Colantuono Stefania, Mitrevski Milica, Yang Baoran, Tola Julia, Carlesimo Maurizio, De Sanctis Giuseppe M, Fiorilli Massimo, Casato Milvia, Visentini Marcella
Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
Department of Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Clin Rheumatol. 2017 Mar;36(3):617-623. doi: 10.1007/s10067-017-3552-6. Epub 2017 Jan 22.
This study aims to evaluate the efficacy and safety of repeated treatments with low-dose rituximab for relapsing mixed cryoglobulinemia vasculitis. Thirty-seven patients with mixed cryoglobulinemia vasculitis refractory to standard of care treatment, 34 of which were HCV-positive, were treated with rituximab at the reduced dosage of 250 mg/m given twice 1 week apart per cycle. Thirty patients (81%) achieved a clinical response; 5 of them remain in remission, 3 were lost to follow-up or died, and 22 relapsed after a mean of 15.7 months. Eleven relapsers were retreated with one (6 patients), 2 (3 patients), or 3 (2 patients) additional rituximab cycles given at each relapse. Clinical and laboratory efficacy and side effects of long-term treatment were evaluated. Clinical response to retreatment was 91% (10/11) at the first relapse, 80% (4/5) at the second relapse, and 100% (2/2) at the third relapse. The mean (±SD) time to relapse was 17.1 ± 14.1 months in 30 patients who were treated with only one cycle (from first cycle to the first relapse) and 45.7 ± 30.6 months (from first cycle to the last observed relapse) in 11 patients treated with 2 or more cycles (p = 0.0037). Severe adverse reactions occurred in 3 patients, in 2 of whom at the first cycle. Our results suggest that repeated treatment of relapsing mixed cryoglobulinemia with a low-dose rituximab regimen is efficacious, safe, and cost-effective for the long-term management of this disorder.
本研究旨在评估低剂量利妥昔单抗重复治疗复发性混合性冷球蛋白血症性血管炎的疗效和安全性。37例对标准治疗无效的混合性冷球蛋白血症性血管炎患者，其中34例丙型肝炎病毒（HCV）阳性，接受利妥昔单抗治疗，剂量为250mg/m²，每周期分两次给药，间隔1周。30例患者（81%）获得临床缓解；其中5例仍处于缓解期，3例失访或死亡，22例在平均15.7个月后复发。11例复发患者在每次复发时分别接受1个（6例患者）、2个（3例患者）或3个（2例患者）额外的利妥昔单抗周期再治疗。评估了长期治疗的临床和实验室疗效及副作用。首次复发时再治疗的临床缓解率为91%（10/11），第二次复发时为80%（4/5），第三次复发时为100%（2/2）。仅接受1个周期治疗的30例患者（从第一个周期到首次复发）复发的平均（±标准差）时间为17.1±14.1个月，接受2个或更多周期治疗的11例患者（从第一个周期到最后一次观察到的复发）为45.7±30.6个月（p=0.0037）。3例患者出现严重不良反应，其中2例在第一个周期出现。我们的结果表明，低剂量利妥昔单抗方案重复治疗复发性混合性冷球蛋白血症对该疾病的长期管理有效、安全且具有成本效益。
