ACTIV-3/TICO Study Group* Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

Introduction: Approximately 30% of patients with a first acute pericarditis episode experience a recurrence B 18 months; * 15% experience multiple recurrences. This study assessed the recurrence and economic burden among patients with multiple recurrences. Methods: Adults with idiopathic pericarditis were identified in the OptumHealth Care Solutions, Inc., database (2007Inc., database ( -2017. Recurrent pericarditis (RP) was defined as C 2 episodes of care separated by [ 28 days; multiple recurrences were defined as C 2 recurrences. Results: Among 944 patients with RP, 375 (39.7%) experienced multiple recurrences and were propensity score-matched 1:1 to 375 patients without recurrence. Among patients with multiple recurrences, median disease duration (time from first episode to end of last recurrence, confirmed by a 1.5-year recurrencefree period) was 2.84 years. The multiple recurrences cohort had higher rates of hospitalizations per-patient-per-month (PPPM) than the no recurrence cohort (rate ratio [95% confidence interval (CI)] = 2.22 [1.35-3.65]). Mean total healthcare costs were significantly higher in the multiple recurrences versus no recurrence cohort

Background: Up to 30% of incident pericarditis patients (pts) recur within 18 months. Recurrences can be debilitating and typically last several weeks despite conventional treatments (Tx). Recurrence burden (likelihood and frequency) is poorly defined. Improved understanding of recurrence burden can inform Tx decisions and the introduction of novel therapies. Method: Adults with idiopathic recurrent pericarditis (RP) were identified in the OptumHealth Reporting and Insights dataset (2007-2017). RP was defined as ≥2 episodes separated by >4 weeks. Disease duration (time from first episode to end of last recurrence, confirmed by a 1.5-year recurrence-free period) was evaluated using Kaplan-Meier analysis. Recurrence frequency and time between recurrences were evaluated among pts with 4+ years of observation. Result: Of the 1,604 RP pts, mean age was 50.7 years and 51.6% were female. Median RP duration was 2.1 and 3.1 years for pts with ≥1 and ≥2 recurrences, respectively ( Figure ). Over 4 years with RP, 15% of pts with ≥1 recurrence and 22% of pts with ≥2 recurrences had more than one episode/year. Mean ± SD time from first episode to first recurrence was 14.5 ± 17.9 months and 10.7 ± 12.1 months between subsequent recurrences. Conclusion: Recurrent pericarditis can span many years. Over half of pts with ≥2 recurrences have RP persisting over 3 years. Subsequent recurrences are more frequent but highly variable, making RP unpredictable. Tx to reduce recurrences could benefit pts with ≥2 recurrences.

Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.