Source From the Laboratory of Immunoregulation (M.C.S.) and Biostatistics Research Branch (Z.H), National Institute of Allergy and Infectious Diseases, Bethesda, MD, and Cleveland Clinic, Cleveland, OH (C.A.L.). email@example.com.
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.