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Revised classification criteria for antiphospholipid syndrome and the thrombotic risk in patients with autoimmune diseases

Summary.  Background: The classification criteria for antiphospholipid syndrome (APS) were updated in 2006. Objective: The aim of the study was to analyze associations between clinical complications and laboratory test abnormalities typical for APS in a group of patients with autoimmune diseases, based on the recently updated criteria. Patients/methods: Three hundred and thirty‐six patients were enrolled into the study, with the majority (n = 235) suffering from systemic lupus erythematosus. Laboratory determinations included: lupus anticoagulant (LA), anticardiolipin (aCL) and anti‐beta2‐glycoprotein I (anti‐β2GPI) antibodies (ABs) [of both immunoglobulin G (IgG) and IgM class]. Results: A significant association was found between laboratory and clinical features of APS; odds ratios (ORs) for thrombosis associated with the presence of LA, aCL, and anti‐β2GPI Abs were 4.04 [95% CI: 2.44–6.68], 3.71 (95% CI 2.32–5.92) and 2.57 (95% CI 1.60–4.1), respectively. Detailed analysis showed marked differences between the risk of clinical complications associated with the presence of an antibody in the IgG class (OR 4.15, 95% CI 2.42–7.12, and OR 4.77, 95% CI 2.37–9.61 for aCL and anti‐β2GPI, respectively) and in the IgM class (OR 2.2, 95% CI 1.31–3.70, and OR 1.9, 95% CI 1.15–3.14 for aCL and anti‐β2GPI, respectively). The postulated inclusion of anti‐β2GPI antibody positivity into the previous laboratory criteria changed only slightly the number of patients diagnosed with APS (from 112 to 117). Conclusions: The updated APS classification criteria clearly represent a step forward. However, our results argue against the use of overall positivity for aCL or anti‐β2GPI, and favor a clear distinction between the IgG and IgM classes of antiphospholipid ABs. Patients with both LA and anti‐β2GPI IgG or LA and aCL IgG positivity may represent the subgroups at the highest risk of thrombotic complications.