Michael C Sneller1, Zonghui Hu, Carol A Langford. 1. Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD 20854, USA. sneller@nih.gov
Abstract
OBJECTIVE: To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis. METHODS: We conducted a single-center, open-label, randomized controlled trial of rituximab (375 mg/ m(2) /week for 4 weeks) compared to the best available therapy (maintenance or increase in immunosuppressive therapy) for HCV-associated cryoglobulinemic vasculitis in patients in whom antiviral therapy had failed to induce remission. The primary end point was disease remission at 6 months from study entry. RESULTS: A total of 24 patients were enrolled (12 in each treatment group). Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, as compared with 1 patient in the control group (8%), a result that met the criterion for stopping the study (P < 0.001). The median duration of remission for rituximab-treated patients who reached the primary end point was 7 months. No adverse effects of rituximab on HCV plasma viremia or on hepatic transaminase levels were observed. CONCLUSION:Rituximab was a well-tolerated and effective treatment in patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.
RCT Entities:
OBJECTIVE: To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis. METHODS: We conducted a single-center, open-label, randomized controlled trial of rituximab (375 mg/ m(2) /week for 4 weeks) compared to the best available therapy (maintenance or increase in immunosuppressive therapy) for HCV-associated cryoglobulinemic vasculitis in patients in whom antiviral therapy had failed to induce remission. The primary end point was disease remission at 6 months from study entry. RESULTS: A total of 24 patients were enrolled (12 in each treatment group). Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, as compared with 1 patient in the control group (8%), a result that met the criterion for stopping the study (P < 0.001). The median duration of remission for rituximab-treated patients who reached the primary end point was 7 months. No adverse effects of rituximab on HCV plasma viremia or on hepatic transaminase levels were observed. CONCLUSION:Rituximab was a well-tolerated and effective treatment in patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.
Authors: N Magy; B Cribier; C Schmitt; B Ellero; D Jaeck; K Boudjema; P Wolf; N Labouret; M Doffoel; A Kirn; F Stoll-Keller Journal: Int J Immunopharmacol Date: 1999-04
Authors: B Soto; A Sánchez-Quijano; L Rodrigo; J A del Olmo; M García-Bengoechea; J Hernández-Quero; C Rey; M A Abad; M Rodríguez; M Sales Gilabert; F González; P Mirón; A Caruz; F Relimpio; R Torronteras; M Leal; E Lissen Journal: J Hepatol Date: 1997-01 Impact factor: 25.083
Authors: A Tarantino; M Campise; G Banfi; R Confalonieri; A Bucci; A Montoli; G Colasanti; I Damilano; G D'Amico; L Minetti Journal: Kidney Int Date: 1995-02 Impact factor: 10.612
Authors: E J Gane; B C Portmann; N V Naoumov; H M Smith; J A Underhill; P T Donaldson; G Maertens; R Williams Journal: N Engl J Med Date: 1996-03-28 Impact factor: 91.245
Authors: F Dammacco; D Sansonno; J H Han; V Shyamala; V Cornacchiulo; A R Iacobelli; G Lauletta; R Rizzi Journal: Blood Date: 1994-11-15 Impact factor: 22.113
Authors: Meghan E Sise; Allyson K Bloom; Jessica Wisocky; Ming V Lin; Jenna L Gustafson; Andrew L Lundquist; David Steele; Michael Thiim; Winfred W Williams; Nikroo Hashemi; Arthur Y Kim; Ravi Thadhani; Raymond T Chung Journal: Hepatology Date: 2015-12-11 Impact factor: 17.425
Authors: Caterina Vacchi; Marcella Visentini; Laura Gragnani; Paolo Fraticelli; Antonio Tavoni; Davide Filippini; Francesco Saccardo; Gianfranco Lauletta; Stefania Colantuono; Fabiola Atzeni; Pietro Pioltelli; Andreina Manfredi; Milvia Casato; Anna Linda Zignego; Giuseppe Monti; Maurizio Pietrogrande; Massimo Galli; Marco Sebastiani Journal: Intern Emerg Med Date: 2020-06-10 Impact factor: 3.397