Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression
We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in kidney transplant recipients on steroid-free, low-dose cyclosporine (CsA) microemulsion maintenance immunosuppression. ATHENA, a pragmatic, p...
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| Veröffentlicht in: | PLoS medicine 2021-06, Vol.18 (6) |
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| creator | Ruggenenti, Piero Cravedi, Paolo Gotti, Eliana Plati, Annarita Marasà, Maddalena Sandrini, Silvio Bossini, Nicola Citterio, Franco Minetti, Enrico Montanaro, Domenico Sabadini, Ettore Tardanico, Regina Martinetti, Davide Gaspari, Flavio Villa, Alessandro Perna, Annalisa Peraro, Francesco Remuzzi, Giuseppe |
| description | We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in kidney transplant recipients on steroid-free, low-dose cyclosporine (CsA) microemulsion maintenance immunosuppression. ATHENA, a pragmatic, prospective, multicenter trial conducted by 6 Italian transplant centers, compared the outcomes of 233 consenting recipients of a first deceased donor kidney transplant induced with low-dose thymoglobulin and basiliximab and randomized to MMF (750 mg twice/day, n = 119) or AZA (75 to 125 mg/day, n = 114) added-on maintenance low-dose CsA microemulsion and 1-week steroid. In patients without acute clinical or subclinical rejections, CsA dose was progressively halved. Primary endpoint was biopsy-proven CAN. Analysis was by intention to treat. Chronicity scores other than CAN predict long-term graft outcome. Study limitations include small sample size and unblinded design. In this study, we found that in deceased donor kidney transplant recipients on low-dose CsA and no steroids, MMF had no significant benefits over AZA. This finding suggests that AZA, due to its lower costs, could safely replace MMF in combination with minimized immunosuppression. |
| doi_str_mv | 10.1371/journal.pmed.1003668 |
| format | Article |
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ATHENA, a pragmatic, prospective, multicenter trial conducted by 6 Italian transplant centers, compared the outcomes of 233 consenting recipients of a first deceased donor kidney transplant induced with low-dose thymoglobulin and basiliximab and randomized to MMF (750 mg twice/day, n = 119) or AZA (75 to 125 mg/day, n = 114) added-on maintenance low-dose CsA microemulsion and 1-week steroid. In patients without acute clinical or subclinical rejections, CsA dose was progressively halved. Primary endpoint was biopsy-proven CAN. Analysis was by intention to treat. Chronicity scores other than CAN predict long-term graft outcome. Study limitations include small sample size and unblinded design. In this study, we found that in deceased donor kidney transplant recipients on low-dose CsA and no steroids, MMF had no significant benefits over AZA. This finding suggests that AZA, due to its lower costs, could safely replace MMF in combination with minimized immunosuppression.</description><identifier>ISSN: 1549-1277</identifier><identifier>EISSN: 1549-1676</identifier><identifier>DOI: 10.1371/journal.pmed.1003668</identifier><language>eng</language><publisher>Public Library of Science</publisher><subject>Azathioprine ; Comparative analysis ; Dosage and administration ; Drug therapy ; Graft rejection ; Kidneys ; Mycophenolate mofetil ; Organ transplant recipients ; Patient outcomes ; Prevention ; Risk factors ; Transplantation</subject><ispartof>PLoS medicine, 2021-06, Vol.18 (6)</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902</link.rule.ids></links><search><creatorcontrib>Ruggenenti, Piero</creatorcontrib><creatorcontrib>Cravedi, Paolo</creatorcontrib><creatorcontrib>Gotti, Eliana</creatorcontrib><creatorcontrib>Plati, Annarita</creatorcontrib><creatorcontrib>Marasà, Maddalena</creatorcontrib><creatorcontrib>Sandrini, Silvio</creatorcontrib><creatorcontrib>Bossini, Nicola</creatorcontrib><creatorcontrib>Citterio, Franco</creatorcontrib><creatorcontrib>Minetti, Enrico</creatorcontrib><creatorcontrib>Montanaro, Domenico</creatorcontrib><creatorcontrib>Sabadini, Ettore</creatorcontrib><creatorcontrib>Tardanico, Regina</creatorcontrib><creatorcontrib>Martinetti, Davide</creatorcontrib><creatorcontrib>Gaspari, Flavio</creatorcontrib><creatorcontrib>Villa, Alessandro</creatorcontrib><creatorcontrib>Perna, Annalisa</creatorcontrib><creatorcontrib>Peraro, Francesco</creatorcontrib><creatorcontrib>Remuzzi, Giuseppe</creatorcontrib><title>Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression</title><title>PLoS medicine</title><description>We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in kidney transplant recipients on steroid-free, low-dose cyclosporine (CsA) microemulsion maintenance immunosuppression. ATHENA, a pragmatic, prospective, multicenter trial conducted by 6 Italian transplant centers, compared the outcomes of 233 consenting recipients of a first deceased donor kidney transplant induced with low-dose thymoglobulin and basiliximab and randomized to MMF (750 mg twice/day, n = 119) or AZA (75 to 125 mg/day, n = 114) added-on maintenance low-dose CsA microemulsion and 1-week steroid. In patients without acute clinical or subclinical rejections, CsA dose was progressively halved. Primary endpoint was biopsy-proven CAN. Analysis was by intention to treat. Chronicity scores other than CAN predict long-term graft outcome. Study limitations include small sample size and unblinded design. In this study, we found that in deceased donor kidney transplant recipients on low-dose CsA and no steroids, MMF had no significant benefits over AZA. This finding suggests that AZA, due to its lower costs, could safely replace MMF in combination with minimized immunosuppression.</description><subject>Azathioprine</subject><subject>Comparative analysis</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Graft rejection</subject><subject>Kidneys</subject><subject>Mycophenolate mofetil</subject><subject>Organ transplant recipients</subject><subject>Patient outcomes</subject><subject>Prevention</subject><subject>Risk factors</subject><subject>Transplantation</subject><issn>1549-1277</issn><issn>1549-1676</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNqN0M1LwzAYBvAiCs7pf-AhJ0GwM2napDmO4cdgOvDrOtL27ZaZJaVvqs6jf7mDKehJT-9z-PE88EbRMaMDxiU7X_quddoOmhVUA0YpFyLfiXosS1XMhBS73zmRcj86QFxSmiiqaC_6uFmXvlmA81YHICtfQzCWvECLHRL9rsPC-KY1Dohx5NlUDtYktNphY7ULpIXSNAZcQOIdwQCtN1VctwBnxPrXuPIIpFyX1mPjtzWrVec8dk3TAqLx7jDaq7VFOPq6_ejx8uJhdB1Pplfj0XASzxnnSSwLXgqd1QVLOM1zrVgFRSFqykutVMorWaQyEZRXStJ8o6iSimuVZbTKcgq8H51ue-fawsy40rsAb2GuO8TZ-P5uNhRCcppuxv6yt_-306ff9uSHXYC2YYHedmHzB_wJPwEG8pJ4</recordid><startdate>20210624</startdate><enddate>20210624</enddate><creator>Ruggenenti, Piero</creator><creator>Cravedi, Paolo</creator><creator>Gotti, Eliana</creator><creator>Plati, Annarita</creator><creator>Marasà, Maddalena</creator><creator>Sandrini, Silvio</creator><creator>Bossini, Nicola</creator><creator>Citterio, Franco</creator><creator>Minetti, Enrico</creator><creator>Montanaro, Domenico</creator><creator>Sabadini, Ettore</creator><creator>Tardanico, Regina</creator><creator>Martinetti, Davide</creator><creator>Gaspari, Flavio</creator><creator>Villa, Alessandro</creator><creator>Perna, Annalisa</creator><creator>Peraro, Francesco</creator><creator>Remuzzi, Giuseppe</creator><general>Public Library of Science</general><scope>IOV</scope><scope>ISN</scope><scope>ISR</scope></search><sort><creationdate>20210624</creationdate><title>Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression</title><author>Ruggenenti, Piero ; Cravedi, Paolo ; Gotti, Eliana ; Plati, Annarita ; Marasà, Maddalena ; Sandrini, Silvio ; Bossini, Nicola ; Citterio, Franco ; Minetti, Enrico ; Montanaro, Domenico ; Sabadini, Ettore ; Tardanico, Regina ; Martinetti, Davide ; Gaspari, Flavio ; Villa, Alessandro ; Perna, Annalisa ; Peraro, Francesco ; Remuzzi, Giuseppe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g1332-7b3c6a5fb123088a91debb6f03ca9943d7b472603d9708b1209793a9550d580e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Azathioprine</topic><topic>Comparative analysis</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Graft rejection</topic><topic>Kidneys</topic><topic>Mycophenolate mofetil</topic><topic>Organ transplant recipients</topic><topic>Patient outcomes</topic><topic>Prevention</topic><topic>Risk factors</topic><topic>Transplantation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ruggenenti, Piero</creatorcontrib><creatorcontrib>Cravedi, Paolo</creatorcontrib><creatorcontrib>Gotti, Eliana</creatorcontrib><creatorcontrib>Plati, Annarita</creatorcontrib><creatorcontrib>Marasà, Maddalena</creatorcontrib><creatorcontrib>Sandrini, Silvio</creatorcontrib><creatorcontrib>Bossini, Nicola</creatorcontrib><creatorcontrib>Citterio, Franco</creatorcontrib><creatorcontrib>Minetti, Enrico</creatorcontrib><creatorcontrib>Montanaro, Domenico</creatorcontrib><creatorcontrib>Sabadini, Ettore</creatorcontrib><creatorcontrib>Tardanico, Regina</creatorcontrib><creatorcontrib>Martinetti, Davide</creatorcontrib><creatorcontrib>Gaspari, Flavio</creatorcontrib><creatorcontrib>Villa, Alessandro</creatorcontrib><creatorcontrib>Perna, Annalisa</creatorcontrib><creatorcontrib>Peraro, Francesco</creatorcontrib><creatorcontrib>Remuzzi, Giuseppe</creatorcontrib><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Canada</collection><collection>Gale In Context: Science</collection><jtitle>PLoS medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ruggenenti, Piero</au><au>Cravedi, Paolo</au><au>Gotti, Eliana</au><au>Plati, Annarita</au><au>Marasà, Maddalena</au><au>Sandrini, Silvio</au><au>Bossini, Nicola</au><au>Citterio, Franco</au><au>Minetti, Enrico</au><au>Montanaro, Domenico</au><au>Sabadini, Ettore</au><au>Tardanico, Regina</au><au>Martinetti, Davide</au><au>Gaspari, Flavio</au><au>Villa, Alessandro</au><au>Perna, Annalisa</au><au>Peraro, Francesco</au><au>Remuzzi, Giuseppe</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression</atitle><jtitle>PLoS medicine</jtitle><date>2021-06-24</date><risdate>2021</risdate><volume>18</volume><issue>6</issue><issn>1549-1277</issn><eissn>1549-1676</eissn><abstract>We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in kidney transplant recipients on steroid-free, low-dose cyclosporine (CsA) microemulsion maintenance immunosuppression. ATHENA, a pragmatic, prospective, multicenter trial conducted by 6 Italian transplant centers, compared the outcomes of 233 consenting recipients of a first deceased donor kidney transplant induced with low-dose thymoglobulin and basiliximab and randomized to MMF (750 mg twice/day, n = 119) or AZA (75 to 125 mg/day, n = 114) added-on maintenance low-dose CsA microemulsion and 1-week steroid. In patients without acute clinical or subclinical rejections, CsA dose was progressively halved. Primary endpoint was biopsy-proven CAN. Analysis was by intention to treat. Chronicity scores other than CAN predict long-term graft outcome. Study limitations include small sample size and unblinded design. In this study, we found that in deceased donor kidney transplant recipients on low-dose CsA and no steroids, MMF had no significant benefits over AZA. This finding suggests that AZA, due to its lower costs, could safely replace MMF in combination with minimized immunosuppression.</abstract><pub>Public Library of Science</pub><doi>10.1371/journal.pmed.1003668</doi></addata></record> |
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| subjects | Azathioprine Comparative analysis Dosage and administration Drug therapy Graft rejection Kidneys Mycophenolate mofetil Organ transplant recipients Patient outcomes Prevention Risk factors Transplantation |
| title | Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression |
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