Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Patients with rheumatoid arthritis (RA) are at increased risk of stroke. This event is associated with considerable sequelae and might result in death or major physical and neurological disability. Despite its clinical relevance data regarding stroke are rare. Our objective was to analyse the impact of different risk factors on the development of stroke within our German biologics register RABBIT.
Methods: RABBIT is an ongoing prospective cohort study. Since 2001 patients have been enrolled at start of an approved biological therapy or a new synthetic DMARD treatment after at least one DMARD failure. At fixed time points at follow-up rheumatologists assess the clinical status, report treatment details and adverse events according to ICH guidelines. We analysed all patients enrolled in the register until 31.08.2012 with at least 3 months of follow-up. All reports of stroke were included, transient ischemic attacks were not. Diagnoses of stroke were re-validated at on-site visits. Medical records as well as hospital reports were analysed. To assess the impact of different risk factors for stroke we performed a multivariate Cox regression analysis. Patients treated with biologics were considered to be exposed to these drugs up to 6 (rituximab: 12) months after the last dose.
Results: 10,159 patients were included. 77% of them were female, the mean age at enrollment was 56 years, mean disease duration 10.4 years, and mean disease activity score (DAS28) 5.5. The mean observation time was 3.5 years. 109 patients experienced a stroke. Older age and male sex were significant risk factors for the development of stroke, as well as hypertension, DAS28 and smoking (see Table). Factors not significantly associated were functional capacity and treatment with antiTNF or other biologics and use of glucocorticoids. As relevant comorbidities we investigated diabetes (db), coronary heart disease (chd), heart failure (hf) and atrial fibrillation (af). All of those were more prevalent in patients who developed a stroke (db 19 vs 10%, chd 17 vs 6%, hf 7 vs 2%, af 3 vs 0.5%). These portions were significantly different in univariate comparisons but did not achieve statistical significance in the multivariate model. DAS28 was a better predictor than erythrocyte sedimentation rate.
|
HR |
95% CI |
Age (by 10 years) |
1.7 |
[1.4; 2.1] |
Males vs. females |
1.6 |
[1.0; 2.4] |
Hypertension (yes/no) |
1.7 |
[1.1; 2.5] |
Atrial fibrillation (yes/no) |
2.8 |
[0.9; 9.1] |
DAS28 at follow-up per unit increase |
1.6 |
[1.4; 1.9] |
Smoking ever vs. no |
1.2 |
[1.0; 1.4] |
antiTNF vs. DMARDs |
1.1 |
[0.8; 1.7] |
Other biologics vs. DMARDs |
1.3 |
[0.8; 2.1] |
Table: Results of the multivariate Cox regression analysis.
Conclusion: Biologic treatments and glucocorticoids did not have an influence on the risk of stroke. Among traditional risk factors for stroke such as age, male gender, smoking and hypertension, a higher disease activity and atrial fibrillation seem to increase the risk for stroke. This could have implications for the cardiovascular risk assessment in patients with RA.
Disclosure:
A. Strangfeld,
MSD, Pfizer, BMS,
8;
Y. Meißner,
None;
A. Richter,
None;
M. Schneider,
Abbvie, GSK, Pfizer, Roche, UCB,
8;
H. P. Tony,
AbbVie, Chugai, MSD, BMS, UCB, Roche,
5,
AbbVie, Chugai, MSD, BMS, UCB, Roche,
8;
K. Gerhold,
None;
A. Zink,
MSD, BMS, Pfizer,
8;
J. Listing,
None.
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