Can Kevzara (sarilumab) be used to treat lupus?

Sarilumab (Kevzara) Is Not Recommended for Lupus Treatment

Sarilumab (Kevzara) is not currently recommended for the treatment of systemic lupus erythematosus (SLE) or lupus nephritis as there is no evidence supporting its efficacy for this condition and it is not FDA-approved for this indication. 1

Current Approved Indications for Sarilumab

• Sarilumab (Kevzara) is only FDA-approved for the treatment of moderate to severe rheumatoid arthritis in adults who have had an inadequate response to or are intolerant of one or more disease-modifying antirheumatic drugs (DMARDs) 2, 3
• It is a fully human IgG1 monoclonal antibody that specifically binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), inhibiting IL-6-mediated signaling 3
• While sarilumab has shown efficacy in rheumatoid arthritis, there are no clinical trials evaluating its use in lupus or lupus nephritis 4, 5

Recommended Treatments for Lupus and Lupus Nephritis

First-Line Treatments for Lupus

• Hydroxychloroquine is strongly recommended for all patients with SLE, including those with lupus nephritis, unless contraindicated 1
• For non-renal manifestations, conventional DMARDs like methotrexate or azathioprine are typically used 1

First-Line Treatments for Lupus Nephritis

For active Class III or IV lupus nephritis, current guidelines recommend glucocorticoids plus one of the following:

1. Mycophenolic acid analogs (MPAA) 1
2. Low-dose intravenous cyclophosphamide 1
3. Belimumab with either MPAA or low-dose cyclophosphamide 1
4. MPAA with a calcineurin inhibitor when kidney function is not severely impaired 1

Biologic Therapies with Evidence for Lupus

• Rituximab: May be considered for refractory lupus nephritis that has failed standard therapies 1
• Belimumab: FDA-approved for SLE and lupus nephritis, with evidence showing it can reduce proteinuria and the risk of kidney flares when added to standard therapy 1
• Obinutuzumab: May be considered for patients with refractory lupus nephritis who have failed standard therapies, particularly those with high baseline proteinuria 6

Why Sarilumab Is Not Used for Lupus

• Despite both lupus and rheumatoid arthritis being autoimmune diseases, they have different pathophysiological mechanisms 1
• While IL-6 inhibition is effective in rheumatoid arthritis, there is insufficient evidence to support its use in lupus 1, 2
• Current guidelines for lupus nephritis (EULAR/ERA-EDTA and KDIGO) do not mention sarilumab as a treatment option 1
• Off-label use of biologics in lupus is generally limited to those with established evidence, such as rituximab 1

Treatment Algorithm for Lupus Nephritis

1. Initial therapy for Class III/IV lupus nephritis:

   • Glucocorticoids plus either MPAA, low-dose cyclophosphamide, belimumab with MPAA/cyclophosphamide, or MPAA with calcineurin inhibitor 1
   • Hydroxychloroquine should be added unless contraindicated 1

2. For refractory disease:

   • Switch from MPAA to cyclophosphamide or vice versa 1
   • Consider rituximab 1
   • Consider obinutuzumab, particularly for patients with high baseline proteinuria 6

3. Maintenance therapy:

   • MPAA or azathioprine for at least 3 years 1
   • Low-dose glucocorticoids (5-7.5 mg/day) 1

Conclusion

For patients with lupus or lupus nephritis, treatment should focus on evidence-based therapies recommended in current guidelines. Sarilumab (Kevzara) should not be used for lupus treatment as there is no clinical evidence supporting its efficacy in this condition, and it is not included in any treatment guidelines for lupus.