TY - JOUR
T1 - Antiphospholipid antibody profile stability over time
T2 - Prospective results from the APS ACTION clinical database and repository
AU - Gkrouzman, Elena
AU - Sevim, Ecem
AU - Finik, Jackie
AU - Andrade, Danieli
AU - Pengo, Vittorio
AU - Sciascia, Savino
AU - Tektonidou, Maria G.
AU - Ugarte, Amaia
AU - Chighizola, Cecilia B.
AU - Belmont, H. Michael
AU - Lopez-Pedrera, Chary
AU - Ji, Lanlan
AU - Fortin, Paul
AU - Efthymiou, Maria
AU - de Jesus, Guilherme Ramires
AU - Branch, D. Ware
AU - Nalli, Cecilia
AU - Petri, Michelle
AU - Rodriguez, Esther
AU - Cervera, Ricard
AU - Knight, Jason S.
AU - Atsumi, Tatsuya
AU - Willis, Rohan
AU - Bertolaccini, Maria Laura
AU - Cohen, Hannah
AU - Rand, Jacob
AU - Erkan, Doruk
N1 - Funding Information:
of Texas Medical Branch, Galveston, Texas, USA;24M.L. Bertolaccini, PhD, Academic Department of Vascular Surgery, King’s College London British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine & Sciences, London, UK; 25J. Rand, MD, Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA; 26D. Erkan, MD, MPH, Barbara Volcker Center for Women and Rheumatic Diseases, Hospital for Special Surgery, Weill Cornell Medicine, New York, New York, USA. MP (Hopkins Lupus Cohort) is supported by a grant from the NIH RO1 AR069572. PF is recipient of a tier 1 Canada Research Chair on Systemic Autoimmune Rheumatic Diseases. MLB is supported by the King’s British Heart Foundation Centre for Research Excellence Award RE/18/2/34213. The rest of the authors report no conflicts of interest. Address correspondence to Dr. E. Gkrouzman, 535 East 70th Street, New York, NY 10021, USA. Email: egkrouzman@gmail.com. Accepted for publication August 18, 2020.
Funding Information:
The APS ACTION registry was created using REDCAP provided by the Clinical and Translational Science Center at Weill Cornell Medical College (CTSC grant UL1 TR000457). For this work, EG was supported by Clinical and Translational Science Center at Weill Cornell Medicine (UL1 TR002384). 1E. Gkrouzman, MD, MS, Hospital for Special Surgery, New York, New York, USA; 2E. Sevim, MD, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, New York, USA; 3J. Finik, MPH, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA; 4D. Andrade, MD, PhD, University of São Paulo, São Paulo, Brazil; 5V. Pengo, MD, University Hospital Padova, Padova, Italy; 6S. Sciascia, MD, PhD, Center of Research of Immunopathology and Rare Diseases, University of Turin, Turin, Italy; 7M.G. Tektonidou, MD, PhD, National and Kapodistrian University of Athens, Athens, Greece; 8A. Ugarte, MD, Hospital Universitario Cruces, Barakaldo, País Vasco, Spain;9C.B. Chighizola, MD, PhD, Clinical Immunology & Rheumatology Unit, IRCCS Istituto Auxologico Italiano, Milan, Italy; 10H.M. Belmont, MD, Hospital for Joint Diseases, New York University, New York, New York, USA;
Publisher Copyright:
© 2021 Journal of Rheumatology. All rights reserved.
PY - 2021/4/1
Y1 - 2021/4/1
N2 - Objective. The APS ACTION Registry studies long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients. Our primary objective was to determine whether clinically meaningful aPL profiles at baseline remain stable over time. Our secondary objectives were to determine (1) whether baseline characteristics differ between patients with stable and unstable aPL profiles, and (2) predictors of unstable aPL profiles over time. Methods. A clinically meaningful aPL profile was defined as positive lupus anticoagulant (LAC) test and/or anticardiolipin (aCL)/anti-β2 glycoprotein-I (anti–β2-GPI) IgG/M ≥ 40 U. Stable aPL profile was defined as a clinically meaningful aPL profile in at least two-thirds of follow-up measurements. Generalized linear mixed models with logit link were used for primary objective analysis. Results. Of 472 patients with clinically meaningful aPL profile at baseline (median follow-up 5.1 yrs), 366/472 (78%) patients had stable aPL profiles over time, 54 (11%) unstable, and 52 (11%) inconclusive. Time did not significantly affect odds of maintaining a clinically meaningful aPL profile at follow-up in univariate (P = 0.906) and multivariable analysis (P = 0.790). Baseline triple aPL positivity decreased (OR 0.25, 95% CI 0.10–0.64, P = 0.004) and isolated LAC test positivity increased (OR 3.3, 95% CI 1.53–7.13, P = 0.002) the odds of an unstable aPL profile over time. Conclusion. Approximately 80% of our international cohort patients with clinically meaningful aPL profiles at baseline remain stable at a median follow-up of 5 years; triple aPL-positivity increase the odds of a stable aPL profile. These results will guide future validation studies of stored blood samples through APS ACTION Core Laboratories.
AB - Objective. The APS ACTION Registry studies long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients. Our primary objective was to determine whether clinically meaningful aPL profiles at baseline remain stable over time. Our secondary objectives were to determine (1) whether baseline characteristics differ between patients with stable and unstable aPL profiles, and (2) predictors of unstable aPL profiles over time. Methods. A clinically meaningful aPL profile was defined as positive lupus anticoagulant (LAC) test and/or anticardiolipin (aCL)/anti-β2 glycoprotein-I (anti–β2-GPI) IgG/M ≥ 40 U. Stable aPL profile was defined as a clinically meaningful aPL profile in at least two-thirds of follow-up measurements. Generalized linear mixed models with logit link were used for primary objective analysis. Results. Of 472 patients with clinically meaningful aPL profile at baseline (median follow-up 5.1 yrs), 366/472 (78%) patients had stable aPL profiles over time, 54 (11%) unstable, and 52 (11%) inconclusive. Time did not significantly affect odds of maintaining a clinically meaningful aPL profile at follow-up in univariate (P = 0.906) and multivariable analysis (P = 0.790). Baseline triple aPL positivity decreased (OR 0.25, 95% CI 0.10–0.64, P = 0.004) and isolated LAC test positivity increased (OR 3.3, 95% CI 1.53–7.13, P = 0.002) the odds of an unstable aPL profile over time. Conclusion. Approximately 80% of our international cohort patients with clinically meaningful aPL profiles at baseline remain stable at a median follow-up of 5 years; triple aPL-positivity increase the odds of a stable aPL profile. These results will guide future validation studies of stored blood samples through APS ACTION Core Laboratories.
KW - Anticardiolipin antibodies
KW - Antiphospholipid antibodies
KW - Antiphospholipid syndrome
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U2 - 10.3899/JRHEUM.200513
DO - 10.3899/JRHEUM.200513
M3 - Review article
C2 - 33259328
AN - SCOPUS:85104683440
SN - 0315-162X
VL - 48
SP - 541
EP - 547
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 4
ER -