Belimumab in the treatment of systemic lupus erythematosus: High disease activity predictors of response

Annals of the Rheumatic Diseases

Volumn 71, Issue 8, 2012, Pages 1343-1349

  Van Vollenhoven, Ronald F ^a   Petri, Michelle A ^b   Cervera, Ricard ^c   Roth, David A ^d   Ji, Beulah N ^e   Kleoudis, Christi S ^d   Zhong, Z John ^d   Freimuth, William ^d  

^a KAROLINSKA INSTITUTE   (Sweden)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c HOSPITAL CLÍNIC   (Spain)

^d GLAXOSMITHKLINE   (United States)

^e GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BELIMUMAB; COMPLEMENT FACTOR; CORTICOSTEROID; DOUBLE STRANDED DNA ANTIBODY; IMMUNOSUPPRESSIVE AGENT; PLACEBO; PREDNISONE;

ACUTE DIARRHEA; ARTICLE; DISEASE ACTIVITY; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG USE; DRUG WITHDRAWAL; HEART ARREST; HUMAN; INFECTION; MULTICENTER STUDY (TOPIC); NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PHASE 3 CLINICAL TRIAL (TOPIC); PREDICTION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY FAILURE; SAFETY OF ESTROGENS IN LUPUS ERYTHEMATOSUS NATIONAL ASSESSMENT-SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY INDEX; SEPSIS; SYSTEMIC LUPUS ERYTHEMATOSUS; UNSPECIFIED SIDE EFFECT;

ANTIBODIES, ANTINUCLEAR; ANTIBODIES, MONOCLONAL; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCOCORTICOIDS; HEALTH STATUS; HUMANS; IMMUNOLOGIC FACTORS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; OUTCOME ASSESSMENT (HEALTH CARE); PROGNOSIS; QUALITY OF LIFE; RECURRENCE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84863850571     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2011-200937     Document Type: Article

References (16)

1. Lau CS, Mak A. The socioeconomic burden of SLE. Nat Rev Rheumatol 2009;5:400-4.
2. Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med 2008;358:929-39. (Pubitemid 351397092)
3. Biesen R, Dähnrich C, Rosemann A, et al. Anti-dsDNA-NcX ELISA: dsDNA-loaded nucleosomes improve diagnosis and monitoring of disease activity in systemic lupus erythematosus. Arthritis Res Ther 2011;13:R26.
4. Merrill JT, Buyon JP. The role of biomarkers in the assessment of lupus. Best Pract Res Clin Rheumatol 2005;19:709-26. (Pubitemid 41258579)
5. Nasiri S, Karimifar M, Bonakdar ZS, et al. Correlation of ESR, C3, C4, anti-DNA and lupus activity based on British Isles Lupus Assessment Group Index in patients of rheumatology clinic. Rheumatol Int 2010;30:1605-9.
6. Petri M, Singh S, Tesfasyone H, et al. Prevalence of flare and influence of demographic and serologic factors on flare risk in systemic lupus erythematosus: a prospective study. J Rheumatol 2009;36:2476-80.
7. Schur PH, Sandson J. Immunologic factors and clinical activity in systemic lupus erythematosus. N Engl J Med 1968;278:533-8.
8. van den Berg L, Nossent H, Rekvig O. Prior anti-dsDNA antibody status does not predict later disease manifestations in systemic lupus erythematosus. Clin Rheumatol 2006;25:347-52.
9. Bertsias G, Ioannidis JP, 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)
10. Furie R, Petri M, Zamani O, et al; BLISS-76 Study Group. 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;63:3918-30.
11. 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;377:721-31.
12. 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.
13. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Care Res 2009;61:1143-51.
14. Gladman DD, Urowitz MB, Kagal A, et al. Accurately describing changes in disease activity in systemic lupus erythematosus. J Rheumatol 2000;27:377-9. (Pubitemid 30095467)
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)