Dr. Langford has received support from Genentech (provided study drug for a clinical trial).
A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus–associated cryoglobulinemic vasculitis†
Article first published online: 28 FEB 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 64, Issue 3, pages 835–842, March 2012
How to Cite
Sneller, M. C., Hu, Z. and Langford, C. A. (2012), A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus–associated cryoglobulinemic vasculitis. Arthritis & Rheumatism, 64: 835–842. doi: 10.1002/art.34322
ClinicalTrials.gov identifier: NCT00029107.
- Issue published online: 28 FEB 2012
- Article first published online: 28 FEB 2012
- Accepted manuscript online: 6 DEC 2011 03:21PM EST
- Manuscript Accepted: 1 DEC 2011
- Manuscript Received: 15 JAN 2011
- Intramural Research Program of the National Institute of Allergy and Infectious Diseases
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/ 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.
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.