| Title | The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria. |
| Publication Type | Journal Article |
| Year of Publication | 2023 |
| Authors | Barbhaiya M, Zuily S, Naden R, Hendry A, Manneville F, Amigo M-C, Amoura Z, Andrade D, Andreoli L, Artim-Esen B, Atsumi T, Avcin T, H Belmont M, Bertolaccini MLaura, D Branch W, Carvalheiras G, Casini A, Cervera R, Cohen H, Costedoat-Chalumeau N, Crowther M, de Jesus G, Delluc A, Desai S, De Sancho M, Devreese KM, Diz-Kucukkaya R, Duarte-García A, Frances C, Garcia D, Gris J-C, Jordan N, Leaf RK, Kello N, Knight JS, Laskin C, Lee AI, Legault K, Levine SR, Levy RA, Limper M, Lockshin MD, Mayer-Pickel K, Musial J, Meroni PLuigi, Orsolini G, Ortel TL, Pengo V, Petri M, Pons-Estel G, Gomez-Puerta JA, Raimboug Q, Roubey R, Sanna G, Seshan SV, Sciascia S, Tektonidou MG, Tincani A, Wahl D, Willis R, Yelnik C, Zuily C, Guillemin F, Costenbader K, Erkan D |
| Corporate Authors | ACR/EULAR APS Classification Criteria Collaborators |
| Journal | Arthritis Rheumatol |
| Volume | 75 |
| Issue | 10 |
| Pagination | 1687-1702 |
| Date Published | 2023 Oct |
| ISSN | 2326-5205 |
| Keywords | Antiphospholipid Syndrome, Autoantibodies, beta 2-Glycoprotein I, Female, Humans, Immunoglobulin G, Immunoglobulin M, Pregnancy, Rheumatology, United States |
| Abstract | OBJECTIVE: To develop new antiphospholipid syndrome (APS) classification criteria with high specificity for use in observational studies and trials, jointly supported by the American College of Rheumatology (ACR) and EULAR. METHODS: This international multidisciplinary initiative included 4 phases: 1) Phase I, criteria generation by surveys and literature review; 2) Phase II, criteria reduction by modified Delphi and nominal group technique exercises; 3) Phase III, criteria definition, further reduction with the guidance of real-world patient scenarios, and weighting via consensus-based multicriteria decision analysis, and threshold identification; and 4) Phase IV, validation using independent adjudicators' consensus as the gold standard. RESULTS: The 2023 ACR/EULAR APS classification criteria include an entry criterion of at least one positive antiphospholipid antibody (aPL) test within 3 years of identification of an aPL-associated clinical criterion, followed by additive weighted criteria (score range 1-7 points each) clustered into 6 clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and 2 laboratory domains (lupus anticoagulant functional coagulation assays, and solid-phase enzyme-linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti-β2 -glycoprotein I antibodies). Patients accumulating at least 3 points each from the clinical and laboratory domains are classified as having APS. In the validation cohort, the new APS criteria versus the 2006 revised Sapporo classification criteria had a specificity of 99% versus 86%, and a sensitivity of 84% versus 99%. CONCLUSION: These new ACR/EULAR APS classification criteria were developed using rigorous methodology with multidisciplinary international input. Hierarchically clustered, weighted, and risk-stratified criteria reflect the current thinking about APS, providing high specificity and a strong foundation for future APS research. |
| DOI | 10.1002/art.42624 |
| Alternate Journal | Arthritis Rheumatol |
| PubMed ID | 37635643 |
Related Faculty:
Surya V. Seshan, M.D.