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Study Summary:

The primary objective of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active systemic lupus erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10. The Systemic Lupus Erythematosus Responder Index (SRI) is a measurement of the activity level of a patient’s disease, and is a composite of three SLE assessment scales: the SELENA-SLEDAI, the Physician Global Assessment (PGA), and the British Isles Lupus Assessment Group (BILAG). Various symptoms, including arthritis, proteinuria, and vasculitis are evaluated using a system of points to determine the severity of disease activity and the progression of the autoimmune disease. An endpoint of SRI-8 indicates an improvement in a patient’s SELENA-SLEDAI score of ≥8 points, with no new lupus flares as measured by BILAG, and no worsening in their PGA score- a decrease in both a patient’s disease activity and their risk of disease flare.

Status:

Enrolling

For latest updates please go to clinicaltrials.gov

 

Blisibimod Posters & Publications:

 

Systemic Lupus Erythematosus Publications:

Albrecht J, Taylor L, Berlin JA, Dulay S, Ang G, Fakharzadeh S, Kantor J, Kim E, Militello G, McGinnis K, Richardson S, Treat J, Vittorio C, Van Voorhees A, Werth VP.  The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): an outcome instrument for cutaneous lupus erythematosus. J Invest Dermatol. 2005;125(5):889-94.
doi:10.1111/j.0022-202X.2005.23889.x

American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. 1999;42:1785-96.
doi: 10.1002/1529-0131(199909)42:9<1785::AID-ANR1>3.0.CO;2-#

American College of Rheumatology 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(11):3427-31.
doi: 10.1002/art.20599

Belouski SS, Wallace D, Weisman M, Ishimori M, Hendricks L, Zack D, et al.  Sample stability and variability of B-cell subsets in blood from healthy subjects and patients with systemic lupus erythematosus. Cytometry Part B (Clinical Cytometry). 2010;78B:49-58.
doi: 10.1002/cyto.b.20482

Bertsias G, Ioannidis JP, Boletis J, Bombardieri S, Cervera R, Dostal C, 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(2):195-205.
doi:10.1136/ard.2007.070367

Bonilla-Martinez ZL, Albrecht J, Troxel AB, Taylor L, Okawa J, Dulay S, Werth VP.  The cutaneous lupus erythematosus disease area and severity index: a responsive instrument to measure activity and damage in patients with cutaneous lupus erythematosus. Arch Dermatol. 2008;144(2):173-80.
doi: 10.1001/archderm.144.2.173.

Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, 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.
doi:10.7326/0003-4819-142-12

Cooperating Clinics Committee of the American Rheumatism Association. A seven-day variability study of 499 patients with rheumatoid arthritis. Arthritis Rheum 1965;8J02-34.
doi: 10.1002/art.1780080214

Danchenko N, Satia JA, and Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus. 2006;15:308–18.
doi: 10.1191/0961203306lu2305xx

FDA Guidance for Industry: Systemic Lupus Erythematosus — Developing Medical Products for Treatment (June 2010)
doi

Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW.  Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009;61(9):1143-51.
doi: 10.1002/art.24698

Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, et al. A Phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocytic stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63:3918-30.
doi: 10.1002/art.30613

Genovese, MC, Mociran, E., Biagini, M., Bojin, S., Sloan-Lancaster, J.; Phase 2 Study of Safety and Efficacy of a Novel Anti-BAFF Monoclonal Antibody, in Patients with RA Treated with Methotrexate (MTX) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1923
doi:10.1136/annrheumdis-2012-202775

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(9):1785-96.
doi: 10.1002/1529-0131(199909)42:9<1785::AID-ANR1>3.0.CO;2-#

Khare, SD, Sarosi, I, Xia XZ, McCabe S, Miner K, Solovyev I, et al. Severe B cell hyperplasia and autoimmune disease in TALL-1 transgenic mice. Proc Natl Acad Sci USA. 2000;97:3370–75.
doi/10.1073/pnas.050580697

Kotzin BL. Systemic lupus erythematosus. Cell. 1996;85:303–06.

Lim SS and Drenkard C. Epidemiology of systemic lupus erythematosus: capturing the butterfly. Curr Rheumatol Rep. 2008;10(4):265–72.
doi: 10.1007/s11926-008-0043-4

Leong KP, Kong KO, Thong BY, Koh ET, Lian TY, Teh CL, et al. Development and preliminary validation of a systemic lupus erythematosus-specific quality-of-life instrument (SLEQOL). Rheumatology. 2005;44:1267–76.
doi: 10.1093/rheumatology/keh605

Manzi S, Sanchez-Guerrero J, Merrill JT, Furie R, Gladman D, Navarra S, 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 May 11 [Epub ahead of print]
doi: 10.1136/annrheumdis-2011-200831

McElhone K, Abbott J, Shelmerdine J, Bruce IN, Ahmad Y, Gordon C, Peers K, Isenberg D, Ferenkeh-Koroma A, Griffiths B, Akil M, Maddison P, Teh LS.  Development and validation of a disease-specific health-related quality of life measure, the LupusQol, for adults with systemic lupus erythematosus.  Arthritis Rheum. 2007;57(6):972-9.
doi: 10.1002/art.22881

Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jiminez RE, et al.  Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial.  Lancet. 2011;377(9767):721-31.
doi: 10.1016/S0140-6736(10)61354-2.

Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005;353(24):2550–58.
doi: 10.1056/NEJMoa051135

Petri M, Stohl W, Chatham W, McCune WJ, Chevrier M, Ryel J, et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum. 2008;58(8):2453–59.
doi: 10.1002/art.23678.

Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS.  Understanding the epidemiology and progression of systemic lupus erythematosus.  Semin Arthritis Rheum. 2010;39:257-68.
doi: 10.1016/j.semarthrit.2008.10.007

Sampson H, Munoz-Furlong A, Campbell R, Adkinson NF, Bock SA, Branum A, et al.  Second symposium on the definition and management of anaphylaxis: Summary report – Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium.  J Allergy Clin Immunol 2006;117:391-7.
doi:10.1016/j.jaci.2005.12.1303

Siegel M and Lee SL. The epidemiology of systemic lupus erythematosus. Semin Arthritis Rheum. 1973;3:1–54.
http://dx.doi.org/10.1016/0049-0172(73)90034-6

Strand V. &. Chu AD. Measuring outcomes in systemic lupus erythematosus clinical trials. Expert review of pharmacoeconomics & outcomes research 2011;11(4):455-468.
doi:10.1586/erp.11.38

van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012;71(8):1343-9.
doi:10.1136/annrheumdis-2011-200937

Westfall PH, Krishen A.  Optimally weighted, fixed sequence and gatekeeper multiple testing procedures.  Journal of Statistical
http://dx.doi.org/10.1016/S0378-3758(01)00077-5

 

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