Belimumab in the management of systemic lupus erythematosus - an update

被引:6
作者
Tesar, Vladimir [1 ,2 ]
Hruskova, Zdenka [1 ,2 ]
机构
[1] Charles Univ Prague, Gen Univ Hosp, Dept Nephrol, Prague, Czech Republic
[2] Charles Univ Prague, Fac Med 1, Prague, Czech Republic
关键词
B cell depletion; B lymphocyte stimulator; belimumab; systemic lupus erythematosus; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; B-LYMPHOCYTE STIMULATOR; MONOCLONAL-ANTIBODY; DISEASE-ACTIVITY; CLINICAL-TRIALS; RENAL OUTCOMES; PHASE-III; EFFICACY; SAFETY; RITUXIMAB;
D O I
10.1080/14712598.2017.1324846
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Introduction: Belimumab is a fully humanised mAb against B lymphocyte stimulator (B-LyS). It is the first biological drug licensed and approved by the US FDA and the European Medicines Agency (EMA) for use in combination with standard immunosuppressants in autoantibody-positive systemic lupus erythematosus (SLE).Areas covered: This manuscript evalues the recent data concerning belimumab's safety and clinical effectiveness and its current place in the treatment of SLE. This includes an overview of the recent data coming from the post-hoc analyses of the BLISS trials, real-life experience with belimumab and the accumulating data on its safety. Attention is also paid to the progress made in the identification of predictors of response to belimumab, recent phase I/II/III studies with subcutaneous belimumab, and experience with B cell modulation coming from recent trials with other B cell modulating drugs.Expert opinion: Belimumab currently has its established role in the treatment of patients with SLE with serologic activity and clinical activity namely in mucocutaneous and musculoskeletal domains despite standard of care treatment. Better identification of patients who can benefit from treatment with belimumab is warranted. Data from ongoing studies in lupus nephritis and other data from observational studies are eagerly awaited.
引用
收藏
页码:901 / 908
页数:8
相关论文
共 55 条
[1]  
Benvenuti F, 2016, LUPUS, V25, P1445
[2]   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 [J].
Bertsias, G. ;
Ioannidis, J. P. A. ;
Boletis, J. ;
Bombardieri, S. ;
Cervera, R. ;
Dostal, C. ;
Font, J. ;
Gilboe, I. M. ;
Houssiau, F. ;
Huizinga, T. ;
Isenberg, D. ;
Kallenberg, C. G. M. ;
Khamashta, M. ;
Piette, J. C. ;
Schneider, M. ;
Smolen, J. ;
Sturfelt, G. ;
Tincani, A. ;
van Vollenhoven, R. ;
Gordon, C. ;
Boumpas, D. T. .
ANNALS OF THE RHEUMATIC DISEASES, 2008, 67 (02) :195-205
[3]   B-cell targeted therapeutics in clinical development [J].
Blueml, Stephan ;
McKeever, Kathleen ;
Ettinger, Rachel ;
Smolen, Josef ;
Herbst, Ronald .
ARTHRITIS RESEARCH & THERAPY, 2013, 15
[4]   Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care [J].
Bruce, I. N. ;
Urowitz, M. ;
van Vollenhoven, R. ;
Aranow, C. ;
Fettiplace, J. ;
Oldham, M. ;
Wilson, B. ;
Molta, C. ;
Roth, D. ;
Gordon, D. .
LUPUS, 2016, 25 (07) :699-709
[5]   Bioavailability, Pharmacokinetics, and Safety of Belimumab Administered Subcutaneously in Healthy Subjects [J].
Cai, Wendy W. ;
Fiscella, Michele ;
Chen, Cecil ;
Zhong, Z. John ;
Freimuth, William W. ;
Subich, David C. .
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2013, 2 (04) :349-357
[6]   Elevated Serum BAFF Levels Are Associated With Rising Anti-Double-Stranded DNA Antibody Levels and Disease Flare Following B Cell Depletion Therapy in Systemic Lupus Erythematosus [J].
Carter, Lucy M. ;
Isenberg, David A. ;
Ehrenstein, Michael R. .
ARTHRITIS AND RHEUMATISM, 2013, 65 (10) :2672-2679
[7]   Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial [J].
Chatham, W. Winn ;
Wallace, Daniel J. ;
Stohl, William ;
Latinis, Kevin M. ;
Manzi, Susan ;
McCune, W. Joseph ;
Tegzova, Dana ;
McKay, James D. ;
Avila-Armengol, Hilario E. ;
Utset, Tammy O. ;
Zhong, Z. John ;
Hough, Douglas R. ;
Freimuth, William W. ;
Thi-Sau Migone .
JOURNAL OF RHEUMATOLOGY, 2012, 39 (08) :1632-1640
[8]   New treatment options for lupus - a focus on belimumab [J].
Chiche, Laurent ;
Jourde, Noemie ;
Thomas, Guillemette ;
Bardin, Nathalie ;
Bornet, Charleric ;
Darque, Albert ;
Mancini, Julien .
THERAPEUTICS AND CLINICAL RISK MANAGEMENT, 2012, 8 :33-43
[9]   Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials [J].
Clowse, Megan E. B. ;
Wallace, Daniel J. ;
Furie, Richard A. ;
Petri, Michelle A. ;
Pike, Marilyn C. ;
Leszczynski, Piotr ;
Neuwelt, C. Michael ;
Hobbs, Kathryn ;
Keiserman, Mauro ;
Duca, Liliana ;
Kalunian, Kenneth C. ;
Galateanu, Catrinel ;
Bongardt, Sabine ;
Stach, Christian ;
Beaudot, Carolyn ;
Kilgallen, Brian ;
Gordon, Caroline .
ARTHRITIS & RHEUMATOLOGY, 2017, 69 (02) :362-375
[10]   Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA [J].
Collins, C. E. ;
Dall'Era, M. ;
Kan, H. ;
Macahilig, C. ;
Molta, C. ;
Koscielny, V. ;
Chang, D. J. .
LUPUS SCIENCE & MEDICINE, 2016, 3 (01)