Browsing by Author "Friedman, Kevin"

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    Multisystem Inflammatory Syndrome in Children — Initial Therapy and Outcomes
    (Massachusetts Medical Society, 2021-07-01) Son, Mary Beth F.; Murray, Nancy; Friedman, Kevin; Young, Cameron C.; Newhams, Margaret M.; Feldstein, Leora R.; Loftis, Laura L.; Tarquinio, Keiko M.; Singh, Aalok R.; Heidemann, Sabrina M.; Soma, Vijaya L.; Riggs, Becky J.; Fitzgerald, Julie C.; Kong, Michele; Doymaz, Sule; Giuliano, John S., Jr.; Keenaghan, Michael A.; Hume, Janet R.; Hobbs, Charlotte V.; Schuster, Jennifer E.; Clouser, Katharine N.; Hall, Mark W.; Smith, Lincoln S.; Horwitz, Steven M.; Schwartz, Stephanie P.; Irby, Katherine; Bradford, Tamara T.; Maddux, Aline B.; Babbitt, Christopher J.; Rowan, Courtney M.; McLaughlin, Gwenn E.; Yager, Phoebe H.; Maamari, Mia; Mack, Elizabeth H.; Carroll, Christopher L.; Montgomery, Vicki L.; Halasa, Natasha B.; Cvijanovich, Natalie Z.; Coates, Bria M.; Rose, Charles E.; Newburger, Jane W.; Patel, Manish M.; Randolph, Adrienne G.; Pediatrics, School of Medicine
    Background: The assessment of real-world effectiveness of immunomodulatory medications for multisystem inflammatory syndrome in children (MIS-C) may guide therapy. Methods: We analyzed surveillance data on inpatients younger than 21 years of age who had MIS-C and were admitted to 1 of 58 U.S. hospitals between March 15 and October 31, 2020. The effectiveness of initial immunomodulatory therapy (day 0, indicating the first day any such therapy for MIS-C was given) with intravenous immune globulin (IVIG) plus glucocorticoids, as compared with IVIG alone, was evaluated with propensity-score matching and inverse probability weighting, with adjustment for baseline MIS-C severity and demographic characteristics. The primary outcome was cardiovascular dysfunction (a composite of left ventricular dysfunction or shock resulting in the use of vasopressors) on or after day 2. Secondary outcomes included the components of the primary outcome, the receipt of adjunctive treatment (glucocorticoids in patients not already receiving glucocorticoids on day 0, a biologic, or a second dose of IVIG) on or after day 1, and persistent or recurrent fever on or after day 2. Results: A total of 518 patients with MIS-C (median age, 8.7 years) received at least one immunomodulatory therapy; 75% had been previously healthy, and 9 died. In the propensity-score-matched analysis, initial treatment with IVIG plus glucocorticoids (103 patients) was associated with a lower risk of cardiovascular dysfunction on or after day 2 than IVIG alone (103 patients) (17% vs. 31%; risk ratio, 0.56; 95% confidence interval [CI], 0.34 to 0.94). The risks of the components of the composite outcome were also lower among those who received IVIG plus glucocorticoids: left ventricular dysfunction occurred in 8% and 17% of the patients, respectively (risk ratio, 0.46; 95% CI, 0.19 to 1.15), and shock resulting in vasopressor use in 13% and 24% (risk ratio, 0.54; 95% CI, 0.29 to 1.00). The use of adjunctive therapy was lower among patients who received IVIG plus glucocorticoids than among those who received IVIG alone (34% vs. 70%; risk ratio, 0.49; 95% CI, 0.36 to 0.65), but the risk of fever was unaffected (31% and 40%, respectively; risk ratio, 0.78; 95% CI, 0.53 to 1.13). The inverse-probability-weighted analysis confirmed the results of the propensity-score-matched analysis. Conclusions: Among children and adolescents with MIS-C, initial treatment with IVIG plus glucocorticoids was associated with a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. (Funded by the Centers for Disease Control and Prevention.).
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    The NHLBI Study on Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC): Design and Objectives
    (Elsevier, 2022) Truong, Dongngan T.; Trachtenberg, Felicia L.; Pearson, Gail D.; Dionne, Audrey; Elias, Matthew D.; Friedman, Kevin; Hayes, Kerri H.; Mahony, Lynn; McCrindle, Brian W.; Oster, Matthew E.; Pemberton, Victoria; Powell, Andrew J.; Russell, Mark W.; Shekerdemian, Lara S.; Son, Mary Beth; Taylor, Michael; Newburger, Jane W.; Pediatrics, School of Medicine
    Background: The Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC) study aims to characterize the frequency and time course of acute and long-term cardiac and non-cardiac sequelae in multisystem inflammatory syndrome in children associated with COVID-19 (MIS-C), which are currently poorly understood. Methods: This multicenter observational cohort study will enroll at least 600 patients <21 years old who meet the Centers for Disease Control and Prevention case definition of MIS-C across multiple North American centers over 2 years. The study will collect detailed hospital and follow-up data for up to 5 years, and optional genetic testing. Cardiac imaging at specific time points includes standardized echocardiographic assessment (all participants) and cardiac magnetic resonance imaging (CMR) in those with left ventricular ejection fraction (LVEF) <45% during the acute illness. The primary outcomes are the worst LVEF and the highest coronary artery z-score of the left anterior descending or right coronary artery. Other outcomes include occurrence and course of non-cardiac organ dysfunction, inflammation, and major medical events. Independent adjudication of cases will classify participants as definite, possible, or not MIS-C. Analysis of the outcomes will include descriptive statistics and regression analysis with stratification by definite or possible MIS-C. The MUSIC study will provide phenotypic data to support basic and translational research studies. Conclusion: The MUSIC study, with the largest cohort of MIS-C patients and the longest follow-up period to date, will make an important contribution to our understanding of the acute cardiac and non-cardiac manifestations of MIS-C and the long-term effects of this public health emergency.