Session Type: Poster Session (Tuesday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Cardiovascular disease is highly prevalent in Rheumatoid Arthritis (RA) and in non-RA subjects with low vitamin D levels. The aim of the present study was to evaluate the long-term risk of serious cardiovascular events (SCVE) RA patients having low vitamin D at time of diagnosis, compared to patients with normal vitamin D levels at RA diagnosis.
Methods: The study is a longitudinal observational study with retrospective evaluation of outcomes using patient record adjudication, based on post-hoc evaluation of an Investigator-Initiated, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study: The CIMESTRA Study (NCT00209859). Patients were recruited at 4 Danish University Clinics from October 1999 to October 2002: 160 early diagnosed, DMARD- and steroid RA-patients, fulfilling ACR 1987 criteria for RA were included in the original CIMESTRA study (NCT00209859). Eligibility criteria excluded most co-morbidities. The original CIMESTRA study treated all patients with methotrexate and intra-articular steroid, aiming at remission. Patients were further randomized to ciclosporine or placebo. Self-reported vitamin D intake was evaluated, and vitamin D supplemented according to national Danish Guidelines.
One-hundred-fifty-eight patients had vitamin D metabolites measured at time of diagnosis, prior to initiation of treatment and eventual vitamin D supplementation, and were included in the current study: Patients were allocated according to serum Dtotal (the sum of 25OHD2 and 25OHD3) at time of diagnosis, comparing “low” = Dtotal < 50 nmol/l to “normal” = Dtotal ≥ 50 nmol/l. One-hundred-forty-two patients were alive without missing data for journal-adjudications after 10 years of follow-up. Primary outcome was a composite of fatal and non-fatal SCVEs. Secondary outcomes were cardiovascular mortality and all-cause mortality. All events were evaluated through patient-record adjudication, using a validated adjudication process (See figure 1).
Odds for SCVE were evaluated using multiple logistic regression, adjusted for original trial group-allocation (ciclosporine or placebo), Trial Center, and the pre-specified, potential confounding variables sex, age at time of diagnosis, smoking, adipositas and ACPA-status, whereas the fully adjusted model further included weight and 1,25(OH)2D, both being statistical significant associated with Dtotal-status at time of diagnosis.
Results: Overall 10-year SCVE incidence was lower than expected (13.9% in patients with low Dtotal, 14.3% in patients with normal Dtotal) (See figure 2). There were no difference in SCVE between Dtotal groups in crude analysis OR=0.91, 95%CI (0.4; 2.3), or in fully adjusted model: OR=0.86, 95%CI (0.2; 3.2) (See table 1) Survival analyses showed no difference in SCVE according to baseline Dtotal, HR=1.15, 95 % CI (0.6; 2.3).
Conclusion: The 10-year SCVE incidence of 13.9% was unexpectedly low. Low vitamin D status at time of RA diagnosis was not associated with long-term SCVE in early diagnosed, aggressively controlled and DMARD treated RA patients.
To cite this abstract in AMA style:Herly M, Stengaard-Pedersen K, Hørslev-Petersen K, Lund Hetland M, Østergaard M, Christensen R, Løgstrup B, Vestergaard P, Junker P, Ellingsen T. Are Vitamin D Metabolite Levels at Time of Diagnosis Associated with Long-term Severe Cardiovascular Events in Early Diagnosed Rheumatoid Arthritis Patients, Aggressively Treated During 10 Year Follow Up? Post-hoc Analyses of Observational Data from the CIMESTRA Cohort [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/are-vitamin-d-metabolite-levels-at-time-of-diagnosis-associated-with-long-term-severe-cardiovascular-events-in-early-diagnosed-rheumatoid-arthritis-patients-aggressively-treated-during-10-year-follow/. Accessed October 27, 2020.
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