Title :

Rituximab as maintenance therapy for ANCA-associated vasculitides: pooled analysis and long-term outcome of 277 patients included in the MAINRITSAN trials.

Author(s) :

Delestre, Florence [Auteur]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases
Charles, Pierre [Auteur]
Institut Mutualiste de Montsouris [IMM]
Université Sorbonne Paris Cité [USPC]
Karras, Alexandre [Auteur]
Université Sorbonne Paris Cité [USPC]
Pagnoux, Christian [Auteur]
University of Toronto
Mount Sinai Hospital [Toronto, Canada] [MSH]
Néel, Antoine [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Cohen, Pascal [Auteur]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases
Aumaître, Olivier [Auteur]
CHU Gabriel Montpied [Clermont-Ferrand]
Faguer, Stanislas [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Gobert, Pierre [Auteur]
Centre Hospitalier Henri Duffaut (Avignon)
Maurier, François [Auteur]
Hôpital-Clinique Claude-Bernard [Metz]
Samson, Maxime [Auteur]
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand [CHU Dijon]
Godmer, Pascal [Auteur]
Centre hospitalier Bretagne Atlantique (Morbihan) [CHBA]
Bonnotte, Bernard [Auteur]
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand [CHU Dijon]
Cottin, Vincent [Auteur]
Hôpital Louis Pradel [CHU - HCL]
Hanrotel-Saliou, Catherine [Auteur]
CHRU - Service de néphrologie, dialyse et transplantation rénale
Le Gallou, Thomas [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Carron, Pierre-Louis [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Desmurs-Clavel, Hélène [Auteur]
Hôpital Edouard Herriot [CHU - HCL]
Direz, Guillaume [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Jourde-Chiche, Noémie [Auteur]
Hôpital de la Conception [CHU - APHM] [LA CONCEPTION]
Lifermann, François [Auteur]
Centre Hospitalier de Dax
Martin-Silva, Nicolas [Auteur]
CHU Caen
Pugnet, Grégory [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Quéméneur, Thomas [Auteur]
Centre hospitalier [Valenciennes, Nord]
Matignon, Marie [Auteur]
Hôpital Henri Mondor
Benhamou, Ygal [Auteur]
Hôpital Charles Nicolle [Rouen]
Daugas, Eric [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Lazaro, Estibaliz [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Limal, Nicolas [Auteur]
Hôpital Henri Mondor
Ducret, Maïzé [Auteur]
Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
Huart, Antoine [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Viallard, Jean-François [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Hachulla, Eric [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Perrodeau, Elodie [Auteur]
Université Sorbonne Paris Cité [USPC]
Puechal, Xavier [Auteur]
Université Sorbonne Paris Cité [USPC]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases
Guillevin, Loïc [Auteur]
Université Sorbonne Paris Cité [USPC]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases
Porcher, Raphaël [Auteur]
Université Sorbonne Paris Cité [USPC]
Terrier, Benjamin [Auteur]
Université Sorbonne Paris Cité [USPC]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases

Journal title :

Annals of the Rheumatic Diseases

Abbreviated title :

Ann Rheum Dis

Publication date :

2023-11-04

ISSN :

1468-2060

English abstract : [en]

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 ...
Show more >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 fixed RTX regimen. However, as this study was underpowered to make this comparison, further prospective studies are needed to determine the potential long-term benefits of extending treatment in these patients.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-02-06T22:21:39Z
2024-03-15T14:49:16Z