Long-term efficacy and safety of rituximab in refractory and relapsing systemic lupus erythematosus

Nephrol Dial Transplant. 2010 Nov;25(11):3586-92. doi: 10.1093/ndt/gfq256. Epub 2010 May 11.


Background: Systemic lupus erythematosus is a relapsing autoimmune disease. Conventional therapy increases the risk of infection and malignancies; furthermore, a minority of patients suffer from refractory disease. B-cell depletion with the chimeric +AFw-anti-CD20 monoclonal antibody, rituximab, is an alternative therapy for relapsing and refractory systemic lupus erythematosus. We sought to assess the long-term efficacy and safety of rituximab in this patient subgroup.

Methods: Thirty-one sequential patients with relapsing or refractory systemic lupus erythematosus, 11 of whom had active lupus nephritis, received rituximab [either 375 mg/m(2)/week × 4 (n = 16) or 1000 mg × 2 (n = 15)]. The median follow-up was 30 months.

Results: Thirty of 31 (97%) patients had depleted peripheral B cells. Twenty-seven of 31 (87%) patients achieved remission (17 complete, 10 partial). Renal response occurred in 10/11 patients (4 complete, 6 partial) with active glomerulonephritis. Clinical improvement was reflected by reductions of disease activity, proteinuria and daily prednisolone dose. Eighteen of 27 (67%) patients relapsed after a median of 11 months. Relapses occurred on or after the return of circulating B cells in 10 but in the absence of B-cell return in 8. Re-treatment with rituximab was effective. Infusion reactions were common (18/31; 58%), and infections occurred in 8/31 (26%) patients.

Conclusions: Rituximab had a high rate of efficacy in relapsing or refractory systemic lupus erythematosus with or without renal involvement. Although relapse was common, it responded to re-treatment. The contribution of rituximab to infection risk was uncertain in view of the complex disease course and concomitant therapy of the patients studied.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Antinuclear / blood
  • Antibodies, Monoclonal, Murine-Derived / adverse effects
  • Antibodies, Monoclonal, Murine-Derived / therapeutic use*
  • Complement C3 / analysis
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Immunosuppressive Agents / therapeutic use
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / immunology
  • Lymphocyte Depletion
  • Male
  • Middle Aged
  • Proteinuria / drug therapy
  • Recurrence
  • Rituximab


  • Antibodies, Antinuclear
  • Antibodies, Monoclonal, Murine-Derived
  • Complement C3
  • Immunoglobulin G
  • Immunosuppressive Agents
  • Rituximab