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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.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).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).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.

Type

Journal article

Journal

Clinical and experimental rheumatology

Publication Date

03/2015

Volume

33

Addresses

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.

Keywords

french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC), Humans, Otorhinolaryngologic Diseases, Kidney Diseases, Peroxidase, Antibodies, Antineutrophil Cytoplasmic, Severity of Illness Index, Cohort Studies, Age Distribution, Patient Selection, Adult, Aged, Middle Aged, Female, Male, Myeloblastin, Randomized Controlled Trials as Topic, Microscopic Polyangiitis, Granulomatosis with Polyangiitis, Observational Studies as Topic