Systemic lupus erythematosus sle is an autoimmune disease. When healthy, our immune system protects the body from germs and cancers. Talk to your doctor about benlysta for more information. Bilag, which documents that no domain of the disease worsened, and a physicians global. New york reuters healthsubcutaneous belimumab improves outcomes in antidsdnapositive hypocomplementemic patients with systemic lupus erythematosus sle, according to results from a phase 3 randomized, controlled trial. The intravenous formulation is indicated for the treatment of active, autoantibodypositive systemic lupus erythematosus sle. Systemic lupus erythematosus sle is a complex autoimmune. The 52week study, also known as bliss52 a study of belimumab in subjects with systemic lupus erythematosus, enrolled 865 patients in countries outside north america latin america, asia pacific, and eastern europe and randomized patients with active lupus to intravenous belimumab 10 mgkg, 1 mgkg, or placebo in addition to their standard lupus medications. Learn about benlysta belimumab, a treatment option that may be right for you.
Benlysta belimumab injectable medication precertification. Sle is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. Systemic lupus erythematosus sle, is the most common type of lupus. In the study of belimumab in subjects with systemic lupus erythematosus bliss52, a global phase iii trial involving 865 patients with moderate sle sledai. Quality assessment and random effects metaanalysis. After a year of treatment, subjects receiving belimumab will be rerandomized 1. Patients with a safety of estrogens in lupus erythematosus. Belimumab treatment for adults with systemic lupus erythematosus. Belimumab is the first biological drug to be approved for the treatment of sle in more than 50 years. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development and sle pathogenesis.
May 2016 n819 trials were randomised, doubleblind, placebocontrolled, parallelgroup studies with followup at 52 weeks and 76 weeks respectively. Belimumab benlysta a breakthrough therapy for systemic lupus erythematosus d rug f orecast. Summary with critical appraisal belimumab treatment for adults with systemic lupus erythematosus 2 authors. Update on systemic lupus erythematosuserythematosus sleerythematosus sle stacy p.
Does the patient have a diagnosis of severe active central nervous system lupus. Prior approval supplemental biologics application 125370s068 provides for updates to the uspi regarding the safety and efficacy of benlysta in adult africanamerican patients with systemic lupus erythematosus sle. Belimumab trade name benlysta has been approved since july 2011 as an addon therapy for adult patients with the autoimmune disease systemic lupus erythematosus sle. Belimumab in systemic lupus erythematosus rmd open. Its overexpression drives systemic lupus erythematosus slelike. Benlysta belimumab dosing, indications, interactions. Belimumab benlysta is a human monoclonal antibody that inhibits soluble blymphocyte stimulator. Lupus nephritis is a major complication of systemic lupus erythematosus sle that. Food and drug administration as a selfinjectable subcutaneous formulation for people with systemic lupus erythematosus being treated with standard therapy.
Update on systemic lupus erythematosuserythematosus. Open access protocol belimumab after b cell depletion. Systemic lupus erythematosus sle is a heter ogenous disease largely dependent on the gen eration of autoreactive antibodies by b cells. 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 erythematosus sle disease.
Belimumab for treating active autoantibody positive. Safety and efficacy of metformin in systemic lupus. Systemic lupus erythematosus sle is a complex, multisystem autoimmune disease of unknown etiology with a heterogeneous range of clinical and serologic. We searched eight electronic databases and reference lists for randomised controlled trials rcts of belimumab against placebo or best supportive care. Systemic lupus erythematosus sle a study to evalulate rituximab rituxan in individuals with lupus. Systemic lupus erythematosus sle is one of the most challenging autoimmune disorders with a complex pathophysiology and diverse clinical presentation. Belimumab for the treatment of systemic lupus erythematosus systemic lupus erythematosus sle is a chronic multisystem disease associated with significant morbidity and mortality. Update on systemic lupus erythematosuserythematosus sle. The finding that selection and survival of b cells are controlled by a variety of signals, including those provided by the longevity factor baff bcell activating factor, also called blys b. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Systemic lupus erythematosus sle systemic lupus erythematosus is a chronic autoimmune disorder that can affect multiple organ systems and is a disease primarily found in working and reproductiveage women.
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 is the only approved biological agent for the treatment of systemic lupus erythematosus sle. Comparison of intravenous and subcutaneous exposure. National assessment selena version of the systemic lupus erythematosus disease activity index sledai score greater than or equal to 4 n 449 were randomly assigned to belimumab 1, 4, or 10 mgkg or placebo in a 52week study. Many drugs have been used to treat sle with suboptimal results, especially in patients with moderatetosevere disease. Pdf recently introduced into the market, belimumab benlysta is a monoclonal. For online submission, the articles should be prepared in two files first. Label approved on 03102011 pdf for benlysta, bla no. Efficacy and safety of rituximab in patients with active. Health service act for benlysta belimumab solution for subcutaneous injection, 200 mgml.
Jun 22, 2016 systemic lupus erythematosus active belimumab. Does the patient have a diagnosis of severe active lupus nephritis. Systemic lupus erythematosus sle is a chronic inflammatory systemic autoimmune disease. Ris procite, reference manager, endnote, bibtex, medlars, refworks. Buyon a study to evaluate avascular necrosis of bone avn in people with lupus. Systemic lupus erythematosus, referred to as sle or lupus, is a chronic longterm disease that causes systemic inflammation which affects multiple organs. Belimumab for the treatment of systemic lupus erythematosus. Systemic lupus erythematosus sle is a chronic autoimmune disorder that can affect multiple organ systems and is a disease primarily found in working and reproductiveage women. Systemic lupus erythematosus sle is a chronic multisystem disease associated with significant morbidity and mortality. Final appraisal determination belimumab for treating active autoantibodypositive systemic lupus erythematosus issue date. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Systemic lupus erythematosus sle is a potentially fatal autoimmune disease that is characterized by.
It was approved by the fda in 2011 for treatment of active, autoantibodypositive, systemic lupus erythematosus sle in adults. Summary with critical appraisal belimumab treatment for adults with systemic lupus erythematosus 5 inflammation and supress the immune system. Documents belimumab for treating active autoantibody. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women. Discoid lupus erythematosus dle affects only the skin, causing thick, red, scaly rashes on the face, neck, and scalp.
Belimumab also known as benlysta is in a class of treatments referred to as monoclonal. Belimumab has not been studied in combination with other biologics or intravenous cyclophosphamide. Efficacy and safety of subcutaneous belimumab in systemic lupus. Belimumab for treating systemic lupus erythematosus. Pdf efficacy of novel monoclonal antibody belimumab in the. Bcbsnc will provide coverage for belimumab benlysta for the treatment of autoantibodypositive systemic lupus erythematosus when it is determined to be medically necessary because the medical criteria and guidelines shown below are met. Belimumab has been formulated for subcutaneous sc administration to improve patient convenience. A 20yearold woman with sle presents with disease flares and receives belimumab, a monoclonal antibody that.
Belimumab significantly improved the sle responder index sri 4 response rate at week 52 com. Jun 01, 2018 this is a doubleblind placebo controlled trial of belimumab, in patients with early lupus, ie lupus diagnosed within 2 years. A study of belimumab in subjects with systemic lupus. With lupus, the immune system misfires and attacks self, the patients own tissues, in a. Druginduced lupus erythematosus dil, a rare form of lupus, is most commonly associated with hydralazine, e. Benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active, autoantibodypositive, systemic lupus erythematosus sle. Patients with pediatriconset sle psle have more severe disease requiring more aggressive immunosuppression than adult sle. Pharmacological therapy includes drugs that reduce the. Pediatric lupus trial of belimumab plus background. A study of belimumab in subjects with systemic lupus erythematosus sle bliss52 the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Belimumab for treating active autoantibodypositive systemic. Favorable response to belimumab in pediatriconset systemic. Belimumab is used with other medications to treat certain types of systemic lupus erythematosus sle or lupus. It is a specific inhibitor of the soluble blymphocyte stimulator blys cytokine, which has been implicated in the pathogenesis of systemic lupus erythematosus sle.
First approved lupus treatment option benlysta belimumab. 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. Belimumab is in a class of treatments referred to as monoclonal antibodies, and has been tested for. Indicated for treatment of patients with active, autoantibodypositive systemic lupus erythematosus sle who are receiving. 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.
Efficacy and safety of belimumab in patients with active systemic lupus erythematosus. This letter is a reminder of the agreed nice and nhs england process for using belimumab to treat active systemic lupus erythematosus sle. Belimumab for systemic lupus erythematosus bevra hannahs hahn, m. Does the patient have a documented diagnosis of systemic lupus erythematosus sle. Belimumab after b cell depletion therapy in patients with systemic lupus erythematosus beat lupus protocol. Belimumab is a monoclonal antibody against b cell activating factor baff and the first bio logical drug to be approved for the treatment of sle in more than 50 years. The department of health considered that this patient access scheme does not constitute an excessive administrative burden on the nhs. Given by iv infusion, belimumab may reduce the number of abnormal b cells thought to be a problem in lupus. There is substantial evidence that b cells play a central. Benlysta is indicated as addon therapy in adult patients with active, autoantibody positive systemic lupus erythematosus sle with a high degree of disease.
Systemic lupus erythematosus sle is a complex heterogeneous disease, posing challenges to clinical trials. Systemic lupus erythematosus sle is a heterogenous disease largely dependent on the generation of autoreactive antibodies by b cells. General characteristics of belimumab clinical trials in patients with sle. Belimumab benlysta, which recently received marketing approval, is the first of a new class of immunomodulators with a novel mechanism of action. Any person who knowingly files a request for authorization of coverage of a medical.
In july 2017, belimumab benlysta, was approved by u. Improving outcomes in systemic lupus erythematosus and. Belimumab for treating active autoantibody positive systemic. Belimumab is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus. Parts of the body affected by sle include the heart, skin, joints, kidneys, lungs, and brain. 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. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation. 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. Belimumab for systemic lupus erythematosus list of authors. It is the only biological agent currently approved for the treatment of nonrenal systemic lupus erythematosus sle.
Does the patient have a diagnosis of active, autoantibodypositive, systemic lupus erythematosus. Aug 29, 2012 belimumab trade name benlysta has been approved since july 2011 as an addon therapy for adult patients with the autoimmune disease systemic lupus erythematosus sle. How promising are biologic therapies in the treatment of systemic lupus erythematosus. Listing a study does not mean it has been evaluated by the u. Safety and efficacy of metformin in systemic lupus erythematosus. Systemic lupus erythematosus sle is one of the most challenging. 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 antiinflammatory drugs. Belimumab is approved in the eu, the usa and other countries as addon therapy. Prior approval supplemental biologics application 125370s068 provides for updates to the uspi regarding the safety and efficacy of benlysta in adult africanamerican. As in other autoimmune diseases, blymphocytes play a central role in lupus pathogenesis.
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