Chaim Putterman1, David S Pisetsky2, Michelle Petri3, Roberto Caricchio4, Alan H B Wu5, Ignacio Sanz6, Jim C Oates7, Steve Wallace8, Rachel Sorek9, Robert Gerwien10, Pennina Safer9, Keren Jakobi-Brook9, Irun R Cohen11. 1. The Division of Rheumatology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY. 2. Durham VA Medical Center, Duke University Medical Center and Medical Research Service, Durham, NC. 3. Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD. 4. Temple Lupus Clinic, Temple University, Philadelphia, PA. 5. Department of Laboratory Medicine, San Francisco General Hospital, San Francisco, CA. 6. Division of Rheumatology, Emory University School of Medicine, Atlanta, GA. 7. Division of Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC. 8. ImmunArray Inc., Richmond, VA, USA. 9. ImmunArray Ltd, Rehovot, Israel. 10. Gerwien Statistical Consulting, Newington, CT, USA. 11. Department of Immunology, The Weizmann Institute of Science, Rehovot, Israel.
Abstract
Objective: We previously described the multiplex autoantibody SLE-key Rule-Out test, which detects a signature of autoantibody reactivity that distinguishes healthy subjects from SLE patients with 94% sensitivity, 75% specificity and 93% negative predictive value; thus, an individual manifesting a positive Rule-Out test score is unlikely to have SLE (e.g. lupus is excluded). The objective of this current study was to evaluate the stability of the lupus-associated signature over time. Methods: We used banked serum samples from healthy subjects (n = 51) and lupus patients (n = 50 individual samples and n = 181 paired samples, for a total of n = 412 serum samples). The samples were drawn at different times after diagnosis to analyse the impact on the SLE-key Rule-Out test of time elapsed since diagnosis and any changes in disease activity (as reflected by the SLEDAI score). Results: The SLE signature remains stable for the first 10 years after diagnosis; in this time frame, <10% of patients manifested a positive Rule-Out score and the SLE-key Rule-Out score was independent of the underlying disease activity as reflected by the SLEDAI score. After ⩾10 years, ∼30% of lupus subjects scored as SLE Ruled-Out; the proportion of patients manifesting this status was even greater in the subset of individuals with a SLEDAI score of 0. Conclusion: These findings raise the possibility that a significant number of SLE patients manifest a change in their serological signature over time, and that such a signature change may signify an evolution in the immunological features of their disease relevant to patient management.
Objective: We previously described the multiplex autoantibody SLE-key Rule-Out test, which detects a signature of autoantibody reactivity that distinguishes healthy subjects from SLEpatients with 94% sensitivity, 75% specificity and 93% negative predictive value; thus, an individual manifesting a positive Rule-Out test score is unlikely to have SLE (e.g. lupus is excluded). The objective of this current study was to evaluate the stability of the lupus-associated signature over time. Methods: We used banked serum samples from healthy subjects (n = 51) and lupus patients (n = 50 individual samples and n = 181 paired samples, for a total of n = 412 serum samples). The samples were drawn at different times after diagnosis to analyse the impact on the SLE-key Rule-Out test of time elapsed since diagnosis and any changes in disease activity (as reflected by the SLEDAI score). Results: The SLE signature remains stable for the first 10 years after diagnosis; in this time frame, <10% of patients manifested a positive Rule-Out score and the SLE-key Rule-Out score was independent of the underlying disease activity as reflected by the SLEDAI score. After ⩾10 years, ∼30% of lupus subjects scored as SLE Ruled-Out; the proportion of patients manifesting this status was even greater in the subset of individuals with a SLEDAI score of 0. Conclusion: These findings raise the possibility that a significant number of SLEpatients manifest a change in their serological signature over time, and that such a signature change may signify an evolution in the immunological features of their disease relevant to patient management.
Authors: Mariangelí Arroyo-Ávila; Yesenia Santiago-Casas; Gerald McGwin; Ryan S Cantor; Michelle Petri; Rosalind Ramsey-Goldman; John D Reveille; Robert P Kimberly; Graciela S Alarcón; Luis M Vilá; Elizabeth E Brown Journal: Clin Rheumatol Date: 2015-04-22 Impact factor: 2.980