Antiphospholipid Antibody Profile Stability over Time: Prospective Results from AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository ("Registry")

Elena Gkrouzman¹, Ecem Sevim ², Jackie Finik ³, Danieli Andrade ⁴, Vittorio Pengo ⁵, Savino Sciascia ⁶, Maria Tektonidou ⁷, Amaia Ugarte ⁸, Cecilia Chighizola ⁹, H Michael Belmont ¹⁰, Laura Pérez Sánchez ¹¹, Lanlan Ji ¹², Paul Fortin ¹³, Maria Efthymiou ¹⁴, Guilherme De Jesus ¹⁵, David Branch ¹⁶, Cecilia Nalli ¹⁷, Michelle Petri ¹⁸, Ricard Cervera ¹⁹, Esther Rodriguez ²⁰, Jason Knight ²¹, Tatsuya Atsumi ²², Rohan Willis ²³, Maria Laura Bertolaccini ²⁴, Hannah Cohen ¹⁴, Jacob Rand ²⁵, Doruk Erkan ¹ and On Behalf Of APS ACTION ²⁶, ¹Hospital for Special Surgery, New York City, ²Hospital for Special Surgery, New York, NY, ³Hospital for Special Surgery, New York, NY, New York, NY, ⁴Hospital das Clinicas, Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil, ⁵Azienda Ospedaliera of Padova, University of Padova, Padova, Italy, ⁶Center of Research of Immunopathology and Rare Diseases- Coordinating Center of Piemonte and Valle d’Aosta Network for Rare Diseases, Department of Clinical and Biological Sciences, University of Turin, Torino, Italy, ⁷First Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece, Athens, Greece, ⁸Hospital Universitario Cruces, University of the Basque Country Autoimmune Diseases Research Unit, Department of Internal M edicine, BioCruces Health, Biscay, Spain, ⁹Rheumatology, Istituto Auxologico Italiano, University of Milan, Milan, Italy, ¹⁰NYU Langone Health, New York, NY, ¹¹IMIBIC/Reina Sofia Hospital/University of Cordoba, Cordoba, Spain, ¹²Peking University First Hospital, Beijing, China (People's Republic), ¹³Division de Rhumatologie, Département de Médecine, CHU de Québec – Université Laval, Axe maladies infectieuses et inflammatoires, Centre de recherche du CHU de Québec – Université Laval, Canada, Quebec, QC, Canada, ¹⁴University College London, London, United Kingdom, ¹⁵Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, ¹⁶University of Utah Health Sciences Center, Salt Lake City, UT, ¹⁷Rheumatology and Clinical Immunology, Spedali Civili, Brescia, Italy, Brescia, Italy, ¹⁸Johns Hopkins University School of Medicine, Baltimore, MD, ¹⁹Hospital Clinic of Barcelona, Barcelona, Spain, ²⁰Hospital Universitario 12 de Octubre, Madrid, Spain, ²¹Division of Rheumatology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, MI, ²²Hokkaido University, Sapporo, Japan, ²³Antiphospholipid Standardization Laboratory, University of Texas Medical Branch, Galveston, TX, ²⁴King's College London, London, United Kingdom, ²⁵Weill Cornell Medicine, New York, ²⁶APS ACTION, New York, NY

Meeting: ACR/ARP Annual Meeting 2019

Keywords: Antiphospholipid antibodies, antiphospholipid syndrome and SLE

Session Information

Date: Monday, November 11, 2019

Title: 4M087: Antiphospholipid Syndrome (1788–1793)

Session Type: ACR Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: APS ACTION “Registry” was created to study long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients with and without other systemic autoimmune diseases. Our primary objective was to determine whether clinically significant aPL profiles at baseline remain stable over time.

Methods: A web-based data capture system is used to store patient demographics and aPL-related medical history. Inclusion criteria are positive aPL, based on 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 prospective analysis of available follow-up (f/u) aPL tests, clinically significant aPL profile was defined as positive lupus anticoagulant (LA) test and/or aCL/aβ₂GPI IgG/M >40U. Stable aPL profile was defined as a clinically significant aPL profile in at least two-thirds of f/u measurements. Univariate and multivariable generalized linear mixed models with logit link were used to assess the effect of time and other variables of interest on odds of clinically significant aPL profile. Wilcoxon rank-sum and Fisher’s exact tests were employed to compare clinical characteristics of patients with stable versus unstable aPL profiles.

Results: As of January 2019, 796 patients were enrolled from 26 centers worldwide, 482 had f/u visits with aPL results, and 472 patients had a clinically significant aPL profile at baseline. Based on aPL profiles at f/u visits (median follow up: 5.1 years [interquartile range [IR]: 4.3, 5.8]; median number of f/u visits with aPL profiles: 2 [interquartile range: 1, 3]), 366/472 (78%) patients had stable aPL profiles over time (54 [11%] unstable; 52 [11%] inconclusive). Time did not affect odds of maintaining a clinically significant aPL profile at f/u (p=0.906). In multivariable analysis, time, age, concomitant systemic autoimmune disease (mainly lupus), smoking history, and hydroxychloroquine use did not affect odds of maintaining a clinically significant aPL profile at f/u. Based on crude unadjusted comparisons, patients with stable aPL profiles, compared to those with unstable profiles, were more likely to have baseline positive LA test, aCL IgM > 40U (positive trend for IgG), aβ₂GPI IgG > 40U (positive trend for IgM), two or more positive aPL tests, and history of arterial events and aspirin use (Table).

Conclusion: In approximately 80% of patients with a baseline clinically significant aPL profile (LA test and/or aCL/aβ₂GPI IgG/M >40U), aPL profiles remain consistently significant (stable) during five years of follow-up. Further multivariate analysis will investigate predictors of aPL profile stability over time, and guide future validation studies of stored samples through APS ACTION core laboratories.

GkrouzmanE_Table

Disclosure: E. Gkrouzman, None; E. Sevim, None; J. Finik, None; D. Andrade, None; V. Pengo, None; S. Sciascia, None; M. Tektonidou, None; A. Ugarte, None; C. Chighizola, None; H. Belmont, None; L. Pérez Sánchez, None; L. Ji, None; P. Fortin, None; M. Efthymiou, None; G. De Jesus, None; D. Branch, None; C. Nalli, None; M. Petri, Eli Lilly and Company, 5, Exagen, 2, 5; R. Cervera, None; E. Rodriguez, None; J. Knight, None; T. Atsumi, AbbVie, 5, 8, Abbvie, 5, 8, Asahi Kasei Pharma Corporation, 8, Astellas Pharma, 8, 9, Astellas Pharma Inc, 8, AstraZeneca, 5, AstraZeneca plc, 5, 8, Bayer Yakuhin, 8, Bayer Yakuhin, Ltd., 8, Bristol-Myers Squibb, 8, 9, Chugai Pharmaceutical Co Ltd, 8, Chugai Pharmaceutical Co., 8, 9, Daiichi Sankyo, 8, 9, Daiichi Sankyo Co Ltd, 8, Eisai Co., Ltd, 8, Eli Lilly and Company, 8, 9, Eli Lilly Japan KK, 8, Elsai Co Ltd, 8, Gilead Sciences, 8, Gilead Sciences, Inc., 8, MEDICAL & BIOLOGICAL LABORATORIES CO., 5, Medical and Biological Laboratories Co Ltd, 5, Mitsubishi Tanabe Pharma, 8, 9, Nippon Shinyaku Co., 8, Novartis, 5, Novartis Pharma KK, 5, Ono Pharmaceutical, 5, ONO Pharmaceutical Co Ltd, 5, Otsuka Pharmaceutical, 8, Pfizer, 5, 9, Pfizer Inc, 5, 8, Sanofi, 9, Takeda Pharmaceutical Company, 8, Takeda Pharmaceuticals, 8; R. Willis, None; M. Bertolaccini, None; H. Cohen, None; J. Rand, None; D. Erkan, None; O. Of APS ACTION, None.

To cite this abstract in AMA style:

Gkrouzman E, Sevim E, Finik J, Andrade D, Pengo V, Sciascia S, Tektonidou M, Ugarte A, Chighizola C, Belmont H, Pérez Sánchez L, Ji L, Fortin P, Efthymiou M, De Jesus G, Branch D, Nalli C, Petri M, Cervera R, Rodriguez E, Knight J, Atsumi T, Willis R, Bertolaccini M, Cohen H, Rand J, Erkan D, Of APS ACTION O. Antiphospholipid Antibody Profile Stability over Time: Prospective Results from AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository (“Registry”) [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/antiphospholipid-antibody-profile-stability-over-time-prospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-clinical-database-and-r/. Accessed .

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