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.

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While therapeutic advances in immunosuppressive drugs e.

Belimumab (Benlysta) – Medical Clinical Policy Bulletins | Aetna

Prescribbing patient was benlhsta on add-on belimumab with quasi-immediate effect on the proteinuria, making it possible to decrease the dosage of the other immunosuppressants and gradually stop them, even the GCS.

No new drugs have been approved for SLE in over 50 years. 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.

The presence of autoantibodies appears to correlate with disease severity. The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52, with RF decreasing further.

Jin and Ding summarized up-to-date pharmacological and clinical data of belimumab in the treatment of rheumatoid arthritis RA. 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.

Ann Int Med ; Method of analysis was by modified intention-to-treat. Case series and literature review. Abnormal serum level of IgG or IgM anticardiolipin antibodies A positive test result for lupus anticoagulant using a standard method A false-positive test result for at least 6 months and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption tests Positive antinuclear antibody An abnormal titer of antinuclear antibody by immunofluorescence or an equivalent assay at any point in time in the absence of drug Source: Dobrowolski C, Erkan D.

The dosage for subcutaneous belimumab is mg once weekly.


Regimens for the treatment of AMR continue to evolve with varying success reported with regards to antibody clearance and improving clinical outcomes.

Prescribint with primary SS were included in the BELISS study, a 1-year open-label trial, if they were positive for anti-SSA or anti-SSB antibodies and had systemic complications or persistent salivary gland enlargement or early disease or biomarkers of B-cell activation. Aran AA, Putterman C.

There were no significant differences between the groups in the number of AEs. In a phase II clinical trial, De Vita and colleagues examined the safety and effectiveness of long-term treatment of SS with belimumab. For precertification of belimumab, callor fax Note: FDA; March 11, Biologic agents for the treatment of lupus nephritis are being studied, including belimumab which was recently approved for non-renal SLE.

The authors concluded that further studies of rituximab in SS are ongoing, and newer agents under trial include belimumab.

Current data suggests that conventional approaches are of sub-optimal efficacy, but emerging therapeutic agents with diverse biological mechanisms offer promise for improved AMR treatment.

She presented initially with chronic dacryoadenitis and screening showed nephrotic-range proteinuria. Since the introduction of etanercept inseveral biotechnological agents have been developed, most of them indicated in the treatment of RA, but also psoriatic arthritis. Belimumab for the treatment of recalcitrant cutaneous lupus.

Belimumab (Benlysta)

In a phase I clinical study, Furie et al evaluated the safety, biological activity, and pharmacokinetics of belimumab in patients with SLE.

Furuta S, Jayne D. Inrormation of refractory discoid lupus and subacute cutaneous lupus. The most common side effects associated with the use of belimumab include diarrhea, fever, and nausea.

The highest-quality studies were selected for meta-analysis.

Belimumab for the beenlysta of early diffuse systemic sclerosis: The disease affects many parts of the body including the brain, heart, joints, kidneys, lungs, and the skin. Oral or nasopharyngeal ulceration, usually painless, observed by a physician. Review History Review History. It significantly increased American College of Rheumatology ACR 20 responses at week 24, especially in patients with high disease activity, positive presceibing factor, no anti-tumor necrosis factor TNF treatment experience and those who had failed methotrexate therapy.


Autologous stem cell transplantation showed the best therapeutic efficacy on skin and internal organs, and looks very promising, as modification of transplantation immunosuppression is decreasing the early high mortality.

Belimumab is administered intravenously over a 1-hour period; it should not be administered with live vaccines. The authors concluded that long-term treatment with belimumab informqtion be beneficial in SS; randomized, double-blind, controlled studies in larger populations are encouraged. Biologics in oral medicine: The authors also presented a literature review concerning the safety and efficacy of belimumab in Genlysta. In both cases, MMF, as induction therapy, was poorly tolerated because of gastro-intestinal GI toxicity.

The rates of adverse events and serious adverse events were similar in the belimumab and placebo groups. Acetylcholine receptor antibody levels decreased over time in both treatment groups.

ICD orescribing covered if selection criteria are met: However, there are still unmet needs. 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.

B-cell-targeted treatment for multiple sclerosis: For example, reducing relapse risk and glucocorticoid toxicity; newer therapies are needed. Patients were randomly assigned by use of a central benlystz voice response system in a 1: The authors 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.

Data from the study were summarized using descriptive statistics. Belimumab, together with low-doses of MMF, was effective as induction lnformation leading to early achievement of complete renal response in these 2 selected cases of LN.