Rituximab is superior to conventional therapy with azathioprine for preventing disease relapse in patients with relapsing ANCA-associated vasculitis (AAV) following re-induction of remission with rituximab, investigators reported at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 virtual congress.
Their conclusion is based on findings from the randomized, controlled RITAZAREM trial, which examined how the medications compared in preventing relapse in 170 patients (median age 59 years; median disease duration of 5.3 years) with AAV following remission induction with rituximab and glucocorticoids.
“The study results clearly showed the superiority of [rituximab] over azathioprine during the treatment period, without our finding any evidence that the substance has a worse profile—on the contrary,” investigator Rona M. Smith, MD, of the University of Cambridge in the United Kingdom, said in an ERA-EDTA press release.
Dr Smith and her colleagues randomly assigned 85 patients to receive rituximab and 85 to receive azathioprine. The rituximab regimen was 1000 mg every 4 months for a total of 5 doses. The azathioprine regimen was 2 mg/kg/day. The follow-up duration was at least 36 months. The primary outcome was time to disease relapse.
By 24 months after study entry (20 months after randomization), 11 patients (13%) in the rituximab arm experienced a relapse compared with 32 (38%) in the azathioprine group. Compared with azathioprine therapy, rituximab therapy was significantly associated with a 70% decreased risk of relapse, Dr Smith said in a video presentation. Two (18%) of the 11 relapses in the rituximab group were severe compared with 12 (38%) of the 32 relapses in the azathioprine arm.
Smith R, Jayne D, Merkel P. A randomized, controlled trial of rituximab versus azathioprine after induction remission with rituximab for patients with anca-associated vasculitis and relapsing disease. Presented at the European Renal Association-European Dialysis and Transplant Association 2020 virtual congress. Abstract LB004.