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/ 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.

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.

• Authors: Michael C Sneller, Zonghui Hu, Carol A Langford
• Journal: Arthritis and rheumatism (Arthritis Rheum) Vol. 64 Issue 3 Pg. 835-42 (Mar 2012) ISSN: 1529-0131 [Electronic] United States
• PMID: 22147444 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Intramural)
• Copyright: Copyright © 2012 by the American College of Rheumatology.

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• Antiviral Agents
• Immunologic Factors
• Rituximab

Topics

• Antibodies, Monoclonal, Murine-Derived (therapeutic use)
• Antiviral Agents (therapeutic use)
• Cryoglobulinemia (complications, drug therapy)
• Drug Resistance, Viral (drug effects)
• Female
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Immunologic Factors (therapeutic use)
• Male
• Middle Aged
• Remission Induction
• Rituximab
• Treatment Outcome