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Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts


1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27

 

  1. Division of Rheumatology, University of Toronto, Canada, and Department of Internal Medicine, National Referral Center for Necrotising Vasculitides and Systemic Sclerosis, Department of Internal Medicine, Hôpital Cochin, University of Paris, France.
  2. Division of Rheumatology, University of Toronto, Canada.
  3. Division of Rheumatology, McMaster University, Hamilton, Canada.
  4. Division of Nephrology and Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
  5. University of Cambridge and Lupus and Vasculitis Unit, Addenbrookes Hospital, Cambridge, UK.
  6. Department of Biostatistics, University of South Florida, Tampa, USA.
  7. Center for Vasculitis Care and Research, Cleveland, USA.
  8. Center for Vasculitis Care and Research, Cleveland, USA.
  9. Division of Rheumatology, University of Utah, Salt Lake City, USA.
  10. Boston University Vasculitis Center, Boston, USA.
  11. Vasculitis Center, University of Pittsburgh Medical Center, Pittsburgh, USA.
  12. Department of Internal Medicine, National Referral Center for Necrotising Vasculitides and Systemic Sclerosis, Department of Internal Medicine, Hôpital Cochin, University Paris-Descartes, Paris, France.
  13. Boston University Vasculitis Center, Boston, USA.
  14. Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, USA.
  15. Division of Rheumatology, Mayo Clinic, Rochester, USA.
  16. Department of Nephrology and Transplantation, Lund University, Skane University Hospital Malmö, Sweden.
  17. Competence Centre for Clinical Research, Skane University, Lund, Sweden.
  18. School of Immunity and Infection, University of Birmingham, Birmingham, UK.
  19. Department of Nephrology, Royal Berkshire Hospital, Reading, Berkshire, UK.
  20. Department of Nephrology, Nuffield Orthopaedic Centre, University of Oxford, Oxford, UK.
  21. School of Immunity and Infection, University of Birmingham, Birmingham, UK.
  22. Department of Ear, Nose and Throat, Rigshospitalet, Copenhagen, Denmark.
  23. Klinikum Offenbach, Offenbach, Germany.
  24. Department of Nephrology, Charles University and General University Hospital First Faculty of Medicine, Prague, Czech Republic.
  25. University of Cambridge and Lupus and Vasculitis Unit, Addenbrookes Hospital, Cambridge, UK.
  26. Vasculitis Center, Division of Rheumatology, University of Pennsylvania, Philadelphia, USA.
  27. Department of Internal Medicine, National Referral Center for Necrotising Vasculitides and Systemic Sclerosis, Department of Internal Medicine, Hôpital Cochin, University Paris-Descartes, Paris, France.

CER8256
2015 Vol.33, N°2 ,Suppl.89
PI 0077, PF 0083
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PMID: 26016754 [PubMed]

Received: 05/01/2015
Accepted : 22/01/2015
In Press: 26/05/2015
Published: 26/05/2015

Abstract

OBJECTIVES:
To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts.
METHODS:
The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE).
RESULTS:
657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively).
CONCLUSIONS:
Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations.

Rheumatology Article