Descriptive analysis of patients positive for anti-phospholipid antibodies included in two Italian registries

Submitted: 13 July 2023
Accepted: 20 September 2023
Published: 12 October 2023
Abstract Views: 534
PDF: 125
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.


The definite diagnosis of antiphospholipid syndrome (APS) depends on the laboratory performance and clinicians’ interpretation. Results from two Italian inception cohort studies of anti-phospholipid antibodies (aPL)-positive subjects, the Italian Survey on ANtiphoSpholipid antibody Positive Individuals Registry (INSPIRE) and the Survey on AnTicoagulated Patients-RegisTry (START) have been compared. Data from INSPIRE were collected by rheumatologists of the FIRMA group while those of START by physicians working in Italian thrombosis centers. Evidence on several, still unraveled, clinical and methodological aspects of ‘real life’ aPL testing and APS diagnosis was collected. In this paper, we report the characteristics of 123 cases enrolled in INSPIRE and 229 in START registries, with particular reference to the reasons why these tests were requested, the obtained aPL profile, and consequent treatment. Laboratory testing for aPL in the absence of clinical criteria defining APS was more frequent in INSPIRE (p<0.0001). The rate of patients in classification category I (more than one aPL test positive) was significantly higher in START (p<0.0001) as well as the use of warfarin. A wide variety of treatments has been observed in patients in classification category II (single aPL positivity). These data indicate that there is a need to harmonize many aspects among the various specialists dealing with APS.



PlumX Metrics


Download data is not yet available.



Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost 2006;4:295-306. DOI:
Cecchi I, Radin M, Rubini E, et al. Clinical manifestations in patients with antiphospholipid antibodies: Beyond thrombosis and pregnancy loss. Lupus 2021:961203321995248. DOI:
Rosa RF, Ugolini-Lopes MR, Zeinad-Valim AK, et al. Difficult clinical situations in the antiphospholipid syndrome. Curr Rheumatol Rep 2015;17:29. DOI:
Abreu MM, Danowski A, Wahl DG, et al. The relevance of "non-criteria" clinical manifestations of antiphospholipid syndrome: 14th International Congress on Antiphospholipid Antibodies Technical Task Force Report on Antiphospholipid Syndrome Clinical Features. Autoimmun Rev 2015;14:401-14. DOI:
Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis 2019;78:1151-9. DOI:
Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40:1725. DOI:
Petri M, Orbai AM, Alarcon GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum 2012;64:2677-86. DOI:
Pengo V, Ruffatti A, Del Ross T, et al. Confirmation of initial antiphospholipid antibody positivity depends on the antiphospholipid antibody profile. J Thromb Haemost 2013;11:1527-31. DOI:
Chayoua W, Kelchtermans H, Gris JC, et al. The (non-)sense of detecting anti-cardiolipin and anti-beta2glycoprotein I IgM antibodies in the antiphospholipid syndrome. J Thromb Haemost 2020;18:169-79. DOI:
Tektonidou MG, Andreoli L, Limper M, et al. EULAR recommendations for the management of antiphospholipid syndrome in adults. Ann Rheum Dis 2019;78:1296-304. DOI:
Garcia D, Akl EA, Carr R, Kearon C. Antiphospholipid antibodies and the risk of recurrence after a first episode of venous thromboembolism: a systematic review. Blood 2013;122:817-24. DOI:
El Hasbani G, Viola M, Sciascia S, et al. Antiphospholipid Antibodies in Inflammatory and Autoimmune Rheumatic and Musculoskeletal Diseases Beyond Lupus: A Systematic Review of the Available Evidence. Rheumatol Ther. 2021;8:81-94. DOI:

How to Cite

Pengo, V., Sarti, L., Antonucci, E., Di Agostino, S., Bison, E., Denas, G., … FIRMA group and START collaborators, on behalf of. (2023). Descriptive analysis of patients positive for anti-phospholipid antibodies included in two Italian registries. Bleeding, Thrombosis and Vascular Biology, 2(3).