Randomised controlled trial of prolonged treatment in the remission phase of ANCA-associated vasculitis

Alexandre Karras*, Christian Pagnoux, Marion Haubitz, Kirsten de Groot, Xavier Puechal, Jan Willem Cohen Tervaert, Marten Segelmark, Loic Guillevin, David Jayne, European Vasculitis Soc

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

105 Citations (Web of Science)

Abstract

Objectives A prospective randomised trial to compare two different durations of maintenance immunosuppressive therapy for the prevention of relapse in anti-neutrophil cytoplasmic antibodies (ANCA)associated vasculitis (AAV).

Methods Patients with AAV were recruited 18-24 months after diagnosis if they were in stable remission after cyclophosphamide/prednisolone-based induction followed by azathioprine/prednisolone maintenance therapy. They were randomised (1: 1) to receive continued azathioprine/prednisolone to 48 months from diagnosis (continuation group) or to withdraw azathioprine/prednisolone by 24 months (withdrawal group). The primary endpoint was the relapse risk, from randomisation to 48 months from diagnosis.

Results One hundred and seventeen patients were randomised and 110 remained to the trial end. At entry, median serum creatinine was 116 mu mol/L (range 58-372), 53% were ANCA positive. The percentage of patients presenting with relapse was higher in the withdrawal than in the continuation treatment group (63% vs 22%, p

Conclusions Prolonged remission maintenance therapy with azathioprine/prednisolone, beyond 24 months after diagnosis reduces relapse risk out to 48 months and improves renal survival in AAV.

Original languageEnglish
Pages (from-to)1662-1668
Number of pages7
JournalAnnals of the Rheumatic Diseases
Volume76
Issue number10
DOIs
Publication statusPublished - Oct 2017

Keywords

  • ANTIBODY-ASSOCIATED VASCULITIS
  • SYSTEMIC VASCULITIDES
  • MAINTENANCE THERAPY
  • RENAL SURVIVAL
  • RISK-FACTORS
  • AZATHIOPRINE
  • RELAPSE
  • PROTEINASE-3
  • INDUCTION
  • DAMAGE

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