The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy
| Autor: | Gema Fernández-Juárez, Jorge Rojas-Rivera, Anne-Els van de Logt, Joana Justino, Angel Sevillano, Fernando Caravaca-Fontán, Ana Ávila, Cristina Rabasco, Virginia Cabello, Alfonso Varela, Montserrat Díez, Guillermo Martín-Reyes, Marian Goicoechea Diezhandino, Luis F. Quintana, Irene Agraz, Juan Ramón Gómez-Martino, Mercedes Cao, Antolina Rodríguez-Moreno, Begoña Rivas, Cristina Galeano, Jose Bonet, Ana Romera, Amir Shabaka, Emmanuelle Plaisier, Mario Espinosa, Jesus Egido, Alfonso Segarra, Gérard Lambeau, Pierre Ronco, Jack Wetzels, Manuel Praga, Fernando Caravaca-Fontan, Hernando Trujillo, Eduardo Gutiérrez, Gema Fernandez Juarez, Alberto Ortiz, Marian Goicoechea, Úrsula Verdalles, Alfons Segarra, Lara Perea, Ildefonso Valera, Mónica Martín, Miguel Angel Pérez Valdivia, Miquel Blasco, Andrés López Muñiz, Ana Avila, Tamara Malek, Montserrat Diaz, Iara DaSilva, Jordi Bonet, Maruja Navarro, Ana Huerta, Ezequiel Rodríguez-Paternina, Ana Vigil, Roberto Alcázar, Vicente Paraíso, Vicente Barrio, Julia Hofstra |
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| Přispěvatelé: | Institut Català de la Salut, [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, Vall d'Hebron Barcelona Hospital Campus, Nephrology Division, Hospital Universitario Fundación Alcorcón, Madrid, Spain, Nephrology Division, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain, Radboud Institute for Health Sciences, Radboud University Medical Center [Nijmegen], Institut de pharmacologie moléculaire et cellulaire (IPMC), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre National de la Recherche Scientifique (CNRS)-Université Côte d'Azur (UCA), Hospital Universitario 12 de Octubre [Madrid], Dr Peset University Hospital, Hospital Reina Sofia, Cordoba, Hospital Universitario Virgen del Rocío [Sevilla], Hospital of Virgen de la Victoria de Malaga, Institut Investigacions Biomèdiques (IBB) Sant Pau [Barcelona, Spain], Hospital Regional Universitario de Málaga = Regional University Hospital of Malaga [Spain], Hospital General Universitario 'Gregorio Marañón' [Madrid], Department of Nephrology, Hospital Clinic, Barcelona, Spain., Vall d'Hebron University Hospital [Barcelona], San Pedro de Alcantara Hospital [Cáceres, Espagne], Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Universidade da Coruña (UDC), Spain, Hospital Clinico San Carlos, Hospital Clínico San Carlos, Hospital Universitario La Paz [Madrid, Espagne], Hospital Universitario Ramón y Cajal [Madrid], Universidad de Alcalá - University of Alcalá (UAH), Germans Trias i Pujol Hospital, Universitat Autònoma de Barcelona (UAB), Hospital General Universitario de Ciudad Real [Ciudad Real, Spain], Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée (CoRaKID), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Radboud Institute for Health Sciences [Nijmegen, the Netherlands], Hospital Universitario Fundación Alcorcón, Hospital Universitario Fundación Jiménez Díaz [Madrid, Spain], Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), Hospital Universitario, A Coruña, Fundació Puigvert [Barcelona, Spain], Germans Trias i Pujol University Hospital [Badalona, Barcelona, Spain] (GTPUH), Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Getafe University Hospital, Madrid, Severo Ochoa Hospital, Hospital Universitario Infanta Leonor [Madrid], Del Henares Hospital, Hospital Universitario Infanta Sofía, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlan ds, Lambeau, Gerard, Centre National de la Recherche Scientifique (CNRS)-Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA), Hospital Regional Universitario de Málaga [Spain], Barcelona Autonomous University, Common and Rare Kidney Diseases = Maladies Rénales Fréquentes et Rares: des Mécanismes Moléculaires à la Médecine Personnalisée (CORAKID), Germans Trias i Pujol University Hospital |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Cyclophosphamide medicine.drug_class [SDV]Life Sciences [q-bio] 030232 urology & nephrology Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Gastroenterology Tacrolimus Primary membranous nephropathy law.invention 03 medical and health sciences 0302 clinical medicine Membranous nephropathy Randomized controlled trial law Internal medicine medicine Corticosteroids ComputingMilieux_MISCELLANEOUS business.industry Male Urogenital Diseases::Urologic Diseases::Kidney Diseases [DISEASES] diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] medicine.disease Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] 3. Good health [SDV] Life Sciences [q-bio] Regimen 030104 developmental biology Nephrology Avaluació de resultats (Assistència sanitària) Corticosteroid Rituximab Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] business Nephrotic syndrome enfermedades urogenitales masculinas::enfermedades urológicas::enfermedades renales [ENFERMEDADES] Ronyons - Malalties - Tractament medicine.drug |
| Zdroj: | Scientia Kidney International Kidney International, 2021, 99 (4), pp.986-998. ⟨10.1016/j.kint.2020.10.014⟩ Kidney International, Nature Publishing Group, 2021, 99 (4), pp.986-998. ⟨10.1016/j.kint.2020.10.014⟩ Kidney International, 99, 4, pp. 986-998 Kidney International, 99, 986-998 |
| ISSN: | 0085-2538 1523-1755 |
| Popis: | Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Red de Investigación Renal (RedInRen); European Renal Association-European Dialysis and Transplant Association (ERA-EDTA); Fundación Renal Iñigo Álvarez de Toledo (FRIAT); Fundación para la Investigación Biomédica Hospital 12 de Octubre (i+12); Centre National de la Recherche Scientifique; Fondation Maladies Rares (LAM-RD_20170304); National Research Agency (ANR, grants MNaims ANR-17-CE17-0012-01); "Investments for the Future" Laboratory of Excellence SIGNALIFE, a network for innovation on signal transduction pathways in life sciences (ANR-11-LABX-0028-01); Initiative of Excellence (IDEX; UCAJedi ANR-15-IDEX-01); Fondation pour la Recherche Médicale (FRM, ING20140129210, DEQ20180339193, FDT201805005509). 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. |
| Databáze: | OpenAIRE |
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