Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results

Cecile M Yelnik, Carl A Laskin, T Flint Porter, D Ware Branch, Jill P Buyon, Marta M Guerra, Michael D Lockshin, Michelle Petri, Joan T Merrill, Lisa R Sammaritano, Mimi Y Kim, Jane E Salmon, Cecile M Yelnik, Carl A Laskin, T Flint Porter, D Ware Branch, Jill P Buyon, Marta M Guerra, Michael D Lockshin, Michelle Petri, Joan T Merrill, Lisa R Sammaritano, Mimi Y Kim, Jane E Salmon

Abstract

Objective: We previously reported that lupus anticoagulant (LAC) is the main predictor of poor pregnancy outcome in antiphospholipid antibody (aPL)-positive patients. We sought to confirm this finding in an independent group of patients who were subsequently recruited into the PROMISSE study.

Methods: The PROMISSE study is a multicentre, prospective, observational study of pregnancy outcomes in women with aPL and/or systemic lupus erythematosus (SLE) that enrolled patients from 2003 to 2015. All consecutive, aPL-positive patients from the PROMISSE study who completed their pregnancy between April 2011 and January 2015 (after the previous PROMISSE report) are included in the current report. Patients were followed monthly until delivery, and aPL was tested at first, second and third trimesters of pregnancy and at 12 weeks post partum. Adverse pregnancy outcomes (APOs) were defined as fetal death after 12 weeks of gestation, neonatal death, delivery prior to 36 weeks of gestation due to pre-eclampsia or placental insufficiency or small-for-gestational age (birth weight <5th percentile).

Results: Forty-four aPL-positive patients are included in this paper. Thirteen patients had APOs, which occurred in 80% of cases during the second trimester of pregnancy. LAC was present in 69% of patients with APOs compared with 27% of patients without APOs (p=0.01). No association was found between anticardiolipin antibodies (aCL) or anti-β2 glycoprotein I antibodies (aβ2GPI) IgG or IgM positivity and APOs. Definite antiphospholipid syndrome (history of thrombosis and/or pregnancy morbidity and aPL) was found in 92% of patients with any APOs compared with 45% of patients without APOs (p=0.004). Conversely, the frequency of SLE was not statistically different between those with and without APOs (30% vs 39%).

Conclusions: Our findings, in an independent group of aPL-positive patients from the PROMISSE study, confirm that LAC, but not aCL and aβ2GPI, is predictive of poor pregnancy outcomes after 12 weeks of pregnancy.

Trial registration number: NCT00198068.

Keywords: Antiphospholipid Antibodies; Antiphospholipid Syndrome; Lupus Anticoagulant; Pregnancy; Systemic Lupus Erythematosus.

References

    1. 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.
    1. Abou-Nassar K, Carrier M, Ramsay T et al. . The association between antiphospholipid antibodies and placenta mediated complications: a systematic review and meta-analysis. Thromb Res 2011;128:77–85.
    1. De Jesus GR, Agmon-Levin N, Andrade CA et al. . 14th International Congress on Antiphospholipid Antibodies Task Force report on obstetric antiphospholipid syndrome. Autoimmun Rev 2014;13:795–813.
    1. Lockshin MD, Kim M, Laskin CA et al. . Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies. Arthritis Rheum 2012;64:2311–8.
    1. Buyon JP, Kim MY, Guerra MM et al. . Predictors of pregnancy outcomes in patients with lupus: a cohort study. Ann Intern Med 2015;163:153–63.
    1. Helgadottir LB, Skjeldestad FE, Jacobsen AF et al. . The association of antiphospholipid antibodies with intrauterine fetal death: a case-control study. Thromb Res 2012;130:32–7.
    1. Alijotas-Reig J, Ferrer-Oliveras R, Ruffatti A et al. . The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): a survey of 247 consecutive cases. Autoimmun Rev 2015;14:387–95.
    1. Ruffatti A, Calligaro A, Hoxha A et al. . Laboratory and clinical features of pregnant women with antiphospholipid syndrome and neonatal outcome. Arthritis Care Res 2010;62:302–7.
    1. Ruffatti A, Tonello M, Visentin MS et al. . Risk factors for pregnancy failure in patients with anti-phospholipid syndrome treated with conventional therapies: a multicentre, case-control study. Rheumatol Oxf Engl 2011;50:1684–9.
    1. Ruiz-Irastorza G, Crowther M, Branch W et al. . Antiphospholipid syndrome. Lancet 2010;376:1498–509.
    1. Mak A, Cheung MW-L, Cheak AA et al. . Combination of heparin and aspirin is superior to aspirin alone in enhancing live births in patients with recurrent pregnancy loss and positive anti-phospholipid antibodies: a meta-analysis of randomized controlled trials and meta-regression. Rheumatol Oxf Engl 2010;49:281–8.
    1. Amengual O, Fujita D, Ota E et al. . Primary prophylaxis to prevent obstetric complications in asymptomatic women with antiphospholipid antibodies: a systematic review. Lupus 2015;24:1135–42.

Source: PubMed

3
Abonnieren