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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorFernández-Juárez, Gema
dc.contributor.authorRojas-Rivera, Jorge
dc.contributor.authorvan de Logt, Anne-Els
dc.contributor.authorJustino, Joana
dc.contributor.authorSevillano, Angel
dc.contributor.authorCaravaca-Fontán, Fernando
dc.contributor.authorAgraz Pamplona, Irene
dc.date.accessioned2022-01-28T07:09:28Z
dc.date.available2022-01-28T07:09:28Z
dc.date.copyright2020
dc.date.issued2021-04
dc.identifier.citationFernández-Juárez G, Rojas-Rivera J, Logt AV, Justino J, Sevillano A, Caravaca-Fontán F, et al. The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy. Kidney Int. 2021 Apr;99(4):986–98.
dc.identifier.issn1523-1755
dc.identifier.urihttp://hdl.handle.net/11351/6922
dc.descriptionCorticosteroids; Cyclophosphamide; Primary membranous nephropathy
dc.description.abstractA cyclical corticosteroid-cyclophosphamide regimen is recommended for patients with primary membranous nephropathy at high risk of progression. We hypothesized that sequential therapy with tacrolimus and rituximab is superior to cyclical alternating treatment with corticosteroids and cyclophosphamide in inducing persistent remission in these patients. This was tested in a randomized, open-label controlled trial of 86 patients with primary membranous nephropathy and persistent nephrotic syndrome after six-months observation and assigned 43 each to receive six-month cyclical treatment with corticosteroid and cyclophosphamide or sequential treatment with tacrolimus (full-dose for six months and tapering for another three months) and rituximab (one gram at month six). The primary outcome was complete or partial remission of nephrotic syndrome at 24 months. This composite outcome occurred in 36 patients (83.7%) in the corticosteroid-cyclophosphamide group and in 25 patients (58.1%) in the tacrolimus-rituximab group (relative risk 1.44; 95% confidence interval 1.08 to 1.92). Complete remission at 24 months occurred in 26 patients (60%) in the corticosteroid-cyclophosphamide group and in 11 patients (26%) in the tacrolimus-rituximab group (2.36; 1.34 to 4.16). Anti-PLA2R titers showed a significant decrease in both groups but the proportion of anti-PLA2R-positive patients who achieved immunological response (depletion of anti-PLA2R antibodies) was significantly higher at three and six months in the corticosteroid-cyclophosphamide group (77% and 92%, respectively), as compared to the tacrolimus-rituximab group (45% and 70%, respectively). Relapses occurred in one patient in the corticosteroid-cyclophosphamide group, and three patients in the tacrolimus-rituximab group. Serious adverse events were similar in both groups. Thus, treatment with corticosteroid-cyclophosphamide induced remission in a significantly greater number of patients with primary membranous nephropathy than tacrolimus-rituximab.
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofseriesKidney International;99(4)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectRonyons - Malalties - Tractament
dc.subjectAvaluació de resultats (Assistència sanitària)
dc.subject.meshKidney Diseases
dc.subject.mesh/drug therapy
dc.subject.meshTreatment Outcome
dc.titleThe STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.kint.2020.10.014
dc.subject.decsenfermedades renales
dc.subject.decs/farmacoterapia
dc.subject.decsresultado del tratamiento
dc.relation.publishversionhttps://doi.org/10.1016/j.kint.2020.10.014
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Fernández-Juárez G] Nephrology Division, Hospital Universitario Fundación Alcorcón, Madrid, Spain. [Rojas-Rivera J] Nephrology Division, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain. [Logt AV] Nephrology Division, Radboud University Medical Center, Nijmegen, The Netherlands. [Justino J] Institut de Pharmacologie Moléculaire et Cellulaire (IPMC), Université Côte d’Azur, Centre National de la Recherche Scientifique (CNRS), Valbonne Sophia Antipolis, France. [Sevillano A, Caravaca-Fontán F] Nephrology Division, Instituto de Investigación Hospital Universitario 12 Octubre, Madrid, Spain. [Agraz I] Divisió de Nefrologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid33166580
dc.identifier.wos000740817900004
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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