Benlysta mg solution for injection in pre-filled syringe. 2. available information, dose adjustment is not required in patients with mild, moderate or severe. Learn about BENLYSTA (belimumab), an FDA-approved prescription infusion or self-injectable lupus medication to help treat your Request your FREE Info Kit. Belimumab (Benlysta) is a biologic reference with prescribing information, dosage, medication administration, and possible side effects.
|Published (Last):||25 February 2011|
|PDF File Size:||3.69 Mb|
|ePub File Size:||4.11 Mb|
|Price:||Free* [*Free Regsitration Required]|
Aetna considers belimumab Benlysta medically necessary for the treatment of adults aged 18 years or older with active systemic lupus erythematosus SLE and positive autoantibody test e. Exclusion Criteria for Belimumab. Aetna considers continuing therapy with belimumab for the treatment of SLE medically necessary for persons aged 18 or older when the following criteria are met:. For precertification of belimumab, callor fax In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies —antibodies that attack and destroy the body’s own healthy tissues.
The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. Belimumab has not been evaluated and is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus or in combination with other biologic products or cyclophosphamide.
The incidence is most frequent in women aged 15 to 25 years. The disease predcribing many parts of the body including the brain, heart, joints, kidneys, lungs, and the skin.
When SLE flares, it can present benoysta chest pain, fatigue, fever, hair loss, benlgsta, light sensitivity, as well as swelling in the joints and joint pain Finnish Medical Society, Conventional treatments of SLE include anti-malarials e.
While therapeutic advances in immunosuppressive drugs e. No new drugs have been approved for SLE in over 50 years. Hence, a lot of hope and excitement has been generated by the development of biological agents designed to eliminate B cells either through direct killing anti-B cell antibodies such as rituximab or attrition by inhibition of survival anti-B-lymphocyte stimulator BLyS [also known asBAFF] agents such as belimumab. Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including auto-reactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Clinical trials of various phases have indicated that belimumab is beneficial for patients with SLE Furie et al, ; Wallace et al, ; Jacobi et al, ; Navarra et al, In benlystx phase I clinical study, Furie et al evaluated the safety, biological activity, and pharmacokinetics of belimumab in patients with SLE.
Patients were followed for 84 to days to assess adverse events, pharmacokinetics, peripheral blood B-cell counts, serology, and SLE disease activity. Data from the study venlysta summarized using descriptive statistics. Chi-square type tests were used to analyze discrete variables.
The Kruskal-Wallis test, the Wilcoxon test, and the analysis of co-variance were used to analyze the continuous variables, as appropriate. The analysis was performed on all randomized patients who received study agent. The incidences of adverse events and laboratory abnormalities were similar among the belimumab and placebo groups.
Belimumab pharmacokinetics were linear across the 1. Long terminal elimination half-life 8. The authors concluded that belimumab was well-tolerated and reduced peripheral B-cell levels in SLE patients.
In a phase II, randomized, double-blind, placebo-controlled, dose-ranging study, Wallace and colleagues evaluated the safety, tolerability, biological activity, and effectiveness of belimumab in combination with standard of care therapy SOC in informaton with active SLE.
Patients with a Safety of Estrogens in Lupus Erythematosus: Significant differences between the treatment and placebo groups were not attained for either primary end point, and no dose response was observed. The median time to first SLE flare was 67 days in the combined belimumab group versus 83 days in the placebo group. Informatio the subgroup The rates of adverse events and serious adverse events were similar in the belimumab and placebo groups.
The authors concluded that belimumab was biologically active and well-tolerated. The effect of belimumab on the reduction of SLE disease activity or flares was not significant.
Phenotypic analysis of lymphocytes was performed using flow cytometry. Circulating antibody-secreting cells were enumerated using enzyme-linked immunospot assay. Serum was analyzed by enzyme-linked immunosorbent assay using an antibody that recognizes products of the V H gene.
Lymphocyte counts, Ig levels, and anti-dsDNA antibody levels were available as part of the clinical trial analyses. Samples were collected on days 0, 84, and and after day The total number of B cells started to decrease from baseline between days 84 and This was due to a decrease in naive and transitional B cells.
Belimumab (Benlysta) – Medical Clinical Policy Bulletins | Aetna
There was only a modest decrease in the frequency of total IgM-producing, but not IgG-producing, cells on days andconsistent with the phenotypic and serologic data. The authors concluded that these findings confirm the dependence of newly formed B cells on BLyS for survival in humans. In contrast, memory B cells and plasma cells are less susceptible to selective BLyS inhibition.
Patients were randomly assigned by use of a central interactive voice response system in a 1: Patients, investigators, study coordinators, and sponsors were masked to treatment assignment. Method of analysis was by modified intention-to-treat. No malignant diseases were reported. The informayion concluded that belimumab has the potential to be the first targeted biological treatment that is approved specifically for SLE, providing a new option for the management of this important prototypic autoimmune disease.
On March 8,the U. Food and Drug Administration approved belimumab Benlysta for the treatment of adult patients with active, autoantibody-positive intormation lupus erythematosus who are receiving standard therapy, including anti-malarials, corticosteroids, immunosuppressives, and non-steroidal anti-inflammatory drugs. The label for Benlysta includes the following limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide.
Belimumab is administered intravenously over a 1-hour period; it should not be administered with live vaccines. The most common side effects associated with the use of belimumab include diarrhea, fever, and nausea. Patients also commonly experienced infusion reactions; thus, pre-treatment with an anti-histamine should be considered.
Belimumab has also been studied in the treatment of other autoimmune diseases such as lupus nephritis, multiple sclerosis, and rheumatoid arthritis Aran and Putterman, ; Hawker, ; Bingham, prrscribing However, in the absence of evidence based on large, randomized, placebo-controlled trials, the role of belimumab for these indications has yet to be established. The American Pprescribing of Rheumatology’s guidelines for screening, treatment, and management of lupus nephritis Hahn et al, notes that alternative therapies e.
Khattri and colleagues stated that the increased awareness of the role of humoral immunophysiology in anti-phospholipid syndrome APS has aroused interest in B cells as therapeutic targets in this disease.
These researchers reviewed the literature on B cell-directed therapies in human and experimental APS. Murine studies include use of modulators of B cell function e. In both human and murine studies, B cell-directed therapies appeared to have clinical and serologic beneficial effects including a decrease in the anti-phospholipid antibody titers after treatment.
O’Neill and Scully noted that biologic therapy has a potential to benefit patients with orofacial manifestations of Sjogren syndrome SS. The most appropriate use of biologics would appear to be in patients with severe or multi-system features of SS, but their use early in the pathogenesis has the potential to prevent disease progression.
Tumor necrosis factor-alpha blockade has not proven effective in SS. B-cell depletion using rituximab has been of benefit, mainly in relation to extra-glandular features, and to some extent in relation to hypo-salivation where there is still residual salivary function.
Rituximab is also effective in the treatment of SS-associated extra-salivary lymphomas, although the therapeutic response in salivary lymphoma is informatoin. Rituximab is given as a single or periodic intravenous infusion.
The authors concluded that further studies of rituximab in SS are ongoing, and newer agents under trial include belimumab. Jin and Ding summarized up-to-date pharmacological and clinical data of belimumab in the treatment of rheumatoid presdribing RA.
A literature search was performed on PubMed using keywords, including belimumab, LymphoStat-B, benlysta, BLyS inhibitor, rheumatoid arthritis and autoimmune disease. References of relevant studies were searched by hand. Abstracts of international conferences up to October were also included. Belimumab was well-tolerated in the treatment of RA over 24 weeks. It significantly increased American College of Rheumatology ACR 20 responses at week 24, especially in patients with high disease activity, positive rheumatoid factor, no anti-tumor necrosis factor TNF treatment experience and those who had failed methotrexate therapy.
The authors concluded that these results suggested that the clinical effectiveness of belimumab for RA needs to be further investigated in future clinical trials.
Careful patient selection may be necessary for belimumab to achieve optimal clinical outcomes in RA. In a single-arm, phase II benlystq trial, Bishton et al evaluated the safety and activity of belimumab in 12 patients with Waldenstrom macroglobulinemia WM. A total of 10 patients had stable disease with therapy, although no objective responses were seen. Correlative studies showed patients to have low or undetectable baseline serum levels of B-lymphocyte stimulator, with the administration of belimumab having no effect on B-cell numbers.
The authors concluded that belimumab cannot be recommended as a single-agent therapy for the treatment of symptomatic WM, although further evaluation in combination with other agents would be justified.
Furuta and Jayne noted that the current standard therapy for anti-neutrophil cytoplasm antibody-associated vasculitis AAVhigh-dose glucocorticoid and cyclophosphamide followed by azathioprine, has improved the disease prognosis.
However, there are still prescribjng needs. For example, reducing relapse risk and glucocorticoid toxicity; newer therapies are needed. These researchers stated that potential newer drugs are emerging following a better understanding of disease mechanisms and the availability of targeted therapies to B cells, T cells, pro-inflammatory cytokines and complement.
Rituximab has proven efficacy in remission induction therapy for AAV, and 2 trials with rituximab as remission maintenance therapy are ongoing. Clinical trials evaluating mycophenolate mofetil as remission induction infomration, gusperimus, belimumab and complement prescrbiing C5a inhibition are also ongoing, and many other potential candidates are being investigated both clinically and experimentally.
The authors benllysta that B-cell therapy is now an established treatment in AAV and several other therapies are under evaluation. However, the unmet need in vasculitis therapy remains large and newer therapies either alone or in combination will need to both improve efficacy and permit reductions in glucocorticoid and immunosuppressive exposure. Schwartz et al stated that renal involvement is a major cause of morbidity prescriving mortality in SLE.
These researchers provided an update on recent discoveries in the pathogenesis, diagnosis, and treatment of lupus nephritis. Localized long-lived plasma cells have been identified as playing an important role in lupus nephritis. In addition, the roles of aberrant expression of microRNAs and pro-inflammatory cytokines have been explored. Early diagnosis is important for effective treatment and multiple biomarkers have been identified; however, none has been yet validated for clinical use.
Biomarker panels may turn out to be more accurate than each individual component. Biologic agents for the treatment of lupus nephritis are being studied, including belimumab which was recently benlysts for non-renal SLE. Rituximab has not proven itself in large, placebo-controlled trials, although it belnysta still being used in refractory cases of lupus nephritis.