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. 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. 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. 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.

Efficacy of low-dose rituximab for the treatment of mixed cryoglobulinemia vasculitis: Phase II clinical trial and systematic review / Visentini, Marcella; Tinelli, Carmine; Colantuono, Stefania; Monti, Monica; Ludovisi, Serena; Gragnani, Laura; Mitrevski, Milica; Ranieri, Jessica; Fognani, Elisa; Piluso, Alessia; Granata, Massimo; De Silvestri, Annalisa; Scotti, Valeria; Mondelli, Mario U.; Zignego, Anna Linda; Fiorilli, Massimo; Casato, Milvia. - In: AUTOIMMUNITY REVIEWS. - ISSN 1568-9972. - STAMPA. - 14:(2015), pp. 889-896. [10.1016/j.autrev.2015.05.013]

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

MONTI, MONICA;GRAGNANI, LAURA;RANIERI, JESSICA;FOGNANI, ELISA;PILUSO, ALESSIA;ZIGNEGO, ANNA LINDA;
2015

Abstract

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. 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. 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. 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.
2015
14
889
896
Goal 3: Good health and well-being for people
Visentini, Marcella; Tinelli, Carmine; Colantuono, Stefania; Monti, Monica; Ludovisi, Serena; Gragnani, Laura; Mitrevski, Milica; Ranieri, Jessica; Fognani, Elisa; Piluso, Alessia; Granata, Massimo; De Silvestri, Annalisa; Scotti, Valeria; Mondelli, Mario U.; Zignego, Anna Linda; Fiorilli, Massimo; Casato, Milvia
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1084576
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