JAMA: Intravenous infusion of immunoglobulin + methylprednisolone vs. The effect of simple infusion of immunoglobulin on the course of fever in children with multiple system inflammatory syndrome

Among hospitalized patients with coronavirus disease (COVID-19) in 2019, only 1% to 2% are children.

However, in April 2020, pediatric patients with severe systemic high inflammatory diseases appeared in Europe and the United States.
These patients were mostly within 2 to 4 weeks after the new coronavirus (SARS-CoV-2) infection.

 This novel disease is called Children's Multiple System Inflammatory Syndrome (MIS-C) or Children's Multiple System Inflammatory Syndrome that is temporarily related to COVID-19.

Shows a variety of clinical symptoms, including persistent fever, digestive system symptoms, skin rash, bilateral non-suppurative conjunctivitis, signs of skin and mucous membrane inflammation, and frequent cardiovascular involvement.

MIS-C is usually associated with hemodynamic failure.
Acute cardiac dysfunction and even death occur in 60% to 75% of cases.

Many children with MIS-C received empirical treatment based on Kawasaki disease guidelines, using intravenous immunoglobulin (IVIG) alone or in combination with corticosteroids.

In some studies, children require second-line treatment, such as tumor necrosis factor inhibitors or interleukin 1 (IL-1) inhibitors, which highlights the importance of defining the best initial treatment.

However, so far, there is still a lack of evidence for the most effective MIS-C therapy.

In the absence of evidence, the Delphi consensus study in the United Kingdom recommends IVIG as the initial treatment to treat MIS-C.

The purpose of this retrospective cohort study was to compare the outcomes of children with MIS-C and SARS-CoV-2 infection treated with IVIG and methylprednisolone and IVIG alone.

The main outcome was treatment failure, which was defined as a fever that lasted 2 days (48 hours) after receiving the initial treatment, or fever again within 7 days after the initial treatment.

This result is similar to the main result used in the treatment study of Kawasaki disease.

Fever is defined as a temperature of 38°C (ie ≥100.
4°F) or higher.

The secondary outcome is second-line treatment, which is defined as a second treatment for MIS-C, such as steroids or biologics, at least 24 hours after the initial treatment.

Hemodynamic support after first-line treatment; after first-line treatment, if the left ventricular ejection fraction is less than 55%, it is defined as acute left ventricular dysfunction; and the length of stay in the pediatric intensive care unit (PICU).

For hemodynamic support and acute left ventricular insufficiency, it is only considered to occur at least 1 day after the start of first-line treatment.

Hemodynamic support is defined as the use of vasoactive or positive amines, rather than an escalation of previously prescribed medications.

Of the 181 children suspected of having MIS-C, 111 met the World Health Organization definition (58 women [52%]; median age was 8.
6 years [interquartile range 4.
7 to 12.
1]).

The five children did not receive any treatment.

Overall, 3 (9%) of 34 children in the IVIG and methylprednisolone group (hereinafter referred to as the combined group) did not respond to treatment, and only 37 of the 72 children in the IVIG group (51%).

The combination group has a lower risk of treatment failure compared with the IVIG-only group (absolute risk difference, -0.
28 [95% CI, -0.
48 to -0.
08]; odds ratio [OR], 0.
25, [95% CI, 0.
09 to 0.
70]; P = .
008). Compared with IVIG-only group, the risk of using second-line therapy was also significantly reduced in the combination group (absolute risk difference was -0.
22 [95% CI, -0.
40 to -0.
04]; odds ratio was 0.
19 [95% CI, 0.
06 to 0.
61]; P = .
004), hemodynamic support (absolute risk difference, -0.
17 [95% CI, -0.
34 to -0.
004]; odds ratio 0.
21 [95% CI, 0.
06 to 0.
76]), initial treatment of acute left ventricular insufficiency ( Absolute risk difference, -0.
18 [95% CI, -0.
35 to -0.
01]; odds ratio 0.
20 [95% CI, 0.
06 to 0.
66]), and length of stay in the pediatric intensive care unit (median, 4 days vs.
6 days) ; The day difference is -2.
4 [95% CI, -4.
0 to -0.
7]).

The experimental results show that in children with MIS-C, the treatment of combined IVIG and methylprednisolone has a smoother course of fever than the use of IVIG alone.

Original link: Naïm Ouldali, MD, PhD1,2,3; Julie Toubiana, MD, PhD.
Published online February 1, 2021.
doi:10.
1001/jama.
2021.
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