메뉴 건너뛰기




Volumn 74, Issue 9, 2015, Pages 1667-1675

A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study

Author keywords

[No Author keywords available]

Indexed keywords

BLISIBIMOD; COMPLEMENT COMPONENT C3; COMPLEMENT COMPONENT C4; CORTICOSTEROID; CREATININE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; PLACEBO; AMG623 PEPTIBODY; ANTIMALARIAL AGENT; ANTINUCLEAR ANTIBODY; HYBRID PROTEIN; IMMUNOLOGIC FACTOR;

EID: 84942111128     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-205144     Document Type: Article
Times cited : (133)

References (27)
  • 1
    • 33744822178 scopus 로고    scopus 로고
    • Epidemiology of systemic lupus erythematosus: A comparison of worldwide disease burden
    • Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006;15:308-18.
    • (2006) Lupus , vol.15 , pp. 308-318
    • Danchenko, N.1    Satia, J.A.2    Anthony, M.S.3
  • 2
    • 0015889208 scopus 로고
    • The epidemiology of systemic lupus erythematosus
    • Siegel M, Lee SL. The epidemiology of systemic lupus erythematosus. Semin Arthritis Rheum 1973;3:1-54.
    • (1973) Semin Arthritis Rheum , vol.3 , pp. 1-54
    • Siegel, M.1    Lee, S.L.2
  • 3
    • 16244423682 scopus 로고    scopus 로고
    • The role of BAFF in immune function and implications for autoimmunity
    • Kalled SL. The role of BAFF in immune function and implications for autoimmunity. Immunol Rev 2005;204:43-54.
    • (2005) Immunol Rev , vol.204 , pp. 43-54
    • Kalled, S.L.1
  • 4
    • 84863756640 scopus 로고    scopus 로고
    • A novel modality of BAFF-specific inhibitor AMG623 peptibody reduces B-cell number and improves outcomes in murine models of autoimmune disease
    • Hsu H, Khare SD, Lee F, et al. A novel modality of BAFF-specific inhibitor AMG623 peptibody reduces B-cell number and improves outcomes in murine models of autoimmune disease. Clin Exp Rheumatol 2012;30:197-201.
    • (2012) Clin Exp Rheumatol , vol.30 , pp. 197-201
    • Hsu, H.1    Khare, S.D.2    Lee, F.3
  • 5
    • 67650931255 scopus 로고    scopus 로고
    • Phase 1a Single- and Phase 1b Multiple-Dose Studies of AMG 623 (an anti-BAFF peptibody) in Systemic Lupus Erythematosus (SLE)
    • Stohl W, Merrill JT, Looney RJ, et al. Phase 1a Single- and Phase 1b Multiple-Dose Studies of AMG 623 (an anti-BAFF peptibody) in Systemic Lupus Erythematosus (SLE). Arthritis Rheum 2008;58:S565.
    • (2008) Arthritis Rheum , vol.58 , pp. S565
    • Stohl, W.1    Merrill, J.T.2    Looney, R.J.3
  • 6
    • 49449092839 scopus 로고    scopus 로고
    • Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus
    • 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;58:2453-9.
    • (2008) Arthritis Rheum , vol.58 , pp. 2453-2459
    • Petri, M.1    Stohl, W.2    Chatham, W.3
  • 7
    • 79952070370 scopus 로고    scopus 로고
    • Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: A randomised, placebocontrolled, phase 3 trial
    • Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebocontrolled, phase 3 trial. Lancet 2011;377:721-31.
    • (2011) Lancet , vol.377 , pp. 721-731
    • Navarra, S.V.1    Guzmán, R.M.2    Gallacher, A.E.3
  • 8
    • 82455198794 scopus 로고    scopus 로고
    • A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus
    • 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;63:3918-30.
    • (2011) Arthritis Rheum , vol.63 , pp. 3918-3930
    • Furie, R.1    Petri, M.2    Zamani, O.3
  • 9
    • 84867398973 scopus 로고    scopus 로고
    • 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
    • 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;71:1833-8.
    • (2012) Ann Rheum Dis , vol.71 , pp. 1833-1838
    • Manzi, S.1    Sánchez-Guerrero, J.2    Merrill, J.T.3
  • 10
    • 84863850571 scopus 로고    scopus 로고
    • Belimumab in the treatment of systemic lupus erythematosus: High disease activity predictors of response
    • 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;71:1343-9.
    • (2012) Ann Rheum Dis , vol.71 , pp. 1343-1349
    • Van Vollenhoven, R.F.1    Petri, M.A.2    Cervera, R.3
  • 11
    • 69749096135 scopus 로고    scopus 로고
    • Novel evidence-based systemic lupus erythematosus responder index
    • Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009;61:1143-51.
    • (2009) Arthritis Rheum , vol.61 , pp. 1143-1151
    • Furie, R.A.1    Petri, M.A.2    Wallace, D.J.3
  • 12
    • 20544443248 scopus 로고    scopus 로고
    • The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: A randomized trial
    • Buyon JP, Petri MA, Kim MY, et al. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann Intern Med 2005;142:953-62.
    • (2005) Ann Intern Med , vol.142 , pp. 953-962
    • Buyon, J.P.1    Petri, M.A.2    Kim, M.Y.3
  • 13
    • 0027325557 scopus 로고
    • The BILAG index: A reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus
    • 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.
    • (1993) Q J Med , vol.86 , pp. 447-458
    • Hay, E.M.1    Bacon, P.A.2    Gordon, C.3
  • 14
    • 0013374274 scopus 로고    scopus 로고
    • Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines
    • Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Arthritis Rheum 1999;42:1785-96.
    • (1999) Arthritis Rheum , vol.42 , pp. 1785-1796
  • 15
    • 28944445445 scopus 로고    scopus 로고
    • Combined oral contraceptives in women with systemic lupus erythematosus
    • Petri M, Kim MY, Kalunian KC, et al. Combined Oral Contraceptives in Women with Systemic Lupus Erythematosus. N Engl J Med 2005;353:2550-8.
    • (2005) N Engl J Med , vol.353 , pp. 2550-2558
    • Petri, M.1    Kim, M.Y.2    Kalunian, K.C.3
  • 16
    • 84858951586 scopus 로고    scopus 로고
    • Durability of response in SLE patients treated with belimumab in the Phase 3 BLISS-52 and BLISS-76 studies
    • Van Vollenhoven R, Schwarting A, Navarra S, et al. Durability of response in SLE patients treated with belimumab in the Phase 3 BLISS-52 and BLISS-76 studies. Ann Rheum Dis 2011;70(Suppl3):321.
    • (2011) Ann Rheum Dis , vol.70 , pp. 321
    • Van Vollenhoven, R.1    Schwarting, A.2    Navarra, S.3
  • 17
    • 0026777352 scopus 로고
    • Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE
    • Bombardier C, Gladman DD, Urowitz MB, et al. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 1992;35:630-40.
    • (1992) Arthritis Rheum , vol.35 , pp. 630-640
    • Bombardier, C.1    Gladman, D.D.2    Urowitz, M.B.3
  • 18
    • 84864740288 scopus 로고    scopus 로고
    • Urinary protein/creatinine ratio versus 24-hour proteinuria in the evaluation of lupus nephritis
    • Solorzano GT, Silva MV, Moreira SR, et al. Urinary protein/creatinine ratio versus 24-hour proteinuria in the evaluation of lupus nephritis. J Bras Nefrol 2012;34:64-7.
    • (2012) J Bras Nefrol , vol.34 , pp. 64-67
    • Solorzano, G.T.1    Silva, M.V.2    Moreira, S.R.3
  • 19
    • 8444226779 scopus 로고    scopus 로고
    • The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: Measures of overall disease activity
    • American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria. The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum 2004;50:3418-26.
    • (2004) Arthritis Rheum , vol.50 , pp. 3418-3426
  • 20
    • 84871574493 scopus 로고    scopus 로고
    • Effect of belimumab treatment on renal outcomes: Results from the phase 3 belimumab clinical trials in patients with SLE
    • Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus 2013;22:63-72.
    • (2013) Lupus , vol.22 , pp. 63-72
    • Dooley, M.A.1    Houssiau, F.2    Aranow, C.3
  • 21
    • 84862002288 scopus 로고    scopus 로고
    • Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus
    • 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;64:2328-37.
    • (2012) Arthritis Rheum , vol.64 , pp. 2328-2337
    • Stohl, W.1    Hiepe, F.2    Latinis, K.M.3
  • 22
    • 17344380531 scopus 로고    scopus 로고
    • TACI and BCMA are receptors for a TNF homologue implicated in B-cell autoimmune disease
    • 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;404:995-9.
    • (2000) Nature , vol.404 , pp. 995-999
    • Gross, J.A.1    Johnston, J.2    Mudri, S.3
  • 23
    • 0029764038 scopus 로고    scopus 로고
    • Heterogeneity and clinical significance of glomerular-binding antibodies in systemic lupus erythematosus
    • Lefkowith JB, Kiehl M, Rubenstein J, et al. Heterogeneity and clinical significance of glomerular-binding antibodies in systemic lupus erythematosus. J Clin Invest 1996;98:1373-80.
    • (1996) J Clin Invest , vol.98 , pp. 1373-1380
    • Lefkowith, J.B.1    Kiehl, M.2    Rubenstein, J.3
  • 24
    • 68949218774 scopus 로고    scopus 로고
    • The Oxford classification of IgA nephropathy: Rationale, clinicopathological correlations, and classification
    • Cattran DC, Coppo R, Cook HT, et al. The Oxford classification of IgA nephropathy: rationale, clinicopathological correlations, and classification. Kidney Int 2009;76:534-45.
    • (2009) Kidney Int , vol.76 , pp. 534-545
    • Cattran, D.C.1    Coppo, R.2    Cook, H.T.3
  • 25
    • 81555207584 scopus 로고    scopus 로고
    • Discrepancies in glomerular and tubulointerstitial/vascular immune complex IgG subclasses in lupus nephritis
    • Satoskar AA, Brodsky SV, Nadasdy G, et al. Discrepancies in glomerular and tubulointerstitial/vascular immune complex IgG subclasses in lupus nephritis. Lupus 2011;20:1396-403.
    • (2011) Lupus , vol.20 , pp. 1396-1403
    • Satoskar, A.A.1    Brodsky, S.V.2    Nadasdy, G.3
  • 26
    • 8444241543 scopus 로고    scopus 로고
    • Criteria for steroid-sparing ability of interventions in systemic lupus erythematosus: Report of a consensus meeting
    • Ad Hoc Working Group on Steroid-Sparing Criteria in Lupus. Criteria for steroid-sparing ability of interventions in systemic lupus erythematosus: report of a consensus meeting. Arthritis Rheum 2004;50: 3427-31.
    • (2004) Arthritis Rheum , vol.50 , pp. 3427-3431
  • 27
    • 78649742730 scopus 로고    scopus 로고
    • EULAR recommendations for the management of systemic lupus erythematosus with neuropsychiatric manifestations: Report of a task force of the EULAR standing committee for clinical affairs
    • Bertsias GK, Ioannidis JPA, Aringer M, et al. EULAR recommendations for the management of systemic lupus erythematosus with neuropsychiatric manifestations: report of a task force of the EULAR standing committee for clinical affairs. Ann Rheum Dis 2010;69:2074-82.
    • (2010) Ann Rheum Dis , vol.69 , pp. 2074-2082
    • Bertsias, G.K.1    Ioannidis, J.P.A.2    Aringer, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.