Charles P, et al. - Authors compared the individually tailored, based on trimestrial biological parameter monitoring, to fixed-schedule rituximab reinfusion for remission maintenance of antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs). No difference was noted in AAV relapse rates between individually tailored and fixed-schedule rituximab regimens. Fewer rituximab infusions were received by individually tailored-arm patients.

Methods

• Experts included the patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in complete remission after induction therapy in an open-label, multicentre, randomised controlled trial.
• A 500mg rituximab infusion at randomisation, with rituximab reinfusion was received by all tailored-arm patients only when CD19+B lymphocytes or ANCA had reappeared or ANCA titre rose markedly based on trimestrial testing until month 18.
• Afixed 500mg rituximab infusion on days 0 and 14 postrandomisation, then 6, 12 and 18 months after the first infusion was received by the controls.
• The number of relapses (new or reappearing symptom(s) or worsening disease with Birmingham Vasculitis Activity Score (BVAS)>0) at month 28 evaluated by an independent Adjudication Committee blinded to treatment group was the primary endpoint.

Results

• As per the data, out of the 162 patients (mean age: 60 years; 42% women) included, 117 (72.2%) had GPA and 45 (27.8%) had MPA.
• Results suggested that preinclusion induction therapy included cyclophosphamide for 100 (61.7%), rituximab for 61 (37.6%) and methotrexate for 1 (0.6%).
• Researchers noted that at month 28, 22 relapses were seen in 21 patients: 14/81 (17.3%) in 13 tailored-infusion recipients and 8/81 (9.9%) in 8 fixed-schedule patients (p=0.22).
• Findings demonstrated that the tailored-infusion vs fixed-schedule group received 248 vs 381 infusions, respectively with medians (IQR) of 3 (2–4) vs 5 (5–5) administrations.