The antiphospholipid antibodies registry of the Argentinean Society of Rheumatology (GESAF-SAR): baseline data of the first 162 patients

Abstract

Objective: Antiphospholipid antibodies registry of the Argentinean Society of Rheumatology (GESAF-SAR) was created to study long-term disease characteristics and outcomes in persistently antiphospholipid antibody (aPL)-positive patients. The objective was to report baseline demographic, clinical, laboratory and treatment characteristics of aPL-positive patients enrolled in the registry.

Materials and Methods: GESAF-SAR is a multicenter, multidisciplinary and longitudinal study. Thirty centers from Argentina participated. Data collection was performed by review of medical records and interview with individuals/patients, after signing an informed consent. A web-based data capture system (ARTHROS) was used. Inclusion criteria: aPL with at least one positive determination of Lupus Anticoagulant (LAC) and/or positive Anticardiolipin Antibodies (aCL) and Anti-βeta 2 Glycoprotein I (aβ2GLPI) IgG and IgM greater 40 or positive aCL and/or aβ2GLPI with levels 20-40 GPL or MPL (at least two determinations) separated by 12 weeks. Patients were followed every 12±3 months. Descriptive cross-sectional analysis of data collected from May to October 2019 was performed.

Results: Overall 162 patients were enrolled, 139 (86%) were women with a mean age at entry of 40.3 years (SD 12.9); 76 (47%) patients were Mestizo, 72 (44%) Caucasians and 14 (9%) others. The socioeconomic level was Medium-Low in 47 patients (29%), Medium in 58 (36%) and Medium-High in 25 (15%). Seventy-four patients (46%) met classification criteria for Primary APS, 37 (23%) were APS associated with autoimmune disease and 2 (1%) were catastrophic APS (CAPS). Of the 111 APS patients, 50 (45%) presented thrombotic manifestations, 44 (40%) obstetric and 16 (15%) both. Forty-nine patients (30%) did not meet classification criteria of APS. A total of 40 (24.7%) venous events, 34 (21%) arterial, 70 (43.2%) obstetric morbidity and 55 (34%) non-criteria manifestations were recorded. Seventy-seven women presented at least one pregnancy with a total 265 gestations, resulting in 104 (39%) live births. Of all gestations, 80 (30%) were miscarriages <10 weeks, 53 (20%) premature births, 42 (16%) placental insufficiency, 24 (9%) preeclampsia and only 2 (1%) eclampsia. Based on aPL profile, 88 (54%) were positive for LAC, 110 (68%) aCL and 74 (46%) for aβ2GLPI. Regarding treatments, 117 (72%) patients received Aspirin, 71 (43.8%) oral anticoagulation, 53 (32.7%) prophylactic heparin, 46 (28.4%) therapeutic heparin, 92 (56.8%) hydroxychloroquine.

Conclusions: In our multi-center Argentinean aPL-positive cohort, at baseline: a) 30% of patients did not meet classification criteria of APS, b) 46% met classification criteria for Primary APS, c) one-fourth were APS associated with autoimmune disease, d) 45% presented thrombotic manifestations, e) the most frequent obstetric morbidity were miscarriages <10 weeks. Future longitudinal analysis of GESAF-SAR Registry will help clarify the risk profiles of aPL in Argentina.