Renée Ysermans , Matthias H. Busch , Joop P. Aendekerk , Jan G.M.C. Damoiseaux , Pieter van Paassen
{"title":"在利妥昔单抗中加入低剂量环磷酰胺进行缓解诱导可能延长ANCA血管炎患者的无复发生存期:一项回顾性研究","authors":"Renée Ysermans , Matthias H. Busch , Joop P. Aendekerk , Jan G.M.C. Damoiseaux , Pieter van Paassen","doi":"10.1016/j.jtauto.2022.100178","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>Rituximab (RTX) and cyclophosphamide (CYC) are effective remission-induction therapies in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, combining these therapies may favor prognosis in patients with a major disease presentation. We conducted a retrospective study to compare patients treated with a combination of RTX and low dose CYC (RTX-CYC) or with RTX only, both followed by tailored maintenance with RTX, with regard to long-term outcomes.</p></div><div><h3>Methods</h3><p>Patients treated in the Maastricht University Medical Center between March 2007 and January 2019, were screened for eligibility. The primary outcome variable was major relapse rate after two and five years. Secondary outcome variables were clinical data and laboratory parameters.</p></div><div><h3>Results</h3><p>Of the 246 screened patients, 34 received RTX-CYC and 28 RTX only for remission-induction. All patients were followed for at least two years, with a median follow-up of 48 months (IQR 24–60). At baseline, renal involvement was more prevalent in the RTX-CYC patients (85% vs. 61%, <em>P</em> = 0.028). Major relapse rates within two years, but not after five years, were significantly lower in the RTX-CYC group (3% vs. 24%, <em>P</em> = 0.032). The rate of infections, hypogammaglobulinemia, end-stage renal disease, malignancies, and mortality did not differ after two and five years.</p></div><div><h3>Conclusion</h3><p>Adding low dose CYC to RTX is safe and may prevent major relapses in patients with severe AAV in the first two years after remission-induction. Randomized controlled trials that compare the efficacy and safety between RTX and a combination of RTX with CYC are needed.</p></div>","PeriodicalId":36425,"journal":{"name":"Journal of Translational Autoimmunity","volume":null,"pages":null},"PeriodicalIF":4.7000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9800337/pdf/","citationCount":"0","resultStr":"{\"title\":\"Adding low dose cyclophosphamide to rituximab for remission-induction may prolong relapse-free survival in patients with ANCA vasculitis: A retrospective study\",\"authors\":\"Renée Ysermans , Matthias H. Busch , Joop P. Aendekerk , Jan G.M.C. Damoiseaux , Pieter van Paassen\",\"doi\":\"10.1016/j.jtauto.2022.100178\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>Rituximab (RTX) and cyclophosphamide (CYC) are effective remission-induction therapies in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, combining these therapies may favor prognosis in patients with a major disease presentation. We conducted a retrospective study to compare patients treated with a combination of RTX and low dose CYC (RTX-CYC) or with RTX only, both followed by tailored maintenance with RTX, with regard to long-term outcomes.</p></div><div><h3>Methods</h3><p>Patients treated in the Maastricht University Medical Center between March 2007 and January 2019, were screened for eligibility. The primary outcome variable was major relapse rate after two and five years. Secondary outcome variables were clinical data and laboratory parameters.</p></div><div><h3>Results</h3><p>Of the 246 screened patients, 34 received RTX-CYC and 28 RTX only for remission-induction. All patients were followed for at least two years, with a median follow-up of 48 months (IQR 24–60). At baseline, renal involvement was more prevalent in the RTX-CYC patients (85% vs. 61%, <em>P</em> = 0.028). Major relapse rates within two years, but not after five years, were significantly lower in the RTX-CYC group (3% vs. 24%, <em>P</em> = 0.032). The rate of infections, hypogammaglobulinemia, end-stage renal disease, malignancies, and mortality did not differ after two and five years.</p></div><div><h3>Conclusion</h3><p>Adding low dose CYC to RTX is safe and may prevent major relapses in patients with severe AAV in the first two years after remission-induction. Randomized controlled trials that compare the efficacy and safety between RTX and a combination of RTX with CYC are needed.</p></div>\",\"PeriodicalId\":36425,\"journal\":{\"name\":\"Journal of Translational Autoimmunity\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9800337/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Translational Autoimmunity\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2589909022000399\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Translational Autoimmunity","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589909022000399","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:利妥昔单抗(RTX)和环磷酰胺(CYC)是抗中性粒细胞胞浆抗体(ANCA)相关血管炎(AAV)的有效缓解诱导疗法。然而,联合这些疗法可能有利于有重大疾病表现的患者的预后。我们进行了一项回顾性研究,比较RTX和低剂量CYC (RTX-CYC)联合治疗或仅RTX治疗的患者,两种治疗均采用RTX进行量身定制的维持,以观察长期结果。方法对2007年3月至2019年1月期间在马斯特里赫特大学医学中心接受治疗的患者进行资格筛选。主要结局变量为2年和5年后的主要复发率。次要结局变量为临床数据和实验室参数。结果在246例筛选的患者中,34例接受RTX- cyc治疗,28例仅用于缓解诱导。所有患者随访至少2年,中位随访48个月(IQR 24-60)。在基线时,肾受累在RTX-CYC患者中更为普遍(85%比61%,P = 0.028)。RTX-CYC组两年内的主要复发率显著低于RTX-CYC组(3% vs. 24%, P = 0.032)。感染率、低丙种球蛋白血症、终末期肾病、恶性肿瘤和死亡率在2年和5年后没有差异。结论在RTX中加入低剂量CYC是安全的,可以预防严重AAV患者在缓解诱导后的头2年内的严重复发。需要进行随机对照试验,比较RTX与RTX联合CYC的疗效和安全性。
Adding low dose cyclophosphamide to rituximab for remission-induction may prolong relapse-free survival in patients with ANCA vasculitis: A retrospective study
Objective
Rituximab (RTX) and cyclophosphamide (CYC) are effective remission-induction therapies in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, combining these therapies may favor prognosis in patients with a major disease presentation. We conducted a retrospective study to compare patients treated with a combination of RTX and low dose CYC (RTX-CYC) or with RTX only, both followed by tailored maintenance with RTX, with regard to long-term outcomes.
Methods
Patients treated in the Maastricht University Medical Center between March 2007 and January 2019, were screened for eligibility. The primary outcome variable was major relapse rate after two and five years. Secondary outcome variables were clinical data and laboratory parameters.
Results
Of the 246 screened patients, 34 received RTX-CYC and 28 RTX only for remission-induction. All patients were followed for at least two years, with a median follow-up of 48 months (IQR 24–60). At baseline, renal involvement was more prevalent in the RTX-CYC patients (85% vs. 61%, P = 0.028). Major relapse rates within two years, but not after five years, were significantly lower in the RTX-CYC group (3% vs. 24%, P = 0.032). The rate of infections, hypogammaglobulinemia, end-stage renal disease, malignancies, and mortality did not differ after two and five years.
Conclusion
Adding low dose CYC to RTX is safe and may prevent major relapses in patients with severe AAV in the first two years after remission-induction. Randomized controlled trials that compare the efficacy and safety between RTX and a combination of RTX with CYC are needed.