title: Retreatment regimen of rituximab monotherapy given at the relapse of severe HCV-related cryoglobulinemic vasculitis: Long-term follow up data of a randomized controlled multicentre study.
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 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.affiliation: DSMB, University of Udine, Udine, Italy; Rheumatology Clinic, University of Udine, Udine, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Quartuccio
authors.affiliation: Rheumatology Clinic, University of Udine, Udine, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Zuliani
authors.affiliation: Rheumatology Clinic, University of Udine, Udine, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Corazza
authors.affiliation: Nephrology, Spedali Civili di Brescia, Brescia, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Scaini
authors.affiliation: Nephrology, Spedali Civili di Brescia, Brescia, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Zani
authors.affiliation: Università di Bologna, Bologna, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Lenzi
authors.affiliation: Rheumatology Unit, University of Pisa, Pisa, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tavoni
authors.affiliation: Rheumatology Clinic, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Sebastiani
authors.affiliation: Centro Multidisciplinare di Immunopatologia e Documentazione su Malattie Rare (CMID), Ospedale S.Giovanni Bosco, Torino, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Baldovino
authors.affiliation: Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Urraro
authors.affiliation: Internal Medicine, Ospedale di Saronno, AO Busto Arsizio, Saronno, VA, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Saccardo
authors.affiliation: Rheumatology Unit, AO Cotugno, Naples, Italy.
authors.forename: Costanza
authors.initials: C
authors.lastname: Sbreglia
authors.affiliation: Internal Medicine, AO Pordenone, Pordenone, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Mazzaro
authors.affiliation: Hematology, AO San Gerardo, Università di Milano-Bicocca, Milano, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Pioltelli
authors.affiliation: Clinica Medica Generale, Ematologia e Immunologia Clinica, Università di Ancona, Ancona, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fraticelli
authors.affiliation: Rheumatology Unit, Ospedale Niguarda Ca' Granda, Milano, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Filippini
authors.affiliation: Clinica Medica Generale, Ematologia e Immunologia Clinica, Università di Ancona, Ancona, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Gabrielli
authors.affiliation: Rheumatology Unit, AO Cotugno, Naples, Italy.
authors.forename: Oreste
authors.initials: O
authors.lastname: Perrella
authors.affiliation: UO Reumatologia, Scafati, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scarpato
authors.affiliation: Centro Multidisciplinare di Immunopatologia e Documentazione su Malattie Rare (CMID), Ospedale S.Giovanni Bosco, Torino, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Roccatello
authors.affiliation: Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Anna Linda
authors.initials: AL
authors.lastname: Zignego
authors.affiliation: Rheumatology Clinic, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Clodoveo
authors.initials: C
authors.lastname: Ferri
authors.affiliation: Rheumatology Unit, University of Pisa, Pisa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Bombardieri
authors.affiliation: Internal Medicine, Policlinico di Zingonia, Bergamo, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Pietrogrande
authors.affiliation: Internal Medicine, Ospedale di Saronno, AO Busto Arsizio, Saronno, VA, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Monti
authors.affiliation: Infectious Diseases, L. Sacco Hospital, Milano, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Galli
authors.affiliation: DSMB, University of Udine, Udine, Italy; Rheumatology Clinic, University of Udine, Udine, Italy. Electronic address: devita.salvatore@aoud.sanita.fvg.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
mesh_terms: D000361:Agammaglobulinemia / Q000188:drug therapy / Q000209:etiology; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D003449:Cryoglobulinemia / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D007558:Italy; D012008:Recurrence; D000069283:Rituximab / Q000627:therapeutic use*; D016896:Treatment Outcome; D014657:Vasculitis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology
chemical_list: D018501:Antirheumatic Agents; D000069283:Rituximab
keywords: Cryoglobulinemia; Hepatitis; Rituximab; Vasculitis