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1. Immunosuppression of HLA identical living-donor kidney transplant recipients: A systematic review.

Author

Pérez-Sáez, M.J., Montero, N., Oliveras, L., Redondo-Pachón, D., Martínez-Simón, D., Abramovicz, D., Maggiore, U., Mariat, C., Mjoen, G., Oniscu, G.C., Peruzzi, L., Sever, M.S., Watschinger, B., Velioglu, A., Demir, E., Gandolfini, I., Hellemans, R., Hilbrands, L.B., Pascual, J., Crespo, M., Pérez-Sáez, M.J., Montero, N., Oliveras, L., Redondo-Pachón, D., Martínez-Simón, D., Abramovicz, D., Maggiore, U., Mariat, C., Mjoen, G., Oniscu, G.C., Peruzzi, L., Sever, M.S., Watschinger, B., Velioglu, A., Demir, E., Gandolfini, I., Hellemans, R., Hilbrands, L.B., Pascual, J., and Crespo, M.

Abstract

Item does not contain fulltext, BACKGROUND: Kidney transplant (KT) recipients of HLA identical siblings (HLAid) have lower immunological risk, but there are no specific recommendations for immunosuppression. Our aim was to analyze evidence about results from HLAid living-donor recipients under different immunosuppression in the current era of immunological risk assessment. METHODS: Systematic review of studies describing associations between outcomes of HLAid living-donor KT recipients according to their immunological risk and applied immunosuppression. RESULTS: From 1351 studies, 16 (5636 KT recipients) were included in the analysis. All studies were retrospective, ten comparing immunosuppression strategies, and six immunological risk strata. Of those ten, six studies were published in 1990 or earlier and only three included tacrolimus. The evidence is poor, and the inclusion of calcineurin inhibitors does not demonstrate better results. Furthermore, only few studies describe different immunosuppression regimens according to the patient immunological risk and, in general, they do not include the assessment with new solid phase assays. CONCLUSIONS: There are no studies analyzing the association of outcomes of HLAid KT recipients with current immunological risk tools. In the absence of evidence, no decision or proposal of immunosuppression adapted to modern immunological risk assessment can be made currently by the Descartes Working Group., 01 december 2023

Published
2023

2. Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European Renal Best Practice position statement

Author

Locatelli, Francesco, Bárány, Peter, Covic, Adrian, De Francisco, Angel, Del Vecchio, Lucia, Goldsmith, David, Hörl, Walter, London, Gerard, Vanholder, Raymond, Van Biesen, Wim, Abramovicz, D., Cannata-Andia, J., Cochat, P., Eckardt, K. U., Fouque, D., Heimburger, O., Jäger, K., Jenkins, S., Lindley, E., MacLeod, A., Marti-Monros, A., Tattersall, J., Wiecek, A., and Wanner, C.

Published
2013
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5. Systemic lupus erythematosus in Europe at the change of the millennium: lessons from the 'Euro-Lupus Project'

Author

Cervera, R, ABARCA-COSTALAGO, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, Ao, Bacarelli, Mr, Bellisai, F, Bernardino, I, BIERNAT-KALUZA, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, Mt, Carcassi, C, Cattaneo, R, Cauli, A, CHWALINSKA-SADOWSKA, H, Contu, L, Cosyns, Jp, Danieli, Mg, Dcruz, D, Depresseux, G, Direskeneli, H, Domenech, I, Espinosa, G, FERNANDEZ-NEBRO, A, Ferrara, Gb, Font, J, Frutos, Ma, Galeazzi, M., GARCIA-CARRASCO, M, GARCIA IGLESIAS MF, GARCIA-TOBARUELA, A, George, J, Gil, A, GONZALEZ-SANTOS, P, Grana, M, Gul, A, Haga, Hj, DE HARO-LIGER, M, Houssiau, F, Hughes, Gr, Ingelmo, M, JEDRYKA-GORAL, A, Khamashta, Ma, Lavilla, P, Levi, Y, LOPEZ-DULPA, M, LOPEZ-SOTO, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perello, I, Petera, P, Petrovic, R, Piette, Jc, Pintado, V, DE PITA, O, Popovic, R, Pucci, G, Puddu, P, DE RAMON, E, RAMOS-CASALS, M, RODRIGUEZ-ANDREU, J, RUIZ-IRASTORZA, G, SANCHEZ-LORA, J, Sanna, G, Scorza, R, Sebastiani, Gd, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, Ra, Smolen, J, Tincani, A, Tokgoz, G, URBANO-MARQUEZ, A, Vasconcelos, C, Vazquez, Jj, Veronesi, J, Vianna, J, Vivancos, J, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, UCL - MD/MNOP - Département de morphologie normale et pathologique, UCL - (SLuc) Service d'anatomie pathologique, Cervera, R, Abarca Costalago, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, A, Bacarelli, M, Bellisai, F, Bernardino, I, Biernat Kaluza, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, M, Carcassi, C, Cattaneo, R, Cauli, A, Chwalinska Sadowska, H, Contu, L, Cosyns, J, Danieli, M, D́cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, Fernández Nebro, A, Ferrara, G, Font, J, Frutos, M, Galeazzi, M, García Carrasco, M, García Iglesias, M, García Tobaruela, A, George, J, Gil, A, González Santos, P, Grana, M, Gül, A, Haga, H, de Haro Liger, M, Houssiau, F, Hughes, G, Ingelmo, M, Jedryka Góral, A, Khamashta, M, Lavilla, P, Levi, Y, López Dupla, M, López Soto, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, J, Pintado, V, de Pita, O, Popovic, R, Pucci, G, Puddu, P, de Ramón, E, Ramos Casals, M, Rodríguez Andreu, J, Ruiz Irastorza, G, Sánchez Lora, J, Sanna, G, Scorza, R, Sebastiani, G, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, R, Smolen, J, Tincani, A, Tokgöz, G, Urbano Márquez, A, Vasconcelos, C, Vázquez, J, Veronesi, M, Vianna, J, and Vivancos, J

Subjects
Male, medicine.medical_specialty, Prognosi, Epidemiology, Immunology, Systemic lupus erythematosu, Disease, Prognostic factors, Autoimmune Disease, Follow-Up Studie, Autoimmune Diseases, Cohort Studies, Systemic lupus erythematosus, immune system diseases, medicine, Immunology and Allergy, Humans, Lupus Erythematosus, Systemic, Prospective Studies, Age of Onset, Mortality, Prospective cohort study, skin and connective tissue diseases, Survival rate, Prognostic factor, business.industry, medicine.disease, Prognosis, Europe, Survival Rate, Prospective Studie, Family medicine, Antibodies, Antinuclear, Cohort, Female, Cohort Studie, Age of onset, Morbidity, business, Human, Cohort study, Follow-Up Studies
Abstract

The "Euro-Lupus Cohort" is composed by 1000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium-the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors. © 2005 Elsevier B.V. All rights reserved.

Published
2006

6. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: Lessons from long-term followup of patients in the euro-lupus nephritis trial

Author

Houssiau, Fa, Vasconcelos, C, D'Cruz, D, Sebastiani, Gd, DE RAMON GARRIDO, E, Danieli, Mg, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gul, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, Ra, Cattaneo, Roberto, Font, J, Depresseux, G, Cosyns, Jp, Cervera, R., Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, Time Factors, Adolescent, Time Factor, Immunology, Injections, Intravenou, Kidney Function Tests, Follow-Up Studie, Immunosuppressive Agent, Rheumatology, Azathioprine, Humans, Cyclophosphamide, Kidney Function Test, Dose-Response Relationship, Drug, Lupus Nephriti, Lupus Nephritis, Survival Rate, Proteinuria, Treatment Outcome, Injections, Intravenous, Female, Immunosuppressive Agents, Follow-Up Studies, Human
Abstract

Arthritis Rheum. 2004 Dec;50(12):3934-40. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial. Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, Cervera R. Université Catholique de Louvain, Brussels, Belgium. houssiau@ruma.ucl.ac.be Abstract OBJECTIVE: In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors. METHODS: Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method. RESULTS: After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria

Published
2004

7. Immunosuppressive therapy in lupus nephritis: the Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide

Author

Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R., SINICO, RENATO ALBERTO, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, Kidney Function Test, Adolescent, Dose-Response Relationship, Drug, Immunology, Remission Induction, Injections, Intravenou, Lupus Nephriti, Middle Aged, Kidney Function Tests, Lupus Nephritis, Immunosuppressive Agent, Rheumatology, Azathioprine, Injections, Intravenous, Humans, Female, Single-Blind Method, Treatment Failure, Cyclophosphamide, Immunosuppressive Agents, Human, Aged
Abstract

Objective. Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment. Methods. In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed. Results. Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-dose group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of followup. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant. Conclusion. The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen

Published
2002

8. Lessons from the 'Euro-Lupus Cohort'

Author

Cervera, R., Abarca Costalago, M., Abramovicz, D., Allegri, F., PASQUALE ANNUNZIATA, Aydintug, Ao, Bacarelli, Mr, Bellisai, F., Bernardino, I., Biernat Kaluza, E., Blockmans, D., Boki, K., LUISA BRACCI, Campanella, V., Camps, Mt, Carcassi, C., Cattaneo, R., Cauli, A., Chwalinska Sadowska, H., Contu, L., Cosyns, Jp, Danieli, Mg, D Cruz, D., Depresseux, G., Direskeneli, H., Domènech, I., Espinosa, G., Fernández Nebro, A., Ferrara, Gb, Font, J., Frutos, Ma, MAURO GALEAZZI, García Carrasco, M., GARCÍA IGLESIAS MF, García Tobaruela, A., George, J., Gil, A., González Santos, P., Grana, M., Gül, A., Haga, Hj, Haro Liger, M., Houssiau, F., Hughes, Gr, Ingelmo, M., Jedryka Góral, A., Khamashta, Ma, Lavilla, P., Levi, Y., López Dupla, M., López Soto, A., Maldykowa, H., Marcolongo, R., Mathieu, A., GABRIELLA MOROZZI, Nicolopoulou, N., Papasteriades, C., Passiu, G., Perelló, I., Petera, P., Petrovic, R., Piette, Jc, Pintado, V., Pita, O., Popovic, R., Pucci, G., Puddu, P., Ramón, E., Ramos Casals, M., Rodríguez Andreu, J., Ruiz Irastroza, G., Sánchez Lora, J., Sanna, G., Scorza, R., Sebastini, Gd, Sherer, Y., Shoenfeld, Y., Simpatico, A., Sinico, Ra, Smolen, J., Tincani, A., Tokgöz, G., Urbano Márquez, A., Vasconcelos, C., Vázquez, Jj, Veronesi, M., Vianni, J., Vivancos, J., EUROPEAN WORKING PARTY ON SYSTEMIC LUPUS ERYTHEMATOSUS, Cervera, R, Abarca Costalago, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, A, Bacarelli, M, Bellisai, F, Bernardino, I, Biernat Kaluza, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, M, Carcassi, C, Cattaneo, R, Cauli, A, Chwalinska Sadowska, H, Contu, L, Cosyns, J, Danieli, M, D'Cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, Fernández Nebro, A, Ferrara, G, Font, J, Frutos, M, Galeazzi, M, García Carrasco, M, García Iglesias, M, García Tobaruela, A, George, J, Gil, A, González Santos, P, Grana, M, Gül, A, Haga, H, de Haro Liger, M, Houssiau, F, Hughes, G, Ingelmo, M, Jedryka Góral, A, Khamashta, M, Lavilla, P, Levi, Y, López Dupla, M, López Soto, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, J, Pintado, V, de Pita, O, Popovic, R, Pucci, G, Puddu, P, de Ramón, E, Ramos Casals, M, Rodríguez Andreu, J, Ruiz Irastroza, G, Sánchez Lora, J, Sanna, G, Scorza, R, Sebastini, G, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, R, Smolen, J, Tincani, A, Tokgöz, G, Urbano Márquez, A, Vasconcelos, C, Vázquez, J, Veronesi, M, Vianni, J, and Vivancos, J

Subjects
Adult, Male, Adolescent, Prognosi, Middle Aged, Prognosis, Cohort Studies, Europe, Survival Rate, Prospective Studie, Antibodies, Antinuclear, Humans, Lupus Erythematosus, Systemic, Female, Prospective Studies, Cohort Studie, Age of Onset, Human
Abstract

The "Euro-Lupus Cohort" is composed by 1,000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium - the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors.

Published
2002

9. European Working Party on Systemic Lupus Erythematosus. Systemic lupus erythematosus in Europe at the change of the millennium: lessons from the 'Euro-Lupus Project'

Author

Cervera, R, ABARCA COSTALAGO, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, Ao, Bacarelli, Mr, Bellisai, F, Bernardino, I, BIERNAT KALUZA, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, Mt, Carcassi, C, Cattaneo, Roberto, Cauli, A, CHWALINSKA SADOWSKA, H, Contu, L, Cosyns, Jp, Danieli, Mg, Dcruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, FERNÁNDEZ NEBRO, A, Ferrara, Gb, Font, J, Frutos, Ma, Galeazzi, M, GARCÌA CARRASCO, M, GARCÍA IGLESIAS MF, GARCÍA TOBARUELA, A, George, J, Gil, A, GONZÁLEZ SANTOS, P, Grana, M, Gül, A, Haga, Hj, DE HARO LIGER, M, Houssiau, F, Hughes, Gr, Ingelmo, M, JEDRYKA GÓRAL, A, Khamashta, Ma, Lavilla, P, Levi, Y, LÓPEZ DULPA, M, LÓPEZ SOTO, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, Jc, Pintado, V, DE PITA, O, Popovic, R, Pucci, G, Puddu, P, DE RAMÓN, E, RAMOS CASALS, M, RODRÍGUEZ ANDREU, J, RUIZ IRASTORZA, G, SANCHEZ LORA, J, Sanna, G, Scorza, R, Sebastiani, Gd, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, Ra, Smolen, J, Tincani, Angela, Tokgöz, G, URBANO MÁRQUEZ, A, Vasconcelos, C, Vázquez, Jj, Veronesi, J, Vianna, J, and Vivancos, J.

Published
2006

10. Early

Author

HOUSSIAU, F.A., VASCONCELOS, C, D'CRUZ, D., SEBASTIANI, G.D., DE RAMON GARRIDO, E., DANIELI, M.G., ABRAMOVICZ, D., BLOCKMANS, D., MATHIEU, A., DIRESKENELI, H., GALEAZZI, M., GUL, A., LEVY, Y., PETERA, P., POPOVIC, R., PETROVIC, R., SINICO, R.A., CATTANEO, R., FONT, J., DEPRESSEUX, G., COSYNS, J.P., and CERVERA, R.

Abstract

Arthritis Rheum. 2004 Dec;50(12):3934-40. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial. Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, Cervera R. Université Catholique de Louvain, Brussels, Belgium. houssiau@ruma.ucl.ac.be Abstract OBJECTIVE: In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors. METHODS: Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method. RESULTS: After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria

Published
2004

11. Immunosuppressive therapy in lupus nephritis: the Euro‐Lupus Nephritis Trial, a randomized trial of low‐dose versus high‐dose intravenous cyclophosphamide

Author

Houssiau, F.A., Vasconcelos, C., D'Cruz, D., Sebastiani, G.D., Garrido Ed Ede, R., Danieli, M.G., Abramovicz, D., Blockmans, D., Mathieu, A., Direskeneli, H., Galeazzi, M., Gül, A., Levy, Y., Petera, P., Popovic, R., Petrovic, R, Sinico, R.A., Cattaneo, R., Font, J., Depresseux, G., Cosyns, J.P., and Cervera, R.

Abstract

Arthritis Rheum. 2002 Aug;46(8):2121-31. Immunosuppressive therapy in lupus nephritis: the Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide. Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, Garrido Ed Ede R, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, Cervera R. Cliniques Universitaires St. Luc, Université Catholique de Louvain, Brussels, Belgium. houssiau@ruma.ucl.ac.be Comment in: Arthritis Rheum. 2003 May;48(5):1466; author reply 1466-7. Abstract OBJECTIVE: Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment. METHODS: In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed. RESULTS: Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-dose group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of followup. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant. CONCLUSION: The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen. PMID: 12209517 [PubMed - indexed for MEDLINE]

Published
2002

12. European Working Party on Systemic Lupus Erythematosus. Lessons from the 'Euro-Lupus Cohort'

Author

Cervera, R, ABARCA COSTALAGO, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, Ao, Bacarelli, Mr, Bellisai, F, Bernardino, I, BIERNAT KALUZA, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, Mt, Carcassi, C, Cattaneo, Roberto, Cauli, A, CHWALINSKA SADOWSKA, H, Contu, L, Cosyns, Jp, Danieli, Mg, D'Cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, FERNÁNDEZ NEBRO, A, Ferrara, Gb, Font, J, Frutos, Ma, Galeazzi, M, GARCÍA CARRASCO, M, GARCÍA IGLESIAS MF, GARCÍA TOBARUELA, A, George, J, Gil, A, GONZÁLEZ SANTOS, P, Grana, M, Gül, A, Haga, Hj, DE HARO LIGER, M, Houssiau, F, Hughes, Gr, Ingelmo, M, JEDRYKA GÓRAL, A, Khamashta, Ma, Lavilla, P, Levi, Y, LÓPEZ DUPLA, M, LÓPEZ SOTO, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, Jc, Pintado, V, DE PITA, O, Popovic, R, Pucci, G, Puddu, P, DE RAMÓN, E, RAMOS CASALS, M, RODRÍGUEZ ANDREU, J, RUIZ IRASTROZA, G, SÁNCHEZ LORA, J, Sanna, G, Scorza, R, Sebastini, Gd, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, Ra, Smolen, J, Tincani, Angela, Tokgöz, G, URBANO MÁRQUEZ, A, Vasconcelos, C, Vázquez, Jj, Veronesi, M, Vianni, J, and Vivancos, J.

Published
2002

13. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide

Author

Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Cauli, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R, Cervera, R., SINICO, RENATO ALBERTO, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Cauli, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R, Cervera, R., and SINICO, RENATO ALBERTO

Abstract

Objective: To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomised prospective trial comparing low-dose (LD) and high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis. Patients and methods: Data for survival and kidney function were prospectively collected during a 10-year period for the 90 patients randomised in the ELNT, except in 6 lost to follow-up. Results: Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (5/44 (11%) vs 2/46 (4%), 6/44 (14%) vs 5/46 (11%) and 2/44 (5%) vs 4/46 (9%), respectively) nor did mean serum creatinine, 24 h proteinuria and damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents and blood pressure lowering drugs. After 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy was confirmed. Conclusion: The data confirm that a LD IVCY regimen followed by AZA - the "Euro-Lupus regimen" - achieves good clinical results in the very long term

Published
2010

14. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: Lessons from long-term followup of patients in the euro-lupus nephritis trial

Author

Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R, Cervera, R., SINICO, RENATO ALBERTO, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, Cervera, R, Cervera, R., and SINICO, RENATO ALBERTO

Abstract

Objective. In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors. Methods. Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method. Results. After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria <1 gm/24 hours) was the best predictor of good long-term renal outcome. Conclusion. Long-term followup of patients from the ELNT confirms that, in lupus nephritis, a remission-inducing regimen of low-dose IV CYC followed by AZA achieves clinical results comparable with those obtained with a high-dose regimen. Early response to therapy is predictive of good long-term renal outcome

Published
2004

15. Lessons from the 'Euro-Lupus Cohort'

Author

Cervera, R, Abarca Costalago, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, A, Bacarelli, M, Bellisai, F, Bernardino, I, Biernat Kaluza, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, M, Carcassi, C, Cattaneo, R, Cauli, A, Chwalinska Sadowska, H, Contu, L, Cosyns, J, Danieli, M, D'Cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, Fernández Nebro, A, Ferrara, G, Font, J, Frutos, M, Galeazzi, M, García Carrasco, M, García Iglesias, M, García Tobaruela, A, George, J, Gil, A, González Santos, P, Grana, M, Gül, A, Haga, H, de Haro Liger, M, Houssiau, F, Hughes, G, Ingelmo, M, Jedryka Góral, A, Khamashta, M, Lavilla, P, Levi, Y, López Dupla, M, López Soto, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, J, Pintado, V, de Pita, O, Popovic, R, Pucci, G, Puddu, P, de Ramón, E, Ramos Casals, M, Rodríguez Andreu, J, Ruiz Irastroza, G, Sánchez Lora, J, Sanna, G, Scorza, R, Sebastini, G, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, R, Smolen, J, Tincani, A, Tokgöz, G, Urbano Márquez, A, Vasconcelos, C, Vázquez, J, Veronesi, M, Vianni, J, Vivancos, J, SINICO, RENATO ALBERTO, Vivancos, J., Cervera, R, Abarca Costalago, M, Abramovicz, D, Allegri, F, Annunziata, P, Aydintug, A, Bacarelli, M, Bellisai, F, Bernardino, I, Biernat Kaluza, E, Blockmans, D, Boki, K, Bracci, L, Campanella, V, Camps, M, Carcassi, C, Cattaneo, R, Cauli, A, Chwalinska Sadowska, H, Contu, L, Cosyns, J, Danieli, M, D'Cruz, D, Depresseux, G, Direskeneli, H, Domènech, I, Espinosa, G, Fernández Nebro, A, Ferrara, G, Font, J, Frutos, M, Galeazzi, M, García Carrasco, M, García Iglesias, M, García Tobaruela, A, George, J, Gil, A, González Santos, P, Grana, M, Gül, A, Haga, H, de Haro Liger, M, Houssiau, F, Hughes, G, Ingelmo, M, Jedryka Góral, A, Khamashta, M, Lavilla, P, Levi, Y, López Dupla, M, López Soto, A, Maldykowa, H, Marcolongo, R, Mathieu, A, Morozzi, G, Nicolopoulou, N, Papasteriades, C, Passiu, G, Perelló, I, Petera, P, Petrovic, R, Piette, J, Pintado, V, de Pita, O, Popovic, R, Pucci, G, Puddu, P, de Ramón, E, Ramos Casals, M, Rodríguez Andreu, J, Ruiz Irastroza, G, Sánchez Lora, J, Sanna, G, Scorza, R, Sebastini, G, Sherer, Y, Shoenfeld, Y, Simpatico, A, Sinico, R, Smolen, J, Tincani, A, Tokgöz, G, Urbano Márquez, A, Vasconcelos, C, Vázquez, J, Veronesi, M, Vianni, J, Vivancos, J, SINICO, RENATO ALBERTO, and Vivancos, J.

Abstract

The "Euro-Lupus Cohort" is composed by 1,000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium - the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors

Published
2002

16. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide

Author

Houssiau, F A, primary, Vasconcelos, C, additional, D’Cruz, D, additional, Sebastiani, G D, additional, de Ramon Garrido, E, additional, Danieli, M G, additional, Abramovicz, D, additional, Blockmans, D, additional, Cauli, A, additional, Direskeneli, H, additional, Galeazzi, M, additional, Gül, A, additional, Levy, Y, additional, Petera, P, additional, Popovic, R, additional, Petrovic, R, additional, Sinico, R A, additional, Cattaneo, R, additional, Font, J, additional, Depresseux, G, additional, Cosyns, J-P, additional, and Cervera, R, additional

Published
2009
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18. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide

Author

David D'Cruz, Daniel Abramovicz, Yair Levy, Gian Domenico Sebastiani, Frédéric Houssiau, Alberto Cauli, Rajko Popovic, Mauro Galeazzi, Geneviève Depresseux, Roberto Cattaneo, Peter Petera, Haner Direskeneli, Ricard Cervera, Carlos Vasconcelos, Radmila Petrovic, E. De Ramon Garrido, Ahmet Gül, Maria Giovanna Danieli, J Font, J-P Cosyns, Renato Alberto Sinico, Daniel Engelbert Blockmans, Houssiau, F, Vasconcelos, C, D'Cruz, D, Sebastiani, G, De Ramon Garrido, E, Danieli, M, Abramovicz, D, Blockmans, D, Cauli, A, Direskeneli, H, Galeazzi, M, Gül, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, R, Cattaneo, R, Font, J, Depresseux, G, Cosyns, J, and Cervera, R

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Cyclophosphamide, Immunology, Lupus nephritis, Urology, Renal function, Injections, Intravenou, Kidney Function Tests, General Biochemistry, Genetics and Molecular Biology, Immunosuppressive Agent, Young Adult, chemistry.chemical_compound, Rheumatology, Azathioprine, medicine, Humans, Immunology and Allergy, Creatinine, Kidney Function Test, Biochemistry, Genetics and Molecular Biology (all), Proteinuria, Dose-Response Relationship, Drug, business.industry, Lupus Nephriti, Middle Aged, medicine.disease, Lupus Nephritis, Surgery, Regimen, Treatment Outcome, chemistry, Epidemiologic Method, Injections, Intravenous, Drug Therapy, Combination, Female, medicine.symptom, Epidemiologic Methods, business, Nephritis, Immunosuppressive Agents, Human, medicine.drug, Kidney disease
Abstract

Objective:To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomised prospective trial comparing low-dose (LD) and high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis.Patients and methods:Data for survival and kidney function were prospectively collected during a 10-year period for the 90 patients randomised in the ELNT, except in 6 lost to follow-up.Results:Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (5/44 (11%) vs 2/46 (4%), 6/44 (14%) vs 5/46 (11%) and 2/44 (5%) vs 4/46 (9%), respectively) nor did mean serum creatinine, 24 h proteinuria and damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents and blood pressure lowering drugs. After 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy was confirmed.Conclusion:The data confirm that a LD IVCY regimen followed by AZA—the “Euro-Lupus regimen”—achieves good clinical results in the very long term.

Published
2009
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19. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial - Lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial

Author

DİRESKENELİ, RAFİ HANER, Houssiau, FA, Vasconcelos, C, D'Cruz, D, Sebastiani, GD, Garrido, ED, Danieli, MG, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gul, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, RA, Cattaneo, R, Font, J, Depresseux, GV, Cosyns, JP, and Cervera, R

Subjects
PREDNISONE, CYCLOPHOSPHAMIDE, COMBINATION, PULSE METHYLPREDNISOLONE, MYCOPHENOLATE-MOFETIL, DISEASE
Abstract

Objective. In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors. Methods. Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method. Results. After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria

Published
2004

20. Immunosuppressive therapy in lupus nephritis - The Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide

Author

DİRESKENELİ, RAFİ HANER, Houssiau, FA, Vasconcelos, C, D'Cruz, D, Sebastiani, GD, Garrido, ED, Danieli, MG, Abramovicz, D, Blockmans, D, Mathieu, A, Direskeneli, H, Galeazzi, M, Gul, A, Levy, Y, Petera, P, Popovic, R, Petrovic, R, Sinico, RA, Cattaneo, R, Font, J, Depresseux, G, Cosyns, JP, and Cervera, R

Subjects
METHYLPREDNISOLONE, ORAL BOLUS CYCLOPHOSPHAMIDE, ERYTHEMATOSUS, MANAGEMENT, PULSE CYCLOPHOSPHAMIDE, COMBINATION, MYCOPHENOLATE-MOFETIL
Abstract

Objective. Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment. Methods. In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed. Results. Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-do se group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of follow-up. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant. Conclusion. The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen.

Published
2002

21. Immunosuppression of HLA identical living-donor kidney transplant recipients: A systematic review.

Author

Pérez-Sáez MJ, Montero N, Oliveras L, Redondo-Pachón D, Martínez-Simón D, Abramovicz D, Maggiore U, Mariat C, Mjoen G, Oniscu GC, Peruzzi L, Sever MS, Watschinger B, Velioglu A, Demir E, Gandolfini I, Hellemans R, Hilbrands L, Pascual J, and Crespo M

Subjects
Humans, Living Donors, Retrospective Studies, Graft Survival, Graft Rejection prevention & control, Immunosuppression Therapy methods, Transplant Recipients, Immunosuppressive Agents therapeutic use, HLA Antigens, Kidney Transplantation
Abstract

Background: Kidney transplant (KT) recipients of HLA identical siblings (HLAid) have lower immunological risk, but there are no specific recommendations for immunosuppression. Our aim was to analyze evidence about results from HLAid living-donor recipients under different immunosuppression in the current era of immunological risk assessment., Methods: Systematic review of studies describing associations between outcomes of HLAid living-donor KT recipients according to their immunological risk and applied immunosuppression., Results: From 1351 studies, 16 (5636 KT recipients) were included in the analysis. All studies were retrospective, ten comparing immunosuppression strategies, and six immunological risk strata. Of those ten, six studies were published in 1990 or earlier and only three included tacrolimus. The evidence is poor, and the inclusion of calcineurin inhibitors does not demonstrate better results. Furthermore, only few studies describe different immunosuppression regimens according to the patient immunological risk and, in general, they do not include the assessment with new solid phase assays., Conclusions: There are no studies analyzing the association of outcomes of HLAid KT recipients with current immunological risk tools. In the absence of evidence, no decision or proposal of immunosuppression adapted to modern immunological risk assessment can be made currently by the Descartes Working Group., Competing Interests: Declaration of Competing Interest The results presented in this paper have not been published previously in whole or part. The authors of this study declare no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Published
2023
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22. Thymoglobulin induction and sirolimus versus tacrolimus in kidney transplant recipients receiving mycophenolate mofetil and steroids.

Author

Glotz D, Charpentier B, Abramovicz D, Lang P, Rostaing L, Rifle G, Vanrenterghem Y, Berthoux F, Bourbigot B, Delahousse M, Chalopin JM, Cassuto E, and Lefrançois N

Subjects
Adolescent, Adult, Aged, Antilymphocyte Serum chemistry, Calcineurin chemistry, Calcineurin Inhibitors, Child, Child, Preschool, Female, Glomerular Filtration Rate, Humans, Immunosuppressive Agents therapeutic use, Male, Middle Aged, Mycophenolic Acid therapeutic use, Treatment Outcome, Antibodies, Monoclonal metabolism, Kidney Transplantation methods, Mycophenolic Acid analogs & derivatives, Sirolimus therapeutic use, Steroids therapeutic use, Tacrolimus therapeutic use
Abstract

Background: To define the role of mammalian target of rapamycin inhibitors in kidney transplantation, we compared efficacy and safety of two immunosuppressive regimens-a calcineurin inhibitor-free regimen with depletive induction versus a calcineurin inhibitor-based regimen., Methods: De novo renal allograft recipients were randomized before transplantation to receive sirolimus (SRL; n=71, group A) or tacrolimus (n=70, group B). All patients received mycophenolate mofetil and corticosteroids. In group A, patients received rabbit antithymocyte globulin induction. In group B, antithymocyte globulin therapy could be given in case of delayed graft function. The estimated glomerular filtration rate (GFR) (Nankivell's formula) at month 12 was the primary endpoint., Results: GFR showed no significant difference at month 12, with 56.1 in group A versus 58.4 mL/min/1.73 m in group B. In functioning grafts, renal function was significantly better in the SRL group, with higher GFR values at months 1, 2, 3, 6, and 9 (P<0.05). At month 12, patient survival and incidence of biopsy-proven rejection were not different between groups (95.8% vs. 97.1%, and 16.9% vs. 12.9%, respectively). However, proportion of graft loss was higher with SRL at months 6 and 12 (11.3% vs. 0.0%, P=0.004; 14.1% vs. 4.3%, P=0.044, respectively). Adverse events and premature withdrawals were more frequent with SRL (P<0.001 and P<0.05, respectively), whereas cytomegalovirus infections were more frequent with tacrolimus (P<0.001)., Conclusion: Patients treated with induction plus SRL, mycophenolate mofetil, and corticosteroids may obtain good renal function but have a higher risk of adverse events, drug withdrawal, and graft loss.

Published
2010
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23. Systemic lupus erythematosus in Europe at the change of the millennium: lessons from the "Euro-Lupus Project".

Author

Cervera R, Abarca-Costalago M, Abramovicz D, Allegri F, Annunziata P, Aydintug AO, Bacarelli MR, Bellisai F, Bernardino I, Biernat-Kaluza E, Blockmans D, Boki K, Bracci L, Campanella V, Camps MT, Carcassi C, Cattaneo R, Cauli A, Cervera R, Chwalinska-Sadowska H, Contu L, Cosyns JP, Danieli MG, DCruz D, Depresseux G, Direskeneli H, Domènech I, Espinosa G, Fernández-Nebro A, Ferrara GB, Font J, Frutos MA, Galeazzi M, Garcìa-Carrasco M, García Iglesias MF, García-Tobaruela A, George J, Gil A, González-Santos P, Grana M, Gül A, Haga HJ, de Haro-Liger M, Houssiau F, Hughes GR, Ingelmo M, Jedryka-Góral A, Khamashta MA, Lavilla P, Levi Y, López-Dulpa M, López-Soto A, Maldykowa H, Marcolongo R, Mathieu A, Morozzi G, Nicolopoulou N, Papasteriades C, Passiu G, Perelló I, Petera P, Petrovic R, Piette JC, Pintado V, de Pita O, Popovic R, Pucci G, Puddu P, de Ramón E, Ramos-Casals M, Rodríguez-Andreu J, Ruiz-Irastorza G, Sanchez-Lora J, Sanna G, Scorza R, Sebastiani GD, Sherer Y, Shoenfeld Y, Simpatico A, Sinico RA, Smolen J, Tincani A, Tokgöz G, Urbano-Márquez A, Vasconcelos C, Vázquez JJ, Veronesi J, Vianna J, and Vivancos J

Subjects
Age of Onset, Antibodies, Antinuclear blood, Autoimmune Diseases blood, Autoimmune Diseases mortality, Cohort Studies, Europe epidemiology, Female, Follow-Up Studies, Humans, Lupus Erythematosus, Systemic blood, Lupus Erythematosus, Systemic mortality, Male, Morbidity, Prognosis, Prospective Studies, Survival Rate, Autoimmune Diseases diagnosis, Autoimmune Diseases epidemiology, Lupus Erythematosus, Systemic diagnosis, Lupus Erythematosus, Systemic epidemiology
Abstract

The "Euro-Lupus Cohort" is composed by 1000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium--the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors.

Published
2006
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24. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial.

Author

Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, de Ramon Garrido E, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, and Cervera R

Subjects
Adolescent, Adult, Cyclophosphamide administration & dosage, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Immunosuppressive Agents administration & dosage, Injections, Intravenous, Kidney Function Tests, Lupus Nephritis mortality, Lupus Nephritis physiopathology, Male, Proteinuria drug therapy, Survival Rate, Time Factors, Treatment Outcome, Azathioprine therapeutic use, Cyclophosphamide therapeutic use, Immunosuppressive Agents therapeutic use, Lupus Nephritis drug therapy
Abstract

Objective: In the Euro-Lupus Nephritis Trial (ELNT), 90 patients with lupus nephritis were randomly assigned to a high-dose intravenous cyclophosphamide (IV CYC) regimen (6 monthly pulses and 2 quarterly pulses with escalating doses) or a low-dose IV CYC regimen (6 pulses of 500 mg given at intervals of 2 weeks), each of which was followed by azathioprine (AZA). After a median followup of 41 months, a difference in efficacy between the 2 regimens was not observed. The present analysis was undertaken to extend the followup and to identify prognostic factors., Methods: Renal function was prospectively assessed quarterly in all 90 patients except 5 who were lost to followup. Survival curves were derived using the Kaplan-Meier method., Results: After a median followup of 73 months, there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen. At long-term followup, 18 patients (8 receiving low-dose and 10 receiving high-dose treatment) had developed permanent renal impairment and were classified as having poor long-term renal outcome. We demonstrated by multivariate analysis that early response to therapy at 6 months (defined as a decrease in serum creatinine level and proteinuria <1 g/24 hours) was the best predictor of good long-term renal outcome., Conclusion: Long-term followup of patients from the ELNT confirms that, in lupus nephritis, a remission-inducing regimen of low-dose IV CYC followed by AZA achieves clinical results comparable with those obtained with a high-dose regimen. Early response to therapy is predictive of good long-term renal outcome.

Published
2004
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25. Lessons from the "Euro-Lupus Cohort".

Author

Cervera R, Abarca-Costalago M, Abramovicz D, Allegri F, Annunziata P, Aydintug AO, Bacarelli MR, Bellisai F, Bernardino I, Biernat-Kaluza E, Blockmans D, Boki K, Bracci L, Campanella V, Camps MT, Carcassi C, Cattaneo R, Cauli A, Chwalinska-Sadowska H, Contu L, Cosyns JP, Danieli MG, D'Cruz D, Depresseux G, Direskeneli H, Domènech I, Espinosa G, Fernández-Nebro A, Ferrara GB, Font J, Frutos MA, Galeazzi M, García-Carrasco M, García-Iglesias MF, García-Tobaruela A, George J, Gil A, González-Santos P, Grana M, Gül A, Haga HJ, de Haro-Liger M, Houssiau F, Hughes GR, Ingelmo M, Jedryka-Góral A, Khamashta MA, Lavilla P, Levi Y, López-Dupla M, López-Soto A, Maldykowa H, Marcolongo R, Mathieu A, Morozzi G, Nicolopoulou N, Papasteriades C, Passiu G, Perelló I, Petera P, Petrovic R, Piette JC, Pintado V, de Pita O, Popovic R, Pucci G, Puddu P, de Ramón E, Ramos-Casals M, Rodríguez-Andreu J, Ruiz-Irastroza G, Sánchez-Lora J, Sanna G, Scorza R, Sebastini GD, Sherer Y, Shoenfeld Y, Simpatico A, Sinico RA, Smolen J, Tincani A, Tokgöz G, Urbano-Márquez A, Vasconcelos C, Vázquez JJ, Veronesi M, Vianni J, and Vivancos J

Subjects
Adolescent, Adult, Age of Onset, Antibodies, Antinuclear blood, Cohort Studies, Europe epidemiology, Female, Humans, Lupus Erythematosus, Systemic blood, Lupus Erythematosus, Systemic mortality, Male, Middle Aged, Prognosis, Prospective Studies, Survival Rate, Lupus Erythematosus, Systemic epidemiology
Abstract

The "Euro-Lupus Cohort" is composed by 1,000 patients with systemic lupus erythematosus (SLE) that have been followed prospectively since 1991. These patients have been gathered by a European consortium - the "Euro-Lupus Project Group". This consortium was originated as part of the network promoted by the "European Working Party on SLE", a working group created in 1990 in order to promote research in Europe on the different problems related to this disease. The "Euro-Lupus Cohort" provides an updated information on the SLE morbidity and mortality characteristics in the present decade as well as defines several clinical and immunological prognostic factors.

Published
2002

26. Immunosuppressive therapy in lupus nephritis: the Euro-Lupus Nephritis Trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide.

Author

Houssiau FA, Vasconcelos C, D'Cruz D, Sebastiani GD, Garrido Ed Ede R, Danieli MG, Abramovicz D, Blockmans D, Mathieu A, Direskeneli H, Galeazzi M, Gül A, Levy Y, Petera P, Popovic R, Petrovic R, Sinico RA, Cattaneo R, Font J, Depresseux G, Cosyns JP, and Cervera R

Subjects
Adolescent, Adult, Aged, Azathioprine therapeutic use, Cyclophosphamide administration & dosage, Dose-Response Relationship, Drug, Female, Humans, Immunosuppressive Agents administration & dosage, Injections, Intravenous, Kidney Function Tests, Lupus Nephritis blood, Lupus Nephritis pathology, Male, Middle Aged, Remission Induction, Single-Blind Method, Treatment Failure, Cyclophosphamide therapeutic use, Immunosuppressive Agents therapeutic use, Lupus Nephritis drug therapy
Abstract

Objective: Glomerulonephritis is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment, followed by azathioprine (AZA) as a remission-maintaining treatment., Methods: In this multicenter, prospective clinical trial (the Euro-Lupus Nephritis Trial [ELNT]), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose IV CYC regimen (6 monthly pulses and 2 quarterly pulses; doses increased according to the white blood cell count nadir) or a low-dose IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by AZA. Intent-to-treat analyses were performed., Results: Followup continued for a median of 41.3 months in the low-dose group and 41 months in the high-dose group. Sixteen percent of those in the low-dose group and 20% of those in the high-dose group experienced treatment failure (not statistically significant by Kaplan-Meier analysis). Levels of serum creatinine, albumin, C3, 24-hour urinary protein, and the disease activity scores significantly improved in both groups during the first year of followup. Renal remission was achieved in 71% of the low-dose group and 54% of the high-dose group (not statistically significant). Renal flares were noted in 27% of the low-dose group and 29% of the high-dose group. Although episodes of severe infection were more than twice as frequent in the high-dose group, the difference was not statistically significant., Conclusion: The data from the ELNT indicate that in European SLE patients with proliferative lupus nephritis, a remission-inducing regimen of low-dose IV CYC (cumulative dose 3 gm) followed by AZA achieves clinical results comparable to those obtained with a high-dose regimen.

Published
2002
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