| Title: |
Rituximab as maintenance therapy for ANCA-associated vasculitides: pooled analysis and long-term outcome of 277 patients included in the MAINRITSAN trials |
| Authors: |
Delestre, Florence; Charles, Pierre; Karras, Alexandre; Pagnoux, Christian; Néel, Antoine; Cohen, Pascal; Aumaître, Olivier; Faguer, Stanislas; Gobert, Pierre; Maurier, Francois; Samson, Maxime; Godmer, Pascal; Bonnotte, Bernard; Cottin, Vincent; Hanrotel-Saliou, Catherine; Le Gallou, Thomas; Carron, Pierre-Louis; Desmurs-Clavel, Hélène; Direz, Guillaume; Jourde-Chiche, Noémie; Lifermann, Francois; Martin-Silva, Nicolas; Pugnet, Grégory; Quéméneur, Thomas; Matignon, Marie; Benhamou, Ygal; Daugas, Eric; Lazaro, Estibaliz; Limal, Nicolas; Ducret, Maïzé; Huart, Antoine; Viallard, Jean-Francois; Hachulla, Eric; Perrodeau, Elodie; Puechal, Xavier; Guillevin, Loïc; Porcher, Raphaël; Terrier, Benjamin; for the French Vasculitis Study Group (FVSG); Agard, Christian; Allard, Julien; Arlet, Jean-Benoît; Bagneres, Denis; Begon, Edouard; Beucher, Anne-Bérangère; Blanchard-Delaunay, Claire; Bocquentin, Frédéric; Bonnin, Anthony; Boumallassa, Ali; Brihaye, Benoit; Buchler, Mathias; Canet, Sébastien; Damade, Richard; Lacroix-Szmania, Isabelle de; Delafosse, Christian; Delbes, Sébastien; Delbrel, Xavier; Menthon, Mathilde de; Moreuil, Claire de; Dhote, Robin; Dunogué, Bertrand; Durel, Cécile-Audrey; Fabre, Marc; Fain, Olivier; Francois, Hélène; Frimat, Marie; Galempoix, Jean-Michel; Gil, Helder; Gilson, Bernard; Gondran, Guillaume; Grassin, Fréderic; Guichard, Isabelle; Guillaud, Constance; Kassem, Hassan; Koreichi, Abdeldjallil; Kyndt, Xavier; Lahaxe, Laure; Lerolle, Nathalie; Leveiller, Guillaume; Lidove, Olivier; Lino-Daniel, Marie; Meaux-Ruault, Nadine; Meckenstock, Roderich; Mestrallet, Stéphanie; Mouthon, Luc; Papo, Thomas; Paule, Romain; Pavel, Simona; Perard, Laurent; Perrot, Serge; Poindron, Vincent; Puyade, Mathieu; Rabot, Nolwenn; Ramassamy, Alain; Régent, Alexis; Rigothier, Claire; Rivière, Sophie; Seror, Raphaèle; Schiffman, Aurélie; Schleinitz, Nicolas; Sene, Damien; Sultan, Audrey; Tieulie, Nathalie; Vinter, Christine; Vinzio, Stéphane; Warzocha, Ursula; Wemeau, Lidwine |
| Publisher Information: |
BMJ Publishing Group Ltd |
| Publication Year: |
2024 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
Vasculitis |
| Description: |
Objective To compare the long-term efficacy and safety of azathioprine (AZA), 18-month fixed-schedule rituximab (RTX), 18-month tailored RTX and 36-month RTX in preventing relapses in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis who achieved a complete remission after induction therapy. Patients treated with 36-month RTX received either a fixed or a tailored regimen for the first 18 months and a fixed regimen for the last 18 months (36-month fixed/fixed RTX and 36-month tailored/fixed RTX, respectively). Methods The Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trials sequentially compared: 18-month fixed-schedule RTX versus AZA (MAINRITSAN); 18-month fixed-schedule RTX versus 18-month tailored-RTX (MAINRITSAN2); and extended therapy to 36 months with four additional RTX infusions after MAINRITSAN2 versus placebo (MAINRITSAN3). Patients were then followed prospectively through month 84 and their data were pooled to analyse relapses and adverse events. The primary endpoint was relapse-free survival at month 84. Results 277 patients were enrolled and divided in 5 groups: AZA (n=58), 18-month fixed-schedule RTX (n=97), 18-month tailored-RTX (n=40), 36-month tailored/fixed RTX (n=42), 36-month fixed/fixed RTX (n=41). After adjustment for prognostic factors, 18-month fixed-schedule RTX was superior to AZA in preventing major relapses at month 84 (HR 0.38, 95% CI 0.20 to 0.71). The 18-month tailored-RTX regimen was associated with an increased risk of major relapse compared with fixed-schedule regimen (HR 2.92, 95% CI 1.43 to 5.96). The risk of major relapse was similar between 36-month fixed/fixed and 18-month fixed-RTX (HR 0.69, 95% CI 0.38 to 1.25). Conclusions According to these results, it appears that the 84-month remission rate is higher with an 18-month fixed RTX regimen compared with AZA and 18-month tailored RTX. Also, extending RTX to 36 months does not appear to reduce the long-term relapse rate compared with the 18-month ... |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://ard.bmj.com/cgi/content/short/83/2/233; http://dx.doi.org/10.1136/ard-2023-224623 |
| DOI: |
10.1136/ard-2023-224623 |
| Availability: |
http://ard.bmj.com/cgi/content/short/83/2/233; https://doi.org/10.1136/ard-2023-224623 |
| Rights: |
Copyright (C) 2024, BMJ Publishing Group Ltd |
| Accession Number: |
edsbas.C5E0D105 |
| Database: |
BASE |