An extension of the RITUX‐ERAH study, multicenter randomized clinical trial comparing rituximab to placebo in acute antibody‐mediated rejection after renal transplantation
É. Bailly, Simon Ville, Gilles Blancho, Emmanuel Morélon, Jamal Bamoulid, Sophie Caillard, Valérie Châtelet, Paolo Malvezzi, Jérôme Tourret, Vincent Vuiblet, Dany Anglicheau, Dominique Bertrand, Philippe Grimbert, Fadi Haidar, Marc Hazzan, Nassim Kamar, Pierre Merville, Christiane Mousson, Vincent Pernin, Claire Pouteil‐Noble, Raj Purgus, Johnny Sayegh, Pierre‐François Westeel, Bénédicte Sautenet, Philippe Gatault, Matthias Büchler
Abstract
The treatment of active antibody-mediated rejection (ABMR) is still a matter of debate, the place of rituximab remaining controversial. The French multicenter double-blind RITUX-ERAH study included 38 patients with ABMR in the first year of renal transplantation. All patients received plasma exchanges, intravenous immunoglobulins, and corticosteroids and were randomly assigned rituximab or placebo infusion at day 5. Additional rituximab infusions were allowed. In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups. Long-term data are needed to conclude. Evaluation of the 7-year outcomes of the RITUX-ERAH study patients according to the rituximab or placebo treatment received. Eleven patients received placebo and 27 at least one infusion of rituximab. Seven years after ABMR, death-censored kidney allograft survival and renal function were not different between the groups. The evolution of anti-HLA sensitization was similar. There was no statistically significant difference in the incidence of infectious or neoplastic complications, but to be noted, seven cancers developed in six patients treated with rituximab (mean period of 44 months post-ABMR). In this cohort, there was no benefit 7 years after ABMR of rituximab in addition to plasma exchanges, intravenous immunoglobulins, and steroids.