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1. Low Preconception Complement Levels Are Associated with Adverse Pregnancy Outcomes in a Multicenter Study of 260 Pregnancies in 197 Women with Antiphospholipid Syndrome or Carriers of Antiphospholipid Antibodies

Author

Cecilia Nalli, Daniele Lini, Laura Andreoli, Francesca Crisafulli, Micaela Fredi, Maria Grazia Lazzaroni, Viktoria Bitsadze, Antonia Calligaro, Valentina Canti, Roberto Caporali, Francesco Carubbi, Cecilia Beatrice Chighizola, Paola Conigliaro, Fabrizio Conti, Caterina De Carolis, Teresa Del Ross, Maria Favaro, Maria Gerosa, Annamaria Iuliano, Jamilya Khizroeva, Alexander Makatsariya, Pier Luigi Meroni, Marta Mosca, Melissa Padovan, Roberto Perricone, Patrizia Rovere-Querini, Gian Domenico Sebastiani, Chiara Tani, Marta Tonello, Simona Truglia, Dina Zucchi, Franco Franceschini, and Angela Tincani

Subjects
pregnancy, complement, antiphospholipid antibodies, antiphospholipid syndrome, gestational outcome, Biology (General), QH301-705.5
Abstract

Antiphospholipid antibodies (aPL) can induce fetal loss in experimental animal models. Human studies did find hypocomplementemia associated with pregnancy complications in patients with antiphospholipid syndrome (APS), but these results are not unanimously confirmed. To investigate if the detection of low C3/C4 could be considered a risk factor for adverse pregnancy outcomes (APO) in APS and aPL carriers’ pregnancies we performed a multicenter study including 503 pregnancies from 11 Italian and 1 Russian centers. Data in women with APS and asymptomatic carriers with persistently positive aPL and preconception complement levels were available for 260 pregnancies. In pregnancies with low preconception C3/C4, a significantly higher prevalence of pregnancy losses was observed (p = 0.008). A subgroup analysis focusing on triple aPL-positive patients found that preconception low C3 and/or C4 levels were associated with an increased rate of pregnancy loss (p = 0.05). Our findings confirm that decreased complement levels before pregnancy are associated with increased risk of APO. This has been seen only in women with triple aPL positivity, indeed single or double positivity does not show this trend. Complement levels are cheap and easy to be measured therefore they could represent a useful aid to identify patients at increased risk of pregnancy loss.

Published
2021
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2. 2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19

Author

Dominique Farge, Corinne Frere, Jean M Connors, Alok A Khorana, Ajay Kakkar, Cihan Ay, Andres Muñoz, Benjamin Brenner, Pedro H Prata, Dialina Brilhante, Darko Antic, Patricia Casais, María Cecilia Guillermo Esposito, Takayuki Ikezoe, Syed A Abutalib, Luis A Meillon-García, Henri Bounameaux, Ingrid Pabinger, James Douketis, Walter Ageno, Fernando Ajauro, Thierry Alcindor, Pantep Angchaisuksiri, Juan I. Arcelus, Raquel Barba, Ali Bazarbachii, Audrey Bellesoeur, Okba Bensaoula, Ilham Benzidia, Darius Bita, Viktoria Bitsadze, Dorit Blickstein, Mark Blostein, Isabel Bogalho, Antonio Brandao, Rodrigo Calado, Antoine Carpentier, Jose Manuel Ceresetto, Rufaro Chitsike, Jérôme Connault, Catarina Jacinto Correia, Benjamin Crichi, Erich V. De Paula, Ahmet M. Demir, Laure Deville, Ludovic Doucet, Vera Dounaevskaia, Cécile Durant, Martin Ellis, Joseph Emmerich, Anna Falanga, Carme Font, Enrique Gallardo, Thomas Gary, Filipe Gonçalves, Jean-Christophe Gris, Hiromi Hayashi, Adrian Hij, Luis Jara-Palomares, David Jiménez, Jamilya Khizroeva, Michel N'Guessan, Florian Langer, Claire Le Hello, Christine Le Maignan, Ramón Lecumberri, Lai Heng Lee, Zachary Liederman, Luisa Lopes dos Santos, Duarte Henrique Machado, Alexander Makatsariya, Alberto Maneyro, Zora Marjanovic, Serban Milhaileanu, Manuel Monreal, Sara Morais, Antonio Moreira, Mikio Mukai, Arlette Ndour, Luciana Correa Oliveira, Remedios Otero-Candelara, Maria Carolina Tostes Pintao, Florian Posch, Pascal Prilollet, Hanadi Rafii, Daniel Dias Ribeiro, Hanno Riess, Marc Righini, Helia Robert-Ebadi, Cynthia Rothschild, Andre Roussin, José Antonio Rueda Camino, Pedro Ruiz-Artacho, Gleb Saharov, Joana Santos, Maxime Sebuhyan, Ali Shamseddine, Galia Spectre Spectre, Ali Taher, Javier Trujillo-Santos, Inna Tzoran, Stéphane Villiers, Raymond Wong, Yugo Yamashita, Alexandra Yannoutsos, and Chikao Yasuda

Subjects
Oncology, Neoplasms, Practice Guidelines as Topic, Anticoagulants, COVID-19, Humans, Hemorrhage, Thrombosis, Venous Thromboembolism, Heparin, Low-Molecular-Weight
Abstract

The International Initiative on Thrombosis and Cancer is an independent academic working group of experts aimed at establishing global consensus for the treatment and prophylaxis of cancer-associated thrombosis. The 2013, 2016, and 2019 International Initiative on Thrombosis and Cancer clinical practice guidelines have been made available through a free, web-based mobile phone application. The 2022 clinical practice guidelines, which are based on a literature review up to Jan 1, 2022, include guidance for patients with cancer and with COVID-19. Key recommendations (grade 1A or 1B) include: (1) low-molecular-weight heparins (LMWHs) for the initial (first 10 days) treatment and maintenance treatment of cancer-associated thrombosis; (2) direct oral anticoagulants for the initial treatment and maintenance treatment of cancer-associated thrombosis in patients who are not at high risk of gastrointestinal or genitourinary bleeding, in the absence of strong drug-drug interactions or of gastrointestinal absorption impairment; (3) LMWHs or direct oral anticoagulants for a minimum of 6 months to treat cancer-associated thrombosis; (4) extended prophylaxis (4 weeks) with LMWHs to prevent postoperative venous thromboembolism after major abdominopelvic surgery in patients not at high risk of bleeding; and (5) primary prophylaxis of venous thromboembolism with LMWHs or direct oral anticoagulants (rivaroxaban or apixaban) in ambulatory patients with locally advanced or metastatic pancreatic cancer who are treated with anticancer therapy and have a low risk of bleeding.

Published
2022

3. Early ADAMTS13 testing associates with pre-eclampsia occurrence in antiphospholipid syndrome

Author

Jamilya Khizroeva, Viktoria Bitsadze, Antonia Perez-Martin, Jean-Christophe Gris, Eric Mercier, Eva Cochery-Nouvellon, Alexander Makatsariya, and Sylvie Bouvier

Subjects
medicine.medical_specialty, Placenta, ADAMTS13 Protein, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Antigen, Pre-Eclampsia, Antiphospholipid syndrome, Pregnancy, hemic and lymphatic diseases, Medicine, Humans, Child, Retrospective Studies, Aspirin, Eclampsia, biology, business.industry, Obstetrics, Pregnancy Outcome, Hematology, medicine.disease, Antiphospholipid Syndrome, ADAMTS13, Pregnancy Complications, medicine.anatomical_structure, 030220 oncology & carcinogenesis, biology.protein, Female, Antibody, business, medicine.drug
Abstract

Women with obstetric antiphospholipid syndrome (oAPS) still develop placental diseases, mainly pre-eclampsia (PEcl), which diagnosis is associated with reduced ADAMTS13 levels. Testing ADAMTS13 in newly pregnant oAPS may provide evidence for risk stratification.We retrospectively investigated the prognostic value of ADAMTS13 activity, antigen and antibodies on stored plasma samples obtained prior to beginning low-molecular weight heparin-low dose aspirin treatment in 513 oAPS women.Some women had evidences of early positive ADAMTS13 antibodies and low ADAMTS13 activity:antigen ratio, suggestive of ADAMTS13 dysfunction. Women with a subsequent PEcl had higher ADAMTS13 antibodies (p 0.0001), and lower ADAMTS13 activity and activity:antigen ratios (p 0.0001). In multivariate analysis, these markers were significant risk factors for PEcl and for the most devastating PEcl subgroups (early-onset PEcl, severe PEcl, PEcl with no living child after 28 days). ADAMTS13-related markers showed acceptable discrimination power to predict clinical events, particularly for ADAMTS13 activity:antigen ratio in predicting PEcl cases with no living child after 28 days (AUC: 0.844 (0.712-0.974), p 0.0001), with excellent negative predictive value (0.990).The characterization of ADAMTS13 in newly pregnant women with oAPS depicts the risk of PEcl occurrence. ADAMTS13 might help identify pregnant women with oAPS not requiring escalating treatment strategies to prevent PEcl.

Published
2021

4. Low Preconception Complement Levels Are Associated with Adverse Pregnancy Outcomes in a Multicenter Study of 260 Pregnancies in 197 Women with Antiphospholipid Syndrome or Carriers of Antiphospholipid Antibodies

Author

Jamilya Khizroeva, Chiara Tani, Simona Truglia, Cecilia Beatrice Chighizola, Pier Luigi Meroni, Franco Franceschini, Roberto Caporali, Daniele Lini, Antonia Calligaro, Francesco Carubbi, Alexander Makatsariya, Francesca Crisafulli, Marta Mosca, Gian Domenico Sebastiani, Patrizia Rovere-Querini, Caterina De Carolis, Angela Tincani, Viktoria Bitsadze, Marta Tonello, Fabrizio Conti, Dina Zucchi, Maria Grazia Lazzaroni, Valentina Canti, Maria Favaro, Teresa Del Ross, Laura Andreoli, Annamaria Iuliano, Cecilia Nalli, Paola Conigliaro, Roberto Perricone, Micaela Fredi, Maria Gerosa, Melissa Padovan, Nalli, C., Lini, D., Andreoli, L., Crisafulli, F., Fredi, M., Lazzaroni, M. G., Bitsadze, V., Calligaro, A., Canti, V., Caporali, R., Carubbi, F., Chighizola, C. B., Conigliaro, P., Conti, F., De Carolis, C., Del Ross, T., Favaro, M., Gerosa, M., Iuliano, A., Khizroeva, J., Makatsariya, A., Meroni, P. L., Mosca, M., Padovan, M., Perricone, R., Rovere-Querini, P., Sebastiani, G. D., Tani, C., Tonello, M., Truglia, S., Zucchi, D., Franceschini, F., and Tincani, A.

Subjects
0301 basic medicine, medicine.medical_specialty, QH301-705.5, Complement, Medicine (miscellaneous), Subgroup analysis, Gestational outcome, Article, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, Antiphospholipid syndrome, immune system diseases, medicine, complement, antiphospholipid antibodies, antiphospholipid syndrome, gestational outcome, pregnancy, Biology (General), Risk factor, Pregnancy outcomes, 030203 arthritis & rheumatology, biology, Obstetrics, business.industry, Antiphospholipid antibodies, medicine.disease, 030104 developmental biology, Multicenter study, biology.protein, Antibody, business, Asymptomatic carrier
Abstract

Antiphospholipid antibodies (aPL) can induce fetal loss in experimental animal models. Human studies did find hypocomplementemia associated with pregnancy complications in patients with antiphospholipid syndrome (APS), but these results are not unanimously confirmed. To investigate if the detection of low C3/C4 could be considered a risk factor for adverse pregnancy outcomes (APO) in APS and aPL carriers’ pregnancies we performed a multicenter study including 503 pregnancies from 11 Italian and 1 Russian centers. Data in women with APS and asymptomatic carriers with persistently positive aPL and preconception complement levels were available for 260 pregnancies. In pregnancies with low preconception C3/C4, a significantly higher prevalence of pregnancy losses was observed (p = 0.008). A subgroup analysis focusing on triple aPL-positive patients found that preconception low C3 and/or C4 levels were associated with an increased rate of pregnancy loss (p = 0.05). Our findings confirm that decreased complement levels before pregnancy are associated with increased risk of APO. This has been seen only in women with triple aPL positivity, indeed single or double positivity does not show this trend. Complement levels are cheap and easy to be measured therefore they could represent a useful aid to identify patients at increased risk of pregnancy loss.

Published
2021

5. 'APS pregnancy – The offspring'

Author

Jamilya Khizroeva, Elisa Fazzi, Laura Andreoli, Alexander Makatsariya, Andrea Lojacono, Yehuda Shoenfeld, Cecilia Nalli, Daniele Lini, Angela Tincani, and Viktoria Bitsadze

Subjects
Male, medicine.medical_specialty, Offspring, neonatal thrombosis, 030204 cardiovascular system & hematology, 03 medical and health sciences, Child Development, 0302 clinical medicine, Rheumatology, Pregnancy, Risk Factors, Antiphospholipid syndrome, children outcome, Humans, Medicine, Neonatal thrombosis, 030203 arthritis & rheumatology, Autoimmune disease, biology, business.industry, Obstetrics, Infant, Newborn, Thrombosis, medicine.disease, Pregnancy Complications, Childbearing age, Antibodies, Antiphospholipid, biology.protein, Female, Nervous System Diseases, Antibody, business
Abstract

BackgroundAntiphospholipid antibody syndrome (APS) is an autoimmune disease that affects women in childbearing age. In recent years, great improvements were achieved in the management of pregnancies in these women. Prematurity could be an issue in these pregnancies, mainly due to the direct pathogenic effect of antiphospholipid antibodies (aPL) on the placental surface. Maternal IgG aPL can cross the placenta and theoretically interact with the growing fetus; it could reach the fetal brain because of the incompleteness of the fetal blood-brain barrier: whether this can have an effect on brain development is still debated. Neonatal thrombosis episodes have been described in children positive for aPL, not always associated with maternal antibody positivity, suggesting the hypothesis of a possible aPL de novo synthesis in fetus and neonates.MethodsA keyword-based literature search was conducted. We also described a case of neonatal catastrophic antiphospholipid syndrome (CAPS).ResultsOffspring of patients with APS are generally healthy but the occurrence of neonatal thrombosis or minor neurological disorders were reported.ConclusionsThe limited number of the available data on this sensitive issue supports the need for further studies. Clinical follow-up of children of mothers with APS seems to be important to exclude, in the neonatal period, the occurrence of aPL associated pathological events such as thrombosis, and in the long-term, impairment in learning skills or behavioral problems.

Published
2020

6. 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer

Author

Ali Shamseddine, Juan I. Arcelus, Isabel Bogalho, Jérôme Connault, Hans Stricker, Maral Koolian, Ali Bazarbachii, Susan Solymoss, Andre Roussin, Thierry André, Gerald A. Soff, Stéphane Villiers, Enrique Gallardo, Ingrid Pabinger, Michel Nguessan, Marc Philip Righini, Hanno Riess, Joseph Emmerich, Pantep Angchaisuksiri, Dorit Blickstein, Ajay K. Kakkar, Dialina Brilhante, Pedro Ruiz-Artacho, Kenneth A. Bauer, Hugo A. Clemente, Emmanuel Messas, Walter Ageno, Anthony Marayevas, Anna Falanga, Vanessa Pachon Olmos, José Antonio Rueda-Camino, Sanjith Saseedharan, Javier Trujillo-Santos, Alexander Makatsariya, Arlette Ndour, Toutou Toussaint, Vicky Tagalakis, Hanadi Rafii, Raymond S.M. Wong, Fernando Ajauro, Antonio Moreira, Henri Bounameaux, Russel D. Hull, Ellis Martin, Florian Posch, Isabelle Madelaine, Joydeep Chakbrabartty, Mark Blostein, Kamal R. Al-Aboudi, Patricia Casais, Thierry Alcindor, Mario Mandalà, Corinne Frere, Lai Heng Lee, Eric Assenat, Ahmet M. Demir, Christine Marosi, Carme Font, Cecilia Guillermo, Luis Meillon, Viktoria Bitsadze, Ana Pais, Luisa Lopes Dos Santos, Ludovic Doucet, Thomas Gary, Andrés Muñoz, Ali T. Taher, Luis Jara-Palomares, Norizaku Yamada, Takayuki Ikezoe, Matthias Preusser, Cécile Durant, Jamilya Khrizroeva, Zora Marjanovic, Barbara Bournet, James D. Douketis, Clemens Feistritzer, Remedios Otero-Candelera, Alok A. Khorana, Jean-Christophe Gris, I. Benzidia, Nigel S. Key, A. Hij, Ramón Lecumberri, Cynthia Rothschild, Duarte Henrique Machado, Manuel Monreal, Jan Beyer-Westendorf, Jean M. Connors, Florian Langer, Darko Antic, Gabriela Cesarman-Maus, Dominique Farge, Benjamin Brenner, Antoine F. Carpentier, Charles W. Francis, Howard A. Liebman, Cihan Ay, Service de Médecine Interne [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), McGill University = Université McGill [Montréal, Canada], Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), Medizinische Universität Wien = Medical University of Vienna, Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), University College of London [London] (UCL), Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, McMaster University [Hamilton, Ontario], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), McGill University, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [APHP]-Sorbonne Université (SU), Service d'Hématologie Clinique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Medical University of Vienna, Universidad Complutense de Madrid [Madrid] (UCM), and Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)

Subjects
medicine.medical_specialty, Vitamin K, Vena Cava Filters, [SDV]Life Sciences [q-bio], education, MEDLINE, 030204 cardiovascular system & hematology, Anticoagulants/administration & dosage/therapeutic use, Venous Thromboembolism/drug therapy/etiology/prevention & control, 03 medical and health sciences, 0302 clinical medicine, Neoplasms, Neoplasms/complications/surgery, Central Venous Catheters, Humans, Medicine, In patient, Vitamin K/antagonists & inhibitors, Factor Xa Inhibitors/therapeutic use, Intensive care medicine, Grading (tumors), Heparin, Low-Molecular-Weight/administration & dosage/therapeutic use, Cause of death, ddc:616, Central Venous Catheters/adverse effects, business.industry, Anticoagulants, Venous Thromboembolism, Heparin, Low-Molecular-Weight, medicine.disease, Thrombosis, 3. Good health, Clinical trial, Clinical Practice, Fondaparinux, Oncology, Fondaparinux/therapeutic use, 030220 oncology & carcinogenesis, business, Venous thromboembolism, Factor Xa Inhibitors
Abstract

International audience; Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. These patients are at a high risk of VTE recurrence and bleeding during anticoagulant therapy. The International Initiative on Thrombosis and Cancer is an independent academic working group aimed at establishing a global consensus for the treatment and prophylaxis of VTE in patients with cancer. The International Initiative on Thrombosis and Cancer last updated its evidence-based clinical practice guidelines in 2016 with a free, web-based mobile phone application, which was subsequently endorsed by the International Society on Thrombosis and Haemostasis. The 2019 International Initiative on Thrombosis and Cancer clinical practice guidelines, which are based on a systematic review of the literature published up to December, 2018, are presented along with a Grading of Recommendations Assessment Development and Evaluation scale methods, with the support of the French National Cancer Institute. These guidelines were reviewed by an expanded international advisory committee and endorsed by the International Society on Thrombosis and Haemostasis. Results from head-to-head clinical trials that compared direct oral anticoagulant with low-molecular-weight heparin are also summarised, along with new evidence for the treatment and prophylaxis of VTE in patients with cancer.

Published
2019
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7. POS0737 LOW PRECONCEPTIONAL COMPLEMENT LEVEL IS RELATED WITH ADVERSE OBSTETRIC OUTCOME IN A MULTICENTRIC COHORT OF PREGNANCY IN PATIENTS WITH APS AND APL POSITIVITY

Author

Angela Tincani, Viktoria Bitsadze, Marta Tonello, P. Melissa, M. G. Lazzaroni, Roberto Caporali, Laura Andreoli, Cecilia Beatrice Chighizola, Jamilya Khizroeva, Valentina Canti, Paola Conigliaro, Roberto Perricone, Gd Sebastiani, Simona Truglia, Francesca Crisafulli, Pl Meroni, Cecilia Nalli, Francesco Carubbi, Franco Franceschini, Chiara Tani, Annamaria Iuliano, Maria Favaro, Antonia Calligaro, Dina Zucchi, Patrizia Rovere-Querini, Alexander Makatsariya, M. Fredi, Maria Gerosa, Marta Mosca, T. Del Ross, Fabrizio Conti, C. De Carolis, and Daniele Lini

Subjects
medicine.medical_specialty, Pregnancy, business.industry, Immunology, medicine.disease, General Biochemistry, Genetics and Molecular Biology, Complement (complexity), Rheumatology, Internal medicine, Cohort, medicine, Immunology and Allergy, In patient, business
Abstract

Background:The role of complement in the antiphospholipid (aPL) related pathology has been widely studied in animal models. Antiphospholipid antibodies can induce fetal loss in experimental animals but mice deficient in specific complement components (C4, C3, C5) appear somehow protected. In addition, in pregnant mice injected with aPL, antibody deposition has been found at decidual level causing focal necrosis, apoptosis and neutrophil infiltrates and supporting aPL pathogenetic potential. On the other hand, human studies did find hypocomplementemia associated to pregnancy complications in patients with obstetric antiphospholipid syndrome (APS). These results, however, are not unanimously confirmed and, in addition, some studies only show increased levels of complement activation products (i.e. Bb) and not decreased levels of C3 and/or C4. A recently study focusing on complement level in early pregnancy and before pregnancy showed a significant correlation with pregnancy complications and loss in a large cohort of primary APS.Objectives:To investigate if the simple detection of low C3 and/or C4 could be considered a risk factor for adverse pregnancy outcome in APS and aPL carriers pregnancies.Methods:We performed a multicentric study including patients from 10 Italian and 1 Russian Centers. Data on pregnancies in women with primary APS (n=434) and asymptomatic carriers with persistently positive aPL but not fulfilling clinical criteria for APS (n=218) were retrospectively collected. Serum C3 and C4 levels were evaluated by nephelometry; hypocomplementemia was defined by local laboratory reference values. Statistical analysis was performed using GraphPad.Results:Preconceptional complement levels and gestational outcome were available for 107 (25%) pregnancies in APS out of 434 and for 196 (90%) pregnancies in aPL carriers women out of 218. In pregnancies with low preconceptional C3 and/or C4, a significantly higher prevalence of pregnancy losses was observed (p=0.019). A subgroup analysis focusing on triple aPL positive patients was also performed. Preconceptional low C3 and/or C4 levels were found to be associated with an increased rate of pregnancy loss (p = 0.027) in this subgroup also. Otherwise, adverse pregnancy outcomes in single or double aPL positive women were not related to preconception complement levels (p = 0.44) (Table 1). Of note, all the pregnancy losses in the triple positive group occurred in patients treated with low dose aspirin and low molecular weight heparin from the time of positive pregnancy test.Conclusion:Our findings confirm that decreased complement levels before pregnancy are associated with increased risk of adverse outcome. This has been seen only in in women with triple aPL positivity, indeed single or double positivity does not show this trend. Complement levels are cheap and easy to be measured therefore they could represent a useful aid to identify patients at increased risk of pregnancy loss. test positivity.References:[1]De Carolis S, et al. Complementemia and obstetric outcome in pregnancy with antiphospholipid syndrome. Lupus (2012) 21:776–8.[2]Kim MY, et al. Complement activation predicts adverse pregnancy outcome in patients with systemic lupus erythematosus and/or antiphospholipid antibodies. Ann Rheum Dis (2018) 77:549–55.[3]Fredi M, et al. Risk Factors for Adverse Maternal and Fetal Outcomes in Women With Confirmed aPL Positivity: Results From a Multicenter Study of 283 Pregnancies. Front Immunol. 2018 May 7;9:864.Triple aPL positivitySingle or double aPL positivityGestational outcomeLow C3/C4 (n=49)Normal C3/C4(n=17)pLow C3/C4 (n=57)Normal C3/C4(n=165)pTerm live birth (>37w)15 (31%)6 (35%)ns34 (60%)110 (67%)nsPreterm live birth (≤37w)22 (45%)11 (65%)ns15 (26%)38 (23%)nsPregnancy losses (abortion and miscarriages)12 (24%)0 (0%)0.0278 (14%) 17 (10%)nsDisclosure of Interests:None declared

Published
2021
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8. FRI0154 SHOULD BE OLDER PATIENTS TESTED FOR ANTIPHOSPHOLIPID ANTIBODIES? 695 CASES FROM THE RETROSPECTIVE SERIES HIBISCUS

Author

Cristina Belizna, Laura Andreoli, S. Udry, Jamilya Khizroeva, Alexander Makatsariya, Raquel Ferrer-Oliveras, Viktoria Bitsadze, Omar Latino, Enrique Esteve-Valverde, Patrick Saulnier, Francesca Pregnolato, Marteen Limper, Ljudmila Stojanovich, Angela Tincani, N. Stanisavljevic, Francesca Regola, Cecilia Beatrice Chighizola, Pl Meroni, A. Djokovic, Jaume Alijotas-Reig, Maria Orietta Borghi, and Katrien Devreese

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Immunology, Cardiovascular risk factors, Hydroxychloroquine, Clinical manifestation, medicine.disease, General Biochemistry, Genetics and Molecular Biology, Rheumatology, Older patients, Antiphospholipid syndrome, Recurrent stroke, Immunology and Allergy, Medicine, Anticardiolipin antibodies, business, Stroke, medicine.drug
Abstract

Background:Although guidelines do not recommend antiphospholipid antibodies testing after 60 yo, recent data reported late onset antiphospholipid syndrome (APS).Objectives:To comparatively analyse the clinical, laboratory features and outcomes in 695 cases with primary APS between patients older and younger than 70 yo.Methods:we have performed an international study within the framework of the International Registry of primary APS patients treated with Hydroxychloroquine, HIBISCUS (an ongoing retrospective and prospective register launched in 2016). 28 centres from 17 countries participate. Data about late onset APS were analysed in 695 patients and were obtained from a standardized form registered in the database containing 66 items with respect to demographics, clinical and biological features.Results:Arterial events and especially stroke represented the main initial and recurrent clinical manifestation in 40 primary APS patients older than 70 yo. There were not statistically significant differences with respect to cardiovascular risk factors between the two groups of patients. A significant male predominance, a familial APS history, a higher prevalence of triple positivity, lower complement levels, and anticardiolipin antibodies (aCL) IgA isotype were found in older patients. Low anticoagulation regimens were safe and efficient, with a low relapse rate in older patients.Conclusion:we suggest that the detection of aPL antibodies should be included into the initial screening panel tests in elderly with thrombotic events, especially arterial, in particular those with recurrent stroke and familial APS.Our study further suggests that lower intensity anticoagulation regimens could be a therapeutic option in older APS patients, as no differences in outcomes and relapse rate were found between patients with high and low intensity anticoagulation regimens.References:[1]Grimaud F et al. Rheumatology. 2019;58:1006-10.[2]Goldman-Mazur S et al. Thromb Res. 2019;176:67-73.[3]Hirmerova J et al. 2017;36:167-73.Disclosure of Interests:Cristina Belizna: None declared, Omar Latino: None declared, Ljudmila Stojanovich: None declared, Patrick Saulnier: None declared, Katrien Devreese: None declared, Sebastien Udry: None declared, Natasa Stanisavljevic: None declared, Aleksandra Djokovic Speakers bureau: KRKA, Astra Zeneca, Actavis, Jaume Alijotas-Reig: None declared, Enrique Esteve-Valverde: None declared, Raquel Ferrer-Oliveras: None declared, Angela Tincani: None declared, Laura Andreoli: None declared, Francesca Regola: None declared, Maarten Limper: None declared, Alexander Makatsariya: None declared, Jamilya Khizroeva: None declared, Viktoria Bitsadze: None declared, Cecilia Chighizola: None declared, Francesca Pregnolato: None declared, Maria Orietta Borghi: None declared, Pier Luigi Meroni: None declared

Published
2020
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9. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome

Author

Patrick Blanco, Maarten Limper, Jamilya Khizroeva, Pier Luigi Meroni, Olivier Lambotte, Nadine Magy-Bertrand, Loic Sentilhes, Raquel Ferrer-Oliveras, Pieter Van Paasen, Jan Willem Cohen Tervaert, Marie Noelle Ungeheuer, Enrique Esteve-Valverde, Katrien Devreese, Ricard Cervera, Laura Andreoli, A. Djokovic, Emmanuel Andrès, Antonia Caligaro, Jean Sibilia, Daniel Henrion, Angela Tincani, Guillaume Mahé, Jose Omar Latino, N. Stanisavljevic, Sebastián Udry, Patrick Saulnier, Ljudmila Stojanovich, Şule Apraş Bilgen, Bernard Imbert, Cédric Landron, Damien Sène, Karina de Leeuw, Céline Fassot, Fatma Said, Boris Bienvenu, Laura Damian, Florence Perrinet, Jaume Alijotas-Reig, Francesca Pregnolato, Alban Godon, Estibaliz Lazaro, Thierry Martin, Viktoria Bitsadze, Laurent Arnaud, Laurent Loufrani, Gilles Pernod, Alexander Makatsariya, Gilberto Pires da Rosa, Noémie Jourde-Chiche, Pierre Yves Jeandel, Elisabeta Candrea, Maria Orietta Borghi, Milena Hasan, Jean Marie Chretien, Crina Sinescu, Cristina Belizna, Mathilde Versini, Pascale Jeannin, Thomas Le Gallou, Fréderic Tollis, Marc Antoine Pistorius, Loukman Omarjee, Valentina Canti, Mohamed Hamidou, Achile Aouba, György Nagy, Ova Shovman, Sébastien Abad, Levent Kilic, Teresa Delross, Howard Amital, Lai-Shan Tam, Zahir Amoura, Christian Muchardt, Amelia Ruffatti, Laurent Chiche, Patrick Jego, Emmanuelle Dernis, Maria Favaro, Miri Blank, Romain Lubin, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Biologie Neurovasculaire et Mitochondriale Intégrée (BNMI), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Université Paris 13 (UP13), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Vall d'Hebron University Hospital [Barcelona], Sackler Faculty of Medicine, Tel Aviv University (TAU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Brescia, CHU Strasbourg, Université de Caen Normandie (UNICAEN), Normandie Université (NU), Hacettepe University = Hacettepe Üniversitesi, Hôpital Saint-Joseph [Marseille], Department of Obstetrics and Gynecology, I.M. Sechenow First Moscow State Medical University, Moscow, Russia., Immunology from Concept and Experiments to Translation (ImmunoConcept), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Università degli Studi di Padova = University of Padua (Unipd), University of Medicine and Pharmacy, Luliu-Hatieganu, Hôpital Européen [Fondation Ambroise Paré - Marseille], Maastricht University [Maastricht], University of Alberta, Universitatea Babeş-Bolyai [Cluj-Napoca], Centre Hospitalier du Mans, Ghent University Hospital, University of Belgrade [Belgrade], Althaia Healthcare Network of Manresa, Barcelona, MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Cardiovascular Functions In Vitro (CARFI), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche Translationnelle - Center for Translational Science (CRT), Institut Pasteur [Paris] (IP), CHU Grenoble, Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA), Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Pontchaillou [Rennes], Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Obstetrics and Gynecology, I.M. Sechenow First Moscow State Medical University, Moscow, Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hospital Carlos G. Durand, Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], University Medical Center Groningen [Groningen] (UMCG), University Medical Center [Utrecht], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cellules Souches et Développement / Stem Cells and Development, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Semmelweis University [Budapest], Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Hospital de São João [Porto], Hôpital La Rabta [Tunis], Hôpital Lariboisière, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Université de Médecine Carol Davila, The Chinese University of Hong Kong [Hong Kong], Diaverum Dialysis Center, Angers, Investigation Clinique et d’Accès aux Ressources Biologiques (Plate-forme) - Clinical Investigation and Access to BioResources (ICAReB), Institut Arnault Tzanck, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), The HIBISCUS study is funded for its French part of the trial by the Ministery of Health, France in 2015 (PHRC N PAPIRUS)., The investigators are very grateful to Professor Y Shoenfeld for the scientific revision of the design and very valuable remarks. The investigators are also grateful to the patients, patients' association, collaborators and networks involved in the trial and to the research staff at all participating hospitals., Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université d'Angers (UA), Hôpital avicenne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris 13 (UP13)-Hôpital Avicenne, Tel Aviv University [Tel Aviv], Service de médecine interne [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Universita degli Studi di Padova, Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Centre de Recherche Translationnelle (CRT), Institut Pasteur [Paris], Université Nice Sophia Antipolis (... - 2019) (UNS), Université Côte d'Azur (UCA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Centre recherche en CardioVasculaire et Nutrition (C2VN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Hôpital Jean Minjoz, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cellules Souches et Développement, Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS), Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre National de la Recherche Scientifique (CNRS)-Université de Bordeaux (UB), Université Paris Diderot - Paris 7 (UPD7)-Hôpital Lariboisière-Fernand-Widal [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
ANTICOAGULANT, Pediatrics, Additional Therapy, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, RECOMMENDATIONS, COMPLEMENT, 0302 clinical medicine, Pregnancy, An international multicenter trial on Hydroxychloroquine for the secondary prevention of relapses in primary antiphospholipid syndrome is launched, Antiphospholipid syndrome, Immunology and Allergy, PREGNANT PATIENTS, SYSTEMIC-LUPUS-ERYTHEMATOSUS, Secondary prevention, Anticoagulant, Pregnancy Outcome, Take home messages, WOMEN, 3. Good health, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, medicine.drug, Hydroxychloroquine, Primary antiphospholipid syndrome, medicine.medical_specialty, medicine.drug_class, Immunology, Relapse rate, Relapse rate in antiphospholipid syndrome (APS) is high despite standard current therapies, 53 centers from 16 countries participate to this international trial, Orphan drug, 03 medical and health sciences, Survival rate in this population is 90.1% at 10 years and 65% at 15 years, There is a need for additional or alternative therapies in this disease, hydroxychloroquine, primary antiphospholipid syndrome, secondary prevention, medicine, MANAGEMENT, Humans, DRUGS, 030203 arthritis & rheumatology, business.industry, Thrombosis, Delivery, Obstetric, medicine.disease, ANTIBODIES, RISK-FACTORS, business
Abstract

International audience; The relapse rate in antiphospholipid syndrome (APS) remains high, i.e. around 20%–21% at 5 years in thrombotic APS and 20–28% in obstetrical APS [2, 3].Hydroxychloroquine (HCQ) appears as an additional therapy, as it possesses immunomodulatory and anti-thrombotic various effects [4–16].Our group recently obtained the orphan designation of HCQ in antiphospholipid syndrome by the European Medicine Agency.Furthermore, the leaders of the project made the proposal of an international project, HIBISCUS, about the use of Hydroxychloroquine in secondary prevention of obstetrical and thrombotic events in primary APS. This study has been launched in several countries and at now, 53 centers from 16 countries participate to this international trial.This trial consists in two parts: a retrospective and a prospective study.The French part of the trial in thrombosis has been granted by the French Minister of Health in December 2015 (the academic trial independent of the pharmaceutical industry PHRC N PAPIRUS) and is coordinated by one of the members of the leading consortium of HIBISCUS.

Published
2018
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