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

BMC Medicine

Andrea Doria²  Yaakov Naparstek¹  Emese Kiss³  Mariele Gatto² 

[1] Senior Deputy Director General for Research and Academic Affairs, Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem 12000, Israel;Division of Rheumatology, University of Padova, Via Giustiniani, 2, Padova 35128, Italy;Rheumatology Division, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary

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

Others  :  854977
DOI  :  10.1186/1741-7015-12-30

 received in 2014-01-27, accepted in 2014-01-27,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Gatto et al.; licensee BioMed Central Ltd.

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