2,947
Views
8
CrossRef citations to date
0
Altmetric
Reviews

Lupus clinical development: will belimumab's approval catalyse a new paradigm for SLE drug development?

, PhD & , BS

Bibliography

  • Schneider P, MacKay F, Steiner V, et al. BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth. J Exp Med 1999;189(11):1747-56
  • Fairfax K, Mackay IR, Mackay F. BAFF/BLyS inhibitors: a new prospect for treatment of systemic lupus erythematosus. IUBMB Life 2012;64(7):595-602
  • Furie R, 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
  • 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(9):1168-78
  • Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009;61(9):1143-51
  • Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol 2012;30(1):69-77
  • A randomized, double blind, baseline controlled study using placebo as reference for assessing the efficacy and safety of hydroxychloroquine sulfate in patients with systemic lupus erythematosus or cutaneous lupus erythematosus in the presence of active lupus erythematosus specific skin lesion. Available from: http://clinicaltrials.gov/ct2/show/NCT01551069
  • 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(6):1919-31
  • 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
  • Genovese MC, Lee E, Satterwhite J, et al. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2013;72(9):1453-60
  • 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(11):1833-8
  • Wallace DJ, Kalunian K, Petri MA, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis 2014;73:183-90
  • Development of a quantitative PCR method to determine interferon signature metric status in sle patients: distribution and clinical & serological associations in two lupus clinical trials. ACR/ARHP Annual Meeting Publications; 2012. Abstract Supplement available from http://www.rheumatology.org/publications/acr_arhp_annual_meeting.asp
  • Efficacy and safety of atacicept for prevention of flares in patients with moderate to severe systemic lupus erythematosus (SLE): 52-Wk Data (APRIL-SLE Trial). EULAR Annual European Congress of Rheumatology; 2013. Available from: http://www.abstracts2view.com/eular/view.php?nu=EULAR13L_THU0276
  • Blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus. Am Coll Rheumatol 2012; Abstract Supplement available from http://www.rheumatology.org/publications/acr_arhp_annual_meeting.asp
  • Ginzler EM, Wax S, Rajeswaran A. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther 2012;14(1):R33
  • A Phase IIb, multi-center, randomized, double-blind, placebo-controlled, multidose, 24-week study to evaluate the efficacy and safety of atacicept in subjects with systemic lupus erythematosus (SLE). Available from: http://clinicaltrials.gov/ct2/show/NCT01972568
  • Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum 2010;62(1):222-33
  • Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the lupus nephritis assessment with rituximab study. Arthritis Rheum 2012;64(4):1215-26
  • Mysler EF, Spindler AJ, Guzman R, et al. Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study. Arthritis Rheum 2013;65(9):2368-79
  • Lauwerys BR, Hachulla E, Spertini F, et al. Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon alpha-kinoid. Arthritis Rheum 2013;65(2):447-56
  • Results of a randomized, placebo-controlled, phase 2a study of sifalimumab, an anti-interferon-alpha monoclonal antibody, administered subcutaneously in subjects with systemic lupus erythematosus. Annual European congress of Rheumatology Publication; 2011. Abstract available from http://www.abstracts2view.com/eular/view.php?nu=EULAR11L_THU0411&terms=
  • Efficacy and safety of rontalizumab (anti-interferon alpha) in sle subjects with restricted immunosuppressant use: results of a randomized, double-blind, placebo-controlled phase 2 study. ACR/ARHP Annual Meeting Publications; 2012. Abstract supplement Available from http://www.rheumatology.org/publications/acr_arhp_annual_meeting.asp
  • Belnoue E, Pihlgren M, McGaha TL, et al. APRIL is critical for plasmablast survival in the bone marrow and poorly expressed by early-life bone marrow stromal cells. Blood 2008;111(5):2755-64
  • Roschke V, Sosnovtseva S, Ward CD, et al. BLyS and APRIL form biologically active heterotrimers that are expressed in patients with systemic immune-based rheumatic diseases. J Immunol 2002;169:4314-21
  • Taylor PC, Feldmann M. Anti-TNF biologic agents: still the therapy of choice for rheumatoid arthritis. Nat Rev Rheumatol 2009;5(10):578-82
  • Merrill JT, Burgoes-Vargas R, Westhoven R, et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010;62(10):3077-87
  • A randomized, double-blind, controlled, phase ii multicenter trial of ctla4ig (abatacept) plus cyclophosphamide vs cyclophosphamide alone in the treatment of lupus nephritis. Available from: http://clinicaltrials.gov/ct2/show/NCT00774852
  • Wallace DJ, Gordon C, Strand V, et al. Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Rheumatology 2013;52(7):1313-22
  • Reddy V, Jayne D, Close D, Isenberg D. B-cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumab and implications for study design. Arthritis Res Ther 2013;15(Suppl 1):S2
  • Van Vollenhoven RF, Parodis I, Levitsky A. Biologics in SLE: towards new approaches. Best Pract Res Clin Rheumatol 2013;27(3):341-9
  • Witt M, Grunke M, Proft F, et al. Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) - results from a nationwide cohort in Germany (GRAID). Lupus 2013;22(11):1142-9
  • Crow MK. Type I interferon in organ-targeted autoimmune and inflammatory diseases. Arthritis Res Ther 2010;12(Suppl 1):S5
  • Shrivastav M, Niewold TB. Nucleic acid sensors and type I interferon production in systemic lupus erythematosus. Front Immunol 2013;4:319
  • A randomized, double-blind, placebo-controlled, single dose, two-period, crossover study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of amg 811 in subjects with discoid lupus erythematosus. Available from: http://clinicaltrials.gov/show/NCT01164917
  • A Phase 1b, randomized, double-blind, placebo-controlled, multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of amg 811 in subjects with systemic lupus erythematosus with and without glomerulonephritis. Available from: http://clinicaltrials.gov/ct2/show/NCT00818948
  • First in human study of an anti-ifn gamma monoclonal antibody in healthy volunteers. Available from: http://clinicaltrials.gov/ct2/show/NCT01459562

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.