MIS-C outcomes with glucocorticoids alone similar to IVIG, combination therapy
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Glucocorticoids alone demonstrate similar recovery rates as intravenous immunoglobin, or combination therapy with both, in patients with multisystem inflammatory syndrome in children, according to data published in The Lancet Rheumatology.
“In the absence of evidence from randomized controlled trials, treatment recommendations for the newly recognized disease were developed by clinical consensus in many countries,” Samuel Channon-Wells, MMath, of Imperial College London, and colleagues wrote. “Based on the similarity of MIS-C to Kawasaki disease, for which intravenous immunoglobulin is the established treatment, national and international guidance has recommended intravenous immunoglobulin as initial treatment, with addition of glucocorticoids or other immunomodulatory agents, or both, for patients with severe illness.”
To examine glucocorticoids compared with IVIG therapy in a large cohort of children with MIS-C, Channon-Wells and colleagues analyzed data collected as part of the Best Available Treatment Study (BATS). For the BATS study, pediatric physicians uploaded data related to potential cases of MIS-C. Data were collected from June 14, 2020, through April 25, 2022. Information on each case included presenting features, patient demographics, laboratory counts and treatments. For this analysis, the researchers counted the first day that patients received immunomodulatory therapy as day 0.
For the primary outcome, Channon-Wells and colleagues used a composite of inotropic support or ventilator support on day 2 or later, or death. The second primary outcome was the time to improvement of one or more levels on the ordinal clinical severity scale. Other secondary outcomes included escalation of immunomodulatory therapy, the presence of a fever at 2 days, inotropic or ventilator support at day 2, death at day 2, the occurrence of coronary artery aneurysm, left ventricular dysfunction at 2 days or later, no improvement in the clinical severity scale at 2 days, and any applied increase of cardiorespiratory support.
The analysis included 2,009 children diagnosed with MIS-C between June 14, 2020, and April 25, 2022. In all, 33.8% underwent IVIG therapy as a first-line, 33.8% received combination therapy with IVIG and glucocorticoids as a first-line, and 24.2% received glucocorticoids only.
Among patients for whom baseline and final data were available, there did not appear to be a difference between therapy groups in achieving the primary outcome. In those who received combination therapy, the adjusted OR for ventilation, inotropic support or death was 1.09 (95% CI, 0.75-1.58), compared with 0.93 (%% CI, 0.58-1.47) for those who received glucocorticoids only.
Meanwhile, those who received combination therapy demonstrated a higher adjusted hazard ratio for time to improvement measurements (HR = 1.04; 95% CI, 0.91-1.2) compared with those who received glucocorticoids alone (HR = 0.84; 95% CI, 0.7-1), according to the researchers.
“Our comparison of treatment outcomes in an international cohort of 2,009 children with MIS-C shows that treatment with glucocorticoids alone, or intravenous immunoglobulin plus glucocorticoids, is not associated with significant differences in primary outcomes in comparison with intravenous immunoglobulin alone,” Channon-Wells and colleagues wrote.
“A non-significant trend towards a slower rate of improvement was shown in patients treated with glucocorticoids alone versus intravenous immunoglobulin, but this comparison was confined to those with less severe illness at presentation,” they added. “A key question for clinicians is whether the potential incremental benefits of intravenous immunoglobulin plus glucocorticoids to reduce severity of illness and accelerate resolution of fever are sufficient to justify the use of both agents.”
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