title: Efficacy and safety of long-term treatment with low-dose rituximab for relapsing mixed cryoglobulinemia vasculitis.
abstract: This study aims to evaluate the efficacy and safety of repeated treatments with low-dose rituximab for relapsing mixed cryoglobulinemia vasculitis. Thirty-seven patients with mixed cryoglobulinemia vasculitis refractory to standard of care treatment, 34 of which were HCV-positive, were treated with rituximab at the reduced dosage of 250 mg/m2given twice 1 week apart per cycle. Thirty patients (81%) achieved a clinical response; 5 of them remain in remission, 3 were lost to follow-up or died, and 22 relapsed after a mean of 15.7 months. Eleven relapsers were retreated with one (6 patients), 2 (3 patients), or 3 (2 patients) additional rituximab cycles given at each relapse. Clinical and laboratory efficacy and side effects of long-term treatment were evaluated. Clinical response to retreatment was 91% (10/11) at the first relapse, 80% (4/5) at the second relapse, and 100% (2/2) at the third relapse. The mean (±SD) time to relapse was 17.1 ± 14.1 months in 30 patients who were treated with only one cycle (from first cycle to the first relapse) and 45.7 ± 30.6 months (from first cycle to the last observed relapse) in 11 patients treated with 2 or more cycles (p = 0.0037). Severe adverse reactions occurred in 3 patients, in 2 of whom at the first cycle. Our results suggest that repeated treatment of relapsing mixed cryoglobulinemia with a low-dose rituximab regimen is efficacious, safe, and cost-effective for the long-term management of this disorder.
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Colantuono
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Milica
authors.initials: M
authors.lastname: Mitrevski
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Baoran
authors.initials: B
authors.lastname: Yang
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Julia
authors.initials: J
authors.lastname: Tola
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Carlesimo
authors.affiliation: Department of Infectious Diseases, Sapienza University of Rome, Rome, Italy.
authors.forename: Giuseppe M
authors.initials: GM
authors.lastname: De Sanctis
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fiorilli
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.
authors.forename: Milvia
authors.initials: M
authors.lastname: Casato
authors.affiliation: Department of Clinical Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy. marcella.visentini@uniroma1.it.
authors.forename: Marcella
authors.initials: M
authors.lastname: Visentini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003449:Cryoglobulinemia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D019233:Retreatment; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014657:Vasculitis / Q000188:drug therapy*
chemical_list: D007155:Immunologic Factors; D000069283:Rituximab
keywords: Low-dose; Mixed cryoglobulinemia; Retreatment; Rituximab