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

Abstract

Objective To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)–associated mixed cryoglobulinemic vasculitis. Methods We conducted a single‐center, open‐label, randomized controlled trial of rituximab (375 mg/ m²/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. Results 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. Conclusion Rituximab was a well‐tolerated and effective treatment in patients with HCV‐associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.