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

Authors :
Visentini M
Tinelli C
Colantuono S
Monti M
Ludovisi S
Gragnani L
Mitrevski M
Ranieri J
Fognani E
Piluso A
Granata M
De Silvestri A
Scotti V
Mondelli MU
Zignego AL
Fiorilli M
Casato M
Source :
Autoimmunity reviews [Autoimmun Rev] 2015 Oct; Vol. 14 (10), pp. 889-96. Date of Electronic Publication: 2015 May 29.
Publication Year :
2015

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.<br />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.<br />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.<br />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.<br /> (Copyright © 2015 Elsevier B.V. All rights reserved.)

Details

Language :
English
ISSN :
1873-0183
Volume :
14
Issue :
10
Database :
MEDLINE
Journal :
Autoimmunity reviews
Publication Type :
Academic Journal
Accession number :
26031898
Full Text :
https://doi.org/10.1016/j.autrev.2015.05.013