title: Pharmacokinetics of mycophenolate mofetil for autoimmune disease in children.
abstract: This study describes the pharmacokinetics of mycophenolate mofetil (MMF) in 15 pediatric patients with vasculitis and connective tissue disease involving the kidney. Patients included 10 with systemic lupus erythematosus (SLE), 1 with antiphospholipid antibody syndrome, 2 with Wegener granulomatosis, and 1 each with Goodpasture syndrome, Henoch-Schönlein-associated nephritis, and 1 with severe tubulointerstitial nephritis and uveitis. All patients were treated with steroids and additional therapy prior to treatment with MMF, which was administered for a median of 491 days. Mean starting dose of MMF was 974+/-282 mg/m(2 )in two divided doses. Pharmacokinetic monitoring of the active compound of MMF, mycophenolic acid (MPA), was performed using an EMIT assay. The mean MPA AUC after a median of 39 days was 61.8+/-31.0 micro gxh/ml, median time to maximum concentration was 60 min, and mean maximum concentration was 18.5+/-8.4 micro g/ml. At last follow-up, mean MMF dose was 900+/-341 mg/m(2) per day, and mean trough MPA concentration was 3.1+/-1.1 (range 0.6-4.6) micro g/ml. Therapy was effective in inducing remission in 4 of 9 patients with active disease. Only 1 of the 5 other patients relapsed. All 6 patients with controlled disease maintained remission. There were few side effects: one episode each of diarrhea and leukocytopenia and two viral infections. We conclude that MMF at 900 mg/m(2) per day appears to be effective in these patients.
authors.affiliation: Department of Pediatrics, Division of Nephrology, Children's Hospital of Eastern Ontario, University of Ottawa, 401 Smyth Road, K1H 8L1, Ottawa, Ontario, Canada. filler@cheo.on.ca
authors.forename: Guido
authors.initials: G
authors.lastname: Filler
authors.forename: Miriam
authors.initials: M
authors.lastname: Hansen
authors.forename: Claire
authors.initials: C
authors.lastname: LeBlanc
authors.forename: Nathalie
authors.initials: N
authors.lastname: Lepage
authors.forename: Doris
authors.initials: D
authors.lastname: Franke
authors.forename: Ingrid
authors.initials: I
authors.lastname: Mai
authors.forename: Janusz
authors.initials: J
authors.lastname: Feber
mesh_terms: D000293:Adolescent; D019867:Anti-Glomerular Basement Membrane Disease / Q000188:drug therapy; D016736:Antiphospholipid Syndrome / Q000188:drug therapy; D001327:Autoimmune Diseases / Q000188:drug therapy*; D002648:Child; D005260:Female; D014890:Granulomatosis with Polyangiitis / Q000188:drug therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*; D009395:Nephritis, Interstitial / Q000188:drug therapy; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid