Antiphospholipid Antibody Profile Stability Over Time: Prospective Results From the APS ACTION Clinical Database and Repository
Elena Gkrouzman, Ecem Sevim, Jackie Finik, Danieli Andrade, Vittorio Pengo, Savino Sciascia, Maria G. Tektonidou, Amaia Ugarte, Cecilia Beatrice Chighizola, H. Michael Belmont, C. López-Pedrera, Lanlan Ji, Paul R. Fortin, Maria Efthymiou, Guilherme Ramires de Jesús, D. Ware Branch, Cecilia Nalli, Michelle Petri, Esther Rodríguez, Ricard Cervera, Jason S. Knight, Tatsuya Atsumi, Rohan Willis, María Laura Bertolaccini, Hannah Cohen, Jacob H. Rand, Doruk Erkan, on behalf of APS ACTION+
Abstract
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 2 glycoprotein-I (anti–β 2 -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.