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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).

Pierre Charles 1, 2, 3, 4 Benjamin Terrier 1, 3, 4 Elodie Perrodeau 5, 6, 4, 7 Pascal Cohen 1, 3, 4 Stanislas Faguer 8 Antoine Huart 8 Mohamed Hamidou 9 Christian Agard 9 Bernard Bonnotte 10, 11 Maxime Samson 10, 11 Alexandre Karras 12 Noemie Jourde-Chiche 13 François Lifermann 14 Pierre Gobert 15 Catherine Hanrotel-Saliou 16 Pascal Godmer 17 Nicolas Martin-Silva 18 Grégory Pugnet 19 Marie Matignon 20 Olivier Aumaître 21 Jean-François Viallard 22 François Maurier 23 Nadine Meaux-Ruault 24 Sophie Rivière 25 Jean Sibilia 26 Xavier Puéchal 1, 3, 4 Philippe Ravaud 5, 6, 4, 7 Luc Mouthon 1, 3, 4 Loïc Guillevin 1, 3, 4 - For The French Vasculitis Study Group
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.
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-02051265
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : mercredi 27 février 2019 - 16:18:58
Dernière modification le : mercredi 14 octobre 2020 - 04:16:15

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Pierre Charles, Benjamin Terrier, Elodie Perrodeau, Pascal Cohen, Stanislas Faguer, et al.. 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).. Annals of the Rheumatic Diseases, BMJ Publishing Group, 2018, 77 (8), pp.1143-1149. ⟨10.1136/annrheumdis-2017-212878⟩. ⟨hal-02051265⟩

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