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Table 1 Biologic therapies proposed for SLE a

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

  Drug Type of molecule RCT phase Pros for use in SLE Cons for use in SLE References
Anti-B cell therapies Rituximab Chimeric anti-CD20 mAb Phase III • Significantly decreased anti-dsDNA antibody titers and increased complement levels vs. placebo. Significantly decreased lupus non-renal flares in Hispanic and African American patients • Did not significantly improve lupus outcome in either renal or non-renal SLE in large cohorts of SLE patients [2, 3]
Ocrelizumab Humanized anti-CD20 mAb Phase III • Significantly increased complement levels and decreased anti-dsDNA titers through week 48 vs. placebo • No significant improvement in renal outcome [15]
• Induced numerically (non-statistically) significant greater renal response vs. placebo • Serious infections in treated patients vs. placebo when added to MMF
Epratuzumab Humanized anti-CD22 mAb Phase IIb • Provided clinical improvement in patients receiving ≥2,400 mg cumulative dose • No significant BILAG improvement after 12 weeks treatment vs. placebo [5]
• Steroid-sparing effect
Belimumab Fully human anti-BlyS mAb Phase III • Significant improvement in moderate-persistent active SLE outcome and decreased flare rates in phase III RCTs (met primary endpoints) • No BILAG assessment [8, 9]
No data on CNS or severe renal involvement
• Significant decrease in anti-dsDNA antibody titers • No advantages by treatment continuation through week 76 (but in post-hoc analysis)
• Steroid-sparing effect
Atacicept Soluble fully human recombinant anti-APRIL fusion protein Phase II • Not availableb • Serious infections and decreased immunoglobulin levels in patients receiving MMF or corticosteroids prior to atacicept [6]
Anti-co-stimulatory molecules Abatacept CTLA4-Ig fusion protein Phase IIb • Reduced BILAG A polyarthritis flares in a phase IIb RCT • Did not reduce overall disease flares vs. placebo in either renal or non-renal SLE [10]
IDEC-131 Humanized anti-CD40 ligand mAb Phase II • Ameliorated SLEDAI in a phase II RCT • No significant superiority to placebo [11, 12]
• Increased risk of thromboembolic events
Anti-cytokines therapies Infliximab Chimeric anti-TNF soluble mAb No RCT performed • Effective on refractory arthritis, nephritis and skin lesions in open-label studies • Severe adverse events following treatment, for example, thrombosis, infections [16, 17]
• Reduction in SLEDAI and SLICC-DI in pilot studies after short-term induction treatment • Induction of pathological/pathogenetic autoantibodies (anti-dsDNA, anti-phospholipid antibodies)
• Increase in IFNα levels following protracted administration
Tocilizumab Humanized IgG1 anti-IL6R mAb Phase I • Significantly reduced SELENA-SLEDAI score (main improvement on arthritis) • Neutropenia and serious infections [18]
• Significantly reduced IgG anti-dsDNA antibody levels • No data on severe SLE
Anakinra Non glycosylated IL1Ra No RCT performed • Improved arthritis in an open-label trial • No long-lasting effect [4]
• No extensive data are available due to very low patients number
Sifalimumab Human mAb blocking multiple IFNα subtypes Phase I • Significantly reduced the rate of disease flares vs. placebo • No data on severe SLE [19]
• Lower request of immunosupressor vs. placebo
  1. aOnly biologic therapies for which published clinical studies are currently available are listed.
  2. bthe study was prematurely terminated and no efficacy measures were undertaken.
  3. anti-dsDNA, anti-double stranded DNA; APRIL, A PRoliferation Inducing Ligand; BILAG, British Isles Lupus Assessment Group; BLyS, B Lymphocyte Stimulator; CNS, central nervous system; IFNα, interferon alpha; IgG, class G immunoglobulin; IL1Ra, interleukin 1 receptor antagonist; IL6R, interleukin-6 receptor; mAb, monoclonal antibody; MMF, mycophenolate mofetil; RCT, randomized controlled trial; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SLICC-DI, Systemic Lupus International Collaborating Clinics group Damage Index; TNFα, tumor necrosis factor alpha.