International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS)

MIYAKIS, S.; LOCKSHIN, M.D.; ATSUMI, T.; BRANCH, D.W.; BREY, R.L.; CERVERA, R.; DERKSEN, R.H.W.M.; DE GROOT, P.G.; KOIKE, T.; MERONI, P.L.; REBER, G.; SHOENFELD, Y.; TINCANI, A.; VLACHOYIANNOPOULOS, P.G.; KRILIS, S.A.

doi:10.1111/j.1538-7836.2006.01753.x

Cited by 7,203Systemic Lupus Erythematosus ResearchVasculitis and related conditionsSystemic Sclerosis and Related Diseases

International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS)

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MIYAKIS, S., LOCKSHIN, M.D., ATSUMI, T., BRANCH, D.W., BREY, R.L., CERVERA, R., DERKSEN, R.H.W.M., DE GROOT, P.G. +7 more·2006·Journal of Thrombosis and Haemostasis

DOI 10.1111/j.1538-7836.2006.01753.x

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Abstract

New clinical, laboratory and experimental insights, since the 1999 publication of the Sapporo preliminary classification criteria for antiphospholipid syndrome (APS), had been addressed at a workshop in Sydney, Australia, before the Eleventh International Congress on antiphospholipid antibodies. In this document, we appraise the existing evidence on clinical and laboratory features of APS addressed during the forum. Based on this, we propose amendments to the Sapporo criteria. We also provide definitions on features of APS that were not included in the updated criteria.

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Positivity for polyreactive aCL antibodies is a classification criterion for APS and SLE.
“Positivity for polyreactive aCL antibodies is a criterion in the classification of two autoimmune conditions: APS and SLE251,252.”
From The role of mitochondria in rheumatic diseases (2022) · cites this paper as [252]
The 'Update of the classification criteria' section identifies persistent, medium- or high-titer IgG or IgM aCL positivity as an APS laboratory criterion, with a specified positivity threshold. It does not identify polyreactivity as a criterion or establish aCL positivity as an SLE classification criterion; the SLE portion of the citing sentence may be supported by its other citation, but not by this paper. (LLM, conf=0.84)
Experimental — accuracy not yet measured
The Sydney criteria's 12-week interval rests on expert opinion, and knowledge about aPL persistence past 3 months is limited.
“The interval of 12 weeks, defined in the Sydney criteria (previously 6 weeks in the Sapporo criteria), was based on expert opinion and little is known on persistence of aPL beyond 3 months.1”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [1]
The Update of the classification criteria section says the Sapporo interval was 6 weeks, proposes 12 weeks, and explicitly states that the proposed time intervals are based on expert opinion. It calls for studies validating those intervals and describes relevant data as poor, but does not specifically say that little is known about aPL persistence beyond 3 months. (LLM, conf=0.83)
Experimental — accuracy not yet measured
Patients with antiphospholipid antibodies are at increased risk of thrombosis or adverse pregnancy outcomes.
“Patients with antiphospholipid antibodies (lupus anticoagulant, anticardiolipin and anti-beta 2 glycoprotein) are at increased risk of thrombosis or adverse pregnancy outcomes.1”
From Evaluation of different ways to identify persistent positivity of lupus anticoagulant in systemic lupus erythematosus (2020) · cites this paper as [1]
The ‘Update of the classification criteria’ section associates medium- or high-titer anticardiolipin antibodies with clinical manifestations of APS and reports that multiple antibody positivity increases thrombosis rates. Table 2 pairs persistent positivity for the named antibodies with thrombosis or pregnancy morbidity as APS criteria. The citing sentence omits those titer and persistence qualifications, so the paper does not establish increased risk for every patient with a positive antibody test. (LLM, conf=0.83)
Experimental — accuracy not yet measured
The presence of 1 or more aPL for 12 or more weeks constitutes the laboratory criteria for APS.
“The presence of 1 or more of these aPL for 12 or more weeks constitutes the laboratory criteria for antiphospholipid syndrome (APS), an autoimmune disorder defined clinically by arterial and venous thrombotic events and/or pregnancy complications.5”
From Lupus anticoagulant test persistence over time and its associations with future thrombotic events (2022) · cites this paper as [5]
The revised laboratory criteria (Table 2) require at least one qualifying aPL test to be positive on two or more occasions at least 12 weeks apart. The citing sentence captures the persistence requirement but omits the repeat-testing requirement and the specified antibody types and titer thresholds; presence of any aPL alone does not suffice. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Lupus anticoagulant results were reported as positive or negative by the MMC laboratory following International Society on Thrombosis and Hemostasis guidelines.
“LAC was reported as positive or negative (LAC+/LAC−) by the MMC laboratory in accordance with the guidelines of the International Society on Thrombosis and Hemostasis (9).”
From Hydroxychloroquine Use Is Associated with Lower Odds of Persistently Positive Antiphospholipid Antibodies and/or Lupus Anticoagulant in Systemic Lupus Erythematosus (2013) · cites this paper as [9]

Lupus anticoagulant is one of three laboratory criteria used to identify antiphospholipid syndrome.
“Lupus anticoagulant (LA) is one of the three laboratory criteria for the identification of the antiphospholipid syndrome (APS).1,2”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [1]
The Sydney criteria (2006) defined persistent positivity as two or more positive findings separated by at least 12 weeks.
“The definition in the Sydney criteria (2006) was changed to 12 weeks.1”
From Evaluation of different ways to identify persistent positivity of lupus anticoagulant in systemic lupus erythematosus (2020) · cites this paper as [1]
The definition of persistent positivity has varied in different iterations of classification criteria for antiphospholipid syndrome.
“The definition of ‘persistent positivity’ has varied in different iterations of classification criteria for antiphospholipid syndrome and has never been based on evidence.”
From Evaluation of different ways to identify persistent positivity of lupus anticoagulant in systemic lupus erythematosus (2020) · cites this paper as [1]
Anti-β2-glycoprotein I IgA is not part of APS classification criteria.
“The presence of anti-β2-glycoprotein I IgA, which is not a part of APS classification criteria, was also independently associated with thrombosis in SLE patients.”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]
The Sydney APS classification criteria include the IgG and IgM isotypes as a laboratory criterion.
“Currently, the Sydney APS classification criteria include the IgG and IgM isotypes as a laboratory criterion [1].”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]
APS is classified as the development of venous and/or arterial thromboses, and/or pregnancy morbidity, in the presence of persistently raised levels of either LA, aCL or anti-β2-glycoprotein I.
“APS has been classified as the development of venous and/or arterial thromboses, and/or pregnancy morbidity, in the presence of persistently raised levels of either the LA, aCL or anti-β2-glycoprotein I [1].”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]
The definition of persistent positivity in the Sapporo criteria (1999) was 6 weeks, but was changed in the Sydney criteria (2006) to 12 weeks.
“The definition of persistent positivity in the Sapporo criteria (1999) [21] was 6 weeks, but was changed in the Sydney criteria (2006) [1] to 12 weeks.”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]
IgA isotypes of aPL were not included in the Sydney APS criteria.
“IgA isotypes of aPL were not included in the Sydney APS criteria, due to conflicting data on the association with APS manifestations [1].”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]
The definition of 'persistent positivity' was 6 weeks in the Sapporo criteria (1999) and revised to 12 weeks in the Sydney criteria (2006).
“The definition of ‘persistent positivity’ was 6 weeks in the Sapporo criteria (1999) [21] and revised to 12 weeks in the Sydney criteria (2006) [1].”
From Antiphospholipid patterns predict risk of thrombosis in systemic lupus erythematosus (2021) · cites this paper as [1]

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Untitled work
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Sapporo-Kriterien
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SPECIAL ARTICLE
(2015)
Classification Criteria for the Antiphospholipid Syndrome: Not the Same as Diagnostic Criteria for Antiphospholipid Syndrome
Favaloro, E. J., Pasalic, L., & Lippi, G. (2023) · Seminars in Thrombosis and Hemostasis · doi:10.1055/s-0043-1776318 · Cited by 20 · see citing works

Authors: MIYAKIS, S., LOCKSHIN, M. D., ATSUMI, T., BRANCH, D. W., BREY, R. L., CERVERA, R., DERKSEN, R. H. W. M., DE GROOT, P. G., KOIKE, T., MERONI, P. L., REBER, G., SHOENFELD, Y., TINCANI, A., VLACHOYIANNOPOULOS, P. G., & KRILIS, S. A.
Affiliations: UNSW Sydney (AU)
Hospital for Special Surgery (US)
Hokkaido University (JP)
University of Utah (US)
The University of Texas at San Antonio Health Science Center (US)
Hospital Clínic de Barcelona (ES)
University Medical Center Utrecht (NL)
University of Milan (IT)
University Hospital of Geneva (CH)
Tel Aviv University (IL)
University of Brescia (IT)
National and Kapodistrian University of Athens (GR)
Corresponding author: KRILIS, S.A.
ORCID: MIYAKIS, S.
LOCKSHIN, M.D.
ATSUMI, T.
BRANCH, D.W.
BREY, R.L.
CERVERA, R.
MERONI, P.L.
SHOENFELD, Y.
TINCANI, A.
VLACHOYIANNOPOULOS, P.G.
KRILIS, S.A.
Venue: Journal of Thrombosis and Haemostasis
Publisher: Elsevier BV
Published: 2006-02
Volume: 4
Issue: 2
Pages: 295-306
ISSN: 1538-7836 (ISSN-L)
DOI: 10.1111/j.1538-7836.2006.01753.x
OpenAlex: W2054330426
Cited by: 7,203
References: 150
Citations by year: 2026: 270 · 2025: 324 · 2024: 410 · 2023: 397 · 2022: 422 · 2021: 442 · 2020: 425 · 2019: 435 · 2018: 379 · 2017: 463 · 2016: 378 · 2015: 340 · 2014: 393 · 2013: 353 · 2012: 381
FWCI: 166.30
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 6154 d)
Locations: Journal of Thrombosis and Haemostasis (publishedVersion)
PubMed (publishedVersion)
Research Online (University of Wollongong) (submittedVersion)
Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion, other-oa)
Funders: American Autoimmune Related Diseases Association
Johns Hopkins University
McGill University
Hospital for Special Surgery
Morehouse School of Medicine
Institut National de la Santé et de la Recherche Médicale
National and Kapodistrian University of Athens
University of North Carolina at Chapel Hill
Topics: Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
Health Sciences › Medicine › Pathology and Forensic Medicine › Systemic Sclerosis and Related Diseases
Keywords: antiphospholipid syndrome, classification criteria, Sapporo criteria, antiphospholipid antibodies, clinical features, laboratory features, thrombosis, miscarriage, lupus anticoagulant
MeSH terms: Female, Heart Diseases, Humans, Kidney Diseases, Nervous System Diseases, Pregnancy, Pregnancy Complications, Prognosis, Risk Factors, Skin Diseases, Thrombocytopenia, Antiphospholipid Syndrome, Antibodies, Antiphospholipid

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