, Volume 27, Issue 3, pp 225–235

Belimumab Therapy in Systemic Lupus Erythematosus

Review Article

DOI: 10.1007/s40259-013-0031-8

Cite this article as:
Zouali, M. & Uy, E.A. BioDrugs (2013) 27: 225. doi:10.1007/s40259-013-0031-8


Systemic lupus erythematosus (SLE) is a complex heterogeneous disease, posing challenges to clinical trials. As in other autoimmune diseases, B-lymphocytes play a central role in lupus pathogenesis. The finding that selection and survival of B cells are controlled by a variety of signals, including those provided by the longevity factor BAFF (B-cell activating factor), also called BLyS (B-lymphocyte stimulator), led to preclinical trials that revealed that BAFF represents a promising therapeutic target for human lupus. Belimumab is a fully human monoclonal antibody directed against BAFF. Lessons learned from early clinical trials led to improved methods and success of phase III trials, with recruitment of patients with both clinically and serologically active disease, development and use of a novel SLE Responder Index, and progressive and special restrictions on immunosuppressive and corticosteroid use. These studies offer an attractive blueprint to conduct future clinical trials in SLE. The overall steroid-sparing ability and benefits of belimumab on musculoskeletal and mucocutaneous organ systems suggest that it has an impact on the clinical management of SLE patients. Future directions include studies to determine the role of belimumab in early SLE, as well as in renal or CNS involvement.

Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  1. 1.Inserm UMR-S 606ParisFrance
  2. 2.University Paris DiderotParisFrance
  3. 3.University of Santo Tomas HospitalManilaPhilippines
  4. 4.Metropolitan Medical CenterManilaPhilippines
  5. 5.Inserm U606, Centre Viggo Petersen, Hôpital LariboisièreParis Cedex 10France