Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: A randomised, placebo-controlled, phase 3 trial

The Lancet

Volumn 377, Issue 9767, 2011, Pages 721-731

  Navarra, Sandra V ^a   Guzmán, Renato M ^b   Gallacher, Alberto E ^c   Hall, Stephen ^d   Levy, Roger A ^e   Jimenez, Renato E ^f   Li, Edmund K M ^g   Thomas, Mathew ^h   Kim, Ho Youn ⁱ   León, Manuel G ^j   Tanasescu, Coman ^k   Nasonov, Eugeny ^l   Lan, Joung Liang ^m   Pineda, Lilia ⁿ   Zhong, Z John ⁿ   Freimuth, William ⁿ   Petri, Michelle A ^o  

^a UNIVERSITY OF SANTO TOMAS HOSPITAL   (Philippines)

^b IDEARG   (Colombia)

^c HOSPITAL BRITÁNICO DE BUENOS AIRES   (Argentina)

^d CABRINI HOSPITAL   (Australia)

^e HOSPITAL UNIVERSITÁRIO PEDRO ERNESTO   (Brazil)

^f Hospital Clinico Viña Del Mar   (Chile)

^g CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^h KERALA INSTITUTE OF MEDICAL SCIENCES   (India)

ⁱ The Catholic University of Korea   (South Korea)

^j Instituto de Ginecología y Reproducción   (Peru)

^k Carol Davila School of Medicine   (Romania)

^l V A NASONOVA RESEARCH INSTITUTE OF RHEUMATOLOGY   (Russian Federation)

^m TAICHUNG VETERANS GENERAL HOSPITAL   (Taiwan)

ⁿ GLAXOSMITHKLINE   (United States)

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

more..

Author keywords

[No Author keywords available]

Indexed keywords

BELIMUMAB; PLACEBO; PREDNISONE;

ADULT; ARTHRALGIA; ARTICLE; ASIA; DIARRHEA; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; EASTERN EUROPE; FEMALE; HEADACHE; HUMAN; HYPERTENSION; IMMUNOGLOBULIN DEFICIENCY; INFECTION; INFLUENZA; INTERACTIVE VOICE RESPONSE SYSTEM; LEUKOCYTE; LYMPHOCYTE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPHIL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SOUTH AND CENTRAL AMERICA; SYSTEMIC LUPUS ERYTHEMATOSUS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

EID: 79952070370     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(10)61354-2     Document Type: Article

References (39)

1. Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med 2008; 358: 929-39. (Pubitemid 351397092)
2. Bernatsky S, Boivin J-F, Joseph L, et al. Mortality in systemic lupus erythematosus. Arthritis Rheum 2006; 54: 2550-57. (Pubitemid 44205016)
3. Cervera R, Khamashta MA, Font J, et al. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine 2003; 82: 299-308. (Pubitemid 37229465)
4. Doria A, Canova M, Tonon M, et al. Infections as triggers and complications of systemic lupus erythematosus. Autoimmun Rev 2008; 8: 24-28.
5. Campbell R Jr, Cooper GS, Gilkeson GS. Two aspects of the clinical and humanistic burden of systemic lupus erythematosus: mortality risk and quality of life early in the course of disease. Arthritis Rheum 2008; 59: 458-64. (Pubitemid 351563526)
6. Thumboo J, Strand V. Health-related quality of life in patients with systemic lupus erythematosus: an update. Ann Acad Med Singapore 2007; 36: 115-22. (Pubitemid 46640263)
7. Moore PA, Belvedere O, Orr A, et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science 1999;285: 260-63. (Pubitemid 29330000)
8. Cancro MP, D'Cruz DP, Khamashta MA. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Invest 2009; 119: 1066-73.
9. Mackay F, Schneider P. Cracking the BAFF code. Nat Rev Immunol 2009; 9: 491-502.
10. Cheema GS, Roschke V, Hilbert DM, Stohl W. Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. Arthritis Rheum 2001; 44: 1313-19. (Pubitemid 32537529)
11. Mariette X, Roux S, Zhang J, et al. The level of BLyS (BAFF) correlates with the titre of autoantibodies in human Sjögren's syndrome. Ann Rheum Dis 2003; 62: 168-71. (Pubitemid 36135394)
12. 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. (Pubitemid 32038409)
13. Collins CE, Gavin AL, Migone T-S, Hilbert DM, Nemazee D, Stohl W. B lymphocyte stimulator (BLyS) isoforms in systemic lupus erythematosus: disease activity correlates better with blood leukocyte BLyS mRNA levels than with plasma BLyS protein levels. Arthritis Res Ther 2006; 8: R6.
14. Petri M, Stohl W, Chatham W, et al. Association of plasma B-lymphocyte stimulator (BLyS) levels and disease activity in systemic lupus erythematosus. Arthritis Rheum 2008; 58: 2453-59.
15. Baker KP, Edwards BM, Main SH, et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheum 2003; 48: 3253-65. (Pubitemid 37409340)
16. Halpern WG, Lappin P, Zanardi T, et al. Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol Sci 2006; 91: 586-99. (Pubitemid 43827311)
17. 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: 1168-78.
18. Petri M, Furie R, Merrill J, et al. Four-year experience of belimumab, a BLyS specific inhibitor, in systemic lupus erythematosus (SLE) patients. Arthritis Rheum 2009; 60 (suppl 10): S774. 2069 (abstr).
19. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009; 61: 1143-51.
20. Kalunian K, Merrill JT. New directions in the treatment of systemic lupus erythematosus. Curr Med Res Opin 2009; 25: 1501-14.
21. Strand V. Lessons learned from clinical trials in SLE. Autoimmun Rev 2007; 6: 209-14. (Pubitemid 46274543)
22. US Food and Drug Administration. Guidance for industry: systemic lupus erythematosus-developing drugs for treatment. 2005. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072063.pdf (accessed Feb 15, 2010).
23. Bertsias G, Gordon C, Boumpas DT. Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future - the EULAR recommendations for the management of SLE and the use of end-points in clinical trials. Lupus 2008; 17: 437-42. (Pubitemid 351798723)
24. Dall'Era M, Wofsy D. Systemic lupus erythematosus clinical trials: an interim analysis. Nat Rev Rheumatol 2009; 5: 348-51.
25. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1725.
26. Petri M, Kim MY, Kalunian KC, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005; 353: 2550-58. (Pubitemid 41785892)
27. Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus 1999; 8: 685-91. (Pubitemid 29520536)
28. Hay EM, Bacon PA, Gordon C, et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med 1993; 86: 447-58. (Pubitemid 23223653)
29. Isenberg DA, Gordon C. From BILAG to BLIPS - disease activity assessment in lupus past, present and future. Lupus 2000; 9: 651-54. (Pubitemid 32011789)
30. Ware JE, Kosinski M. The SF-36 health survey (version 2.0) technical note. Boston, MA: Health Assessment Lab, 1997.
31. Gladman DD, Urowitz MB, Kagal A, Hallett D. Accurately describing changes in disease activity in systemic lupus erythematosus. J Rheumatol 2000; 27: 377-79. (Pubitemid 30095467)
32. Gordon C, Sutcliffe N, Skan J, Stoll T, Isenberg DA. Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford) 2003; 42: 1372-79. (Pubitemid 37407029)
33. Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 1992; 35: 630-40.
34. Ho A, Madger LS, Barr SG, Petri M. Decreases in anti-double stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus. Arthritis Rheum 2001; 44: 2342-49. (Pubitemid 32977502)
35. Yee CS, Farewell V, Isenberg DA, et al. British Isles Lupus Assessment Group 2004 index is valid for assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum 2007; 56: 4113-19.
36. Bertsias G, Ioannidis JPA, Boletis J, et al. EULAR recommendations for the management of systemic lupus erythematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis 2008; 67: 195-205. (Pubitemid 351183308)
37. Zhu TY, Tam LS, Lee VW, Lee KK, Li EK. The impact of flare on disease costs of patients with systemic lupus erythematosus. Arthritis Rheum 2009; 61: 1159-67.
38. Zonana-Nacach A, Barr SG, Magder LS, Petri M. Damage in systemic lupus erythematosus and its association with corticosteroids. Arthritis Rheum 2000; 43: 1801-08. (Pubitemid 30642567)
39. Chatham WW, Kimberly RP. Treatment of lupus with corticosteroids. Lupus 2001; 10: 140-47. (Pubitemid 32410067)