Background/Purpose: Increasing interest has focussed upon assays which are not currently included in the Antiphospholipid syndrome (APS) classification criteria to detect antibodies directed against other phospholipids (PL), PL binding proteins, coagulation factors and a mechanistic test for resistance of Annexin A5 (AA5) anticoagulant activity. Therefore, we carried out a systematic review to try and establish the prevalence of each non-criteria assay in APS and control populations. Methods: We searched PubMed and EMBASE using the keywords APS, antiphospholipid antibodies (aPL), non criteria, new assays, aCL, LA, anti-domain (aD)I, Ig A antiB2 GPI, antiphosphatidylserine (aPS),antiphosphatidylethanolamine (aPE), antiphosphatidic acid (aPA), antiprothrombin (aPT), antiphosphatidylserine-prothtombin (aPS-PT), anti-cardiolipin/vimentin (CL/Vm) and AA5 resistance. Each publication was systematically examined. Results: We selected 15 (6 retrospective, 1 case-control and 8 cross-sectional) studies from which we were able to extract original data on prevalence of non-criteria aPL in 1535 patients with APS and 1184 healthy and disease controls. We found the largest APS sample size from 3 studies of aDI, which found a prevalence of 34.26% of aDI in 645 patients with APS patients versus 3.3% in 30 healthy controls (HC). In reducing order of samples size. Three studies found an overall prevalence of 7.8% of IgM and 4.3% IgG aPE in 337 patients with APS compared with 3.9% IgM and 0.9% IgG aPE in 340 HC. IgA aCL were found in 37.46% of APS patients (n=262), 37.8% autoimmune disease (n=37) controls and 3.4% in healthy and atherosclerosis (n=527) controls. In contrast, 55% of 196 patients with APS were positive for IgA anti-B2GPI, versus 32.9% in 382 atherosclerosis and 13% in 145 healthy controls. The prevalence of AA5 resistance from 3 studies was 66.83% in 163 patients with APS compared with 0% in 80 HC. In 132 APS patients, 27.56% were positive for IgM aPT and 36% positive for IgG aPT versus 5% IgG and 0% IgM in HC.

All of the remaining studies contained less than 100 patients with APS. Studies of other non-criteria aPL identified: 24% IgM and 65.5% IgG aPA in 67 APS patients versus 0% IgM/G aPA in 104 HC; 36.6% IgM and 50.8% IgG aPS in 89 APS patients versus 1% IgM and 0% IgG aPS in 104 HC;  33.8% IgM and 38.8% IgG aPI in 89 APS patients versus 0% in HC; 25% IgM and 27.5% IgG aPS/PT in 44 APS patients versus 3% IgM and 0% IgG in 138 disease controls; and 80% IgM and 92.4% IgG anti-CL/Vm in 40 APS patients versus 0% IgM/G in 32 HC. Conclusion: We found the highest prevalence of non-criteria aPL in the largest number of patients with APS in studies of AA5 resistance and aDI. Further prospective studies however are urgently required to confirm these findings.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/what-is-the-prevalence-of-non-criteria-antiphospholipid-antibodies-in-patients-with-antiphospholipid-syndrome/