RT Journal Article
SR Electronic
T1 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)
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1143
OP 1149
DO 10.1136/annrheumdis-2017-212878
VO 77
IS 8
A1 Charles, Pierre
A1 Terrier, Benjamin
A1 Perrodeau, Élodie
A1 Cohen, Pascal
A1 Faguer, Stanislas
A1 Huart, Antoine
A1 Hamidou, Mohamed
A1 Agard, Christian
A1 Bonnotte, Bernard
A1 Samson, Maxime
A1 Karras, Alexandre
A1 Jourde-Chiche, Noémie
A1 Lifermann, François
A1 Gobert, Pierre
A1 Hanrotel-Saliou, Catherine
A1 Godmer, Pascal
A1 Martin-Silva, Nicolas
A1 Pugnet, Grégory
A1 Matignon, Marie
A1 Aumaitre, Olivier
A1 Viallard, Jean-François
A1 Maurier, François
A1 Meaux-Ruault, Nadine
A1 Rivière, Sophie
A1 Sibilia, Jean
A1 Puéchal, Xavier
A1 Ravaud, Philippe
A1 Mouthon, Luc
A1 Guillevin, Loïc
A1 
YR 2018
UL http://ard.bmj.com/content/77/8/1143.abstract
AB 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.