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Belimumab

In Systemic Lupus Erythematosus

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Abstract

Belimumab is a fully human recombinant IgG1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells and hence prevents the survival and differentiation of selected B-cell subsets. It is available in the US, the EU and Canada for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite receiving standard therapy.

At 52 weeks, a significantly greater proportion of belimumab 10 mg/kg than placebo recipients experienced a response as assessed by the SLE Responder Index (primary endpoint) in the randomized, double-blind, multinational, phase III BLISS-52 and BLISS-76 trials in patients with active seropositive SLE receiving standard therapy.

A significantly greater proportion of belimumab than placebo recipients achieved a ≥4 point reduction in the SELENA-SLEDAI score at week 52 in both BLISS trials. However, the SLE Responder Index response rate was not significantly different between belimumab and placebo at 76 weeks in BLISS-76.

Belimumab was generally well tolerated in the BLISS trials. During the double-blind periods of these trials and the phase II trial, twice as many deaths were reported with belimumab than placebo (six vs three). There were no meaningful differences between the incidence of serious infections and malignancies with belimumab or placebo.

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Acknowledgements and Disclosures

The manuscript was reviewed by: R. Cervera, Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Spain; M.A. Khamashta, Lupus Research Unit, The Rayne Institute, St Thomas’ Hospital, London, United Kingdom.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author(s) on the basis of scientific and editorial merit.

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  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, Auckland, 0754, New Zealand

    Celeste B. Burness & Paul L. McCormack

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  1. Celeste B. Burness
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  2. Paul L. McCormack
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Correspondence to Celeste B. Burness.

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Burness, C.B., McCormack, P.L. Belimumab. Drugs 71, 2435–2444 (2011). https://doi.org/10.2165/11208440-000000000-00000

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