Breaking the ice in systemic lupus erythematosus: Belimumab, a promising new therapy

Lupus

Volumn 22, Issue 4, 2013, Pages 361-371

  Mosak, J ^a   Furie, R ^a  

^a North Shore LIJ Health System ^*  (United States)

Author keywords

belimumab; Systemic lupus erythematosus; treatment

Indexed keywords

BELIMUMAB; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PLACEBO; PREDNISONE;

ARTHRALGIA; ARTICLE; CELLULITIS; DISEASE ACTIVITY; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG INDUCED HEADACHE; DRUG SAFETY; FATIGUE; FOLLOW UP; HUMAN; NAUSEA; NONHUMAN; OBSERVATIONAL STUDY; PRIORITY JOURNAL; STUDY DESIGN; SYSTEMIC LUPUS ERYTHEMATOSUS; TRANSIENT ISCHEMIC ATTACK; UPPER RESPIRATORY TRACT INFECTION;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; B-CELL ACTIVATING FACTOR; B-LYMPHOCYTES; CELL DIFFERENTIATION; CELL SURVIVAL; DRUG APPROVAL; DRUG DESIGN; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LUPUS ERYTHEMATOSUS, SYSTEMIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84875935281     PISSN: 09612033     EISSN: 14770962     Source Type: Journal    
DOI: 10.1177/0961203312471575     Document Type: Article

References (29)

1. Dillon SR, Harder B, Lewis KB, et al. B-lymphocyte stimulator/a proliferation-inducing ligand heterotrimers are elevated in the sera of patients with autoimmune disease and are neutralized by atacicept and B-cell maturation antigen immunoglobulin. Arthritis Res Ther. 2013 ; 12: R48 - R48
2. Moore PA, Belvedere O, Orr A, et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science. 1999 ; 285: 260-263
3. Stohl W. BLySfulness does not equal blissfulness in systemic lupus erythematosus: a therapeutic role for BLyS antagonists. Curr Dir Autoimmun. 2005 ; 8: 289-304
4. 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
5. Stohl W, Scholz JL, Cancro MP. Targeting BLyS in rheumatic disease: the sometimes-bumpy road from bench to bedside. Curr Opin Rheumatol. 2011 ; 23: 305-310
6. Day ES, Cachero TG, Qian F, et al. Selectivity of BAFF/BLyS and APRIL for binding to the TNF family receptors BAFFR/BR3 and BCMA. Biochemistry. 2005 ; 44: 1919-1931
7. Gross JA, Johnston J, Mudri S, et al. TACI and BCMA are receptors for a TNF homologue implicated in B-cell autoimmune disease. Nature. 2000 ; 404: 995-999
8. Mackay F, Woodcock SA, Lawton P, et al. Mice transgenic for BAFF develop lymphocytic disorders along with autoimmune manifestations. J Exp Med. 1999 ; 190: 1697-1710
9. Khare SD, Sarosi I, Xia XZ, et al. Severe B cell hyperplasia and autoimmune disease in TALL-1 transgenic mice. Proc Natl Acad Sci U S A 2000; 97: 3370-3375.
10. Ramanujam M, Wang X, Huang W, et al. Similarities and differences between selective and nonselective BAFF blockade in murine SLE. J Clin Invest. 2006 ; 116: 724-734
11. 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
12. Cheema G, Roschke V, Hilbert D, et al. Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. Arthritis Rheum. 2001 ; 44: 1313-1319
13. 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
14. Furie RA, Stohl W, Ginzler EM, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther. 2008 ; 10: R109 - R109
15. 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
16. Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus. 1999 ; 8: 685-691
17. Draft guidance for industry on systemic lupus erythematosus-developing drugs for treatment. FEDERAL REGISTER, 70 FR 15868, 22 March 2005. http://www.gpo.gov/fdsys/granule/FR-2005-03-29/05-6085/content-detail.html.
18. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 ; 61: 1143-111
19. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 ; 377: 721-731
20. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 ; 63: 3918-3930
21. Merrill JT, Ginzler EM, Wallace DJ, et al. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 ; 64: 3364-3373
22. Stohl W, Hiepe F, Latinis KM, et al. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 ; 64: 2328-2337
23. Chatham WW, Wallace DJ, Stohl W, et al. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 ; 39: 1632-1640
24. Van Vollenhoven RF, Petri MA, Cervera R, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 ; 71: 1343-1349
25. Manzi S, Sánchez-Guerrero J, Merrill JT, et al. Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Ann Rheum Dis. 2012 ; 71: 1833-1838
26. Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: Results from phase 3 belimumab clinical trials in patients with systemic lupus erythematosus. [abstract]. Arthritis Rheum. 2011 ; 63: 2472-2472
27. GlaxoSmithKline (UK). Benlysta® (belimumab) SmPC. 2012. http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/125370s016lbl.pdf.
28. Furie RA, Zhong ZJ, Freimuth W, Petri M. Clinical and laboratory correlates in responders (by the Systemic Lupus Erythematosus Responder Index) in phase 3 belimumab clinical trials. [abstract]. Arthritis Rheum. 2011 ; 63: 1367-1367
29. Strand V, Cooper S, Zhong ZJ, Dennis G. Responders in the phase 3 belimumab clinical trials in patients with systemic lupus erythematosus reported improvements in fatigue and health-related quality of life at week 52. [abstract]. Arthritis Rheum. 2011 ; 63: 1369-1369