The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria
© 2023 American College of Rheumatology..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:75 |
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| Enthalten in: |
Arthritis & rheumatology (Hoboken, N.J.) - 75(2023), 10 vom: 28. Okt., Seite 1687-1702 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Barbhaiya, Medha [VerfasserIn] |
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| Links: |
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| Themen: |
Autoantibodies |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 04.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/art.42624 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a © 2023 American College of Rheumatology. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a beta 2-Glycoprotein I |2 NLM | |
| 650 | 7 | |a Autoantibodies |2 NLM | |
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| 700 | 1 | |a Naden, Ray |e verfasserin |4 aut | |
| 700 | 1 | |a Hendry, Alison |e verfasserin |4 aut | |
| 700 | 1 | |a Manneville, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Amigo, Mary-Carmen |e verfasserin |4 aut | |
| 700 | 1 | |a Amoura, Zahir |e verfasserin |4 aut | |
| 700 | 1 | |a Andrade, Danieli |e verfasserin |4 aut | |
| 700 | 1 | |a Andreoli, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Artim-Esen, Bahar |e verfasserin |4 aut | |
| 700 | 1 | |a Atsumi, Tatsuya |e verfasserin |4 aut | |
| 700 | 1 | |a Avcin, Tadej |e verfasserin |4 aut | |
| 700 | 1 | |a Belmont, H Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Bertolaccini, Maria Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Branch, D Ware |e verfasserin |4 aut | |
| 700 | 1 | |a Carvalheiras, Graziela |e verfasserin |4 aut | |
| 700 | 1 | |a Casini, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Cervera, Ricard |e verfasserin |4 aut | |
| 700 | 1 | |a Cohen, Hannah |e verfasserin |4 aut | |
| 700 | 1 | |a Costedoat-Chalumeau, Nathalie |e verfasserin |4 aut | |
| 700 | 1 | |a Crowther, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a de Jesus, Guilherme |e verfasserin |4 aut | |
| 700 | 1 | |a Delluc, Aurelien |e verfasserin |4 aut | |
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| 700 | 1 | |a Devreese, Katrien M |e verfasserin |4 aut | |
| 700 | 1 | |a Diz-Kucukkaya, Reyhan |e verfasserin |4 aut | |
| 700 | 1 | |a Duarte-Garcia, Ali |e verfasserin |4 aut | |
| 700 | 1 | |a Frances, Camille |e verfasserin |4 aut | |
| 700 | 1 | |a Garcia, David |e verfasserin |4 aut | |
| 700 | 1 | |a Gris, Jean-Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Jordan, Natasha |e verfasserin |4 aut | |
| 700 | 1 | |a Leaf, Rebecca K |e verfasserin |4 aut | |
| 700 | 1 | |a Kello, Nina |e verfasserin |4 aut | |
| 700 | 1 | |a Knight, Jason S |e verfasserin |4 aut | |
| 700 | 1 | |a Laskin, Carl |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Alfred I |e verfasserin |4 aut | |
| 700 | 1 | |a Legault, Kimberly |e verfasserin |4 aut | |
| 700 | 1 | |a Levine, Steve R |e verfasserin |4 aut | |
| 700 | 1 | |a Levy, Roger A |e verfasserin |4 aut | |
| 700 | 1 | |a Limper, Maarten |e verfasserin |4 aut | |
| 700 | 1 | |a Lockshin, Michael D |e verfasserin |4 aut | |
| 700 | 1 | |a Mayer-Pickel, Karoline |e verfasserin |4 aut | |
| 700 | 1 | |a Musial, Jack |e verfasserin |4 aut | |
| 700 | 1 | |a Meroni, Pier Luigi |e verfasserin |4 aut | |
| 700 | 1 | |a Orsolini, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Ortel, Thomas L |e verfasserin |4 aut | |
| 700 | 1 | |a Pengo, Vittorio |e verfasserin |4 aut | |
| 700 | 1 | |a Petri, Michelle |e verfasserin |4 aut | |
| 700 | 1 | |a Pons-Estel, Guillermo |e verfasserin |4 aut | |
| 700 | 1 | |a Gomez-Puerta, Jose A |e verfasserin |4 aut | |
| 700 | 1 | |a Raimboug, Quentin |e verfasserin |4 aut | |
| 700 | 1 | |a Roubey, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Sanna, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Seshan, Surya V |e verfasserin |4 aut | |
| 700 | 1 | |a Sciascia, Savino |e verfasserin |4 aut | |
| 700 | 1 | |a Tektonidou, Maria G |e verfasserin |4 aut | |
| 700 | 1 | |a Tincani, Angela |e verfasserin |4 aut | |
| 700 | 1 | |a Wahl, Denis |e verfasserin |4 aut | |
| 700 | 1 | |a Willis, Rohan |e verfasserin |4 aut | |
| 700 | 1 | |a Yelnik, Cecile |e verfasserin |4 aut | |
| 700 | 1 | |a Zuily, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Guillemin, Francis |e verfasserin |4 aut | |
| 700 | 1 | |a Costenbader, Karen |e verfasserin |4 aut | |
| 700 | 1 | |a Erkan, Doruk |e verfasserin |4 aut | |
| 700 | 0 | |a ACR/EULAR APS Classification Criteria Collaborators |e verfasserin |4 aut | |
| 700 | 1 | |a Barbhaiya, Medha |e investigator |4 oth | |
| 700 | 1 | |a Costenbader, Karen |e investigator |4 oth | |
| 700 | 1 | |a Erkan, Doruk |e investigator |4 oth | |
| 700 | 1 | |a Guillemin, Francis |e investigator |4 oth | |
| 700 | 1 | |a Hendry, Alison |e investigator |4 oth | |
| 700 | 1 | |a Manneville, Florian |e investigator |4 oth | |
| 700 | 1 | |a Naden, Ray |e investigator |4 oth | |
| 700 | 1 | |a Zuily, Stephane |e investigator |4 oth | |
| 700 | 1 | |a Amigo, Mary-Carmen |e investigator |4 oth | |
| 700 | 1 | |a Atsumi, Tatsuya |e investigator |4 oth | |
| 700 | 1 | |a Bertolaccini, Maria Laura |e investigator |4 oth | |
| 700 | 1 | |a Branch, D Ware |e investigator |4 oth | |
| 700 | 1 | |a de Jesus, Guilherme |e investigator |4 oth | |
| 700 | 1 | |a Devreese, Katrien M |e investigator |4 oth | |
| 700 | 1 | |a Frances, Camille |e investigator |4 oth | |
| 700 | 1 | |a Garcia, David |e investigator |4 oth | |
| 700 | 1 | |a Levine, Steve R |e investigator |4 oth | |
| 700 | 1 | |a Levy, Roger A |e investigator |4 oth | |
| 700 | 1 | |a Lockshin, Michael D |e investigator |4 oth | |
| 700 | 1 | |a Ortel, Thomas L |e investigator |4 oth | |
| 700 | 1 | |a Sciascia, Savino |e investigator |4 oth | |
| 700 | 1 | |a Tektonidou, Maria G |e investigator |4 oth | |
| 700 | 1 | |a Wahl, Denis |e investigator |4 oth | |
| 700 | 1 | |a Willis, Rohan |e investigator |4 oth | |
| 700 | 1 | |a Crowther, Mark |e investigator |4 oth | |
| 700 | 1 | |a Alessandro, Casini |e investigator |4 oth | |
| 700 | 1 | |a Andrade, Danieli |e investigator |4 oth | |
| 700 | 1 | |a Andreoli, Laura |e investigator |4 oth | |
| 700 | 1 | |a Artim-Esen, Bahar |e investigator |4 oth | |
| 700 | 1 | |a Avcin, Tadej |e investigator |4 oth | |
| 700 | 1 | |a Belmont, Michael H |e investigator |4 oth | |
| 700 | 1 | |a Carvalheiras, Graziela |e investigator |4 oth | |
| 700 | 1 | |a Cervera, Ricard |e investigator |4 oth | |
| 700 | 1 | |a Costedoat-Chalumeau, Nathalie |e investigator |4 oth | |
| 700 | 1 | |a Duarte-Garcia, Ali |e investigator |4 oth | |
| 700 | 1 | |a Desai, Sheetal |e investigator |4 oth | |
| 700 | 1 | |a De Sancho, Maria |e investigator |4 oth | |
| 700 | 1 | |a Diz-Kucukkaya, Reyhan |e investigator |4 oth | |
| 700 | 1 | |a Delluc, Aurelien |e investigator |4 oth | |
| 700 | 1 | |a Gris, Jean-Christophe |e investigator |4 oth | |
| 700 | 1 | |a Jordan, Natasha |e investigator |4 oth | |
| 700 | 1 | |a Leaf, Rebecca K |e investigator |4 oth | |
| 700 | 1 | |a Knight, Jason S |e investigator |4 oth | |
| 700 | 1 | |a Laskin, Carl |e investigator |4 oth | |
| 700 | 1 | |a Lee, Alfred I |e investigator |4 oth | |
| 700 | 1 | |a Legault, Kimberly |e investigator |4 oth | |
| 700 | 1 | |a Kello, Nina |e investigator |4 oth | |
| 700 | 1 | |a Limper, Maarten |e investigator |4 oth | |
| 700 | 1 | |a Mayer-Pickel, Karoline |e investigator |4 oth | |
| 700 | 1 | |a Meroni, Pier Luigi |e investigator |4 oth | |
| 700 | 1 | |a Musial, Jack |e investigator |4 oth | |
| 700 | 1 | |a Orsolini, Giovanni |e investigator |4 oth | |
| 700 | 1 | |a Pengo, Vittorio |e investigator |4 oth | |
| 700 | 1 | |a Petri, Michelle |e investigator |4 oth | |
| 700 | 1 | |a Pons-Estel, Guillermo |e investigator |4 oth | |
| 700 | 1 | |a Raimboug, Quentin |e investigator |4 oth | |
| 700 | 1 | |a Gomez Puerta, Jose A |e investigator |4 oth | |
| 700 | 1 | |a Sanna, Giovanni |e investigator |4 oth | |
| 700 | 1 | |a Seshan, Surya V |e investigator |4 oth | |
| 700 | 1 | |a Tincani, Angela |e investigator |4 oth | |
| 700 | 1 | |a Yelnik, Cecile |e investigator |4 oth | |
| 700 | 1 | |a Zuily, Catherine |e investigator |4 oth | |
| 700 | 1 | |a Amoura, Zahir |e investigator |4 oth | |
| 700 | 1 | |a Cohen, Hannah |e investigator |4 oth | |
| 700 | 1 | |a Roubey, Robert |e investigator |4 oth | |
| 700 | 1 | |a Agmon-Levin, Nancy |e investigator |4 oth | |
| 700 | 1 | |a Aguilar, Cassyanne |e investigator |4 oth | |
| 700 | 1 | |a Alba, Paula |e investigator |4 oth | |
| 700 | 1 | |a Alpan, Oral |e investigator |4 oth | |
| 700 | 1 | |a Ambrozic, Ales |e investigator |4 oth | |
| 700 | 1 | |a Andrade, Luis |e investigator |4 oth | |
| 700 | 1 | |a Appenzeller, Simone |e investigator |4 oth | |
| 700 | 1 | |a Berkun, Yackov |e investigator |4 oth | |
| 700 | 1 | |a Cabral, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Canaud, Guillame |e investigator |4 oth | |
| 700 | 1 | |a Chen, Pojen |e investigator |4 oth | |
| 700 | 1 | |a Chighizola, Cecilia |e investigator |4 oth | |
| 700 | 1 | |a Cimaz, Rolando |e investigator |4 oth | |
| 700 | 1 | |a Cuadrado, Maria Jose |e investigator |4 oth | |
| 700 | 1 | |a de Groot, Philip G |e investigator |4 oth | |
| 700 | 1 | |a de Moerloose, Philippe |e investigator |4 oth | |
| 700 | 1 | |a Derksen, Ronald |e investigator |4 oth | |
| 700 | 1 | |a Dörner, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Fortin, Paul |e investigator |4 oth | |
| 700 | 1 | |a Giannakopoulos, Bill |e investigator |4 oth | |
| 700 | 1 | |a Gonzalez, Emilio B |e investigator |4 oth | |
| 700 | 1 | |a Inanc, Murat |e investigator |4 oth | |
| 700 | 1 | |a Kenet, Gili |e investigator |4 oth | |
| 700 | 1 | |a Khamashta, Munther |e investigator |4 oth | |
| 700 | 1 | |a Kriegel, Martin |e investigator |4 oth | |
| 700 | 1 | |a Krilis, Steven |e investigator |4 oth | |
| 700 | 1 | |a Ladha, Danyal |e investigator |4 oth | |
| 700 | 1 | |a Massicotte, Patti |e investigator |4 oth | |
| 700 | 1 | |a McCarty, Gale |e investigator |4 oth | |
| 700 | 1 | |a Mikdashi, Jamal |e investigator |4 oth | |
| 700 | 1 | |a Myones, Barry |e investigator |4 oth | |
| 700 | 1 | |a Sammaritano, Lisa |e investigator |4 oth | |
| 700 | 1 | |a Signorelli, Flavio |e investigator |4 oth | |
| 700 | 1 | |a Soybilgic, Arzu |e investigator |4 oth | |
| 700 | 1 | |a Woller, Scott |e investigator |4 oth | |
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