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

french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC)

Research output: Contribution to journalArticle

25 Citations (Scopus)

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.

Original languageEnglish (US)
JournalClinical and Experimental Rheumatology
Volume33
Issue number2
StatePublished - Mar 1 2015

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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Clinical Trials
Vasculitis
Randomized Controlled Trials
Minocycline
Kidney Diseases
Pharynx
Nose
Ear
Kidney
Recurrence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC) (2015). Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts. Clinical and Experimental Rheumatology, 33(2).

Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts. / french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC).

In: Clinical and Experimental Rheumatology, Vol. 33, No. 2, 01.03.2015.

Research output: Contribution to journalArticle

french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC) 2015, 'Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts', Clinical and Experimental Rheumatology, vol. 33, no. 2.
french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC). Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts. Clinical and Experimental Rheumatology. 2015 Mar 1;33(2).
french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC). / Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts. In: Clinical and Experimental Rheumatology. 2015 ; Vol. 33, No. 2.
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title = "Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts",
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.",
author = "{french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC)} and C. Pagnoux and S. Carette and Khalidi, {N. A.} and M. Walsh and Hiemstra, {T. F.} and D. Cuthbertson and C. Langford and G. Hoffman and Koening, {C. L.} and Monach, {P. A.} and L. Moreland and L. Mouthon and P. Seo and Ulrich Specks and Ytterberg, {Steven R} and K. Westman and P. Hoglund and L. Harper and O. Flossman and R. Luqmani and Savage, {C. O.} and N. Rasmussen and {de Groot}, K. and V. Tesar and D. Jayne and Merkel, {P. A.} and L. Guillevin",
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T1 - Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

AU - french Vasculitis Study Group (FVSG), European Vasculitis Society (EUVAS) and Vasculitis Clinical Research Consortium (VCRC)

AU - Pagnoux, C.

AU - Carette, S.

AU - Khalidi, N. A.

AU - Walsh, M.

AU - Hiemstra, T. F.

AU - Cuthbertson, D.

AU - Langford, C.

AU - Hoffman, G.

AU - Koening, C. L.

AU - Monach, P. A.

AU - Moreland, L.

AU - Mouthon, L.

AU - Seo, P.

AU - Specks, Ulrich

AU - Ytterberg, Steven R

AU - Westman, K.

AU - Hoglund, P.

AU - Harper, L.

AU - Flossman, O.

AU - Luqmani, R.

AU - Savage, C. O.

AU - Rasmussen, N.

AU - de Groot, K.

AU - Tesar, V.

AU - Jayne, D.

AU - Merkel, P. A.

AU - Guillevin, L.

PY - 2015/3/1

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N2 - 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.

AB - 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.

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