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

Mariele Gatto, E. Kiss, Yaakov Naparstek, Andrea Doria

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number30
JournalBMC Medicine
Volume12
Issue number1
DOIs
Publication statusPublished - Feb 17 2014

Fingerprint

Off-Label Use
Biological Therapy
Systemic Lupus Erythematosus
Cell- and Tissue-Based Therapy
Biological Products
Antibodies, Monoclonal, Humanized
Immunoglobulin Fragments
Biological Factors
Therapeutics
Immunosuppressive Agents
Adrenal Cortex Hormones
B-Lymphocytes
Randomized Controlled Trials
Cytokines
T-Lymphocytes
Safety

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

In-/off-label use of biologic therapy in systemic lupus erythematosus. / Gatto, Mariele; Kiss, E.; Naparstek, Yaakov; Doria, Andrea.

In: BMC Medicine, Vol. 12, No. 1, 30, 17.02.2014.

Research output: Contribution to journalArticle

Gatto, Mariele ; Kiss, E. ; Naparstek, Yaakov ; Doria, Andrea. / In-/off-label use of biologic therapy in systemic lupus erythematosus. In: BMC Medicine. 2014 ; Vol. 12, No. 1.
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