TY - JOUR
T1 - Treatment of Multisystem Inflammatory Syndrome in Children
AU - BATS Consortium
AU - McArdle, Andrew J.
AU - Vito, Ortensia
AU - Patel, Harsita
AU - Seaby, Eleanor G.
AU - Shah, Priyen
AU - Wilson, Clare
AU - Broderick, Claire
AU - Nijman, Ruud
AU - Tremoulet, Adriana H.
AU - Munblit, Daniel
AU - Ulloa-Gutierrez, Rolando
AU - Carter, Michael J.
AU - De, Tisham
AU - Hoggart, Clive
AU - Whittaker, Elizabeth
AU - Herberg, Jethro A.
AU - Kaforou, Myrsini
AU - Cunnington, Aubrey J.
AU - Levin, Michael
AU - Vazquez, Jorge Agrimbau
AU - Carmona, Rodrigo
AU - Perez, Laura
AU - Rubinos, Mayra
AU - Veliz, Natalia
AU - Yori, Silvana
AU - Haerynck, Filomeen
AU - Hoste, Levi
AU - Leal, Izabel Alves
AU - Da Silva, Andre Ricardo Araujo
AU - Silva, Anna Esther Araujo
AU - Barchik, Andrea
AU - Barreiro, Sabrina T.A.
AU - Cochrane, Natalia
AU - Teixeira, Cristiane Henriques
AU - Arauj, Julienne Martins
AU - Ossa, Rolando Andres Paternina De La
AU - Vieira, Cristina Souza
AU - Dimitrova, Anna
AU - Ganeva, Margarita
AU - Stefanov, Stefan
AU - Telcharova-Mihaylovska, Albena
AU - Biggs, Catherine M.
AU - Scuccimarri, Rosie
AU - Withington, Davinia
AU - Raul, Bustos B.
AU - Ampuero, Camila
AU - Aravena, Javiera
AU - Casanova, Daniel
AU - Cruces, Pablo
AU - Diaz, Franco
N1 - Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - BACKGROUND Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2. METHODS We performed an international observational cohort study of clinical and outcome data regarding suspected MIS-C that had been uploaded by physicians onto a Web-based database. We used inverse-probability weighting and generalized linear models to evaluate intravenous immune globulin (IVIG) as a reference, as compared with IVIG plus glucocorticoids and glucocorticoids alone. There were two primary outcomes: the first was a composite of inotropic support or mechanical ventilation by day 2 or later or death; the second was a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation and the time until a reduction in organ failure and inflammation. RESULTS Data were available regarding the course of treatment for 614 children from 32 countries from June 2020 through February 2021; 490 met the World Health Organization criteria for MIS-C. Of the 614 children with suspected MIS-C, 246 received primary treatment with IVIG alone, 208 with IVIG plus glucocorticoids, and 99 with glucocorticoids alone; 22 children received other treatment combinations, including biologic agents, and 39 received no immunomodulatory therapy. Receipt of inotropic or ventilatory support or death occurred in 56 patients who received IVIG plus glucocorticoids (adjusted odds ratio for the comparison with IVIG alone, 0.77; 95% confidence interval [CI], 0.33 to 1.82) and in 17 patients who received glucocorticoids alone (adjusted odds ratio, 0.54; 95% CI, 0.22 to 1.33). The adjusted odds ratios for a reduction in disease severity were similar in the two groups, as compared with IVIG alone (0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone). The time until a reduction in disease severity was similar in the three groups. CONCLUSIONS We found no evidence that recovery from MIS-C differed after primary treatment with IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone, although significant differences may emerge as more data accrue.
AB - BACKGROUND Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2. METHODS We performed an international observational cohort study of clinical and outcome data regarding suspected MIS-C that had been uploaded by physicians onto a Web-based database. We used inverse-probability weighting and generalized linear models to evaluate intravenous immune globulin (IVIG) as a reference, as compared with IVIG plus glucocorticoids and glucocorticoids alone. There were two primary outcomes: the first was a composite of inotropic support or mechanical ventilation by day 2 or later or death; the second was a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation and the time until a reduction in organ failure and inflammation. RESULTS Data were available regarding the course of treatment for 614 children from 32 countries from June 2020 through February 2021; 490 met the World Health Organization criteria for MIS-C. Of the 614 children with suspected MIS-C, 246 received primary treatment with IVIG alone, 208 with IVIG plus glucocorticoids, and 99 with glucocorticoids alone; 22 children received other treatment combinations, including biologic agents, and 39 received no immunomodulatory therapy. Receipt of inotropic or ventilatory support or death occurred in 56 patients who received IVIG plus glucocorticoids (adjusted odds ratio for the comparison with IVIG alone, 0.77; 95% confidence interval [CI], 0.33 to 1.82) and in 17 patients who received glucocorticoids alone (adjusted odds ratio, 0.54; 95% CI, 0.22 to 1.33). The adjusted odds ratios for a reduction in disease severity were similar in the two groups, as compared with IVIG alone (0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone). The time until a reduction in disease severity was similar in the three groups. CONCLUSIONS We found no evidence that recovery from MIS-C differed after primary treatment with IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone, although significant differences may emerge as more data accrue.
UR - http://www.scopus.com/inward/record.url?scp=85109171399&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2102968
DO - 10.1056/NEJMoa2102968
M3 - Article
C2 - 34133854
AN - SCOPUS:85109171399
SN - 0028-4793
VL - 385
SP - 11
EP - 22
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 1
ER -