Sneller Michael C, Hu Zonghui, Langford Carol A
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD 20854, USA.
Arthritis Rheum. 2012 Mar;64(3):835-42. doi: 10.1002/art.34322.
To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis.
We conducted a single-center, open-label, randomized controlled trial of rituximab (375 mg/ m(2) /week for 4 weeks) compared to the best available therapy (maintenance or increase in immunosuppressive therapy) for HCV-associated cryoglobulinemic vasculitis in patients in whom antiviral therapy had failed to induce remission. The primary end point was disease remission at 6 months from study entry.
A total of 24 patients were enrolled (12 in each treatment group). Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, as compared with 1 patient in the control group (8%), a result that met the criterion for stopping the study (P < 0.001). The median duration of remission for rituximab-treated patients who reached the primary end point was 7 months. No adverse effects of rituximab on HCV plasma viremia or on hepatic transaminase levels were observed.
Rituximab was a well-tolerated and effective treatment in patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.
对利妥昔单抗治疗丙型肝炎病毒（HCV）相关混合性冷球蛋白血症性血管炎患者进行一项随机对照试验。
我们进行了一项单中心、开放标签的随机对照试验，将利妥昔单抗（375mg/m²/周，共4周）与抗病毒治疗未能诱导缓解的HCV相关冷球蛋白血症性血管炎患者的最佳可用治疗方法（维持或增加免疫抑制治疗）进行比较。主要终点是从研究入组起6个月时的疾病缓解情况。
共纳入24例患者（每个治疗组12例）。两组的基线疾病活动度和器官受累情况相似。利妥昔单抗组有10例患者（83%）在研究第6个月时病情缓解，而对照组仅有1例患者（8%）缓解，这一结果符合研究终止标准（P<0.001）。达到主要终点的利妥昔单抗治疗患者的缓解持续时间中位数为7个月。未观察到利妥昔单抗对HCV血浆病毒血症或肝转氨酶水平有不良影响。
对于抗病毒治疗未能诱导缓解的HCV相关冷球蛋白血症性血管炎患者，利妥昔单抗是一种耐受性良好且有效的治疗方法。
