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). - Université de Bourgogne Accéder directement au contenu
Article Dans Une Revue Annals of the Rheumatic Diseases Année : 2018

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).

1 Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
2 IMM - Institut Mutualiste de Montsouris
3 Hôpital Cochin [AP-HP]
4 UPD5 - Université Paris Descartes - Paris 5
5 CRESS (U1153 / UMR_A_1125 / UMR_S_1153) - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité
6 Centre d'épidémiologie Clinique [Hôtel-Dieu]
7 USPC - Université Sorbonne Paris Cité
8 Département de Néphrologie et Transplantation d'organes [CHU Toulouse]
9 Service de médecine interne [Nantes]
10 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
11 Service de médecine interne et immunologie clinique (SOC 1) [CHU de Dijon]
12 HEGP - Hôpital Européen Georges Pompidou [APHP]
13 Centre de néphrologie et transplantation rénale [Hôpital de la Conception - APHM]
14 Service de Médecine Interne [Dax]
15 Centre Hospitalier Henri Duffaut (Avignon)
16 CHRU - Service de néphrologie, dialyse et transplantation rénale
17 Service de Médecine interne - Maladies hématologiques - Maladies infectieuses [Vannes]
18 Service de médecine interne [CHU Caen]
19 Service Médecine Interne et immunologie clinique [CHU Toulouse]
20 Service de néphrologie [CHU Henri Mondor]
21 Service de Médecine Interne [CHU Clermont-Ferrand]
22 Service de médecine interne et maladies infectieuses [Bordeaux]
23 Service de médecine interne [hôpitaux privés de Metz]
24 Med Int - BESANCON - Service de médecine interne
25 Département de médecine interne, centre d'investigation clinique, CHU de Montpellier,
26 Service de rhumatologie [Strasbourg]
François Lifermann
  • Fonction : Auteur
  • PersonId : 955440

Résumé

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.
Fichier non déposé

Dates et versions

hal-02051265 , version 1 (27-02-2019)

Identifiants

Citer

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, 2018, 77 (8), pp.1143-1149. ⟨10.1136/annrheumdis-2017-212878⟩. ⟨hal-02051265⟩
110 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More