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dc.contributor.authorRojas-Rivera, Jorge
dc.contributor.authorFervenza, Fernando C.
dc.contributor.authorOrtiz Arduán, Alberto 
dc.contributor.otherUAM. Departamento de Medicinaes_ES
dc.date.accessioned2023-07-27T11:20:49Z
dc.date.available2023-07-27T11:20:49Z
dc.date.issued2021-12-21
dc.identifier.citationDrugs volume 82 (2022): 109-132en_US
dc.identifier.issn0012-6667 (print)en_US
dc.identifier.issn1179-1950 (online)en_US
dc.identifier.urihttp://hdl.handle.net/10486/708060
dc.description.abstractImmunosuppressive therapy is mandatory for primary membranous nephropathy with persistent nephrotic proteinuria or anti-phospholipase A2 receptor antibodies, reduced kidney function, or another risk factor for progression. Rituximab has demonstrated efficacy for proteinuria remission compared with renin-angiotensin system blockade or cyclosporine in two well-powered randomized controlled trials. More recently, STARMEN showed that alternating glucocorticoid-cyclophosphamide is superior to sequential tacrolimus-rituximab for proteinuria remission, although it was associated with a higher risk of non-serious adverse events. However, sequential tacrolimus-rituximab involved delayed lower dose rituximab and was the worst-performing rituximab regimen among those tested in randomized clinical trials. The RI-CYCLO pilot study did not demonstrate superiority of glucocorticoid-cyclophosphamide over rituximab and found no difference in adverse events. Overall, STARMEN and RI-CYCLO confirmed the efficacy of glucocorticoid-cyclophosphamide in patients with high-risk membranous nephropathy and the role of rituximab as a valid alternative. However, none of the trials tested an optimized rituximab protocol involving a second rituximab cycle before declaring treatment failure. Calcineurin inhibitors should be considered third-line drugs and sequential use of calcineurin inhibitor rituximab did not add over rituximab-only regimens. We critically review recent randomized controlled trials, propose a research agenda, and call for multinational pragmatic trials that enroll patients at referral centers to address unmet research needsen_US
dc.description.sponsorshipResearch by the authors was supported by FIS/Fondos FEDER (PI18/01366, PI19/00588, PI19/00815, DTS18/00032, ERAPerMed-JTC2018 (KIDNEY ATTACK AC18/00064 and PERSTIGAN AC18/00071, ISCIII-RETIC REDinREN RD016/0009), Sociedad Española de Nefrología, Fundación Renal Iñigo Álvarez de Toledo (FRIAT), and Comunidad de Madrid en Biomedicina B2017/BMD3686 CIFRA2-CMen_US
dc.format.extent24 pag.es_ES
dc.format.mimetypeapplication/pdfen_US
dc.language.isoengen_US
dc.publisherAdis
dc.relation.ispartofDrugsen_US
dc.rights© The Author(s) 2021en_US
dc.subject.otherImmunosuppressive therapyen_US
dc.subject.otherMembranous Nephropathyen_US
dc.subject.otherRituximaben_US
dc.subject.otherSTARMENen_US
dc.subject.otherGlucocorticoid-cyclophosphamiden_US
dc.subject.otherRI-CYCLOen_US
dc.titleRecent clinical trials insights into the treatment of primary membranous nephropathyen_US
dc.typereviewen_US
dc.subject.ecienciaMedicinaes_ES
dc.identifier.doi10.1007/s40265-021-01656-1es_ES
dc.identifier.publicationfirstpage109es_ES
dc.identifier.publicationissue2es_ES
dc.identifier.publicationlastpage132es_ES
dc.identifier.publicationvolume82es_ES
dc.relation.projectIDGobierno de España. PI18/01366es_ES
dc.relation.projectIDGobierno de España. PI19/00588es_ES
dc.relation.projectIDGobierno de España. PI19/00815es_ES
dc.relation.projectIDGobierno de España. DTS18/00032es_ES
dc.relation.projectIDGobierno de España. AC18/00064es_ES
dc.relation.projectIDGobierno de España. AC18/00071es_ES
dc.relation.projectIDGobierno de España. RD016/0009es_ES
dc.relation.projectIDComunidad de Madrid. B2017/BMD3686 CIFRA2-CMes_ES
dc.type.versioninfo:eu-repo/semantics/publishedVersionen_US
dc.rights.ccReconocimiento-NoComercial
dc.rights.accessRightsopenAccessen_US
dc.facultadUAMFacultad de Medicinaes_ES
dc.institutoUAMInstituto de Investigación Sanitaria Fundación Jiménez Díaz (ISS-FJD)es_ES


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