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      Mycophenolate Mofetil for Remission Induction in Severe Lupus Nephritis

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          Abstract

          Background: Mycophenolate mofetil (MMF) is a potential alternative immunosuppressive to cyclophosphamide or azathioprine for the treatment of lupus nephritis. It has a superior toxicity profile to cyclophosphamide and is more effective than azathioprine when used in combination with cyclosporin for renal transplantation. Methods: This open label study assessed the safety and efficacy of an induction regimen of MMF and prednisolone in 24 patients, with active WHO Class III, IV or V lupus nephritis, without previous exposure to cyclophosphamide or MMF. Patients received MMF 2 g/day and a tapering dose of oral prednisolone and were followed for 12 months. Renal response was defined using the validated BILAG (British Isles Lupus Assessment Group) Index. Results: 20 patients achieved complete renal remission, 2 partial renal remission and 2 had renal disease refractory to MMF. Five patients were withdrawn, 2 for progressive renal disease, 2 for extra-renal flares and 1 following a severe infection. No patient was withdrawn for drug intolerance. There were 18 adverse events of which 10 were infections. Clinical improvement was mirrored by normalisation of complement levels and marked falls in circulating anti-double-stranded DNA antibodies. Follow-up for a mean period of 35 months documented only one episode of renal relapse which subsequently remitted with re-introduction of MMF. One patient died after 18 months’ follow-up with uterine malignancy. Conclusions: MMF with prednisolone was effective for remission induction in severe lupus nephritis and was well tolerated.

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          Most cited references 11

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          Efficacy of mycophenolate mofetil in patients with diffuse proliferative lupus nephritis. Hong Kong-Guangzhou Nephrology Study Group.

          The combination of cyclophosphamide and prednisolone is effective for the treatment of severe lupus nephritis but has serious adverse effects. Whether mycophenolate mofetil can be substituted for cyclophosphamide is not known. In 42 patients with diffuse proliferative lupus nephritis we compared the efficacy and side effects of a regimen of prednisolone and mycophenolate mofetil given for 12 months with those of a regimen of prednisolone and cyclophosphamide given for 6 months, followed by prednisolone and azathioprine for 6 months. Complete remission was defined as a value for urinary protein excretion that was less than 0.3 g per 24 hours, with normal urinary sediment, a normal serum albumin concentration, and values for serum creatinine and creatinine clearance that were no more than 15 percent above the base-line values. Partial remission was defined as a value for urinary protein excretion that was between 0.3 and 2.9 g per 24 hours, with a serum albumin concentration of at least 30 g per liter. Eighty-one percent of the 21 patients treated with mycophenolate mofetil and prednisolone (group 1) had a complete remission, and 14 percent had a partial remission, as compared with 76 percent and 14 percent, respectively, of the 21 patients treated with cyclophosphamide and prednisolone followed by azathioprine and prednisolone (group 2). The improvements in the degree of proteinuria and the serum albumin and creatinine concentrations were similar in the two groups. One patient in each group discontinued treatment because of side effects. Infections were noted in 19 percent of the patients in group 1 and in 33 percent of those in group 2 (P = 0.29). Other adverse effects occurred only in group 2; they included amenorrhea (in 23 percent of the patients), hair loss (19 percent), leukopenia (10 percent), and death (10 percent). The rates of relapse were 15 percent and 11 percent, respectively. For the treatment of diffuse proliferative lupus nephritis, the combination of mycophenolate mofetil and prednisolone is as effective as a regimen of cyclophosphamide and prednisolone followed by azathioprine and prednisolone but is less toxic.
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            Remission, relapse, and re-remission of proliferative lupus nephritis treated with cyclophosphamide.

            Remission, relapse, and re-remission of proliferative lupus nephritis treated with cyclophosphamide. Long-term intravenous cyclophosphamide (IVC) in combination with corticosteroids is standard therapy for proliferative lupus nephritis, but it has limitations. There are few data on long-term remission rates, predictors of relapse, and the ability to achieve a second remission with currently recommended IVC regimens. A cohort of 85 patients with proliferative lupus glomerulonephritis (focal N = 33, diffuse N = 52) treated with IVC was assembled in three institutions. Timing and predictors of remission, relapse, and re-remission were evaluated with Kaplan-Meier analyses and Cox models. The median time to remission was 10 months, whereas an estimated 22% of patients had not remitted after 2 years. The median time to relapse among 63 patients who had achieved remission was 79 months. In multivariate models, adverse predictors of remission were a delay in the initiation of therapy from the time nephritis was clinically diagnosed [hazard ratio (HR) 0.58, P = 0. 063] and a higher amount of proteinuria (HR 0.86 per 1 g/24 hours, P = 0.014). Predictors of earlier relapse for patients entering remission included a longer time to remission (HR 1.029 per month, P = 0.025), a history of central nervous system involvement (HR 8.41, P = 0.002), and World Health Organization histology (P = 0.01). Among the 23 patients who relapsed during follow-up, the median time to re-remission was 32 months, and with three exceptions, all patients took substantially longer time to remit the second time compared with their first remission (P = 0.01). The time to re-remission was longer in patients who had taken longer to remit the first time (HR 0.979 per month, P = 0.16), in patients who had relapsed earlier after the first remission (HR 1.071 per month, P = 0.002), and in those with evidence of chronicity in the original kidney biopsy (P = 0.015). Prolonged courses with a cumulative risk of toxicity are needed to achieve remission in many first-treated patients and in most patients treated for a second time. The optimal management of patients with identified adverse predictors of response needs further study.
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              Current issues in therapeutic drug monitoring of mycophenolic acid: report of a roundtable discussion.

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                Author and article information

                Journal
                NEC
                Nephron Clin Pract
                10.1159/issn.1660-2110
                Nephron Clinical Practice
                S. Karger AG
                1660-2110
                2005
                July 2005
                15 April 2005
                : 100
                : 3
                : c92-c100
                Affiliations
                aRenal Unit, Addenbrooke’s Hospital, Cambridge; bDepartment of Nephrology, Queen Elizabeth Hospital, Birmingham; cSouth West Thames Renal Research Institute, St Helier Hospital, Carshalton; dRenal Unit, Royal Free Hospital, London; eDepartment of Rheumatology, Queen Elizabeth Hospital, Birmingham; fJames Cook University Hospital, Middlesbrough; gAcademic Renal Unit, Southmead Hospital, Bristol, and hRenal Unit, Hope Hospital, Salford, UK
                Article
                85054 Nephron Clin Pract 2005;100:c92–c100
                10.1159/000085054
                15824513
                © 2005 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 3, Tables: 6, References: 19, Pages: 1
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/85054
                Categories
                Original Paper

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