利妥昔单抗对肝炎病毒感染的相关血管炎有效

A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis.

Sneller MC, Hu Z, Langford CA.

OBJECTIVES:

To report on the results of a randomized controlled trial of rituximab in hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis.

METHODS:

We conducted an open-label single center randomized controlled trial of rituximab (375 mg/m(2) per week for 4 weeks) compared to best available therapy for treatment of patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission. The primary endpoint was remission at 6 months from study entry.

RESULTS:

A total of 24 patients were enrolled. 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, compared with 1 patient in the control group (8%), a result that met criterion for stopping the study (P<0.001). The median duration of remission for rituximab-treated patients reaching the primary endpoint was 7 months. No adverse effect of rituximab on HCV plasma viremia or hepatic transaminase levels was observed.

CONCLUSIONS:

Therapy with rituximab was well tolerated and effective treatment for patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy fails to induce remission.