Category Author, year Study design
Number of aPL measurement Comparison/intervention Results/conclusion RCT Erkan et al., 2007 [29 ] RCT with parallel prospective cohort RCT = 98; cohort
≥2.6 weeks apart; observational 2.4 years RCT: ASA 81 mg daily (
) versus placebo (
) (i) HR: 1.04 (95% CI: 0.69–1.56)
Finazzi et al., 2005 [31 ] Randomized trial 109 3.6 years Conventional intensity or ASA alone
Conventional group HR 2.18 (95% CI 0.92–5.15)
Erkan et al., 2002 [10 ] Cross-sectional 56 Not specified Logistic regression analysis (ASA and/or HCQ use) Probability of thrombotic event decreased in patients taking ASA +/− HCQ (HCQ only in patients with Connective tissue disease)—78% of patient had Connective tissue disease Wahl et al., 2000 [30 ] Decision analysis Observation ASA anticoagulation In aPL-positive SLE patients, benefit of primary prophylaxis with ASA outweighs risk Willis et al., 2012 [74 ] Multiethnic, multicenter cohort (LUMINA) 35 Not specified Comparison of SLAM-R scores Decrease in SLAM-R after HCQ therapy strongly correlated with decreases in IFN-
(
) Petri, 1996 [27 ] Hopkins cohort study 100 12 months Predictors for thrombosis in SLE patients and effects of HCQ on thrombosis High anti-dsDNA and low C3, atherosclerosis (hypertension, hyperlipidemia, and elevated homocysteine) Prospective Girón-González et al., 2004 [39 ] Prospective 178 >2.8–12 weeks apart ASA 325 mg/d or All patients received thromboprophylaxis during high risk situations; no thrombotic events occurred Levine et al., 2002 [4 ] Prospective study 22 Not specified Effect of HCQ on the AnxA5-RA in aPL-positive patients Positive AnxA5-RA, triple aPL-positive, double aPL-positive, and single aPL-positive were observed in 87%, 69%, 15%, Pierangeli et al., 1997 [26 ] Prospective study 100 Not specified Comparing the results of AnxA5 resistance assay before and after administration of HCQ HCQ was found to be effective in reducing thrombosis events Cervera et al., 2009 [55 ] Multicentre prospective study 1000 5 years Morbidity and mortality in patients with APS LDA can prevent thrombosis Tarr et al., 2007 [32 ] Prospective 27281 ≥2.6 weeks apart Prophylaxis (
) versus observation (
)** Lower incidence of thrombosis in prophylaxis group versus observation group (1/52 versus 2/29 had stroke or TIA) Ruiz-Irastorza et al., 2006 [44 ] Prospective cohort 232 1 Effect of antimalarial drugs in preventing thrombosis in SLE patients through a Cox regression-multiple-failure time survival analysis model aPL positivity (HR 3.16, 95% CI 1.45–6.88) Rubenstein et al., 2006 [42 ] Cohort study 1795 Not specified Capability of HCQ in reducing thrombosis HCQ was found to be effective Retrospective Hereng et al., 2008 [40 ] Retrospective 103 (36% SLE or other Connective tissue disease) 64 months +/− 24 ASA (
) versus observation (
); HCQ in connective tissue disease (i) In ASA group, lower frequency of thrombotic events observed (12% versus 35.7% overall; 11% versus 4% in SLE, particularly in the SLE or AIT subgroups of patients)
Ruffatti et al., 2009 [13 ] Retrospective 370 (35% SLE) 56.3 months 134 long-term prophylaxes with ASA Combination of high and long-term risk period of prophylaxis protective against thrombosis Tektonidou et al., 2009 [36 ] Retrospective 288.144 aPL-positive ≥2–12 weeks apart Adjusted survival analysis (ASA 80–100 mg/d, HCQ) (i) HR per month: ASA 0.98 (95% CI: 0.96–0.99) and HCQ 0.99 (95% CI: 0.98–1.00) Kaiser et al., 2009 [41 ] Retrospective 1930.516 aPL-positive 1 Logistic regression analysis (HCQ use) (i) OR 0.63 (95% CI: 0.48–0.83) Mok et al., 2005 [37 ] Retrospective 83 11 years HCQ intake showed lower risk for thrombotic events (OR 0.21 95% CI: 0.06–0.81) Broder and Putterman, 2013 [38 ] Retrospective study 90 Not specified Link between HCQ aPL and LAC levels 19% of the study population showed persistent LAC+ and/or at least 1 aPL ≥ 40 U Wallace et al., 1993 [28 ] Retrospective 72 6 years Logistic regression analysis (HCQ use)
