Renal Unit, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
Clin J Am Soc Nephrol. 2010 Aug;5(8):1394-400. doi: 10.2215/CJN.08821209. Epub 2010 May 24.
Ongoing randomized trials seek to validate the efficacy of rituximab as an induction agent for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, no studies directly address the role of rituximab as maintenance therapy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This retrospective study reports the authors' experience with continuous rituximab administration in 39 patients in complete or partial remission at the time of rituximab initiation. All 39 patients had at least 1 year of follow-up, and 20 had 2 years of follow-up.
Disease activity, as measured by a modified Birmingham Vasculitis Activity Score, decreased from a median of 1 at baseline to 0 at 12 (P < 0.001) and 24 months (P = 0.02). Three patients experienced nonorgan-threatening flares during 708 patient-months of follow-up. Each flare occurred after at least 20 months of follow-up. The percentage of patients on cytotoxic immunosuppression decreased from 87% at baseline to 41% at 12 months (P < 0.001) and 30% at 24 months (P = 0.002). The percentage of patients on prednisone decreased from 92% at baseline to 59% at 12 months (P < 0.001) and 55% at 24 months (P = 0.02). Two patients developed late-onset neutropenia; both responded to treatment with recombinant granulocyte colony-stimulating factor.
The successful use of continuous anti-B cell therapy in patients with AAV in complete or partial remission is reported. This extends the potential role of rituximab beyond induction to include maintenance therapy. However, more data are required regarding the delayed adverse effects of rituximab.
正在进行的随机试验旨在验证利妥昔单抗作为抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)诱导剂的疗效。然而,尚无研究直接探讨利妥昔单抗作为维持治疗的作用。
设计、设置、参与者和测量:本回顾性研究报告了作者在利妥昔单抗起始时处于完全或部分缓解的 39 例患者中连续使用利妥昔单抗的经验。所有 39 例患者均有至少 1 年的随访,其中 20 例有 2 年的随访。
用改良的伯明翰血管炎活动评分衡量,疾病活动度从基线时的中位数 1 分降至 12 个月时的 0 分(P<0.001)和 24 个月时的 0 分(P=0.02)。在 708 个患者月的随访期间,有 3 例患者出现非危及器官的发作。每次发作均发生在至少 20 个月的随访后。接受细胞毒性免疫抑制治疗的患者比例从基线时的 87%降至 12 个月时的 41%(P<0.001)和 24 个月时的 30%(P=0.002)。接受泼尼松治疗的患者比例从基线时的 92%降至 12 个月时的 59%(P<0.001)和 24 个月时的 55%(P=0.02)。有 2 例患者出现迟发性中性粒细胞减少症;两者均对重组粒细胞集落刺激因子治疗有反应。
报告了在完全或部分缓解的 AAV 患者中成功使用连续抗 B 细胞治疗。这将利妥昔单抗的潜在作用扩展到诱导治疗之外,包括维持治疗。然而,需要更多关于利妥昔单抗延迟不良反应的数据。