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J S Hui-Yuen, S C Nguyen, A D Askanase
Belimumab (Benlysta) is a fully-humanized monoclonal antibody that inhibits B-lymphocyte stimulator (also known as B cell activating factor) and was approved by the U.S. Federal Drug Administration and European Medicines Evaluation Agency for treatment in adults with autoantibody-positive systemic lupus erythematosus (SLE). Rituximab (Rituxan) is a chimeric anti-CD20 monoclonal antibody targeting B lymphocytes. This review discusses the key findings of the phase III trials in adults with SLE and of real-world use of belimumab and rituximab in the care of both adult and pediatric SLE patients...
September 2016: Lupus
Joyce S Hui-Yuen, Xiao Q Li, Anca D Askanase
Belimumab (Benlysta(®)) is a fully humanized monoclonal antibody that inhibits B-lymphocyte stimulator (also known as B cell activating factor of the tumor necrosis factor family) and was approved by the US Food and Drug Administration and the European Medicines Evaluation Agency for treatment of autoantibody-positive systemic lupus erythematosus (SLE) in adults. This review discusses the key findings of the phase III trials, post hoc analyses, and real-world postmarketing use of belimumab in the routine care of SLE patients...
August 2015: Therapeutic Advances in Musculoskeletal Disease
Marianne Frieri, William Heuser, Joshua Bliss
Recently introduced into the market, belimumab (Benlysta) is a monoclonal antibody that has potential clinically efficacious applications for the treatment of lupus nephritis. Lupus nephritis is a major complication of systemic lupus erythematosus (SLE) that can lead to significant illness or even death without proper intervention and treatment. With vast implications through a novel mechanism, belimumab offers a new standard of treatment for physicians in the complications associated with SLE, specifically lupus nephritis...
April 2015: Journal of Pharmacology & Pharmacotherapeutics
Estefania Cogollo, Estafania Cogollo, Marta Amaral Silva, David Isenberg
The importance of B cell activating factors in the generation of autoantibodies in patients with systemic lupus erythematosus (SLE) is now recognized. The two key factors, known as BAFF and APRIL, produced by a variety of cells including monocytes, dendritic cells and T cells, also help to regulate B cell maturation, function and survival. Biologic agents that block these factors have now been developed and tried out in large scale clinical trials in SLE patients. Benlysta which blocks BAFF has met some of its end points in clinical trials and is approved for use in patients with skin and joint disease who have failed conventional drugs...
2015: Drug Design, Development and Therapy
Anca D Askanase, Jinoos Yazdany, Charles T Molta
Belimumab (Benlysta) is a human recombinant monoclonal antibody that targets and inhibits soluble B-lymphocyte stimulator, also known as B-cell activating factor, a proliferation and survival factor for B cells. The published clinical trials data showed that in patients with active systemic lupus erythematosus (SLE), belimumab effectively reduced peripheral B-cell levels and improved disease activity. This article reviews the belimumab clinical trials and the post-marketing experience with belimumab in the treatment of those lupus patients with persistent active disease despite current standard of care (SOC) therapy...
August 2014: Rheumatic Diseases Clinics of North America
Joyce S Hui-Yuen, Liza Mariel Bermudez-Santiago, Josephine Isgro, Andrew H Eichenfield, Amy J Starr, Lisa F Imundo, Anca Askanase
BACKGROUND/PURPOSE: Belimumab (Benlysta) is a human monoclonal antibody inhibiting soluble B-lymphocyte stimulator that was approved by the Food and Drug Administration in 2011 for treatment of active, autoantibody-positive, systemic lupus erythematosus (SLE) in adults. To date, there have been no published data on the use of belimumab in childhood-onset SLE. METHODS: This is a case series of patients with childhood-onset SLE treated with belimumab at our institution...
March 2014: Arthritis & Rheumatology
Mirjana Ziemer, Linda Milkova, Manfred Kunz
Lupus erythematosus (LE) is an important dermatologic autoimmune disease. In many respects, it may be regarded as a model autoimmune disease due to its spectrum of autoimmune antibodies and involvement of different organ systems, as well as response to immunosuppressive agents which target B cells and T cells and their cytokines. A recently published article in this Journal summarized the most important knowledge about epidemiology, genetics, and immunology of LE. Here, the different clinical manifestations, diagnostic procedures and current therapeutic approaches will be described...
April 2014: Journal der Deutschen Dermatologischen Gesellschaft, Journal of the German Society of Dermatology: JDDG
(no author information available yet)
Systemic lupus erythematosus is a chronic inflammatory autoimmune disease with variable clinical manifestations, mainly affecting women between the ages of 16 and 55 years. It can be life-threatening, especially when renal or neurological involvement occurs. Belimumab (Benlysta", Glaxo-SmithKline) is an immunosuppressant monoclonal antibody that inhibits B cell differentiation into antibody-producing plasma cells. Belimumab is authorised in the European Union for the treatment of adults with autoantibody-positive systemic lupus erythematosus when the disease remains highly active despite "standard" therapy, usually comprising a corticosteroid or another immunosuppressant...
June 2013: Prescrire International
B Aubry-Rozier, I Fabreguet
Systemic lupus erythematosus and primary Sjögren's syndrom are the two major connective tissue diseases. A better knowledge of their physiopathology allows us today to propose an adapted therapy. Moreover progress concerns the oldest treatment, hydroxychloroquine, and biotherapy. Hydroxychloroquine is still an actual treatment for lupus, its positive effects are better understood today. Nevertheless it does not seem to be efficient to treat primitive Sjögren. Biotherapy targeting B lymphocytes seems efficient in these two connective tissue diseases...
March 13, 2013: Revue Médicale Suisse
Xingzhong Jin, Changhai Ding
INTRODUCTION: B lymphocyte stimulator (BLyS) is a major regulatory factor that controls the development and survival of B cells. Elevated serum levels of BLyS have been associated with rheumatoid arthritis (RA). Belimumab is a fully human monoclonal antibody that inhibits BLyS and it is being developed for the treatment of RA. This review aims to summarize up-to-date pharmacological and clinical data of belimumab in the treatment of RA. AREAS COVERED: A literature search was performed on PubMed using keywords, including belimumab, LymphoStat-B, benlysta, BLyS inhibitor, rheumatoid arthritis and autoimmune disease...
February 2013: Expert Opinion on Biological Therapy
Mark Ratner
On 17 May, Human Genome Sciences (HGS) formally rejected a $2.6 billion unsolicited takeover offer by GlaxoSmithKline. The Maryland-based biotech firm had long partnered with the UK drug giant to develop drugs including Benlysta (belimumab), HGS's first drug on the market and the first new medicine approved to fight lupus in 50 years. But, at $13 a share, GSK's bid was deemed "inadequate" by the HGS board. Recent history in the biotech sector shows how high the stakes are in such negotiations. Since last November, six biopharma buyouts have exceeded $1 billion each, with Gilead Sciences' purchase last year of the hepatitis C specialist Pharmasset topping the charts at a whopping $11...
June 2012: Nature Medicine
Katrina Shum, Anca Askanase
Benlysta (belimumab) is a fully human recombinant monoclonal IgG antibody that neutralizes soluble B-lymphocyte stimulator and inhibits its biologic activity. Benlysta was recently approved by the US Food and Drug Administration to treat systemic lupus erythematosus (SLE). The current review discusses the data from the belimumab clinical trials and the role of this new medication in the treatment of SLE. We propose that Benlysta should be used in antinuclear antibody-positive patients with active disease in whom the goal of therapy is to decrease SLE activity, reduce flares, and help lower background medications...
August 2012: Current Rheumatology Reports
Raymond Lamore, Sapna Parmar, Khilna Patel, Olga Hilas
No abstract text is available yet for this article.
April 2012: P & T: a Peer-reviewed Journal for Formulary Management
Diane Lewis Horowitz, Richard Furie
The March 2011 approval of belimumab (Benlysta) by the US Food and Drug Administration has left rheumatologists in a bit of a quandary regarding its use. It is officially intended for adult patients with autoantibody-positive systemic lupus erythematosus whose disease remains active despite receipt of standard-of-care therapy. The approved indication is broad and leaves interpretation to individual rheumatologists. Analyses of the phase 2 and 3 clinical trials of belimumab help answer some of the commonly asked questions, such as the following: 1) Who is the appropriate patient for belimumab? 2) How does one measure response? 3) When should results be expected in a patient newly treated with belimumab? 4) When should belimumab be discontinued?...
August 2012: Current Rheumatology Reports
Eric G Boyce, Bryan E Fusco
BACKGROUND: Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulating protein, was the first biologic agent approved for, and the first drug approved in 55 years for, the treatment of systemic lupus erythematosus (SLE) by the US Food and Drug Administration (FDA). OBJECTIVE: This article reviews the current research on belimumab and provides recommendations on its use in the treatment of SLE. METHODS: The Cochrane Library, EBSCO, IPA, MEDLINE, and SCOPUS were searched for research published from January 2000 to November 2011, using the search terms belimumab, Benlysta, and Lympho-Stat B...
May 2012: Clinical Therapeutics
Lesley J Scott, Celeste B Burness, Paul L McCormack
Belimumab (Benlysta®), a fully human recombinant IgG1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells, is indicated for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite receiving standard therapy. In multinational trials, significantly more belimumab recipients than placebo recipients achieved an SLE Responder Index response at 52 weeks.
June 1, 2012: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Ronald F Parsons, Ming Yu, Kumar Vivek, Ghazal Zekavat, Susan Y Rostami, Amin S Ziaie, Yanping Luo, Brigitte Koeberlein, Robert R Redfield, Christopher D Ward, Thi-Sau Migone, Michael P Cancro, Ali Naji, Hooman Noorchashm
BACKGROUND: Immunologic rejection is a major barrier to successful long-term outcomes in clinical transplantation. The importance of B lymphocytes-and their secretory products, alloantibodies-in the pathogenesis of allograft rejection is accepted. Furthermore, it is now clear that the dominant regulator of peripheral B-cell homeostasis and tolerance is the B-lymphocyte stimulator (BLyS), also referred to as the B-cell activating factor (BAFF). Recently, a novel class of clinical immunotherapeutic agents specific for BLyS, and its family of cytokines, has emerged for the treatment of B-cell-mediated diseases...
April 15, 2012: Transplantation
William Stohl, David M Hilbert
For the first time in more than 50 years, the US Food and Drug Administration has approved a drug specifically for the treatment of systemic lupus erythematosus (SLE). This drug, belimumab (Benlysta), is a human monoclonal antibody that neutralizes the B-cell survival factor, B-lymphocyte stimulator (BLyS). The approval of belimumab combined a pioneering approach to genomics-based gene discovery, an astute appreciation of translational medicine, a disciplined clinical strategy, a willingness to take calculated risks, a devoted cadre of patients and physicians and a healthy dose of serendipity...
January 2012: Nature Biotechnology
G J Dennis
Belimumab (Benlysta), which recently received marketing approval, is the first of a new class of immunomodulators with a novel mechanism of action. It is a specific inhibitor of the soluble B-lymphocyte stimulator (BLyS) cytokine, which has been implicated in the pathogenesis of systemic lupus erythematosus (SLE). Two large phase III randomized controlled clinical trials evaluated the safety and efficacy of belimumab combined with standard therapy and showed that the efficacy of this treatment was significantly superior to placebo plus standard therapy...
January 2012: Clinical Pharmacology and Therapeutics
(no author information available yet)
No abstract text is available yet for this article.
November 2011: Perspective Infirmière: Revue Officielle de L'Ordre des Infirmières et Infirmiers du Québec
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