Efficacy of low-dose rituximab for the treatment of mixed cryoglobulinemia vasculitis: Phase II clinical trial and systematic review.

Abstract

OBJECTIVE:

To evaluate whether rituximab at a low dose of 250 mg/m(2) × 2 may be as effective as at higher dosages, most commonly 375 mg/m(2)×4, used in previous studies on the treatment of patients with refractory mixed cryoglobulinemia (MC) vasculitis associated with hepatitis C virus (HCV) infection.

METHODS:

We conducted a phase 2, single-arm two-stage trial (EUDRACT n. 2008-000086-38) of low-dose rituximab in 52 patients with HCV-associated MC who were ineligible/intolerant or non-responder to antiviral therapy. The primary outcomes were response of vasculitis evaluated by the Birmingham Vasculitis Activity Score (BVAS) at months 3, 6 and 12, rate of relapses and time to relapse, and rate of adverse events. Our data were compared with those reported in 19 published studies selected among 291 reviewed in a literature search.

RESULTS:

The cumulative response rate (complete and partial) at month 3 was 81% in our patients, and 86% in 208 patients from studies using high-dose rituximab. The relapse rate and median time to relapse were, respectively, 41% and 6 months in our study, and 32% and 7 months in high-dose studies. Treatment-related adverse events were 11.5% in our study and 19.9% in high-dose studies. None of these differences was statistically significant.

CONCLUSION:

Rituximab at a low dosage of 250 mg/m(2) × 2 is as effective as at higher dosages for treating MC vasculitis. This low-dose regimen may improve the cost/benefit profile of rituximab therapy for MC.

• Authors: Marcella Visentini, Carmine Tinelli, Stefania Colantuono, Monica Monti, Serena Ludovisi, Laura Gragnani, Milica Mitrevski, Jessica Ranieri, Elisa Fognani, Alessia Piluso, Massimo Granata, Annalisa De Silvestri, Valeria Scotti, Mario U Mondelli, Anna Linda Zignego, Massimo Fiorilli, Milvia Casato
• Journal: Autoimmunity reviews (Autoimmun Rev) Vol. 14 Issue 10 Pg. 889-96 (Oct 2015) ISSN: 1873-0183 [Electronic] Netherlands
• PMID: 26031898 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Systematic Review)
• Copyright: Copyright © 2015 Elsevier B.V. All rights reserved.

Chemical References

• Rituximab

Topics

• Aged
• Female
• Humans
• Male
• Cost-Benefit Analysis
• Cryoglobulinemia (complications, drug therapy)
• Recurrence
• Rituximab (administration & dosage, therapeutic use)
• Vasculitis (complications)