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    Benlysta

    Drugs - Benlysta (belimumab) [Human Genome Sciences]

    November 2011

    Therapeutic area - Systemic Lupus Erythematosus

    FDA approved indication

    BENLYSTA ® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

    Limitations of use

    The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

    Approval criteria

    • Patient must have a diagnosis of systemic lupus erythematosus (SLE) AND
    • Patient must have documentation that they are autoantibody positive, as evidenced by ANA (>1:80) and/or anti-dsDNA (>30IU/mL) AND
    • Patient must have documented SLEDAI SCORE and Physicians Global Assessment prior to treatment initiation AND
    • Patient must be currently receiving standard therapy consisting of either; corticosteroids (e.g. prednisone, methylprednisolone), immunosuppresives (e.g. azathioprine, methotrexate, mycophenolate) or antimalarials (e.g. hydroxychloroquine), and have been on a stable dose for at least 3 months

    Exclusion criteria

    • Diagnosis of severe active lupus nephritis OR 
    • Diagnosis of severe active central nervous system lupus OR 
    • Concomitant use of other biologics OR 
    • Concomitant use of intravenous cyclophosphamide OR
    • Active infection in last 60 days OR
    • Live vaccines within the last 30 days

    Initial and continuation of therapy approvals

    First approval will be limited to 3 months. Longer courses of therapy may be approved after documentation of clinical benefit from the patient's medical records maintained by the requesting practitioner verifying a reduction in the patient's signs and symptoms of SLE as evidence by medical progress notes.

    Live vaccines

    Combination of basal insulin and GLP-1 receptor agonists are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin or GLP-1 receptor agonist. They are not recommended as first-line therapy for patients inadequately controlled on diet and exercise.

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