Ann. Rheum. Dis. 2018 Apr 25
Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2).
ABSTRACT
OBJECTIVE
To compare individually tailored, based on trimestrial biological parameter monitoring, to fixed-schedule rituximab reinfusion for remission maintenance of antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs).
METHODS
Patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in complete remission after induction therapy were included in an open-label, multicentre, randomised controlled trial. All tailored-arm patients received a 500 mg rituximab infusion at randomisation, with rituximab reinfusion only when CD19+B lymphocytes or ANCA had reappeared or ANCA titre rose markedly based on trimestrial testing until month 18. Controls received a fixed 500 mg rituximab infusion on days 0 and 14 postrandomisation, then 6, 12 and 18 months after the first infusion. The primary endpoint was 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.
RESULTS
Among the 162 patients (mean age: 60 years; 42% women) included, 117 (72.2%) had GPA and 45 (27.8%) had MPA. Preinclusion induction therapy included cyclophosphamide for 100 (61.7%), rituximab for 61 (37.6%) and methotrexate for 1 (0.6%). At month 28, 21 patients had suffered 22 relapses: 14/81 (17.3%) in 13 tailored-infusion recipients and 8/81 (9.9%) in 8 fixed-schedule patients (p=0.22). The tailored-infusion versus fixed-schedule group, respectively, received 248 vs 381 infusions, with medians (IQR) of 3 (2-4) vs 5 (5-5) administrations.
CONCLUSION
AAV relapse rates did not differ significantly between individually tailored and fixed-schedule rituximab regimens. Individually tailored-arm patients received fewer rituximab infusions.
TRIAL REGISTRATION NUMBER
NCT01731561; Results.
Related Questions
New comment by at Vanderbilt University Medical Center ( September 15, 2020)
Much like Dr. Dua, I tend to use scheduled dosing of RTX for the first two years, and then on a case-by-case basis decide if spacing out the infusions makes sense on the balan...
This question is part of a collaboration with RheumMadness and is in reference to Pathogenic ANCA (RAVE Trial).
New answer by at Valley Children's Healthcare (December 12, 2023)
Every visit.
If you use both, how do you decide which to use for a particular patient?
New answer by at Director, Vasculitis Clinical Research Consortium (September 11, 2020)
This is a fairly hot question in the field, and one that reflects the success we have had with advancing therapy for ANCA-associated vasculitis; it’s nice to have choice...
At what CD 19/20 level do you redose? Is this lab dependent?
Do you also use these levels to instruct patients when to get vaccinated?
New answer by at Mayo Clinic College of Medicine (January 21, 2023)
In the MAINRITSAN 2 trial, a tailored rituximab regimen adapted to ANCA-positivity or ANCA-titre change and/or circulating CD19+ B cell repopulation was compared with f...