Citation

Chiche L, Jourde N, Thomas G, Bardin N, Bornet C, Darque A, Mancini J. Ther. Clin. Risk Manag. 2012; 8: 33-43.

Copyright

(Copyright © 2012, Dove Press)

DOI

10.2147/TCRM.S19819

PMID

unavailable

Abstract

Belimumab is the first biologic approved for patients with systemic lupus erythematosus (SLE). Belimumab is the first of a new class of drug targeting B cell-stimulating factors or their receptors to reach the market. Its target, BLyS, also known as BAFF (B cellactivating factor from the tumor necrosis factor family), is a type II transmembrane protein that exists in both membrane-bound and soluble forms. Additionally to a robust rational from murine experiments conducted in lupus prone mice, BLyS circulating levels are increased in SLE patients. After the negative results of a Phase II trial, two Phase III trials met their primary endpoints. Some SLE patients are still refractory to the standard options of care or necessitate prolonged high-dose corticotherapy and/or long-term immunosuppressive regimens. However, some experts still feel that the effect of this biologic might not be clinically relevant and blame the use of the new systemic lupus response index as well as the discrepancies between both trials and the noninclusion of the severe form of the disease as nephritis. In this review, we aim to discuss the characteristics of belimumab, critically evaluate the different steps of its development, and consider its future place in the arsenal against SLE, taking into account the patients' perspectives. © 2012 Chiche et al, publisher and licensee Dove Medical Press Ltd.

Language: en

Keywords

human; Treatment; depression; suicide attempt; treatment outcome; disease severity; Adverse effects; review; unclassified drug; neutropenia; thrombocytopenia; disease course; drug mechanism; acetylsalicylic acid; nonhuman; placebo; nonsteroid antiinflammatory agent; long term care; drug megadose; drug screening; corticosteroid; systemic lupus erythematosus; infection; drug half life; disease control; protein expression; Systemic lupus erythematosus; drug clearance; azathioprine; methylprednisolone; immunosuppressive treatment; treatment response; mycophenolic acid 2 morpholinoethyl ester; disease activity; methotrexate; injection site reaction; protein localization; cyclophosphamide; treatment duration; prednisolone; chloroquine; cyclosporin; thalidomide; drug targeting; prednisone; hydroxychloroquine; randomized controlled trial (topic); rituximab; corticosteroid therapy; nephritis; interleukin 4; cell activity; B cell activating factor; belimumab; phase 2 clinical trial (topic); phase 3 clinical trial (topic); a 623; amg 623; APRIL protein; atacicept; Belimumab; BLyS; interleukin 4 receptor; Monoclonal antibodies; tabalumab; transmembrane activator and CAML interactor