Background Antiphospholipid syndrome (APS) is characterized by venous, microvascular and/or arterial and/or obstetric morbidity (obstetric APS) in patients who are persistently positive for antiphospholipid antibodies (aPL). The mainstay of treatment is based on anticoagulation therapy; however, increasing interest is currently received by the antimalarial hydroxychloroquine (HCQ). The use of HCQ has been associated with a reduced risk of thrombosis but HCQ's antithrombotic mechanism of action is unclear particularly in patients with aPL and APS.
Objectives The aim of our study was to assess soluble tissue factor (TF) levels in HCQ naïve-patients with persistent aPL or APS at baseline and 12 weeks after commencing HCQ. We hypothesise that HCQ lowers levels of soluble TF.
Methods Twenty- two individuals with APS with or without other associated autoimmune disease (20 females, two males, median age 55 (range 18–70) years) had blood samples taken before and 12 weeks after starting HCQ 200mg. Plasma was stored at -80oC and thawed to measure TF using Imubind TF kit (Invitech Ltd, Cambridgeshire, UK). The assay was performed according to the manufacturer's instructions. Patient characteristics are outlined in table 1. Statistical analysis was performed using SPSS Version 22. For continuous normally distributed data a two-tailed student's paired t-test was performed. A value of p=0.05 was considered as significant. There are no previous data in this area, so we were unable to do a power calculation to work out study size. Our study is therefore a pilot study.
Results Soluble TF levels were above our normal range (40–300 pg/ml) prior to the commencement of HCQ and were significantly reduced (pre level mean (SD) 401.8 (152.8) pg/ml versus post 300.9 (108) pg/ml (p=0.010).
Conclusions There was a significant reduction in soluble TF levels in this patient cohort of patients with apL and APS after commencing HCQ. Our previous work has shown that HCQ has not affected complement turnover, VEGF levels, thromboelastometry findings or CRP levels. Our findings of a reduction of soluble TF levels in aPL positive patients after the commencement of HCQ maybe a key mechanism by which HCQ reduces thrombotic risk. Further studies of a larger patient cohort are required to confirm our observation.
Miyakis, S., et al., International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost, 2006. 4(2): p. 295–306.
Disclosure of Interest K. Schreiber Shareholder of: Novo Nordisk, Grant/research support from: educational support from Daiichi Sankyo, K. Breen: None declared, K. Parmar: None declared, B. Hunt: None declared