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Mycophenolate Mofetil in Systemic Lupus Erythematosus: Efficacy and Tolerability in 86 Patients
CECILIA N. PISONI, FRANCISCO J. SANCHEZ, YOUSUF KARIM, MARIA J. CUADRADO, DAVID P. D'CRUZ, IAN C. ABBS, MUNTHER A. KHAMASHTA, and GRAHAM R.V. HUGHES
ABSTRACT.
Objective. To assess the indications, efficacy, and tolerability of mycophenolate mofetil (MMF) in patients with systemic lupus erythematosus (SLE) resistant to other immunosuppressive therapy. Methods. Records of 93 patients with SLE were retrospectively reviewed. Seven patients were excluded. The remaining 86 patients received other immunosuppressive drugs before MMF. Efficacy was measured by changes in daily oral prednisolone dose, European Consensus Lupus Activity Measurement Index (ECLAM), erythrocyte sedimentation rate (ESR), C-reactive protein, and dsDNA antibody titer. In renal patients, changes in serum creatinine, creatinine clearance, chromium-51 EDTA glomerular filtration rate (EDTA-GFR), and 24 hour urine protein excretion were also evaluated. Results. Indications for MMF were mainly renal involvement (59% of patients), uncontrolled disease activity (14%), and other SLE related manifestations (13%). Overall, we found a significant reduction in the steroid dosage, ECLAM, ESR, and anti-dsDNA antibody titer. Renal patients (n = 35) showed a significant reduction in urinary 24 hour protein excretion. Levels of serum creatinine, creatinine clearance, and EDTA-GFR showed no significant change during treatment. Thirty-seven patients (42.8%) developed adverse events. Gastrointestinal intolerance in 25 (29%) and infections in 20 (23.2%) were the most frequent. The drug was discontinued in 14 (16.3%) patients due to side effects and 6 patients discontinued MMF because they achieved disease remission and were trying to conceive. MMF was stopped due to lack of efficacy in 12 patients. Conclusion. Our data suggest that MMF is a good therapeutic alternative for patients with SLE and renal involvement or refractory disease activity. (J Rheumatol 2005;32:1047-52) Key Indexing Terms:
MYCOPHENOLATE MOFETIL
From the Lupus Research Unit, The Rayne Institute, St. Thomas' Hospital, London, UK. C.N. Pisoni, MD, Research Fellow; F.J. Sanchez, MD, Research Fellow; Y. Karim, MRCP, MRCPath, Lecturer in Immunology; M.J. Cuadrado, MD, PhD, Consultant Rheumatologist; D.P. D'Cruz, MD, FRCP, Consultant Rheumatologist; I. Abbs, BSc, FRCP, Consultant Nephrologist; M.A. Khamashta, MD, PhD, FRCP, Consultant Physician; G.R.V. Hughes, MD, FRCP, Consultant Rheumatologist. Address reprint requests to Dr. C.N. Pisoni, Lupus Research Unit, The Rayne Institute, St. Thomas' Hospital, 4th floor, Lambeth Wing, Lambeth Palace Road, London SE1 7EH, UK. E-mail: ceciliapisoni@yahoo.com.ar Accepted for publication December 13, 2004. |