No difference in MIS-C recovery outcomes between IVIG, glucocorticoids, combined therapy
Click Here to Manage Email Alerts
There is no evidence that recovery from multisystem inflammatory syndrome in children differs following treatment with glucocorticoids alone, intravenous immune globulin alone or a combination of the two, according to data.
“Since coronary-artery aneurysm is an important overlapping feature of both [multisystem inflammatory syndrome (MIS-C)] and Kawasaki’s disease, intravenous immune globulin (IVIG), the proven treatment for Kawasaki’s disease, has been widely adopted as an initial therapy, and withholding IVIG is considered unacceptable by some clinicians,” Andrew J. McArdle, MB, BChir, of Imperial College London, and colleagues wrote in the New England Journal of Medicine.
“However, some children with MIS-C recover with supportive treatment alone, so aggressive attempts to suppress the inflammatory response may not necessarily translate into clinical benefit,” they added. “Randomized trials are needed to establish the most effective treatment of MIS-C.”
To provide evidence for MIS-C treatment recommendations, McArdle and colleagues conducted an international, observational cohort study of clinical and outcome data that physicians had uploaded to an online database. As the accuracy of definitions currently used for MIS-C is unknown — with experience suggesting a spectrum of inflammatory conditions following COVID-19 — the researchers included children who met the published criteria as well as those with any suspected inflammatory illness after SARS-CoV-2 infection.
In all, McArdle and colleagues included data on 614 pediatric patients from 81 hospitals across 34 countries, all uploaded from June 20, 2020, to Feb. 24. Among these children, 246 received primary treatment with IVIG alone, 208 received combination with IVIG plus glucocorticoids and 99 received glucocorticoids alone. In addition, 22 patients received other treatment combinations, including biologic agents, while 39 received no immunomodulatory therapy.
The researchers used inverse-probability weighting and generalized linear models to analyze IVIG alone as a reference, compared with glucocorticoids alone and combination therapy with both. There were two primary outcomes: A composite of inotropic support or mechanical ventilation by day 2 or later or death, and a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation, as well as the time until a reduction in organ failure and inflammation.
According to the researchers, 56 patients treated with IVIG plus glucocorticoids received inotropic or ventilatory support, or died, with an adjusted odds ratio of 0.77 compared with IVIG alone (95% CI, 0.33-1.82). Meanwhile, inotropic or ventilatory support, or death, occurred in 17 patients who received glucocorticoids alone (0.54; 95% CI, 0.22-1.33). Adjusted ORs for reduced disease severity were similar between the IVIG-alone (0.93) and combination groups (0.9), compared with IVIG alone. The time until disease severity reduction was similar across all three groups.
“In a pragmatically defined international cohort of patients with suspected MIS-C, we found no evidence of substantial differences in the two primary outcomes among children who received the three most common treatments for this disorder (IVIG alone, IVIG plus glucocorticoids, and glucocorticoids alone),” McArdle and colleagues wrote.
“However, when we restricted the analyses to patients who met the WHO criteria for MIS-C, we found modest evidence of benefit with glucocorticoids alone over IVIG alone for both primary outcomes,” they added. “The confidence intervals for inferences about treatment effect admit the possibility of actual benefit from one or more of the treatments relative to the others.”
Collapse
Click Here to Manage Email Alerts