{"title":"诱导高风险原发性膜性肾病早期缓解的新方法。","authors":"Zinaida Kochoyan, Vladimir A Dobronravov","doi":"10.1093/ndt/gfae138","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This prospective single-arm trial with historic controls evaluated the efficacy and safety of treatment based on a combination of rituximab, intravenous cyclophosphamide and corticosteroids (RCP) administered at lower cumulative doses for the induction of early remission in primary membranous nephropathy (PMN).</p><p><strong>Methods: </strong>We prospectively enrolled 30 high-risk PMN patients with persistent nephrotic syndrome (NS) and elevated antibodies to the phospholipase A2 receptor who underwent RCP therapy. We compared the effectiveness of RCP with that of historic controls who received rituximab-based therapy (RTX, n = 15) or cyclosporine + corticosteroids (CSA, n = 42). The primary outcomes were complete remission (CR) and overall remission (OR) by Month 12 and the time to remission.</p><p><strong>Results: </strong>In the RCP group, the OR and CR rates by 12 months (97% and 60%) were higher than those in the RTX group (60% and 7%, P ≤ .009) and the CSA group (50% and 24%, P ≤ .003). The median time to OR [2.8 (1.6-3.9) months] was shorter compared with RTX [7.1 (3.4-17.5) months, P = .008] and CSA [7.3 (6.0-13.6) months, P < .001]. In adjusted Cox regression, hazard ratios for OR and CR attainment for RCP versus other treatments were 5.2 (95% CI 2.8-9.6) and 4.8 (95% CI 2.2-10.3), respectively. Propensity score-matched group analyses confirmed these results. One serious adverse event occurred in the RCP group in the follow-up of 56 patient-years.</p><p><strong>Conclusions: </strong>RCP therapy is considered effective and safe for inducing early remission in high-risk PMN patients.</p>","PeriodicalId":19078,"journal":{"name":"Nephrology Dialysis Transplantation","volume":" ","pages":"60-70"},"PeriodicalIF":4.8000,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A novel approach to induce early remission in high-risk primary membranous nephropathy.\",\"authors\":\"Zinaida Kochoyan, Vladimir A Dobronravov\",\"doi\":\"10.1093/ndt/gfae138\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This prospective single-arm trial with historic controls evaluated the efficacy and safety of treatment based on a combination of rituximab, intravenous cyclophosphamide and corticosteroids (RCP) administered at lower cumulative doses for the induction of early remission in primary membranous nephropathy (PMN).</p><p><strong>Methods: </strong>We prospectively enrolled 30 high-risk PMN patients with persistent nephrotic syndrome (NS) and elevated antibodies to the phospholipase A2 receptor who underwent RCP therapy. We compared the effectiveness of RCP with that of historic controls who received rituximab-based therapy (RTX, n = 15) or cyclosporine + corticosteroids (CSA, n = 42). The primary outcomes were complete remission (CR) and overall remission (OR) by Month 12 and the time to remission.</p><p><strong>Results: </strong>In the RCP group, the OR and CR rates by 12 months (97% and 60%) were higher than those in the RTX group (60% and 7%, P ≤ .009) and the CSA group (50% and 24%, P ≤ .003). The median time to OR [2.8 (1.6-3.9) months] was shorter compared with RTX [7.1 (3.4-17.5) months, P = .008] and CSA [7.3 (6.0-13.6) months, P < .001]. In adjusted Cox regression, hazard ratios for OR and CR attainment for RCP versus other treatments were 5.2 (95% CI 2.8-9.6) and 4.8 (95% CI 2.2-10.3), respectively. Propensity score-matched group analyses confirmed these results. One serious adverse event occurred in the RCP group in the follow-up of 56 patient-years.</p><p><strong>Conclusions: </strong>RCP therapy is considered effective and safe for inducing early remission in high-risk PMN patients.</p>\",\"PeriodicalId\":19078,\"journal\":{\"name\":\"Nephrology Dialysis Transplantation\",\"volume\":\" \",\"pages\":\"60-70\"},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2024-12-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nephrology Dialysis Transplantation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ndt/gfae138\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"TRANSPLANTATION\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nephrology Dialysis Transplantation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ndt/gfae138","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"TRANSPLANTATION","Score":null,"Total":0}
A novel approach to induce early remission in high-risk primary membranous nephropathy.
Background: This prospective single-arm trial with historic controls evaluated the efficacy and safety of treatment based on a combination of rituximab, intravenous cyclophosphamide and corticosteroids (RCP) administered at lower cumulative doses for the induction of early remission in primary membranous nephropathy (PMN).
Methods: We prospectively enrolled 30 high-risk PMN patients with persistent nephrotic syndrome (NS) and elevated antibodies to the phospholipase A2 receptor who underwent RCP therapy. We compared the effectiveness of RCP with that of historic controls who received rituximab-based therapy (RTX, n = 15) or cyclosporine + corticosteroids (CSA, n = 42). The primary outcomes were complete remission (CR) and overall remission (OR) by Month 12 and the time to remission.
Results: In the RCP group, the OR and CR rates by 12 months (97% and 60%) were higher than those in the RTX group (60% and 7%, P ≤ .009) and the CSA group (50% and 24%, P ≤ .003). The median time to OR [2.8 (1.6-3.9) months] was shorter compared with RTX [7.1 (3.4-17.5) months, P = .008] and CSA [7.3 (6.0-13.6) months, P < .001]. In adjusted Cox regression, hazard ratios for OR and CR attainment for RCP versus other treatments were 5.2 (95% CI 2.8-9.6) and 4.8 (95% CI 2.2-10.3), respectively. Propensity score-matched group analyses confirmed these results. One serious adverse event occurred in the RCP group in the follow-up of 56 patient-years.
Conclusions: RCP therapy is considered effective and safe for inducing early remission in high-risk PMN patients.
期刊介绍:
Nephrology Dialysis Transplantation (ndt) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis and transplantation. ndt is an official journal of the [ERA-EDTA](http://www.era-edta.org/) (European Renal Association-European Dialysis and Transplant Association). Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world. All research articles in this journal have undergone peer review.
Print ISSN: 0931-0509.