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

Mariele Gatto, Emese Kiss, Yaakov Naparstek, Andrea Doria

Research output: Contribution to journalComment/debate

26 Citations (Scopus)


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
Issue number1
Publication statusPublished - Feb 17 2014


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

ASJC Scopus subject areas

  • Medicine(all)

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