von Allwörden Katja, Klapa Sebastian, Werth Stephan Christian, Leheis Anja, Graßhoff Hanna, Müller Antje, Riemekasten Gabriela, Nitschke Martin, Thaçi Diamant, Lamprecht Peter
Department of Rheumatology and Clinical Immunology, University of Lübeck, Germany.
Department of Rheumatology and Clinical Immunology, University of Lübeck, and Institute of Experimental Medicine, Christian-Albrechts-University of Kiel c/o German Naval Medical Institute, Kronshagen, Germany.
Clin Exp Rheumatol. 2025 Sep 2. doi: 10.55563/clinexprheumatol/cfyh9p.
This retrospective cohort study aimed to evaluate real-world data on the efficacy of rituximab (RTX) alone versus combined rituximab/cyclophosphamide (RTX/CYC) induction therapy, followed by RTX maintenance, compared with cyclophosphamide-azathioprine (CYC-AZA) therapy in ANCA-associated vasculitis (AAV).
Patients with new-onset or relapsing organ- or life-threatening AAV (granulomatosis with polyangiitis [GPA] n=97; microscopic polyangiitis [MPA], n=69) were followed over 24-months. Patients with previous RTX and/or CYC therapy were excluded. Treatment comprised combination of GC with either RTX alone or RTX/CYC combination for remission induction, each followed by RTX maintenance therapy, or CYC-AZA therapy. The primary outcome measure was complete remission defined as absence of vasculitis activity with no concomitant GC therapy after 12 and 24 months.
20% and 35% of the patients in the RTX group and 22% and 33% in the RTX/CYC group achieved complete remission at 12 and 24 months, contrasting with 3% and 9% in the CYC-AZA group (p=0.008 and p=0.003, respectively). The majority of patients achieved remission with concomitant GC therapy at any time during the 24-months observation period (RTX, 88%; RTX/CYC, 87%; CYC-AZA, 81%; p=0.097). RTX alone was associated with a lower relapse rate compared with RTX/CYC in the subgroup of GPA patients (p=0.041). Moreover, RTX alone was comparably effective to RTX/CYC and CYC-AZA in terms of relapse in patients with severe renal disease (p=0.091).
RTX alone was similarly effective to RTX/CYC combination and CYC-AZA therapy in AAV patients, including those with severe renal involvement.
这项回顾性队列研究旨在评估利妥昔单抗（RTX）单药与利妥昔单抗/环磷酰胺（RTX/CYC）联合诱导治疗，继以RTX维持治疗，与环磷酰胺-硫唑嘌呤（CYC-AZA）治疗相比，在抗中性粒细胞胞浆抗体相关性血管炎（AAV）中的真实世界疗效数据。
对新发或复发的器官受累或危及生命的AAV患者（肉芽肿性多血管炎[GPA]97例；显微镜下多血管炎[MPA]69例）进行了24个月的随访。排除既往接受过RTX和/或CYC治疗的患者。治疗包括糖皮质激素（GC）与单独RTX或RTX/CYC联合用于诱导缓解，随后均接受RTX维持治疗，或CYC-AZA治疗。主要结局指标为完全缓解，定义为12个月和24个月时无血管炎活动且未同时使用GC治疗。
RTX组20%和35%的患者在12个月和24个月时达到完全缓解，RTX/CYC组为22%和33%，而CYC-AZA组为3%和9%（分别为p=0.008和p=0.003）。在24个月的观察期内，大多数患者在任何时间同时使用GC治疗时达到缓解（RTX组88%；RTX/CYC组87%；CYC-AZA组81%；p=0.097）。在GPA患者亚组中，单独使用RTX与RTX/CYC相比复发率更低（p=0.041）。此外，在重症肾病患者的复发方面，单独使用RTX与RTX/CYC和CYC-AZA的效果相当（p=0.091）。
在AAV患者中，包括那些有严重肾脏受累的患者，单独使用RTX与RTX/CYC联合及CYC-AZA治疗同样有效。
