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Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts |pdf=|usr=}}{{26016754 }} gab.com Text Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts JO: Clin Exp Rheumatol http://www.kidney.de/pget.php?&tw=1&pmid=26016754 #FOAvip 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. Twit Text FOAVip Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts ????Clin Exp Rheumatol http://www.kidney.de/pget.php?&tw=1&pmid=26016754 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26016754 #FOAvip English Wikipedia <ref>{{Cite pmid|26016754 }}</ref> Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts #MMPMID26016754 Pagnoux C ; Carette S ; Khalidi NA ; Walsh M ; Hiemstra TF ; Cuthbertson D ; Langford C ; Hoffman G ; Koening CL ; Monach PA ; Moreland L ; Mouthon L ; Seo P ; Specks U ; Ytterberg S ; Westman K ; Hoglund P ; Harper L ; Flossman O ; Luqmani R ; Savage CO ; Rasmussen N ; de Groot K ; Tesar V ; Jayne D ; Merkel PA ; Guillevin L Clin Exp Rheumatol 2015[Mar]; 33 (2 Suppl 89 ): S-77-83 PMID26016754 show ga 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. |*Observational Studies as Topic [MESH] |*Randomized Controlled Trials as Topic [MESH] |Adult [MESH] |Age Distribution [MESH] |Aged [MESH] |Antibodies, Antineutrophil Cytoplasmic/immunology [MESH] |Cohort Studies [MESH] |Female [MESH] |Granulomatosis with Polyangiitis/complications/*epidemiology/immunology [MESH] |Humans [MESH] |Kidney Diseases/etiology [MESH] |Male [MESH] |Microscopic Polyangiitis/complications/*epidemiology/immunology [MESH] |Middle Aged [MESH] |Myeloblastin/immunology [MESH] |Otorhinolaryngologic Diseases/etiology [MESH] |Patient Selection [MESH] |Peroxidase/immunology [MESH]Comparability of patients with ANCA-associated vasculitis enrolled in (epmc).pdf DeepDyve Pubget Overpricing