TY - JOUR
T1 - Retreatment regimen of rituximab monotherapy given at the relapse of severe HCV-related cryoglobulinemic vasculitis
T2 - Long-term follow up data of a randomized controlled multicentre study
AU - Quartuccio, Luca
AU - Zuliani, Francesca
AU - Corazza, Laura
AU - Scaini, Patrizia
AU - Zani, Roberta
AU - Lenzi, Marco
AU - Tavoni, Antonio
AU - Sebastiani, Marco
AU - Baldovino, Simone
AU - Urraro, Teresa
AU - Saccardo, Francesco
AU - Sbreglia, Costanza
AU - Mazzaro, Cesare
AU - Pioltelli, Piero
AU - Fraticelli, Paolo
AU - Filippini, Davide
AU - Gabrielli, Armando
AU - Perrella, Oreste
AU - Scarpato, Salvatore
AU - Roccatello, Dario
AU - Zignego, Anna Linda
AU - Ferri, Clodoveo
AU - Bombardieri, Stefano
AU - Pietrogrande, Maurizio
AU - Monti, Giuseppe
AU - Galli, Massimo
AU - De Vita, Salvatore
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
KW - Cryoglobulinemia
KW - Hepatitis
KW - Rituximab
KW - Vasculitis
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U2 - 10.1016/j.jaut.2015.07.012
DO - 10.1016/j.jaut.2015.07.012
M3 - Article
C2 - 26255249
AN - SCOPUS:84940889459
VL - 63
SP - 88
EP - 93
JO - Journal of Autoimmunity
JF - Journal of Autoimmunity
SN - 0896-8411
ER -