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Treatment of Multisystem Inflammatory Syndrome in Children
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...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Massachusetts Medical Society
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220965/ https://www.ncbi.nlm.nih.gov/pubmed/34133854 http://dx.doi.org/10.1056/NEJMoa2102968 |
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author | McArdle, Andrew J. Vito, Ortensia Patel, Harsita Seaby, Eleanor G. Shah, Priyen Wilson, Clare Broderick, Claire Nijman, Ruud Tremoulet, Adriana H. Munblit, Daniel Ulloa-Gutierrez, Rolando Carter, Michael J. De, Tisham Hoggart, Clive Whittaker, Elizabeth Herberg, Jethro A. Kaforou, Myrsini Cunnington, Aubrey J. Levin, Michael |
author_facet | McArdle, Andrew J. Vito, Ortensia Patel, Harsita Seaby, Eleanor G. Shah, Priyen Wilson, Clare Broderick, Claire Nijman, Ruud Tremoulet, Adriana H. Munblit, Daniel Ulloa-Gutierrez, Rolando Carter, Michael J. De, Tisham Hoggart, Clive Whittaker, Elizabeth Herberg, Jethro A. Kaforou, Myrsini Cunnington, Aubrey J. Levin, Michael |
author_sort | McArdle, Andrew J. |
collection | PubMed |
description | 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. (Funded by the European Union’s Horizon 2020 Program and others; BATS ISRCTN number, ISRCTN69546370.) |
format | Online Article Text |
id | pubmed-8220965 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Massachusetts Medical Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-82209652021-06-28 Treatment of Multisystem Inflammatory Syndrome in Children McArdle, Andrew J. Vito, Ortensia Patel, Harsita Seaby, Eleanor G. Shah, Priyen Wilson, Clare Broderick, Claire Nijman, Ruud Tremoulet, Adriana H. Munblit, Daniel Ulloa-Gutierrez, Rolando Carter, Michael J. De, Tisham Hoggart, Clive Whittaker, Elizabeth Herberg, Jethro A. Kaforou, Myrsini Cunnington, Aubrey J. Levin, Michael N Engl J Med Original Article 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. (Funded by the European Union’s Horizon 2020 Program and others; BATS ISRCTN number, ISRCTN69546370.) Massachusetts Medical Society 2021-06-16 /pmc/articles/PMC8220965/ /pubmed/34133854 http://dx.doi.org/10.1056/NEJMoa2102968 Text en Copyright © 2021 Massachusetts Medical Society. All rights reserved. http://www.nejmgroup.org/legal/terms-of-use.htm This article is made available via the PMC Open Access Subset for unrestricted re-use, except commercial resale, and analyses in any form or by any means with acknowledgment of the original source. These permissions are granted for the duration of the Covid-19 pandemic or until revoked in writing. Upon expiration of these permissions, PMC is granted a license to make this article available via PMC and Europe PMC, subject to existing copyright protections. |
spellingShingle | Original Article McArdle, Andrew J. Vito, Ortensia Patel, Harsita Seaby, Eleanor G. Shah, Priyen Wilson, Clare Broderick, Claire Nijman, Ruud Tremoulet, Adriana H. Munblit, Daniel Ulloa-Gutierrez, Rolando Carter, Michael J. De, Tisham Hoggart, Clive Whittaker, Elizabeth Herberg, Jethro A. Kaforou, Myrsini Cunnington, Aubrey J. Levin, Michael Treatment of Multisystem Inflammatory Syndrome in Children |
title | Treatment of Multisystem Inflammatory Syndrome in Children |
title_full | Treatment of Multisystem Inflammatory Syndrome in Children |
title_fullStr | Treatment of Multisystem Inflammatory Syndrome in Children |
title_full_unstemmed | Treatment of Multisystem Inflammatory Syndrome in Children |
title_short | Treatment of Multisystem Inflammatory Syndrome in Children |
title_sort | treatment of multisystem inflammatory syndrome in children |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220965/ https://www.ncbi.nlm.nih.gov/pubmed/34133854 http://dx.doi.org/10.1056/NEJMoa2102968 |
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