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Open Access Commentary

In-/off-label use of biologic therapy in systemic lupus erythematosus

Mariele Gatto1, Emese Kiss23, Yaakov Naparstek4 and Andrea Doria1*

  • * Corresponding author: Andrea Doria

  • † Equal contributors

Author Affiliations

1 Division of Rheumatology, University of Padova, Via Giustiniani, 2, Padova 35128, Italy

2 Department of Clinical Immunology, Adult- and Paediatric Rheumatology, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary

3 Rheumatology Division, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary

4 Senior Deputy Director General for Research and Academic Affairs, Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem 12000, Israel

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BMC Medicine 2014, 12:30  doi:10.1186/1741-7015-12-30

Published: 17 February 2014


Current therapies for systemic lupus erythematosus (SLE) include corticosteroids as a persistent mainstay and traditional immunosuppressants which are given according to disease severity, organ involvement and patient status. No treatment entails certain efficacy devoid of mild-to-moderate adverse effects. Nowadays, novel therapies are being developed aiming to target specific molecules involved in SLE development and progression which show variable effectiveness and safety. Biologic agents considered for SLE comprise monoclonal antibodies (chimeric, humanized or fully human) as well as fusion molecules or antibody fragments mostly consisting of B cell-targeted therapies beside anti-cytokines as well as T cell-targeted therapies. Encouraging evidence on biologics is mostly provided by case series or uncontrolled studies; conversely, larger randomized controlled clinical trials have frequently missed their primary endpoints with the exception of BLISS-52 and BLISS-76 trials. Actually, apart from belimumab, biologics are employed in clinical practice as off-label treatments for lupus and results are often promising, depending on specific SLE features, dose regimens and individual responsiveness.

Systemic lupus erythematosus; Biologic therapy; Randomized controlled trials; Belimumab; Anti-B cell therapies