dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Fernández-Juárez, Gema |
dc.contributor.author | Rojas-Rivera, Jorge |
dc.contributor.author | van de Logt, Anne-Els |
dc.contributor.author | Justino, Joana |
dc.contributor.author | Sevillano, Angel |
dc.contributor.author | Agraz Pamplona, Irene |
dc.contributor.author | Caravaca-Fontán, Fernando |
dc.date.accessioned | 2022-01-28T07:09:28Z |
dc.date.available | 2022-01-28T07:09:28Z |
dc.date.copyright | 2020 |
dc.date.issued | 2021-04 |
dc.identifier.citation | Fernández-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.issn | 1523-1755 |
dc.identifier.uri | https://hdl.handle.net/11351/6922 |
dc.description | Corticosteroids; Cyclophosphamide; Primary membranous nephropathy |
dc.description.abstract | A 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.iso | eng |
dc.publisher | Elsevier |
dc.relation.ispartofseries | Kidney International;99(4) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Ronyons - Malalties - Tractament |
dc.subject | Avaluació de resultats (Assistència sanitària) |
dc.subject.mesh | Kidney Diseases |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Treatment Outcome |
dc.title | The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1016/j.kint.2020.10.014 |
dc.subject.decs | enfermedades renales |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | resultado del tratamiento |
dc.relation.publishversion | https://doi.org/10.1016/j.kint.2020.10.014 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 33166580 |
dc.identifier.wos | 000740817900004 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |