Safety of Baricitinib 4 mg for the Treatment of Moderate to Severe Rheumatoid Arthritis.

OBJECTIVE: We evaluated the safety of baricitinib 4 mg at 24 weeks for the treatment of moderate to severe rheumatoid arthritis (RA). METHODS: Multiple databases were searched from inception up to November 26, 2019 for randomized controlled trials comparing baricitinib 4 mg with placebo for the treatment of moderate to severe RA. The safety outcomes of interest were the incidence of serious adverse events, adverse events leading to study discontinuation, all infections, and serious infections. Adjusted risk ratios (RRs) with 95% confidence intervals (CIs) were pooled for safety outcomes. The Cochrane tool was used to assess the risk of bias. RESULTS: This analysis included four randomized controlled trials with 3106 patients. For serious adverse events, the pooled RR (95% CI) was 1.09 (0.76-1.57). For adverse events leading to study discontinuation, the pooled RR (95% CI) was 1.41 (0.94-2.11). For all reported infections, the pooled RR (95% CI) was 1.24 (1.10-1.40), For serious infections, pooled RR (95% CI) was 0.97 (0.51-2.57). CONCLUSIONS: Patients with RA taking 4 mg baricitinib daily did have an increased risk of infections; however, the incidence of serious adverse events, adverse events leading to study discontinuation, or serious infections were not significantly different in patients treated with baricitinib 4 mg compared with placebo.

Accurate Prediction of False ST-Segment Elevation Myocardial Infarction: Ready for Prime Time?

The incidence of inappropriate cardiac catheterization lab activation for treatment of a false ST-segment elevation myocardial infarction (STEMI) has been reported to be 2.6%-36%. Excessive inappropriate catheterization lab activation may be associated with risks to patients, provider fatigue and improper resource usage. HYPOTHESIS: To derive and validate a prediction score to more accurately classify patients with STEMI. METHODS AND RESULTS: We conducted a retrospective cohort analysis of 1144 consecutive patients initially diagnosed with STEMI between September 2008 and January 2013. The incidence of catheterization laboratory activation for false STEMI was 21.4%. Multiple logistic regression identified 8 factors as important for prediction of false STEMI. Using a prediction rule derived from these factors, the area under the curve for differentiating false from true STEMI patients was 0.80 (95% CI: 0.75-0.84). Using objective standards, criteria were defined that had 95% specificity for detecting patients with an incorrect diagnosis of STEMI. IN CONCLUSION: A prediction rule has been derived and validated in a large, racially diverse group to identify false STEMI patients with an incorrect classification rate of 5%, which is an improvement over current clinical practice. Prediction rules may be particularly useful in patients with atypical presentations in which emergent catheterization cannot be achieved rapidly or carries significant patient risk.

A web-based tool to predict acute kidney injury in patients with ST-elevation myocardial infarction: Development, internal validation and comparison.

BACKGROUND: In ST-elevation myocardial infarction (STEMI), acute kidney injury (AKI) may increase subsequent morbidity and mortality. Still, it remains difficult to predict AKI risk in these patients. We sought to 1) determine the frequency and clinical outcomes of AKI and, 2) develop, validate and compare a web-based tool for predicting AKI. METHODS & FINDINGS: In a racially diverse series of 1144 consecutive STEMI patients, Stage 1 or greater AKI occurred in 12.9% and was severe (Stage 2-3) in 2.9%. AKI was associated with increased mortality (5.7-fold, unadjusted) and hospital stay (2.5-fold). AKI was associated with systolic dysfunction, increased left ventricular end-diastolic pressures, hypotension and intra-aortic balloon counterpulsation. A computational algorithm (UT-AKI) was derived and internally validated. It showed higher sensitivity and improved overall prediction for AKI (area under the curve 0.76) vs. other published indices. Higher UT-AKI scores were associated with more severe AKI, longer hospital stay and greater hospital mortality. CONCLUSIONS: In a large, racially diverse cohort of STEMI patients, Stage 1 or greater AKI was relatively common and was associated with significant morbidity and mortality. A web-accessible, internally validated tool was developed with improved overall value for predicting AKI. By identifying patients at increased risk, this tool may help physicians tailor post-procedural diagnostic and therapeutic strategies after STEMI to reduce AKI and its associated morbidity and mortality.

Racial Difference in Symptom Onset to Door Time in ST Elevation Myocardial Infarction.

BACKGROUND: There are poorer outcomes following ST elevation myocardial infarction in blacks compared to white patients despite comparable door-to-reperfusion time. We hypothesized that delays to hospital presentation may be contributory. METHODS AND RESULTS: We conducted a retrospective analysis of the 1144 patients admitted for STEMI in our institution from 2008 to 2013. The door-to-balloon time (D2BT) and symptom-onset-to-door time (SODT) were compared by race. Bivariate analysis was done comparing the median D2BT and SODT. Stratified analyses were done to evaluate the effect of race on D2BT and SODT, accounting for insurance status, age, sex and comorbidities. The mean age was 59±13 years; 56% of this population was black and 41% was white. Males accounted for 66% of this population. The median D2BT was 60 minutes (interquartile range [IQR] 42-82), and median SODT was 120 minutes (IQR 60-720). There was no significant difference in D2BT by race (P=0.86). Black patients presented to the emergency room (ER) later than whites (SODT=180 [IQR 60-1400] vs 120 [IQR 60-560] minutes, P<0.01) and were more likely to be uninsured (P<0.01). After controlling for comorbidities, insurance, and socioeconomic status, blacks were 60% more likely to present late after a STEMI (OR 1.6, P<0.01). A subset analysis excluding transferred patients showed similar results. CONCLUSIONS: Black patients present later to the ER after STEMI with no difference in D2BT compared to whites. This difference in time to presentation may be one of the factors accounting for poor outcomes in this population.