|Title||Antiphospholipid Antibody Profile Stability Over Time: Prospective Results From the APS ACTION Clinical Database and Repository.|
|Publication Type||Journal Article|
|Year of Publication||2021|
|Authors||Gkrouzman E, Sevim E, Finik J, Andrade D, Pengo V, Sciascia S, Tektonidou MG, Ugarte A, Chighizola CB, H Belmont M, Lopez-Pedrera C, Ji L, Fortin P, Efthymiou M, de Jesus GRamires, D Branch W, Nalli C, Petri M, Rodriguez E, Cervera R, Knight JS, Atsumi T, Willis R, Bertolaccini MLaura, Cohen H, Rand J, Erkan D|
|Corporate Authors||APS ACTION+|
|Date Published||2021 04|
|Keywords||Antibodies, Antiphospholipid, Antiphospholipid Syndrome, beta 2-Glycoprotein I, Cohort Studies, Humans, Prospective Studies|
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-β glycoprotein-I (anti-β-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 ( = 0.906) and multivariable analysis ( = 0.790). Baseline triple aPL positivity decreased (OR 0.25, 95% CI 0.10-0.64, = 0.004) and isolated LAC test positivity increased (OR 3.3, 95% CI 1.53-7.13, = 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.
|Alternate Journal||J Rheumatol|
|Grant List||R01 AR069572 / AR / NIAMS NIH HHS / United States |
UL1 TR000457 / TR / NCATS NIH HHS / United States
UL1 TR002384 / TR / NCATS NIH HHS / United States
RE/18/2/34213 / BHF_ / British Heart Foundation / United Kingdom
Jacob H. Rand, M.D.