Belimumab - Wikipedia. Belimumab (trade name Benlysta, previously known as Lympho. What can we learn from recent trials regarding the treatment options for systemic lupus erythematosus? B cell depletion with the monoclonal antibody rituximab is attracting increasing attention in systemic lupus erythematosus, vasculitis, and primary glomerulonephritis. Stat- B) is a human monoclonal antibody that inhibits B- cell activating factor (BAFF). However, the major phase III trials excluded the more severe cases of SLE with kidney and brain damage, so its effectiveness has not been demonstrated in those cases. A Phase III study for SLE patients with kidney disease is now recruiting. The UK National Institute for Health and Care Excellence (NICE) calculated the cost of belimumab at . Phase II trials for Sj. The most severe cases, with kidney and central nervous system involvement, were excluded from the trials. The efficacy and safety of belimumab was demonstrated in 2 Phase III randomized, controlled studies, BLISS- 5. They were divided into a placebo and 2 dosage groups of belimumab, in addition to standard therapy. The primary end point was a reduction of . Belimumab significantly improved the response rate, reduced disease activity and severe flares, and was well tolerated. SELENA- SLEDAI scores reduced by . Sales rose to $3. It is suggested that patients be treated with an antihistamine prior to a belimumab infusion. Infections are due to the immunosuppressant properties of the drug. Rituximab; Monoclonal antibody; Type: Whole antibody: Source: Chimeric (mouse/human) Target: CD20: Clinical data; Trade names: Rituxan, others: AHFS/Drugs.com: Monograph. We are devoted to solving the mystery of lupus, one of the world’s cruelest, most unpredictable, and devastating diseases, while giving caring support to those who. Efficacy of B-Cell–Targeted Therapy with Rituximab in Patients with Rheumatoid Arthritis. Edwards, M.D., Leszek Szczepa Combination of belimumab with other immunosuppressants, especially those targeting B lymphocytes such as anti- CD2. Likewise, the combination with intravenous cyclophosphamide is not recommended, as well as administering live vaccines during treatment with belimumab. B cells develop in the bone marrow and continue to mature peripherally in secondary lymphoid organs and (as recently discovered) in the gut. When autoimmune B cells attack the body's own tissues, they are normally destroyed by cell suicide (apoptosis). In order to survive, B cells need survival factors. Researchers theorize that SLE is caused when autoimmune B cells proliferate, and survival factors protect them from cell suicide. B- cell activating factor (BAFF), also called B- lymphocyte stimulator (BLy. S), is required for the development and survival of B cells. In SLE, BAFF is overexpressed. Researchers theorize that BAFF overexpression causes autoimmune B cell proliferation and survival, which causes SLE. Belimumab is a human antibody that binds to BAFF, preventing BAFF from binding to B cells. Without the survival factor BAFF, B cells commit suicide, and no longer contribute to the autoimmune damage of SLE. BAFF is secreted by a variety of cells: monocytes and macrophages, bone marrowstromal cells, astrocytes, synoviocytes during rheumatoid arthritis, salivary epithelial cells during Sj. It is possible that belimumab binds primarily to circulating soluble BAFF, therefore not inducing antibody- dependent cellular cytotoxicity that could be expected from this Ig. G1- type antibody. Under this agreement, CAT would identify antibodies and HGS would select appropriate ones to take into clinical trials. It was named Lympho. Stat- B and subsequently called belimumab. The companies would share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement. Food and Drug Administration (FDA) for treatment of SLE on March 9, 2. It was not tested in severe forms of SLE, which involve active damage to the kidneys or central nervous system in the phase III trials. Subjects with active kidney disease were included in the Phase II trials of the drug. Study participants of African American or African descent did not significantly respond to belimumab. Annual prices of generic prescription drugs are prednisone, $1. This is more than the normally accepted cost of . The manufacturer offered the UK National Health Service a discount, the amount of which were confidential, which still did not bring it into the acceptable range. It blocks activation of TACI by APRIL and BLy. S. It failed a phase II trial for multiple sclerosis. It blocks activation of this receptor by BLy. S, and is in early stage pharmaceutical development. Ocrelizumab, ofatumumab and . Kaveri; Luc Mouthon & Jagadeesh Bayry (September 9, 2. Stephen Paget, Medscape Rheumatology, Mar 2. Edwards BM, Barash SC, Main SH, et al. Human Genome Sciences. Archived from the original on 2. April 2. 01. 1. Archived from the original on March 1. Retrieved 1. 1 March 2. Human Genome Sciences. Archived from the original on 2. April 2. 01. 1. Food and Drug Administration (FDA). Walker, Washington Correspondent, Med. Page Today, November 1. F. D. A. Panel Backs Drug for Lupus By ANDREW POLLACK, New York Times, November 1. M^Andrew Pollack, . Approves Benlysta, a New Lupus Drug. Food and Drug Administration (FDA)^2. Meeting Materials, Arthritis Advisory Committee. U. S. Food and Drug Administration (FDA)^WRAL Tech Wire: GSK wins OK for Lupus drug in Europe, Canada^Bevra Hannahs Hahn (April 1. N.; Ren, S.; Song, A.; Gelzleichter, T. The American Journal of Pathology. Chemokine. CSFInterferon. Agonists: Albinterferon. Interferon alpha (interferon alfa, IFN- .
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