2023 ACR/EULAR antiphospholipid syndrome classification criteria

被引:142
作者
Barbhaiya, Medha [1 ]
Zuily, Stephane [2 ,3 ]
Naden, Ray [4 ]
Hendry, Alison [5 ]
Manneville, Florian [6 ]
Amigo, Mary-Carmen [7 ]
Amoura, Zahir [8 ]
Andrade, Danieli [9 ]
Andreoli, Laura [10 ]
Artim-Esen, Bahar [11 ]
Atsumi, Tatsuya [12 ]
Avcin, Tadej [13 ]
Belmont, Michael H. [14 ]
Bertolaccini, Maria Laura [15 ]
Branch, D. Ware [16 ]
Carvalheiras, Graziela [17 ]
Casini, Alessandro [18 ]
Cervera, Ricard [19 ]
Cohen, Hannah [20 ]
Costedoat-Chalumeau, Nathalie [21 ]
Crowther, Mark [22 ]
de Jesus, Guilherme [23 ]
Delluc, Aurelien [24 ,25 ]
Desai, Sheetal [26 ]
De Sancho, Maria [27 ]
Devreese, Katrien M. [28 ,29 ]
Diz-Kucukkaya, Reyhan [30 ]
Duarte-Garcia, Ali [31 ]
Frances, Camille [32 ]
Garcia, David [33 ]
Gris, Jean-Christophe [34 ]
Jordan, Natasha [35 ]
Leaf, Rebecca K. [36 ]
Kello, Nina [37 ]
Knight, Jason S. [38 ]
Laskin, Carl [39 ]
Lee, Alfred I. [40 ]
Legault, Kimberly [41 ]
Levine, Steve R. [42 ,43 ]
Levy, Roger A. [44 ,45 ]
Limper, Maarten [46 ]
Lockshin, Michael D. [1 ]
Mayer-Pickel, Karoline [47 ]
Musial, Jack [48 ]
Meroni, Pier Luigi [49 ]
Orsolini, Giovanni [50 ]
Ortel, Thomas L. [51 ]
Pengo, Vittorio [52 ]
Petri, Michelle [53 ]
Pons-Estel, Guillermo [54 ]
机构
[1] Weill Cornell Med, Hosp Special Surg, Barbara Volcker Ctr Women & Rheumat Dis, New York, NY USA
[2] Univ Lorraine, French Natl Referral Ctr System & Autoimmune Dis, Vasc Med Div, Inserm,DCAC, Nancy, France
[3] CHRU Nancy, Nancy, France
[4] Auckland City Hosp, Dept Med & Obstet, Auckland, New Zealand
[5] Middlemore Hosp, Dept Gen Med, Auckland, New Zealand
[6] Univ Lorraine, Inserm, CHRU Nancy, CIC Clin Epidemiol, Nancy, France
[7] ABC Med Ctr, Dept Internal Med, Serv Rheumatol, Mexico City, Mexico
[8] Sorbonne Univ, Ctr Immunol & Malad Infect,Hop Pitie Salpetriere, French Natl Reference Ctr System Lupus Erythemat, Antiphospholipid Antibody Syndrome,Serv Med Inter, Paris, France
[9] Univ Sao Paulo, Dept Rheumatol, Sao Paulo, Brazil
[10] Univ Brescia, Rheumatol & Clin Immunol Unit, ASST Spedali Civili, Dept Clin & Expt Sci, Brescia, Italy
[11] Istanbul Univ, Sch Med, Dept Rheumatol, Istanbul, Turkiye
[12] Hokkaido Univ, Dept Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
[13] Univ Ljubljana, Univ Med Ctr, Childrens Hosp, Dept Allergol Rheumatol & Clin Immunol, Ljubljana, Slovenia
[14] NYU, Hosp Joint Dis, Dept Rheumatol, New York, NY USA
[15] Kings Coll London, Sch Cardiovasc & Metab Med & Sci, Acad Dept Vasc Surg, London, England
[16] Univ Utah Hlth, Dept Obstet & Gynecol, Salt Lake City, UT USA
[17] Ctr Hosp Porto, Hosp Santo Antonio, Unidade Imunol Clin, Porto, Portugal
[18] Univ Hosp Geneva, Div Angiol & Hemostasis, Geneva, Switzerland
[19] Univ Barcelona, Hosp Clin, Dept Autoimmune Dis, Barcelona, Spain
[20] UCL, Dept Haematol, London, England
[21] Univ Paris, Hop Cochin, AP HP, Serv Med Interne,Ctr Reference Malad Autoimmune &, Paris, France
[22] McMaster Univ, Dept Med, Hamilton, ON, Canada
[23] Univ Estado Rio de Janeiro, Dept Obstet, Rio De Janeiro, Brazil
[24] Univ Ottawa, Dept Med, Ottawa, ON, Canada
[25] Ottawa Hosp, Res Inst, Ottawa, ON, Canada
[26] Univ Calif Irvine, Div Rheumatol, Irvine, CA USA
[27] Weill Cornell Med, Div Hematol & Oncol, New York, NY USA
[28] Ghent Univ Hosp, Dept Lab Med, Coagulat Lab, Ghent, Belgium
[29] Univ Ghent, Dept Diagnost Sci, Ghent, Belgium
[30] Istanbul Univ, Dept Mol Biol & Genet, Sch Sci, Istanbul, Turkiye
[31] Mayo Clin, Div Rheumatol, Rochester, MN USA
[32] Tenon Hosp, Dept Dermatol Allergol, Paris, France
[33] Univ Washington, Dept Hematol, Seattle, WA USA
[34] Univ Montpellier, UMR UA11, INSERM, Dept Hematol,CHRU Nimes, Montpellier, France
[35] Addenbrookes Hosp, Dept Rheumatol, Cambridge, England
[36] Massachusetts Gen Hosp, Dept Hematol, Boston, MA USA
[37] Northwell Hlth, Div Rheumatol, New York, NY USA
[38] Univ Michigan, Div Rheumatol, Ann Arbor, MI USA
[39] Univ Toronto, TRIO Fertil, Div Rheumatol, Toronto, ON, Canada
[40] Yale Sch Med, Dept Hematol, New Haven, CT USA
[41] McMaster Univ, Div Rheumatol, Hamilton, ON, Canada
[42] Suny Downstate Hlth Sci Univ, Downstate Stroke Ctr, Kings Cty Hosp Ctr, Brooklyn, NY USA
[43] Jaffe Stroke Ctr, Maimonides Med Ctr, Brooklyn, NY USA
[44] Univ Estado Rio de Janeiro, Dept Rheumatol, Rio De Janeiro, Brazil
[45] GlaxoSmithKline, Collegeville, PA USA
[46] Univ Utrecht, Univ Med Ctr, Dept Med & Clin Immunol, Utrecht, Netherlands
[47] Med Univ Graz, Dept Obstet, Graz, Austria
[48] Jagiellonian Univ, Sch Med, Dept Med, Krakow, Poland
[49] IRCCS Ist Auxol Italiano, Immunorheumatol Res Lab, Milan, Italy
[50] Univ Hosp Verona, Dept Rheumatol, Verona, Italy
关键词
antiphospholipid syndrome; thrombosis; antibodies; antiphospholipid; INTERNATIONAL CONSENSUS STATEMENT; SYSTEMIC-SCLEROSIS; ISCHEMIC-STROKE; ANTIBODIES; DIAGNOSIS; UPDATE;
D O I
10.1136/ard-2023-224609
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 four 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 six clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and two laboratory domains (lupus anticoagulant functional coagulation assays, and solid-phase enzyme-linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti-beta(2)-glycoprotein I antibodies). Patients accumulating at least three points each from the clinical and laboratory domains are classified as having APS. In the validation cohort, the new APS criteria vs the 2006 revised Sapporo classification criteria had a specificity of 99% vs 86%, and a sensitivity of 84% vs 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.
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收藏
页码:1258 / 1270
页数:13
相关论文
共 44 条
  • [1] CLASSIFICATION OF SUBTYPE OF ACUTE ISCHEMIC STROKE - DEFINITIONS FOR USE IN A MULTICENTER CLINICAL-TRIAL
    ADAMS, HP
    BENDIXEN, BH
    KAPPELLE, LJ
    BILLER, J
    LOVE, BB
    GORDON, DL
    MARSH, EE
    KASE, CS
    WOLF, PA
    BABIKIAN, VL
    LICATAGEHR, EE
    ALLEN, N
    BRASS, LM
    FAYAD, PB
    PAVALKIS, FJ
    WEINBERGER, JM
    TUHRIM, S
    RUDOLPH, SH
    HOROWITZ, DR
    BITTON, A
    MOHR, JP
    SACCO, RL
    CLAVIJO, M
    ROSENBAUM, DM
    SPARR, SA
    KATZ, P
    KLONOWSKI, E
    CULEBRAS, A
    CAREY, G
    MARTIR, NI
    FICARRA, C
    HOGAN, EL
    CARTER, T
    GURECKI, P
    MUNTZ, BK
    RAMIREZLASSEPAS, M
    TULLOCH, JW
    QUINONES, MR
    MENDEZ, M
    ZHANG, SM
    ALA, T
    JOHNSTON, KC
    ANDERSON, DC
    TARREL, RM
    NANCE, MA
    BUDLIE, SR
    DIERICH, M
    HELGASON, CM
    HIER, DB
    SHAPIRO, RA
    [J]. STROKE, 1993, 24 (01) : 35 - 41
  • [2] Distinctions Between Diagnostic and Classification Criteria?
    Aggarwal, Rohit
    Ringold, Sarah
    Khanna, Dinesh
    Neogi, Tuhina
    Johnson, Sindhu R.
    Miller, Amy
    Brunner, Hermine I.
    Ogawa, Rikke
    Felson, David
    Ogdie, Alexis
    Aletaha, Daniel
    Feldman, Brian M.
    [J]. ARTHRITIS CARE & RESEARCH, 2015, 67 (07) : 891 - 897
  • [3] The ASCOD Phenotyping of Ischemic Stroke (Updated ASCO Phenotyping)
    Amarenco, P.
    Bogousslavsky, J.
    Caplan, R.
    Donnan, G. A.
    Wolf, M. E.
    Hennerici, M. G.
    [J]. CEREBROVASCULAR DISEASES, 2013, 36 (01) : 1 - 5
  • [5] [Anonymous], 2020, Obstet Gynecol, V135, P1492, DOI [10.1097/AOG.0000000000003018, 10.1097/AOG.0000000000003892]
  • [6] Aringer M, 2019, ARTHRITIS RHEUMATOL, V71, P1400, DOI [10.1002/art.40930, 10.1136/annrheumdis-2018-214819]
  • [7] DEVELOPMENT OF NEW INTERNATIONAL CLASSIFICATION CRITERIA FOR ANTIPHOSPHOLIPID SYNDROME: PHASE III CASE COLLECTION RESULTS
    Barbhaiya, M.
    Erkan, D.
    Ahmadzadeh, Y.
    Costenbader, K.
    Naden, R.
    Zuily, S.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2020, 79 : 64 - 64
  • [8] Barbhaiya M., 2016, LUPUS, V25
  • [9] 2023 ACR/EULAR antiphospholipid syndrome classification criteria
    Barbhaiya, Medha
    Zuily, Stephane
    Naden, Ray
    Hendry, Alison
    Manneville, Florian
    Amigo, Mary-Carmen
    Amoura, Zahir
    Andrade, Danieli
    Andreoli, Laura
    Artim-Esen, Bahar
    Atsumi, Tatsuya
    Avcin, Tadej
    Belmont, Michael H.
    Bertolaccini, Maria Laura
    Branch, D. Ware
    Carvalheiras, Graziela
    Casini, Alessandro
    Cervera, Ricard
    Cohen, Hannah
    Costedoat-Chalumeau, Nathalie
    Crowther, Mark
    de Jesus, Guilherme
    Delluc, Aurelien
    Desai, Sheetal
    De Sancho, Maria
    Devreese, Katrien M.
    Diz-Kucukkaya, Reyhan
    Duarte-Garcia, Ali
    Frances, Camille
    Garcia, David
    Gris, Jean-Christophe
    Jordan, Natasha
    Leaf, Rebecca K.
    Kello, Nina
    Knight, Jason S.
    Laskin, Carl
    Lee, Alfred I.
    Legault, Kimberly
    Levine, Steve R.
    Levy, Roger A.
    Limper, Maarten
    Lockshin, Michael D.
    Mayer-Pickel, Karoline
    Musial, Jack
    Meroni, Pier Luigi
    Orsolini, Giovanni
    Ortel, Thomas L.
    Pengo, Vittorio
    Petri, Michelle
    Pons-Estel, Guillermo
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2023, 82 (10) : 1258 - 1270
  • [10] Development of a New International Antiphospholipid Syndrome Classification Criteria Phase I/II Report: Generation and Reduction of Candidate Criteria
    Barbhaiya, Medha
    Zuily, Stephane
    Ahmadzadeh, Yasaman
    Amigo, Mary-Carmen
    Avcin, Tadej
    Bertolaccini, Maria Laura
    Branch, D. Ware
    de Jesus, Guilherme
    Devreese, Katrien M. J.
    Frances, Camille
    Garcia, David
    Guillemin, Francis
    Levine, Steven R.
    Levy, Roger A.
    Lockshin, Michael D.
    Ortel, Thomas L.
    Seshan, Surya V.
    Tektonidou, Maria
    Wahl, Denis
    Willis, Rohan
    Naden, Ray
    Costenbader, Karen
    Erkan, Doruk
    [J]. ARTHRITIS CARE & RESEARCH, 2021, 73 (10) : 1490 - 1501