Rymarz Aleksandra, Matyjek Anna, Sułek-Jakóbczyk Magdalena, Mosakowska Magdalena, Niemczyk Stanisław
Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine, 128 Szaserów Street, 04-141 Warsaw, Poland.
J Clin Med. 2021 Feb 16;10(4):786. doi: 10.3390/jcm10040786.
Rituximab (RTX), a monoclonal antibody against the CD20 molecule, is used as an induction therapy in the treatment of small vessel vasculitis (SVV). The aim of the study was to evaluate the efficacy and safety of RTX induction therapy for refractory SVV. A retrospective analysis of 20 patients treated with RTX for active SVV (BVAS/WG ≥ 3) was performed to assess the remission rate and the drug-related severe adverse events 6 months after therapy. The mean age of the studied population was 49 ± 13 years (50% female), 90% of which were PR3-ANCA positive. Complete remission was achieved in 85% of patients, and partial remission was achieved in a further 10% within 6 months after RTX infusions. The remission rate was not influenced by kidney function. Adverse events such as infections (25%), a late onset of neutropenia (10%) and severe hypogammaglobulinemia (5%) were noted. The patients who developed adverse events were older (42 ± 11 vs. 57 ± 12 years; = 0.014) and had a higher serum creatinine level (1.3 mg/dL vs. 3.35 mg/dL; = 0.044). Patients with a glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m had a nine-fold higher risk of side effects (OR 9.0, 95%CI: 1.14-71.0). In conclusion, RTX was highly effective as an induction therapy in patients with SVV. Advanced kidney failure with an eGFR lower than 30 mL/min/1.73 m was one of the risk factors for the occurrence of side effects.
利妥昔单抗（RTX）是一种抗CD20分子的单克隆抗体，用作治疗小血管炎（SVV）的诱导疗法。本研究的目的是评估RTX诱导疗法治疗难治性SVV的疗效和安全性。对20例接受RTX治疗活动性SVV（BVAS/WG≥3）的患者进行回顾性分析，以评估治疗6个月后的缓解率和药物相关严重不良事件。研究人群的平均年龄为49±13岁（50%为女性），其中90%为PR3-ANCA阳性。85%的患者实现完全缓解，在RTX输注后6个月内另有10%实现部分缓解。缓解率不受肾功能影响。记录到不良事件，如感染（25%）、迟发性中性粒细胞减少（10%）和严重低丙种球蛋白血症（5%）。发生不良事件的患者年龄较大（42±11岁对57±12岁；P=0.014），血清肌酐水平较高（1.3mg/dL对3.35mg/dL；P=0.044）。肾小球滤过率（eGFR）低于30mL/min/1.73m²的患者出现副作用的风险高9倍（OR 9.0，95%CI：1.14-71.0）。总之，RTX作为SVV患者的诱导疗法非常有效。eGFR低于30mL/min/1.73m²的晚期肾衰竭是发生副作用的危险因素之一。
