Lupus Clinic, Reumatologia, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, 00161 Rome, Italy.
Dipartimento di Medicina Traslazionale e di Precisione, Sapienza Università di Roma, 00161 Rome, Italy.
Biomolecules. 2022 Aug 7;12(8):1088. doi: 10.3390/biom12081088.
We longitudinally followed a single-center cohort of anti-phospholipid (aPL) positive healthy subjects to evaluate the evolution to systemic autoimmune diseases (sAD) and to describe clinical and serological associated features. Since 2010, we have consecutively screened healthy subjects who were positive, in at least two consecutive determinations, for one or more aPL [anti-Cardiolipin (aCL) IgM/IgG, anti-Beta2Glycoprotein I (aB2GPI) IgM/IgG, Lupus Anticoagulant (LA)]. All subjects were evaluated every six months, or in accordance with the patient's clinical course, in order to record the development of clinical and laboratory features suggestive for sAD. Ninety-five subjects [M/F 20/75, median age at first determination 46 years, Interquartile Range (IQR) 19] were enrolled. Thirty-three subjects (34.7%) were positive for only one aPL [15 (15.8%) for aCL, 15 (15.8%) for LA, and 5 (5.3%) for aB2GPI]; 37 (38.9%) had double positivity [32 (33.6%) for aCL and aB2GPI; 5 (5.3%) for aCL and LA], 23 (24.2%) had triple positivity. We prospectively followed up our cohort for a median period of 72 months (IQR 84). During a total follow-up of 7692 person-months, we found an absolute risk for sAD development equal to 1.8%. Specifically, 14 (14.7%) patients developed a sAD: in four patients (4.2%), after developing a thrombotic event, an antiphospholipid syndrome was diagnosed, 7 (7.4%) patients developed an Undifferentiated Connective Tissue Disease after a median period of 76 months (IQR 75.5), and lastly, three (3.1%) patients could be classified as affected by Systemic Lupus Erythematosus according to the ACR/EULAR 2019 criteria. The presence of triple positivity status resulted in being significantly associated with the progression to sAD ( = 0.03). In conclusion, we observed the development of sAD in almost 15% of aPL positive subjects. Triple positivity was significantly associated with this progression, suggesting a possible role as biomarker for this condition. Thus, our results could suggest the need for periodic follow-up for such patients to assess early diagnosis and treatment.
我们对一组抗磷脂 (aPL) 阳性的健康受试者进行了前瞻性队列研究，以评估其向系统性自身免疫性疾病 (sAD) 的发展情况，并描述其临床和血清学相关特征。自 2010 年以来，我们连续筛查了至少连续两次检测结果为阳性的健康受试者，其检测结果为一种或多种 aPL [抗心磷脂 (aCL) IgM/IgG、抗β2 糖蛋白 I (aB2GPI) IgM/IgG、狼疮抗凝物 (LA)]。所有受试者每 6 个月或根据患者的临床病程进行评估，以记录提示 sAD 的临床和实验室特征的发展。共纳入 95 例受试者 [M/F 20/75，首次检测中位年龄 46 岁，四分位距 (IQR) 19]。33 例受试者 (34.7%) 仅有一种 aPL 阳性 [15 例 (15.8%) 为 aCL，15 例 (15.8%) 为 LA，5 例 (5.3%) 为 aB2GPI]；37 例 (38.9%) 为双阳性 [32 例 (33.6%) 为 aCL 和 aB2GPI；5 例 (5.3%) 为 aCL 和 LA]，23 例 (24.2%) 为三阳性。我们前瞻性地对队列进行了中位 72 个月 (IQR 84) 的随访。在 7692 人年的总随访期间，我们发现 sAD 发展的绝对风险为 1.8%。具体来说，14 例患者 (14.7%) 发生了 sAD：4 例患者 (4.2%) 在发生血栓事件后，诊断为抗磷脂综合征，7 例患者 (7.4%) 在中位时间 76 个月 (IQR 75.5) 后发展为未分化结缔组织病，最后，根据 ACR/EULAR 2019 标准，3 例 (3.1%) 患者可被归类为系统性红斑狼疮患者。三阳性状态的存在与 sAD 的进展显著相关 ( = 0.03)。总之，我们观察到在抗磷脂阳性的受试者中，近 15%的患者发生了 sAD。三阳性与这一进展显著相关，提示其可能作为该疾病的生物标志物。因此，我们的研究结果表明，需要对这些患者进行定期随访，以评估早期诊断和治疗。
