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Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study
INTRODUCTION: While the role of mycophenolate mofetil (MMF) in the management of lupus nephritis has been increasingly recognized, limited information is available regarding its efficacy and safety as a long-term maintenance treatment. The aim of the present study was to evaluate the efficacy and sa...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3046515/ https://www.ncbi.nlm.nih.gov/pubmed/21059275 http://dx.doi.org/10.1186/ar3184 |
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author | Laskari, Katerina Mavragani, Clio P Tzioufas, Athanasios G Moutsopoulos, Haralampos M |
author_facet | Laskari, Katerina Mavragani, Clio P Tzioufas, Athanasios G Moutsopoulos, Haralampos M |
author_sort | Laskari, Katerina |
collection | PubMed |
description | INTRODUCTION: While the role of mycophenolate mofetil (MMF) in the management of lupus nephritis has been increasingly recognized, limited information is available regarding its efficacy and safety as a long-term maintenance treatment. The aim of the present study was to evaluate the efficacy and safety profile of MMF as maintenance therapy for proliferative lupus nephritis. METHODS: Thirty-three consecutive patients with proliferative lupus nephritis received induction therapy with five to seven monthly intravenous (iv) pulses of cyclophosphamide (CYC) plus iv steroids followed by oral MMF 2 g/day as maintenance therapy for a median time of 29 months (range 9 to 71 months). Primary end points were the achievement of renal remission, complete renal remission, disease remission - renal and extrarenal -, the occurrence of renal relapse, chronic renal failure and death. Secondary end points were the extrarenal disease activity and drug adverse events. The clinical and laboratory parameters were compared during follow-up by means of nonparametric statistical tests. Time to event analysis was performed according to the Kaplan-Meier method. RESULTS: A significant improvement of all renal parameters was observed at the end of the induction treatment and at the latest follow-up compared to baseline. The rate of patients achieving renal remission until the end of follow-up was 73%, whereas that of complete renal remission was 58%. The median survival times in the Kaplan-Meier analyses were 7 and 16 months, respectively. Remission was maintained in all but four (12%) patients who relapsed within 19 to 39 months after initial response. At the end of follow-up, 51% of the patients had reached disease remission. The median survival time of disease remission was 18 months. Extrarenal manifestations were well controlled in most of the patients. In one patient receiving MMF, extrarenal activity led to treatment discontinuation. Non life-threatening drug adverse events developed in 18 patients (58%) and included infections, amenorrhea, myelotoxicity, gastrointestinal complications, hypercholesterolemia, alopecia and drug intolerance. None of the patients developed chronic renal insufficiency or died from any cause. CONCLUSIONS: MMF appeared to be efficacious and safe as maintenance treatment for proliferative lupus nephritis. |
format | Text |
id | pubmed-3046515 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-30465152011-03-01 Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study Laskari, Katerina Mavragani, Clio P Tzioufas, Athanasios G Moutsopoulos, Haralampos M Arthritis Res Ther Research Article INTRODUCTION: While the role of mycophenolate mofetil (MMF) in the management of lupus nephritis has been increasingly recognized, limited information is available regarding its efficacy and safety as a long-term maintenance treatment. The aim of the present study was to evaluate the efficacy and safety profile of MMF as maintenance therapy for proliferative lupus nephritis. METHODS: Thirty-three consecutive patients with proliferative lupus nephritis received induction therapy with five to seven monthly intravenous (iv) pulses of cyclophosphamide (CYC) plus iv steroids followed by oral MMF 2 g/day as maintenance therapy for a median time of 29 months (range 9 to 71 months). Primary end points were the achievement of renal remission, complete renal remission, disease remission - renal and extrarenal -, the occurrence of renal relapse, chronic renal failure and death. Secondary end points were the extrarenal disease activity and drug adverse events. The clinical and laboratory parameters were compared during follow-up by means of nonparametric statistical tests. Time to event analysis was performed according to the Kaplan-Meier method. RESULTS: A significant improvement of all renal parameters was observed at the end of the induction treatment and at the latest follow-up compared to baseline. The rate of patients achieving renal remission until the end of follow-up was 73%, whereas that of complete renal remission was 58%. The median survival times in the Kaplan-Meier analyses were 7 and 16 months, respectively. Remission was maintained in all but four (12%) patients who relapsed within 19 to 39 months after initial response. At the end of follow-up, 51% of the patients had reached disease remission. The median survival time of disease remission was 18 months. Extrarenal manifestations were well controlled in most of the patients. In one patient receiving MMF, extrarenal activity led to treatment discontinuation. Non life-threatening drug adverse events developed in 18 patients (58%) and included infections, amenorrhea, myelotoxicity, gastrointestinal complications, hypercholesterolemia, alopecia and drug intolerance. None of the patients developed chronic renal insufficiency or died from any cause. CONCLUSIONS: MMF appeared to be efficacious and safe as maintenance treatment for proliferative lupus nephritis. BioMed Central 2010 2010-11-09 /pmc/articles/PMC3046515/ /pubmed/21059275 http://dx.doi.org/10.1186/ar3184 Text en Copyright ©2010 Laskari et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Laskari, Katerina Mavragani, Clio P Tzioufas, Athanasios G Moutsopoulos, Haralampos M Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title | Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title_full | Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title_fullStr | Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title_full_unstemmed | Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title_short | Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
title_sort | mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3046515/ https://www.ncbi.nlm.nih.gov/pubmed/21059275 http://dx.doi.org/10.1186/ar3184 |
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