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.
ABSTRACT
Background: During the frst months of the Sars-CoV-2 pandemic, antimalarial drugs were the central axis of the treatment of patients with acute respiratory infection. After that, several studies reported a risk of prolongation of corrected QT interval (QTc) at the electrocardiogram (ECG). Historically, these drugs, have been the common denominator in the treatment of patients with Systemic Lupus Erythematosus (SLE). Objectives: To analyze the possible relationship between the use of antima-larial drugs ant the electrocardiographic alterations in patients diagnosed with SLE. Methods: Cross-sectional study in patients diagnosed with SLE (SLICC 2012). In all of them, we performed a 12-lead ECG at rest. We measured the QT interval: manually and automatically, ant its correction was made according to the Hodge formule (QTc). Results: 91 patients diagnosed with SLE were included in the study. Of the total of patients included in the study, 64 were in current treatment with an antimalar-ial drug, with a mean of 9.09 (5.73) years of treatment, and a mean cumulative dosage of 813.16 (436.12) gr. Of the patients on current treatment with antimalarial drugs, 4.69% had a prolonged QTc, compared to 3.7% of the patients without current treatment with these drugs. We analyzed the possible relationship between the QTc interval, the current treatment with antimalarial drugs, and the cumulated dosage of this medication. We corrected the lineal regression models by the years of disease evolution, the presence or absence of known heart disease, the women gender, and other treatments such as antiarrhythmics or beta-blockers. We found a statistically signifcant association between taking antimalarial drugs and the elongated QTc interval (p= 0,001). Nevertheless, in the multivariate analysis, we did not found a signifcant relationship between the ECG alterations and the treatment with antimalarial drugs. Conclusion: In our study, we did not observe a direct relationship between the intake of antimalarial drugs and the alteration of the corrected QT interval.
ABSTRACT
Background: The need to avoid the transmission of COVID19 infection has forced to promote teleconsultations for rheumatic diseases follow-up. However, remote monitoring for rheumatic diseases which require clinical examination, as rheumatoid arthritis (RA), may affect to the evaluation of clinical activity, including the biological therapies follow-up. Due to that, count on tools as Patient Reported Outcomes (PROs) could help the remote monitoring of patients when it is not advisable their physical presence in health centers, being a great help in RA control. Objectives: We aim to assess the association among the tiredness, disability and pain perception with the clinical activity in RA patients. Methods: We performed a prospective observational study of three months of follow-up in RA patients (ACR/EULAR 2010) who are newly on biological or anti-JAK therapy. A basal visit and 1, 3 months follow-up visits were conducted. We analyzed changes during follow-up in the PROs parameters reported by patients through FACIT-fatigue and HAQ questionnaires, as well as pain VAS (0-10). Moreover we measured clinical activity through Das28, Das28-CRP, SDAI and CDAI index. Results: We included 60 patients (83.3% female), with a mean age of 55 (13) and mean disease evolution of 13 (11) years. At the basal visit, 55% of them exhibited increased levels of CRP and the 48.3% of ESR, showing moderate or high clinical activity the 83.3% of the total patients. 39 patients started anti-JAK therapy and 21 with TNF-α inhibitors. The 33.34% of patients were under monotherapy, and the 46.67% previously have been treated with biological therapy. The 77.36% of the total number of patients was on the biological therapy at 6 months of follow-up, while the 22.64% discontinued at 6 months of follow-up (9 due to inefficacy and 3 due to adverse effects). 48 patients continued the treatment in the 6 months after, and 12 patients discontinued due to ineffectiveness or drug intolerance. Clinical activity, fatigue, disability and pain perception are shown in Table 1. Using a mixed linear regression model the association among the fatigue, disability and pain perception with clinical activity was conducted, corrected by age, smoking habits, time of disease evolution, BMI, previous biological/anti-JAK therapy administration and current dose of steroids. We observed a signifcant association among clinical activity and fatigue (P<0.001), disability (P<0.001) and pain perception (P<0.001). The statistical analyses showed a signifcant association where a high fatigue is increased in cases with high pain perception (P>0.001) and high number of swollen joints (P=0.002), but not in high levels of CRP and ESR. Fatigue was higher in those cases whom discontinued treatment (P=0.044) regardless of which therapy was chosen. No effect of age, time of disease evolution, steroid dose, BMI or previous therapy and smoking habits in the PROs values was observed. Conclusion: PROs would be helpful in the disease control in those cases where a remote monitoring is needed, since HAQ or FACIT-FATIGUE index showed a signif-cant association with clinical activity index in RA. Because of its ease for shipping and handling by the health professional, PROs could be a useful tool in the disease control. Its implementation in the remote monitoring of RA patient, as has been the case of Covid19 pandemic, results in an improvement of the clinic evaluation of RA patient, due to required information to clinical management is reported, avoiding presence consultation in those situations when it is required.