ABSTRACT
Background: The risk of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) is higher than individuals from the general population due to chronic infammation. Current CV risk screening and management strategies underestimate the actual CV risk in RA. Thus, an adequate CV risk stratifcation has special relevance in RA to identify patients at risk of CV disease. Objectives: To assess the incidence of cardiovascular events in a RA cohort after a 2 years follow-up. Methods: A cohort study was performed in which inclusion criteria were adult RA patients and matched adults in terms of age, sex and CV risk factors (controls). Population over 75 years old, patients with established CV disease and/or stage III chronic kidney disease were excluded. Controls with other infam-matory diseases, pregnant women or any malignancy were also excluded. This study was performed from July-2019 to January-2022. CV risk assessment included risk factors collection and US evaluation consisted in detection of plaques and measurement of the intima-media thickness in both right and left carotid. Results: Overall, a total of 200 cases and 111 healthy controls were enrolled in the study. Demographical and clinical variables were comparable between cases and controls and are shown in Table 1. US study revealed a higher IMT in both right and left carotid arteries with greater presence of plaques in patients than in controls (CI 95% [1.542;3.436], p<0.001). Plaques were found in both carotid arteries in the 32% of cases and 9.91% of controls. The longer duration of RA was related to a higher presence of carotid plaques (95% [1.015;1.056], p<0.001). Eight patients (4%) presented a cardiovascular event, and one of them died (0.5%). The events consisted in 2 angina pectoris, 3 transient ischemic attack, 1 acute myocardial infarction, 1 lacunar stroke and 1 cardiac arrest. Six out those 8 patients demonstrated bilateral plaque presence at baseline. Two patient caused loss of follow up due to death related to Covid-19. Not a single cardiovascular event was reported in the control group. Conclusion: Our results shows that cardiovascular events are increased in RA patients and US study may be useful in predicting an event.
ABSTRACT
Background: Recent published data have emerged some concerns about safety of Janus kinase (JAK) inhibitors and FDA have established prescribing restrictions. Objectives: The aim of this study was to analyze the safety profile of current approved JAK inhibitors in Europe with data from a Real World cohort. Methods: A single center observational study was performed including patients who had initiated treatment with Tofacitinib, Baricitinib or Upadacitinib from September, 2017 to January, 2022. Demographic, clinical, laboratory and safety variables were collected from baseline and at months 1, 3, 6 and every six months. Safety data was collected including any adverse event (AE) due to any cause. An AE was considered serious if it was life-threatening or result in hospitaliza-tion, disability or in death. All AE and SAE were expressed adjusted by exposure (E/100 PY). Results: A total of 194 patients were included whom baseline demographic and disease characteristics are exposed in Table 1. Drug exposure was 265.5 patient-years. Overall, 214 AE were detected being mild upper tract respiratory infection the most frequently registered (15.82 E/100PY) followed by Urinary tract Infection accounting 7.16 E/100PY. 10 Serious Infections were detected in 10 patients of which 5 were pneumonia (1.88 E/100PY), 1 cellulitis (0.38 E/100PY) and 2 COVID-19 (0.76 E/100PY). 12 herpetic infection were detected in 9 patients (4.52 E/100PY) of which 7 were caused by herpes zoster (2.64 E/100PY) and 5 by herpes simplex (1.88 E/100PY) 3 cases were mono-metameric and 4 multi-metameric. Moreover, 2 patient developed postherpetic neuralgia. A patient with RA developed Miliary Tuberculosis (0.38 E/100PY) with a negative IGRA test prior to the JAKi. A patient with RA suffered a Myocardial Infarction (0.38 E/100PY). 7 RA patients developed malignancy (2.64 E/100PY), one with oral squamous cell carcinoma, two Bowen carcinoma, one breast cancer, 2 basal cell carcinoma and a colorectal metastatic cancer. Not a single case of thromboembolic event nor Hepatitis B Virus reactivation were registered. 2 patients died, one with cancer and the other suffered a severe COVID-19 (unvaccinated). Conclusion: In this updated analysis of 194 patients treated with JAKi, the three approved JAKi showed a safety profile consistent with data from RCT. The patients under JAK therapy should be carefully evaluated on their follow-up.