Luca Quartuccio1, Francesca Zuliani2, Laura Corazza2, Patrizia Scaini3, Roberta Zani3, Marco Lenzi4, Antonio Tavoni5, Marco Sebastiani6, Simone Baldovino7, Teresa Urraro8, Francesco Saccardo9, Costanza Sbreglia10, Cesare Mazzaro11, Piero Pioltelli12, Paolo Fraticelli13, Davide Filippini14, Armando Gabrielli13, Oreste Perrella10, Salvatore Scarpato15, Dario Roccatello7, Anna Linda Zignego8, Clodoveo Ferri6, Stefano Bombardieri5, Maurizio Pietrogrande16, Giuseppe Monti9, Massimo Galli17, Salvatore De Vita18. 1. DSMB, University of Udine, Udine, Italy; Rheumatology Clinic, University of Udine, Udine, Italy. 2. Rheumatology Clinic, University of Udine, Udine, Italy. 3. Nephrology, Spedali Civili di Brescia, Brescia, Italy. 4. Università di Bologna, Bologna, Italy. 5. Rheumatology Unit, University of Pisa, Pisa, Italy. 6. Rheumatology Clinic, University of Modena and Reggio Emilia, Modena, Italy. 7. Centro Multidisciplinare di Immunopatologia e Documentazione su Malattie Rare (CMID), Ospedale S.Giovanni Bosco, Torino, Italy. 8. Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 9. Internal Medicine, Ospedale di Saronno, AO Busto Arsizio, Saronno, VA, Italy. 10. Rheumatology Unit, AO Cotugno, Naples, Italy. 11. Internal Medicine, AO Pordenone, Pordenone, Italy. 12. Hematology, AO San Gerardo, Università di Milano-Bicocca, Milano, Italy. 13. Clinica Medica Generale, Ematologia e Immunologia Clinica, Università di Ancona, Ancona, Italy. 14. Rheumatology Unit, Ospedale Niguarda Ca' Granda, Milano, Italy. 15. UO Reumatologia, Scafati, Italy. 16. Internal Medicine, Policlinico di Zingonia, Bergamo, Italy. 17. Infectious Diseases, L. Sacco Hospital, Milano, Italy. 18. DSMB, University of Udine, Udine, Italy; Rheumatology Clinic, University of Udine, Udine, Italy. Electronic address: devita.salvatore@aoud.sanita.fvg.it.
Abstract
OBJECTIVE: To evaluate the efficacy and safety in the long term of a retreatment regimen with Rituximab (RTX) alone administered at clinical relapse in cryoglobulinemic vasculitis (CV). METHODS:Thirty patients with severe HCV-related CV, previously enrolled in the multicentre Italian trial onRTX in the treatment of CV, were retrospectively evaluated after the end of the trial. All of them were managed with RTX alone at clinical relapse, if any. Disease activity at the last available follow up was defined as complete remission (absence of active disease), partial remission (response > 50% of at least one manifestation among glomerulonephritis, peripheral neuropathy or skin ulcers) or active disease. RESULTS: The mean follow up after the first RTX cycle was 72.6 (20.4) months. After the end of the trial, 21/30 (70%) patients showed an active follow up [81.7 (10.9) months)], 3/30 (10%) lost follow up and 6/30 (20%) died. 12/21 (57.1%) patients were in complete disease remission, 5/21 (23.8%) showed a partial response and 4/21 (19%) had an active disease. 17/30 (56.7%) patients needed retreatment for relapse with a mean time to retreatment of 22.3 (12.1) months. Treatment survival of this regimen was 7.6 (0.3) years. Recurrent non-severe infections occurred in 3/30, with chronic hypogammaglobulinemia in 2/3 patients. CONCLUSIONS: A long-term regimen of retreatment with RTX alone given at clinical relapse seems to be effective and safe in CV, with a low rate of infections and severe hypogammaglobulinemia.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety in the long term of a retreatment regimen with Rituximab (RTX) alone administered at clinical relapse in cryoglobulinemic vasculitis (CV). METHODS: Thirty patients with severe HCV-related CV, previously enrolled in the multicentre Italian trial on RTX in the treatment of CV, were retrospectively evaluated after the end of the trial. All of them were managed with RTX alone at clinical relapse, if any. Disease activity at the last available follow up was defined as complete remission (absence of active disease), partial remission (response > 50% of at least one manifestation among glomerulonephritis, peripheral neuropathy or skin ulcers) or active disease. RESULTS: The mean follow up after the first RTX cycle was 72.6 (20.4) months. After the end of the trial, 21/30 (70%) patients showed an active follow up [81.7 (10.9) months)], 3/30 (10%) lost follow up and 6/30 (20%) died. 12/21 (57.1%) patients were in complete disease remission, 5/21 (23.8%) showed a partial response and 4/21 (19%) had an active disease. 17/30 (56.7%) patients needed retreatment for relapse with a mean time to retreatment of 22.3 (12.1) months. Treatment survival of this regimen was 7.6 (0.3) years. Recurrent non-severe infections occurred in 3/30, with chronic hypogammaglobulinemia in 2/3 patients. CONCLUSIONS: A long-term regimen of retreatment with RTX alone given at clinical relapse seems to be effective and safe in CV, with a low rate of infections and severe hypogammaglobulinemia.
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
Authors: Luca Quartuccio; Alessandra Bortoluzzi; Carlo Alberto Scirè; Antonio Marangoni; Giulia Del Frate; Elena Treppo; Laura Castelnovo; Francesco Saccardo; Roberta Zani; Marco Candela; Paolo Fraticelli; Cesare Mazzaro; Piero Renoldi; Patrizia Scaini; Davide Antonio Filippini; Marcella Visentini; Salvatore Scarpato; Dilia Giuggioli; Maria Teresa Mascia; Marco Sebastiani; Anna Linda Zignego; Gianfranco Lauletta; Massimo Fiorilli; Milvia Casato; Clodoveo Ferri; Maurizio Pietrogrande; Pietro Enrico Pioltelli; Salvatore De Vita; Giuseppe Monti; Massimo Galli Journal: Clin Rheumatol Date: 2022-09-28 Impact factor: 3.650