autoimmune and inflammatory diseases. Autoimmunity Feb; 43:48-55.
47. Bahjat FR, Pine PR, Reitsma A, et al. An orally bioavailable spleen tyrosine kinase inhibitor delays disease progression and prolongs survival in murine lupus. Arthritis Rheum 2008; 58:1433-1444.
48. Deng GM, Liu L, Bahjat R, et al. Inhibition of spleen tyrosine kinase suppresses skin and kidney disease in lupus prone mice. Arthritis Rheum. 2010 Mar 10. [Epub ahead of print]
49. Weinblatt ME, Kavanaugh A, Burgos-Vargas R, et al. Treatment of rheumatoid arthritis with a Syk kinase inhibitor: a twelve-week, randomized, placebo-controlled trial. Arthritis Rheum 2008; 58:3309-3318.
50. Aringer M, Smolen JS. SLE: complex cytokine effects in a complex autoimmune disease: tumor necrosis factor in systemic lupus erythematosus. Arthritis Res Ther 2003; 5:172-177.
51. Aringer M, Smolen JS. The role of tumor necrosis factor-alpha in systemic lupus erythematosus. Arthritis Res Ther 2008; 10:202.
52. Aringer M, Houssiau F, Gordon C, et al. Adverse events and efficacy of TNF-alpha blockade with infliximab in patients with systemic lupus erythematosus: long-term follow-up of 13 patients. Rheumatology (Oxford) 2009; 48:1451-1454.
53. Matsumura R, Umemiya K, Sugiyama T, et al. Antitumor necrosis factor therapy in patients with difficult-to-treat lupus nephritis: a prospective series of nine patients. Clin Exp Rheumatol 2009; 27:416-421.
54. Takahashi N, Naniwa T, Banno S. Successful use of etanercept in the treatment of acute lupus hemophagocytic syndrome. Mod Rheumatol 2008; 18:72-75.
55. Uppal SS, Hayat SJ, Raghupathy R. Efficacy and safety of infliximab in active SLE: a pilot study. Lupus 2009; 18:690-697
56. ClinicalTrials.gov. TNF blockade with remicade in active lupus nephritis WHO class V (TRIAL) (NCT00368264). http://clinicaltrialsgov/ct2/show/NCT003 68264?term=SLE+AND+TNF&rank=1. Accessed February 16, 2010
57. ClinicalTrials.gov. Etanercept for the treatment of lupus nephritis (NCT 00447265). http://clinicaltrialsgov/ct2/show/NCT00447265?term=SLE+ AND+TNF&rank=3. Accessed February 16, 2010.
58. Soforo E, Baumgartner M, Francis L, et al. Induction of systemic lupus erythematosus with tumor necrosis factor blockers. J Rheumatol Jan; 37: 204-205.
59. Pascual V, Farkas L, Banchereau J. Systemic lupus erythematosus: all roads lead to type I interferons. Curr Opin Immunol 2006; 18:676-682. (Pubitemid 44635182)
60. Wilson LE, Widman D, Dikman SH, Gorevic PD. Autoimmune disease complicating antiviral therapy for hepatitis C virus infection. Semin Arthritis Rheum 2002; 32:163-173
61. ClinicalTrials.gov. A study to evaluate safety and tolerability of IV or SC dose of MEDI-545 in patients with systemic lupus erythematosus (NCT 01031836). http://clinicaltrialsgov/ct2/show/NCT01031836?term=interfer- on+AND+sle&rank=1. Accessed February 16, 2010
62. ClinicalTrials.gov. A study to evaluate safety and tolerability of subcutaneous doses of MEDI-545 in subjects with lupus (NCT00657189). http://clinical trialsgov/ct2/show/NCT00657189?term=interferon+AND+sle&rank= 6. Accessed February 16, 2010.
63. Liang B, Gardner DB, Griswold DE, et al. Antiinterleukin-6 monoclonal antibody inhibits autoimmune responses in a murine model of systemic lupus erythematosus. Immunology 2006; 119:296-305.
64. Illei GG, Shirota Y, Yarboro CH, et al. Tocilizumab in systemic lupus erythe-matosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum Feb; 62:542-552.