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. 2022 Jun;9(1):e000633.
doi: 10.1136/lupus-2021-000633.

Pregnancy outcomes in antiphospholipid antibody positive patients: prospective results from the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository ('Registry')

Zeynep Belce Erton #  1 , Ecem Sevim #  2   3 , Guilherme Ramires de Jesús  4   5 , Ricard Cervera  6 , Lanlan Ji  7 , Vittorio Pengo  8 , Amaia Ugarte  9 , Danieli Andrade  10 , Laura Andreoli  11   12 , Tatsuya Atsumi  13 , Paul R Fortin  14 , Maria Gerosa  15 , Yu Zuo  16 , Michelle Petri  17 , Savino Sciascia  18 , Maria G Tektonidou  19 , Maria Angeles Aguirre-Zamorano  20 , D Ware Branch  21   22 , Doruk Erkan  23 ; APS ACTION
Collaborators, Affiliations

Pregnancy outcomes in antiphospholipid antibody positive patients: prospective results from the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository ('Registry')

Zeynep Belce Erton et al. Lupus Sci Med. 2022 Jun.

Abstract

Objectives: To describe the outcomes of pregnancies in antiphospholipid antibody (aPL)-positive patients since the inception of the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking Registry.

Methods: We identified persistently aPL-positive patients recorded as 'pregnant' during prospective follow-up, and defined 'aPL-related outcome' as a composite of: (1) Preterm live delivery (PTLD) at or before 37th week due to pre-eclampsia (PEC), eclampsia, small-for-gestational age (SGA) and/or placental insufficiency (PI); or (2) Otherwise unexplained fetal death after the 10th week of gestation. The primary objective was to describe the characteristics of patients with and without aPL-related composite outcomes based on their first observed pregnancies following registry recruitment.

Results: Of the 55 first pregnancies observed after registry recruitment among nulliparous and multiparous participants, 15 (27%) resulted in early pregnancy loss <10 weeks gestation. Of the remaining 40 pregnancies: (1) 26 (65%) resulted in term live delivery (TLD), 4 (10%) in PTLD between 34.0 weeks and 36.6 weeks, 5 (12.5%) in PTLD before 34th week, and 5 (12.5%) in fetal death (two associated with genetic anomalies); and (2) The aPL-related composite outcome occurred in 9 (23%). One of 26 (4%) pregnancies with TLD, 3/4 (75%) with PTLD between 34.0 weeks and 36.6 weeks, and 3/5 (60%) with PTLD before 34th week were complicated with PEC, SGA and/or PI. Fifty of 55 (91%) pregnancies were in lupus anticoagulant positive subjects, as well as all pregnancies with aPL-related composite outcome.

Conclusion: In our multicentre, international, aPL-positive cohort, of 55 first pregnancies observed prospectively, 15 (27%) were complicated by early pregnancy loss. Of the remaining 40 pregnancies, composite pregnancy morbidity was observed in 9 (23%) pregnancies.

Keywords: antibodies, anticardiolipin; antibodies, antiphospholipid; antiphospholipid syndrome.

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Conflict of interest statement

Competing interests: MAP is the chair for the Belimumab Pregnancy Registry, supported by GSK. DWB is the co-principal investigator of The TNF-alpha Blockade with Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS, supported by a grant from the NIH/NIAMS R21AR21069189-03S1. DWB is the principal investigator of The Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE, supported by UCB Pharma Inc.

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