title: 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.
  
  
  CONCLUSIONS
  Rituximab was a well-tolerated and effective treatment in patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD 20854, USA. sneller@nih.gov
authors.forename: Michael C
authors.initials: MC
authors.lastname: Sneller
authors.forename: Zonghui
authors.initials: Z
authors.lastname: Hu
authors.forename: Carol A
authors.initials: CA
authors.lastname: Langford
mesh_terms: D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D003449:Cryoglobulinemia / Q000150:complications / Q000188:drug therapy*; D024882:Drug Resistance, Viral / Q000187:drug effects*; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000998:Antiviral Agents; D007155:Immunologic Factors; D000069283:Rituximab