Rituximab combined with Peg-interferon-ribavirin in refractory hepatitis C virus-associated cryoglobulinaemia vasculitis.

Abstract

OBJECTIVES:

To report the results of a pilot study using rituximab combined with Peg-interferon (IFN) alpha2b-ribavirin in severe refractory hepatitis C virus (HCV) related mixed cryoglobulinaemia (MC) vasculitis.

METHODS:

Sixteen consecutive patients with severe HCV-MC vasculitis that were resistant (n = 11) or relapser (n = 5) to a previous combination treatment with standard (n = 10) or Peg-IFNalpha2b (n = 6) plus ribavirin were included. They were treated with rituximab (375 mg/m2 intravenously weekly for 4 weeks) combined with Peg-IFNalpha2b (1.5 mug/kg per week subcutaneously) plus ribavirin (600-1200 mg/day orally) for 12 months.

RESULTS:

Fifteen patients (93.7%) showed clinical improvement, 10 of whom (62.5%) were clinical complete responders (CR). HCV RNA and serum cryoglobulin became undetectable in all the clinical CR. Peripheral blood B cell depletion was achieved in all patients (CD19+ cells, 111 (SD 32)/mm3 at baseline versus 2(2)/mm3 after the fourth infusion of rituximab) with reconstitution starting at the end of antiviral treatment. Compared with clinical CR, the partial or non-responders had a 3.6 times longer duration of vasculitis prior to treatment and a lower rate of early virological response. Treatment was well tolerated with no infectious complications. After a mean follow-up of 19.4 (SD 3.6) months, two patients experienced clinical relapse associated with a simultaneous reappearance of HCV RNA and cryoglobulin and an increase in the number of B cells.

CONCLUSIONS:

Rituximab combined with Peg-IFNalpha2b-ribavirin represents a safe and effective treatment option in severe refractory HCV-MC vasculitis.

• Authors: D Saadoun, M Resche-Rigon, D Sene, L Perard, A Karras, P Cacoub
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 67 Issue 10 Pg. 1431-6 (Oct 2008) ISSN: 1468-2060 [Electronic] England
• PMID: 18178690 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• Rituximab
• peginterferon alfa-2b

Topics

• Adult
• Aged
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Murine-Derived
• Antiviral Agents (therapeutic use)
• Cryoglobulinemia (complications, drug therapy)
• Drug Therapy, Combination
• Female
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Interferon alpha-2
• Interferon-alpha (therapeutic use)
• Male
• Middle Aged
• Pilot Projects
• Polyethylene Glycols
• Recombinant Proteins
• Ribavirin (therapeutic use)
• Rituximab
• Treatment Outcome
• Vasculitis (drug therapy, virology)