TY - JOUR
T1 - Multisystem inflammatory syndrome in children - Initial therapy and outcomes
AU - the Overcoming COVID-19 Investigators
AU - Son, Mary Beth F.
AU - Murray, Nancy
AU - Friedman, Kevin
AU - Young, Cameron C.
AU - Newhams, Margaret M.
AU - Feldstein, Leora R.
AU - Loftis, Laura L.
AU - Tarquinio, Keiko M.
AU - Singh, Aalok R.
AU - Heidemann, Sabrina M.
AU - Soma, Vijaya L.
AU - Riggs, Becky J.
AU - Fitzgerald, Julie C.
AU - Kong, Michele
AU - Doymaz, Sule
AU - Giuliano, John S.
AU - Keenaghan, Michael A.
AU - Hume, Janet R.
AU - Hobbs, Charlotte V.
AU - Schuster, Jennifer E.
AU - Clouser, Katharine N.
AU - Hall, Mark W.
AU - Smith, Lincoln S.
AU - Horwitz, Steven M.
AU - Schwartz, Stephanie P.
AU - Irby, Katherine
AU - Bradford, Tamara T.
AU - Maddux, Aline B.
AU - Babbitt, Christopher J.
AU - Rowan, Courtney M.
AU - McLaughlin, Gwenn E.
AU - Yager, Phoebe H.
AU - Maamari, Mia
AU - Mack, Elizabeth H.
AU - Carroll, Christopher L.
AU - Montgomery, Vicki L.
AU - Halasa, Natasha B.
AU - Cvijanovich, Natalie Z.
AU - Coates, Bria M.
AU - Rose, Charles E.
AU - Newburger, Jane W.
AU - Patel, Manish M.
AU - Randolph, Adrienne G.
N1 - Funding Information:
The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Supported by the Centers for Disease Control and Prevention under a contract with Boston Children’s Hospital. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85109162117&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2102605
DO - 10.1056/NEJMoa2102605
M3 - Article
C2 - 34133855
AN - SCOPUS:85109162117
SN - 0028-4793
VL - 385
SP - 23
EP - 34
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 1
ER -