Belimumab trade name benlysta, previously known as lymphostatb is a human monoclonal antibody that inhibits bcell activating factor baff, also known as blymphocyte stimulator blys. Belimumab in systemic lupus erythematosus rmd open. Effects of belimumab on pregnant patients with systemic lupus erythematosus sle are unknown. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune b. Sle is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. Benlysta mg solution for injection in prefilled syringe. Response to belimumab among patients with systemic lupus. The patient became pregnant again and we describe its successful outcome here.
A multicenter, randomized, placebocontrolled trial to evaluate the safety, efficacy, and pharmacokinetics of belimumab, a human monoclonal antiblys antibody, plus standard therapy in pediatric patients with systemic lupus erythematosus. Learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Belimumab benlysta is a human monoclonal antibody that inhibits soluble blymphocyte stimulator. Nct0452531 was conducted in 49 centres across china, japan and south. Many drugs have been used to treat sle with suboptimal results, especially in patients with moderatetosevere disease. Belimumab trade name benlysta is a human monoclonal antibody that inhibits the cytokine b cell activating factor known as baff or blys and is to some extent responsible for the the increased autoantibody production observed in patients with systemic lupus erythematosus sle. Belimumab is the first biological therapy licensed for sle. Belimumab is a human monoclonal antibody that binds to and inhibits the biological activity of b lymphocyte stimulator, 1 a potent b cell survival factor associated with human systemic lupus. Systemic lupus erythematosus in patients with chronic cutaneous discoid lupus erythematosus. Clinical and laboratory findings in seventeen patients.
Use of belimumab throughout 2 consecutive pregnancies in a. Systemic lupus erythematosus sle is a complex heterogeneous disease, posing challenges to clinical trials. Belimumab for treating active autoantibody positive. Belimumab for the treatment of systemic lupus erythematosus systemic lupus erythematosus sle is a chronic multisystem disease associated with significant morbidity and mortality. Recent phase iii clinical trials with belimumab in patients with active systemic lupus erythematosus sle have been completed and achieved primary efficacy endpoints employing validated disease activity measures sledai and bilag as well as additional secondary endpoints related to disease flares and sparing of corticosteroid use. There is substantial evidence that b cells play a central role in the pathogenesis of this disease 1,2, both in mouse models and humans 3. Belimumab is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus. A pivotal phase iii, randomised, placebocontrolled study. Rheumatologists n92 identified adults with sle who had received. Systemic lupus erythematosus sle is a heterogenous disease largely dependent on the generation of autoreactive antibodies by b cells. It is approved in the united states, canada, and europe to treat systemic lupus erythematosus sle. Belimumab for treating systemic lupus erythematosus. Belimumab has a marketing authorisation as addon therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus with a high degree of disease activity for example. Belimumab is the first biological drug to be approved for the treatment of sle in more.
Methods this phase iii, multicentre, randomised, doubleblind, placebocontrolled study bel1750. Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus sle. Adaptation to the italian setting of a budget impact model with a time horizon of 4 years year 0 without belimumab, years with belimumab to compare treatment, administration, and. Systemic lupus erythematosus sle is one of the most challenging autoimmune disorders with a complex pathophysiology and diverse clinical presentation. Belimumab benlysta, which recently received marketing approval, is the first of a new class of immunomodulators with a novel mechanism of action. This monoclonal antibody is only considered as treatment when the disease is still active in spite of standard therapy. Systemic lupus erythematosus sle is a chronic inflammatory disorder that is driven by autoantibodies that target multiple organ systems. The risk of active le during pregnancy is increased if you have had active systemic le in the previous 6 months, and if your medication was stopped or reduced just before or during pregnancy. Efficacy and safety data of belimumab in patients with. Treatment of patients with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving standard therapy. The study evaluates the costs of systemic lupus erythematosus sle and the budget impact due to the introduction of belimumab in the italian setting. It is the only biological agent currently approved for the treatment of nonrenal systemic lupus erythematosus sle. Methods this observational cohort study was conducted in us clinical practices. Belimumab is approved in the eu, the usa and other countries as addon therapy in adult.
A 20yearold woman with sle presents with disease flares and receives belimumab, a monoclonal antibody that binds to bcell activating factor, inhibiting bcell stimulation. Safety and effectiveness of belimumab in systemic lupus erythematosus registry sable the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Information will be collected on serious events that are not that common or may only be seen with longterm treatment. We investigated the effects of 2 biologic treatments. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development and sle pathogenesis. Use of belimumab throughout 2 consecutive pregnancies in a patient with systemic lupus erythematosus to the editor. Systemic lupus erythematosus sle is an autoimmune disease characterized by complex pathophysiology and heterogeneous clinical picture. Its overexpression drives systemic lupus erythematosus slelike disease in mice 68.
Systemic lupus erythematosus sle, is the most common type of lupus. Parts of the body affected by sle include the heart, skin, joints, kidneys. Undoubtedly, b cells play a crucial role in the pathogenesis of sle. Real life experience on the effect of belimumab in. Pharmacologic neutralization or genetic elimination. It took about 8 months for the infusions to work and actually make me feel better and my labs normal. Objective accumulating evidence supports an impaired health. Belimumab is a monoclonal antibody against bcell activating factor baff and the first biological drug to be approved for the treatment of sle in more than 50 years. To our knowledge, we described the first case of a patient with active sle who was treated with belimumab throughout her pregnancy1. Predictors of low disease activity and clinical remission.
Given by iv infusion, belimumab may reduce the number of abnormal b cells thought to be a problem in lupus. Benlysta for intravenous use is available as 120 mg in a 5ml. Efficacy and safety of subcutaneous belimumab in systemic. It was approved by the fda in 2011 for treatment of active, autoantibodypositive, systemic lupus erythematosus sle in adults. Smoking and preexisting organ damage reduce the efficacy. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Pediatric lupus trial of belimumab plus background. Systemic lupus erythematosus sle is a complex autoimmune rheumatic disease. Belimumab benlysta pregnancy registry the belimumab benlysta pregnancy registry is a prospective cohort study that enrolls women with systemic lupus erythematosus sle who have been given exposed to commerciallysupplied belimumab within the 4 months prior to andor during pregnancy. Benlysta belimumab dosing, indications, interactions. Belimumab is the first biologic drug approved for systemic lupus erythematosus sle.
Belimumab for the treatment of systemic lupus erythematosus. Sle patients who received belimumab 10 mgkg n 563 in the bliss52 and bliss76 clinical trials were surveyed. As in other autoimmune diseases, blymphocytes play a central role in lupus pathogenesis. Patients with a safety of estrogens in lupus erythematosus. Recent advances in the management of systemic lupus. To date, the majority of studies have focused on bcell target therapies 47. In most studies of pregnant women, skin, joint andor haematological manifestations are most. Belimumab for systemic lupus erythematosus bevra hannahs hahn, m. How effective is belimumab benlysta in the treatment of.
The performance of baseline factors in predicting attainment of low disease activity defined as lupus low disease activity state or clinical remission defined as clinical csledai2k 0 at week 52 from treatment initiation was. Blys is also associated with sle in humans 911 and correlates with disease activity 12. It is a specific inhibitor of the soluble blymphocyte stimulator blys cytokine, which has been implicated in the pathogenesis of systemic lupus erythematosus sle. Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three swedish reallife settings. Objective to examine disease activity and clinical outcomes, and describe overall patterns of systemic lupus erythematosus sle care in patients who received belimumab in a realworld clinical setting. Safety and effectiveness of belimumab in systemic lupus. Usual pediatric dose for systemic lupus erythematosus. Belimumab for treating systemic lupus erythematosus dear colleague, this letter is a reminder of the agreed nice and nhs england process for using belimumab to treat active systemic lupus erythematosus sle. Food and drug administration today approved benlysta belimumab to treat patients with active, autoantibodypositive lupus systemic lupus erythematosus who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti. Documents belimumab for treating active autoantibody. In june 2016, nice published technology appraisal guidance on belimumab for treating active autoantibodypositive sle.
694 1005 1455 756 240 15 465 1151 427 1316 120 1476 1294 777 516 583 656 911 1595 151 181 1079 1323 73 527 95 1304 262 83 829 191 664 662 766 648 156 266 1266 55 1361 1438 850 480 781 401