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AB0370 An open label trial assessing the efficacy of mycophenolate sodium in active systemic lupus erythematosus patients without renal impairment
  1. F. Yahya1,
  2. R. Jasmin1,
  3. T. E. Cheah1,
  4. C. T. Ng1,
  5. S. Sockalingam1
  1. 1Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia

Abstract

Background Systemic lupus erythematosus (SLE) is an autoimmune disease which is associated with a wide range of clinical, immunological and haematological manifestations. There is an inflammatory response which involves a number of auto antibodies directed at self antigens. The use of mycophenolate is currently becoming more widely used in the treatment of SLE.(1-3) Due to paucity of data in using mycophenolate sodium in SLE, we designed a prospective study to assess the efficacy and safety of this medication in active SLE patients without renal involvement (non-renal SLE).

Objectives This study aimed to assess the efficacy of mycophenolate sodium in active SLE patients without renal involvement.

Methods A total of 14 active SLE patients without renal involvement were randomised either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Score (SLEDAI) score, other organ specific parameters and immunological parameters including anti-dsDNA and C3. Steroid-sparing effect of mycophenolate sodium was also evaluated.

Results Mycophenolate sodium had a significant reduction in SLEDAI scores (p<0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ-specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. However, both of these results were not statistically significant. No major adverse events were reported in the study.

Conclusions In conclusion, mycophenolate sodium can be considered as a safe alternative immunosuppressant in the treatment of SLE with extra renal manifestations. Due to the limitations in the study, a larger prospective study should be performed to explore its efficacy in SLE.

  1. Bandelier C, Guerne PA, Genevay S, Finckh A, Gabay C. Clinical experience with mycophenolate mofetil in systemic autoimmune conditions refractory to common immunosuppressive therapies. Swiss medical weekly. 2009;139(3-4):41-6. Epub 2009/01/27.

  2. Fine DM. Pharmacological therapy of lupus nephritis. JAMA : the journal of the American Medical Association. 2005;293(24):3053-60. Epub 2005/06/24.

  3. Gaubitz M, Schorat A, Schotte H, Kern P, Domschke W. Mycophenolate mofetil for the treatment of systemic lupus erythematosus: an open pilot trial. Lupus. 1999;8(9):731-6. Epub 1999/12/22.

Acknowledgements We would like to thank Novartis for supplying the medications and other healthcare staff who were involved in this study.

Disclosure of Interest F. Yahya Grant/research support from: Novartis, R. Jasmin Grant/research support from: Novartis, T. E. Cheah Grant/research support from: Novartis, C. T. Ng Grant/research support from: Novartis, S. Sockalingam Grant/research support from: Novartis

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