Session Information
Date: Sunday, October 21, 2018
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: APS ACTION Registry was created to study the natural course of disease over 10 years in persistently antiphospholipid antibody (aPL) positive patients with or without systemic autoimmune diseases. The objective of this analysis was to describe the new pregnancy outcomes of the aPL-positive patients since the inception of the registry.
Methods: A web-based data capture system is used to store patient demographics, history, and medications. The inclusion criteria are positive aPL, based on the laboratory section of the Updated Sapporo APS Classification Criteria, tested at least twice within one year prior to enrollment. Patients are followed every 12±3 months with clinical data and blood collection. For this descriptive analysis, we identified patients who were recorded as “pregnant” during the prospective follow-up; new “aPL-related pregnancy morbidity” was defined as: a) live birth with small-for-gestational-age (SGA) infant with/without preeclampsia (PEC); b) preterm live birth (PTLB) ≤ 34th week of gestation due to PEC or eclampsia; or c) fetal death ≥ 10th week of gestation. Categorical variables were analyzed using chi-square test or Fisher’s exact test, and continuous variables using Student’s t-test or ANOVA.
Results: Since the inception of the registry in 2012, 55 pregnancies were recorded in 42 aPL-positive patients. Three pregnancies, ongoing at the time of data lock, were excluded. Of 40 patients included (mean maternal age: 32.9 ± 5.2 y; primary aPL/APS: 30 [75%]; systemic lupus erythematosus [SLE]: 10 [25%]), 10 (25%) did not fulfill clinical APS classification criteria, 5 (13%) had obstetric APS (OAPS), 12 (30%) thrombotic APS (TAPS), and 13 (33%) OAPS+TAPS. Pregnancy outcomes (Table) were not different between patients with or without TAPS, with and without OAPS, with or without APS, and with OAPS and with TAPS with one exception: term live birth occurred in 12/34 (35%) of pregnancies of patients with history of TAPS compared to 12/18 (67%) of pregnancies of patients without history of TAPS (p: 0.03). The analysis of all the pregnancy morbidity combined showed no significant difference between the groups. Forty-four of 52 (85%) pregnancies were treated with low dose aspirin (LDA) and/or low-molecular weight heparin (LMWH) (37 with LDA+LMWH): 5/52 (10%) due to OAPS only (LDA+LMWH: 5); 14/52 (27%) TAPS only (LDA+LMWH: 12); 16/52 (31%) OAPS and TAPS (LDA+LMWH: 13); and 9/52 (17%) despite no APS classification (LDA+LMWH: 7). Medications were not different among patients with different new pregnancy outcomes.
Conclusion: In our multi-center international prospective aPL-positive cohort, after excluding one-fourth of pregnancies complicated by pre-embryonic or embryonic losses before 10 weeks of gestation: a) five of 39 (13%) resulted in fetal deaths; and b) 34 of 39 (87%) resulted in live birth, while 12 of 39 (31%) patients had “aPL-related pregnancy morbidity”.
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Clinical and Laboratory Characteristics of Newly Pregnant Patients Included in AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository (“Registry”), by Pregnancy Outcomes |
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TLB n: 24 (46%) |
PTLB* n: 10 (19%) |
FD** n: 5 (10%) |
PELS*** n: 13 (25%) |
p |
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Additional Pregnancy Morbidity |
SGA/PEC: 1 PEC: 1 |
SGA/PEC: 2 PEC: 3 SGA: 1 |
– |
– |
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History of Lupus |
7 (29%) |
2 (20%) |
3 (60%) |
2 (15%) |
0.28 |
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History of Thrombosis History of Pregnancy History of Pregnancy Morbidity · ≥1 Fetal Death ≥ 10w · ≥1 Preterm Delivery ≤ 34w · ≥1 Pre-Emb/Emb Loss < 10w |
12 (50%) 20 (83%) 16 (67%) 9 (38%) 6 (25%) 8 (33%) |
7 (70%) 7 (70%) 2 (20%) 1 (10%) 2 (20%) 2 (20%) |
4 (80%) 3 (60%) 3 (60%) 2 (40%) 1 (20%) 2 (40%) |
11 (85%) 10 (77%) 9 (69%) 5 (38%) 4 (31%) 6 (46%) |
0.16 0.67 0.14 0.38 0.94 0.25 |
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Laboratory Category · Lupus Anticoagulant (+) Only · Double aPL (+) · Triple aPL (+) |
. 9 (38%) 6 (25%) 9 (38%) |
. 2 (20%) 2 (20%) 6 (60%) |
. 4 (80%) – 1 (20%) |
. 3 (23%) 2 (15%) 8 (62%) |
. 0.10 0.80 0.26 |
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Rx During Pregnancy · No LDA / LMWH · LDA alone · LMWH alone · LDA + LMWH · Hydroxychloroquine |
. 1 (4%) 1 (4%) 5 (21%) 17 (71%) 14 (58%) |
. 1 (10%) – 1 (10%) 8 (80%) 5 (50%) |
. 2 (40%) – – 3 (60%) 3 (60%) |
. 4 (31%) – – 9 (69%) 6 (46%) |
. 0.06 – 0.53 0.88 0.90 |
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TLB: term live birth; PTLB: preterm live birth; FD: fetal death; PELS: pre-embryonic or embryonic loss; SGA: small for gestational age; PEC: preeclampsia; LDA: Low-dose aspirin; LMWH: Low-molecular-weight-heparin. * 7/10 at or before 34w of gestation; ** 10-20w of gestation: 2, ≥20w: 3); ***3rd consecutive loss only for one patient |
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To cite this abstract in AMA style:
Sevim E, Andrade D, Banzato A, Tektonidou M, Ugarte A, Chighizola CB, Ji L, Branch D, Ramires de Jesus G, Andreoli L, Petri M, Cervera R, Knight JS, Atsumi T, Erkan D. Pregnancy Outcomes of Antiphospholipid Antibody Positive Patients: Prospective Results from Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository (“Registry”) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/pregnancy-outcomes-of-antiphospholipid-antibody-positive-patients-prospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-clinical-da/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/pregnancy-outcomes-of-antiphospholipid-antibody-positive-patients-prospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-clinical-da/