Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides. Issue 8 (3rd May 2018)

• Record Type: Journal Article
• Authors: Terrier, Benjamin; Pagnoux, Christian; Perrodeau, Élodie; Karras, Adexandre; Khouatra, Chahera; Aumaître, Olivier; Cohen, Pascal; Decaux, Olivier; Desmurs-Clavel, Hélène; Maurier, François; Gobert, Pierre; Quémeneur, Thomas; Blanchard-Delaunay, Claire; Bonnotte, Bernard; Carron, Pierre-Louis; Daugas, Eric; Ducret, Marize; Godmer, Pascal; Hamidou, Mohamed; Lidove, Olivier; Limal, Nicolas; Puéchal, Xavier; Mouthon, Luc; Ravaud, Philippe; Guillevin, Loïc
• Other Names: author non-byline.; Vendé Florence author non-byline.; Samson Maxime author non-byline.; Hatron Pierre‑Yves author non-byline.; Koreichi Abdeldjallil author non-byline.; Ramassamy Alain author non-byline.; Francois Hélène author non-byline.; Boumallassa Ali author non-byline.; Beucher Anne-Bérangère author non-byline.; Delluc Aurélien author non-byline.; Graffin Bruno author non-byline.; Hanrotel-Saliou Catherine author non-byline.; Grange Claire author non-byline.; Launay David author non-byline.; Bagnères Denis author non-byline.; Begon Edouard author non-byline.; Grassin Frédéric author non-byline.; Bocquentin Frédérique author non-byline.; Gondran Guillaume author non-byline.; Delacroix Isabelle author non-byline.; Guichard Isabelle author non-byline.; Marie Isabelle author non-byline.; Pourrat Jaques author non-byline.; Viallard Jean-François author non-byline.; Wallaert Benoit author non-byline.; Lahaxe Laure author non-byline.; Vrigneaud Laurence author non-byline.; Fabre Marc author non-byline.; Frimat Marie author non-byline.; Lino Marie author non-byline.; Gayraud Martine author non-byline.; Buchler Matthias author non-byline.; Niel-Duriez Myriam author non-byline.; Rabot Nolwenn author non-byline.; Seror Raphaèle author non-byline.; Meckenstock Roderich author non-byline.; Perrot Serge author non-byline.; Seiberras Serge author non-byline.; Dhote Robin author non-byline.; Poindron Vincent author non-byline.; Rieu Virginie author non-byline.; Delbrel Xavier author non-byline.; Kyndt Xavier author non-byline.; Ollivier Yann author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 77:Issue 8(2018)
• Page Start: 1150
• Page End: 1156
• Publication Date: 2018-05-03
• Subjects: systemic vasculitis -- granulomatosis with polyangiitis -- treatment; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-212768
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objective: To compare long-term efficacy of remission-maintenance regimens in patients with newly diagnosed or relapsing antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitides. Methods: The 28-month Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis trial compared rituximab with azathioprine to maintain remission in patients with newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis or renal-limited ANCA-associated vasculitis. Thereafter, prospective patient follow-up lasted until month 60. The primary endpoint was the major-relapse rate at month 60. Relapse and serious adverse event-free survival were also assessed. Results: Among the 115 enrolled patients, only one was lost to follow-up at month 60. For the azathioprine and rituximab groups, respectively, at month 60, the major relapse-free survival rates were 49.4% (95% CI 38.0% to 64.3%) and 71.9% (95% CI 61.2% to 84.6%) (p=0.003); minor and major relapse-free survival rates were 37.2% (95% CI 26.5% to 52.2%) and 57.9% (95% CI 46.4% to 72.2%) (p=0.012); overall survival rates were 93.0% (95% CI 86.7% to 99.9%) and 100% (p=0.045) and cumulative glucocorticoid use was comparable. Quality-adjusted time without symptoms and toxicity analysis showed that rituximab-treated patients had 12.6 months more without relapse or toxicity than those given azathioprine (p<0.001). Antiproteinase-3-ANCA positivity and azathioprine arm were independently associated with higher risk of relapse. HRs of positive ANCA to predict relapse increased over time. Conclusion: The rate of sustained remission for ANCA-associated vasculitis patients, following rituximab-based or azathioprine-based maintenance regimens, remained superior over 60 months with rituximab, with better overall survival. Trial registration number: NCT00748644 .