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Ann Rheum Dis. 2018 Aug;77(8):1150-1156. doi: 10.1136/annrheumdis-2017-212768. Epub 2018 May 3.

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

Author information

1
Department of Internal Medicine, Hôpital Cochin, Université Paris Descartes, Sorbonne Paris Cité, INSERM Unité 1016, Centre de Référence pour les Maladies Auto-immunes Rares, Paris, France.
2
Department of Rheumatology, Mount Sinai Hospital, Toronto, Ontario, Canada.
3
Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, INSERM Unité 738, Paris, France.
4
Unité de Néphrologie, Hôpital Européen Georges-Pompidou, Université Paris Descartea, Paris, France.
5
Service de Pneumologie, Centre de Référence pour Maladies Pulmonaires Rares, Hôpital Universitaire Louis Pradel, Lyon, France.
6
Service de Médecine Interne, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
7
Département de Médecine Interne, Hôpitaux Universitaires de Rennes, Hôpital Sud, Université Rennes I, IGDR-UMR 6290, Rennes, France.
8
Service de Médecine Interne, Hôpital Edouard Herriot, Lyon, France.
9
Service de Médecine Interne et d'Immunologie Clinique, Site Belle Isle, HPM, Metz, France.
10
Département de Médecine Interne, Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France.
11
Département de Néphrologie and Département de Médecine Interne, Centre Hospitalier de Valenciennes, Valenciennes, France.
12
Service de Médecine Interne, Centre Hospitalier Général de Niort, Niort, France.
13
Service de Médecine Interne et d'Immunologie Clinique, Centre Hospitalier Universitaire de Dijon, Université de Bourgogne, IFR100, Dijon, France.
14
Service de Néphrologie, Dialyse et Transplantation, Centre Hospitalier Universitaire de Grenoble, Grenoble, France.
15
Service de Néphrologie, INSERM Unité 699, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Université Paris Diderot, Paris, France.
16
Département de Néphrologie, Hôpital d'Annecy, Annecy, France.
17
Service de Médecine Interne, Clinique Rhône Durance, Avignon, France.
18
Département de Médecine Interne, Centre Hospitalier Universitaire Hôtel-Dieu, Nantes, France.
19
Département de Médecine Interne, Hôpital La Croix Saint-Simon, Paris, France.
20
Service de Médecine Interne, Centre de Référence Labellisé pour la Prise en Charge des Cytopénies Auto-immunes de l'Adulte, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Vasculitis Clinic, Créteil, France.
21
Hôpital Cochin, Centre de Référence Maladies Systémiques et Autoimmunes Rares, AP HP, Université Paris Descartes, Service de Médecine Interne, Paris, France.

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

PMID:
29724729
DOI:
10.1136/annrheumdis-2017-212768
[Indexed for MEDLINE]

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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