Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides - PubMed (original) (raw)

Randomized Controlled Trial

. 2018 Aug;77(8):1150-1156.

doi: 10.1136/annrheumdis-2017-212768. Epub 2018 May 3.

Christian Pagnoux 1 2, Élodie Perrodeau 3, Adexandre Karras 4, Chahera Khouatra 5, Olivier Aumaître 6, Pascal Cohen 1, Olivier Decaux 7, Hélène Desmurs-Clavel 8, François Maurier 9, Pierre Gobert 10, Thomas Quémeneur 11, Claire Blanchard-Delaunay 12, Bernard Bonnotte 13, Pierre-Louis Carron 14, Eric Daugas 15, Marize Ducret 16, Pascal Godmer 17, Mohamed Hamidou 18, Olivier Lidove 19, Nicolas Limal 20, Xavier Puéchal 1, Luc Mouthon 1, Philippe Ravaud 3, Loïc Guillevin 1 21; French Vasculitis Study Group

Collaborators, Affiliations

Randomized Controlled Trial

Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides

Benjamin Terrier et al. Ann Rheum Dis. 2018 Aug.

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.

Keywords: granulomatosis with polyangiitis; systemic vasculitis; treatment.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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Conflict of interest statement

Competing interests: BT has received lecture fees from Roche/Genentech and advisory board fees from ChemoCentryx. CP has received research grants and lecture fees from Roche/Genentech and advisory board fees from ChemoCentryx and Sano.

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