Search

Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra-renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra-renal SLE., Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ-specific parameters and immunological parameters, including anti-double stranded DNA and C3. Steroid-sparing effect of mycophenolate sodium was also evaluated., Results: Mycophenolate sodium produced 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. No major adverse events were reported in this study., Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra-renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non-renal SLE is warranted., (© 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.)

Objective: Metabolic disturbances are common in patients with renal function impairment and are related to high rates of cardiovascular incidents and mortality. Kidney transplantation leads to improved survival but may lead to additional metabolic alterations caused by immunosuppressive drugs and improved nutrition., Materials and Methods: The short-term effect of oral fructose load on serum uric acid (UA), plasma lipids, and blood pressure (BP) was studied in 85 patients with chronic kidney disease (CKD) and impairment of renal function (glomerular filtration rate 50-65 ml/min per 1.73 m(2)), comprising 55 renal transplant recipients (RTR) treated with standard triple immunosuppressive therapy including a calcineurin inhibitor (CNI) cyclosporine A (CsA) or tacrolimus (Tac) and 30 non-transplanted patients with CKD. Both non-transplanted CKD patients and RTR had stable renal function and a comparable degree of kidney dysfunction. All subjects received orally 70 g of fructose dissolved in 200 ml of water. Serum UA, lipids, and blood pressure were measured at baseline and 60, 120, 180, and 240 minutes after fructose administration., Results: There was a significant increase of serum UA concentration (p<0.001) in both CKD patients and RTR--CsA- or Tac-treated patients comparable in the latter. Total cholesterol (TC), LDL, and HDL cholesterol significantly decreased and serum triglycerides (TG) markedly increased in RTR, whereas in CKD patients all serum lipid fractions increased. Blood pressure was unaffected by fructose intake., Conclusion: Both non-transplanted and transplanted patients with mild renal function impairment show similar acute purine metabolic disturbances following oral administration of fructose but in the latter dietary fructose may induce a smaller hyperlipidemic response., (© 2013 Elsevier Inc. All rights reserved.)

Background: Mycophenolate mofetil (MMF) has enjoyed increasing popularity as an emerging immunosuppressant treatment for various autoimmune dermatologic conditions, including pyoderma gangrenosum (PG)., Objective: The aim of this study was to examine the efficacy and safety of MMF as used in PG., Methods: A retrospective chart review was conducted for all patients with PG treated with MMF at our institution (Victoria, Australia) for the past 11 years (2001-2012)., Results: We identified 26 patients, 14 female and 12 male. Nine patients (34.6%) had associated systemic conditions. All patients received prednisolone. MMF was used as a first-line steroid-sparing agent in 11 patients (42.3%), second-line in 14 (53.8%), and third-line in 1 (3.85%). The average duration of treatment was 12.1 months. Fourteen patients experienced side effects (53.8%), although most were mild (26.9%). One patient died after a sigmoid colon perforation (3.85%). Overall 22 patients demonstrated clinical improvement during MMF treatment (84.6%). Thirteen patients achieved complete ulcer healing (50%), 10 while taking MMF and 3 after ceasing it., Limitations: This is a retrospective study based on a single-center cohort., Conclusion: Our experience suggests that MMF is highly efficacious in PG together with prednisolone, or as part of combination therapy with other immunosuppressants., (Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

Introduction: Mycophenolate sodium, an enteric-coated tablet (EC-MPS), is as effective and safe as mycophenolate mofetil (MMF) in preventing transplant rejection. EC-MPS and MMF improve the outcome of severe lupus nephritis (LN) and have fewer side effects than pulsed intravenous cyclophosphamide. Blood concentrations of mycophenolic acid (MPA), the active metabolite of EC-MPS, vary between participants despite fixed dosing. Interpatient variability has been studied in transplantation, but not well documented in LN. The relationship between MPA concentration and its clinical effect on LN has not been described., Methods and Analysis: This is a prospective, open-label, randomised controlled trial. -32 participants with LN who meet the inclusion and exclusion criteria will be randomised into two groups: one receiving a fixed dose of EC-MPS and the second, a dosing regimen that is titrated with therapeutic drug monitoring. Included participants will have blood sampled over a period of 8-12 h on three different occasions. Pharmacokinetic parameters will be calculated using non-compartmental methods., Ethics and Dissemination: The Human Research and Ethics Committee of the Royal Brisbane Women's Hospital have approved this study. The study is registered with Australian and New Zealand Clinical Trials Registry-ACTRN12611000798965 We planned to present the de-identified information at conferences and publish the results in medical journals., Trial Registration: ACTRN12611000798965.

Introduction: Renal transplant recipients are at increased risk of venous thromboembolic events, which is in part caused by their treatment with maintenance immunosuppressive drugs. Because we observed an increased incidence of venous thromboembolic events in renal transplant recipients treated with the mTOR inhibitor (mTORi) everolimus, we aimed to identify prothrombotic mechanisms of this immunosuppressive drug., Materials and Methods: In a single center study, nested in a multi-center randomized controlled trial, we measured parameters of coagulation, anti-coagulation and fibrinolysis in renal transplant recipients, receiving the mTORi everolimus (n=16, mTOR group) and compared them to a similar patient group, receiving a calcineurin inhibitor and/or mycophenolate sodium (n=20, non-mTOR group). All patients were at least 6 months following transplantation with a stable transplant function., Results: The use of an mTORi was associated with significantly higher levels of von Willebrand factor, prothrombin fragment 1+2, thrombin-activatable fibrinolysis inhibitor and plasminogen activator inhibitor-1 as compared to a non-mTORi based immunosuppressive regimen., Conclusions: Treatment with an mTORi leads to increased endothelial activation, thrombin formation and impaired fibrinolysis in renal transplant recipients. This suggests an increased risk of thrombotic events in renal transplant recipients treated with mTOR inhibitors. A prospective study to establish the precise risk of thrombotic events in these patients is urgently needed., (© 2013.)