Data di Pubblicazione:
2013
Abstract:
Background: the preliminary Classification Criteria for cryoglobulinemic vasculitis (CV) have been developed in 2011 by an European cooperative study (1).
Objectives: to validate these Classification Criteria for CV with the participation of non-European Countries.
Methods: 20 Centres from Europe, Egypt, and Japan partecipated. New consecutive, unselected patients with CV (Group A) and controls (subjects with cryoglobulins without a CV based on the golden standard clinical judgment; Group B) were studied. A sample size of 140 patients for each group was estimated to obtain a sensitivity (SE) and a specificity (SP) of at least 90±5%, according to the previous results (1). A dedicated chart was distributed to the Centres. The sensitivity and specificity of the 2011 Classification Criteria were calculated in the present validation series by comparing Group A versus Group B.
Results: 251 patients in Group A and 175 controls in Group B were recruited. The questionnaire (at least 2/3 positive answers) showed a SE of 89.2% (95% CI 85.4-93.1) and a SP of 93.7% (95% CI 90.1-97.3); the clinical item (at least 3/4 clinical items among constitutional, articular, vascular and neurologic involvement) showed a SE of 76.1% (95% CI 70.8-81.4) and a SP of 88.6% (95% CI 83.8-93.9), and the laboratory item (at least 2/3 tests, among positive rheumatoid factor, low C4, and the presence of serum monoclonal component) showed 75.1% (95% CI 69.5-80.7) of SE and 71.5% (95% CI 64.6-78.4) of SP. The final 2011 Classification Criteria (at least 2/3 positive items) showed a SE of 89.3% (95% CI 85.3-93.3) and a SP of 93.9 % (95% CI 90.3-97.6).
Conclusions: Conclusion: The 2011 International Classification Criteria for the cryoglobulinemic vasculitis have been validated in a new cohort of real cases and controls. Patients where CV is suspected on clinical grounds, but where cryoglobulins are negative, cannot be classified, since positive serum cryoglobulinemia is a conditio sine qua non for classification (1). However, the performance of these criteria on this subset of patients is under evaluation.
References:
De Vita S, et al. Ann Rheum Dis 2011;70:1183-90
Objectives: to validate these Classification Criteria for CV with the participation of non-European Countries.
Methods: 20 Centres from Europe, Egypt, and Japan partecipated. New consecutive, unselected patients with CV (Group A) and controls (subjects with cryoglobulins without a CV based on the golden standard clinical judgment; Group B) were studied. A sample size of 140 patients for each group was estimated to obtain a sensitivity (SE) and a specificity (SP) of at least 90±5%, according to the previous results (1). A dedicated chart was distributed to the Centres. The sensitivity and specificity of the 2011 Classification Criteria were calculated in the present validation series by comparing Group A versus Group B.
Results: 251 patients in Group A and 175 controls in Group B were recruited. The questionnaire (at least 2/3 positive answers) showed a SE of 89.2% (95% CI 85.4-93.1) and a SP of 93.7% (95% CI 90.1-97.3); the clinical item (at least 3/4 clinical items among constitutional, articular, vascular and neurologic involvement) showed a SE of 76.1% (95% CI 70.8-81.4) and a SP of 88.6% (95% CI 83.8-93.9), and the laboratory item (at least 2/3 tests, among positive rheumatoid factor, low C4, and the presence of serum monoclonal component) showed 75.1% (95% CI 69.5-80.7) of SE and 71.5% (95% CI 64.6-78.4) of SP. The final 2011 Classification Criteria (at least 2/3 positive items) showed a SE of 89.3% (95% CI 85.3-93.3) and a SP of 93.9 % (95% CI 90.3-97.6).
Conclusions: Conclusion: The 2011 International Classification Criteria for the cryoglobulinemic vasculitis have been validated in a new cohort of real cases and controls. Patients where CV is suspected on clinical grounds, but where cryoglobulins are negative, cannot be classified, since positive serum cryoglobulinemia is a conditio sine qua non for classification (1). However, the performance of these criteria on this subset of patients is under evaluation.
References:
De Vita S, et al. Ann Rheum Dis 2011;70:1183-90
Tipologia CRIS:
1.5 Abstract in rivista
Elenco autori:
De Vita, S; Quartuccio, L; Isola, M; Corazza, L; Ramos-Casals, M; Retamozo, S; Ragab, G; Zoheir, N; El Menyaw, Nm; Salem, M; Sansonno, D; Conteduca, V; Feraaccioli, G; Gremese, E; Tzioufas, A; Voulgarelis, M; Vassilopoulos, D; Koutsianas, C; Zignego, Al; Urraro, T; Pipitone, N; Salvarani, C; Ghinoi, A; Guillevin, L; Terrier, B; Cacoub, P; Filippini, D; Saccardo, F; Gabrielli, A; Fraticelli, P; Tomsic, M; Ferri, C; Sebastiani, M; Tavoni, A; Catarsi, E; Mazzaro, C; Pioltelli, P; Nishimoto, N; Scaini, P; Monti, G; Pietrogrande, M; Galli, M; Bombardieri, S
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