Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository Analysis: Pregnancy Outcomes Since Inception

Ecem Sevim¹, Danieli Andrade², Alessandra Banzato³, D. Ware Branch⁴, Ricard Cervera⁵, Guilherme Ramires de Jesus⁶, Jason S. Knight⁷, Pier Luigi Meroni⁸, Maria Tektonidou⁹, Angela Tincani¹⁰, Amaia Ugarte¹¹, Zhang Zhuoli¹², Doruk Erkan¹³ and , on Behalf of APS ACTION .¹⁴, ¹Umraniye Research and Training Hospital, Istanbul Health Sciences University, Istanbul, Turkey, ²Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR., Sao Paulo, Brazil, ³Department of Cardiac Thoracic and Vascular Sciences, Clinical Cardiology, Thrombosis Centre, University of Padova, Padova, Italy, ⁴Obstetrics and Gynecology, University of Utah and Intermountain Healthcare, Salt Lake City, UT, ⁵Department of Autoimmune Diseases, Institut Clínic de Medicina i Dermatologia, Hospital Clínic de Barcelona, Barcelona, Spain, ⁶Obstetrics, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, ⁷., University of Michigan, Ann Arbor, MI, ⁸Istituto Ortopedico Gaetano Pini, University of Milan, Milano, Italy, ⁹First Department of Internal Medicine, School of Medicine, National University of Athens, Athens, Greece, ¹⁰Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy, ¹¹Autoimmune Diseases Research Unit, Department of Internal Medicine, BioCruces Health Research Institute, Hospital Universitario Cruces, University of the Basque Country, Biscay, Spain, ¹²Department of Rheumatology and Immunology,Peking University First Hospital, Peking University First Hospital, Beijing, China, ¹³Rheumatology, Hospital for Special Surgery- Weill Cornell Medicine, New York, NY, ¹⁴., New York, NY

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Antiphospholipid antibodies and pregnancy

Session Information

Date: Sunday, November 5, 2017

Title: Antiphospholipid Syndrome Poster

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: APS ACTION Clinical Database and Repository (‘‘Registry’’) was created to study the natural course of disease over 10 years in persistently antiphospholipid antibody (aPL) positive patients with/without other systemic autoimmune diseases. Our objective 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 Updated Sapporo Classification Criteria at least twice within one year prior to enrollment. Patients are followed every 12±3 months with clinical data and blood collection. For this analysis, we identified all patients who were recorded as “pregnant” during the prospective follow-up.

Results: Since the inception of the registry in 5/2012, 45 pregnancies were recorded in 36 aPL-positive patients (mean age 33.4 ± 4.9 y; lupus: 5 [14%]; LA-positive alone: 16 [44%]; triple aPL-positive: 11 [31%]; double aPL-positive: 7 [19%]; obstetric APS [OAPS]: 5 [14%]; thrombotic APS [TAPS]: 10 [28%]; OAPS+TAPS: 12 [33%]; and no history of OAPS/TAPS: 9 [25%]). Of 45 pregnancies (28 patients had one pregnancy, seven had two, and one had three), 23 (51%) resulted in term live birth (preeclampsia [PEC]: 1; and small for gestational age [SGA]: 2), eight (18%) preterm live birth (mean delivery week [w] 33.5 ± 1.7; PEC: 4; and SGA: 1), 12 (27%) (pre) embryonic loss < 10w, one (2%) fetal death > 20w, and one was ongoing at the time of data lock (Table). Term live birth occurred in 12/21 (57%) of pregnancies of patients with history of OAPS (no treatment: 1; Aspirin [ASA]: 1; low-molecular-weight-heparin [LMWH]:2; and ASA+LMWH: 8), compared to 11/24 (46%) of pregnancies of patients without history of OAPS (no treatment: 1; ASA:1; LMWH:2; and ASA+LMWH: 7). (p: 0.38). Pre-term live birth occurred in 3/21 (14%) of pregnancies of patients with history of OAPS (no treatment: 1; and ASA+LMWH: 2), compared to 5/24 (21%) of pregnancies of patients without history of OAPS (ASA+LMWH: 5) (p: 0.70). Similarly, term and preterm live birth rates were not different between patients with and without TAPS.

Conclusion: Fifty percent and 20% of pregnancies in our multi-center international aPL-positive cohort resulted in term and preterm live births, respectively. While 80% of the pregnancies were treated with low dose aspirin +/- LMWH, only 60% had had a history of pregnancy morbidity fulfilling the Updated Sapporo Classification Criteria. Term and preterm live birth rates were similar between patients with and without history of obstetric APS or thrombotic APS; no pregnancy was complicated with fetal loss between 10-20 weeks; and only one with fetal loss after 20 weeks.

Term LB

(n: 23)

Preterm LB

(n: 8)

(Pre)Emb. Loss^a

(n: 12)

Fetal Loss^b

(n:1)

History of Pregnancy

22 (96%)

6 (75%)

10 (83%)

History of Pregnancy Morbidity

– >1 Fetal Loss

– >1 Preterm Delivery

– >3^c (Pre)Embryonic Loss

– >1 (Pre) Embryonic Loss

No History of Pregnancy Morbidity

10 (45%)

4 (18%)

2 (9%)

8 (35%)

5 (23%)

1 (17%)

2 (34%)

5 (50%)

3 (30%)

5 (50%)

1 (10%)

Treatment During Pregnancy

– No ASA/LMWH

– ASA

– LMWH

– ASA + LMWH

– Hydroxychloroquine

4 (17%)

8 (38%)

2 (9%)

9 (39%)

13 (57%)

1 (13%)

6 (75%)

4 (50%)

4 (33%)

2 (17%)

6 (50%)

LB: live birth; ASA: low-dose aspirin; LMWH: low-molecular-weight-heparin; ^a: (pre)embryonic loss < 10 weeks of gestation; ^b: fetal loss > 20 weeks of gestation; ^c: consecutive

Disclosure: E. Sevim, None; D. Andrade, None; A. Banzato, None; D. W. Branch, None; R. Cervera, None; G. Ramires de Jesus, None; J. S. Knight, None; P. L. Meroni, None; M. Tektonidou, None; A. Tincani, None; A. Ugarte, None; Z. Zhuoli, None; D. Erkan, None; O. B. O. A. A. ., None.

To cite this abstract in AMA style:

Sevim E, Andrade D, Banzato A, Branch DW, Cervera R, Ramires de Jesus G, Knight JS, Meroni PL, Tektonidou M, Tincani A, Ugarte A, Zhuoli Z, Erkan D, . OBOAA. Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository Analysis: Pregnancy Outcomes Since Inception [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-clinical-database-and-repository-analysis-pregnancy-outcomes-since-inception/. Accessed .

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