Long-term follow-up of patients with severe ANCA-associated vasculitis comparing plasma exchange to intravenous methylprednisolone treatment is unclear

Kidney Int. 2013 Aug;84(2):397-402. doi: 10.1038/ki.2013.131. Epub 2013 Apr 24.

Abstract

Patients with antineutrophil cytoplasm antibody-associated vasculitis (AAV) requiring dialysis at diagnosis are at risk for developing end-stage renal disease (ESRD) or dying. Short-term results of a trial comparing plasma exchange (PLEX) to intravenous methylprednisolone (IV MeP) suggested PLEX improved renal recovery. Here we conducted long-term follow-up to see if this trend persisted. A total of 137 patients with newly diagnosed AAV and a serum creatinine over 500 μmol/l or requiring dialysis were randomized such that 69 received PLEX and 68 received IV MeP in addition to cyclophosphamide and oral glucocorticoids. The patients were followed for a median of 3.95 years. In each group there were 35 deaths, while 23 PLEX and 33 IV MeP patients developed ESRD. The hazard ratio for PLEX compared to IV MeP for the primary composite outcome of death or ESRD was 0.81 (95% confidence interval 0.53-1.23). The hazard ratio for all-cause death was 1.08 with a subhazard ratio for ESRD of 0.64 (95% confidence interval 0.40-1.05). Thus, although short-term results with PLEX are encouraging, the long-term benefits remain unclear. Further research is required to determine the role of PLEX in AAV. Given the poor outcomes of patients with severe AAV, improved treatment is urgently needed.

Trial registration: ClinicalTrials.gov NCT01408836.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Administration, Oral
  • Aged
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / blood
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / complications
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / diagnosis
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / drug therapy
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / mortality
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / therapy*
  • Biomarkers / blood
  • Creatinine / blood
  • Cyclophosphamide / administration & dosage
  • Disease Progression
  • Drug Therapy, Combination
  • Europe
  • Female
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Kaplan-Meier Estimate
  • Kidney Failure, Chronic / etiology
  • Kidney Failure, Chronic / mortality
  • Kidney Failure, Chronic / therapy
  • Male
  • Methylprednisolone / administration & dosage*
  • Methylprednisolone / adverse effects
  • Middle Aged
  • Plasma Exchange* / adverse effects
  • Plasma Exchange* / mortality
  • Proportional Hazards Models
  • Renal Dialysis
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Up-Regulation

Substances

  • Biomarkers
  • Glucocorticoids
  • Immunosuppressive Agents
  • Cyclophosphamide
  • Creatinine
  • Methylprednisolone

Associated data

  • ClinicalTrials.gov/NCT01408836
  • ISRCTN/ISRCTN52952998