IVIG Plus Glucocorticoids Effective for Treating COVID-19 Pediatric Syndrome

A large multicenter clinical trial has found intravenous immune globulin (IVIG) plus glucocorticoids may be better than IVIG alone for treating multisystem inflammatory syndrome in children (MIS-C) caused by COVID-19.

In the study, 596 patients with MIS-C were treated at one of 58 U.S. hospitals, 87 percent (518) of whom were treated with at least one immunomodulatory agent. The median age of the patients was 8.7 years. More than half of the patients (286; 55 percent) had involvement of five or more organ systems, and 196 (38 percent) met the complete or incomplete criteria for Kawasaki disease, a vasculitis of childhood that the investigators noted has some overlapping presentations with MIS-C and responds well to IVIG therapy, the standard of care for the disease.

The primary outcome of the study was cardiovascular dysfunction, a composite of left ventricular dysfunction or shock resulting in the use of vasopressors, on or after day two of therapy. Secondary outcomes included the need for adjunctive treatments such as a glucocorticoid in patients not already receiving them, a biologic or a second dose of IVIG, and a persistent or recurrent fever.

Results showed initial treatment with IVIG plus glucocorticoids (103 patients) was associated with a lower risk for cardiovascular dysfunction on or after day two than IVIG alone (103 patients). The risks of the components of the composite outcome also were lower among those who received IVIG plus glucocorticoids: Left ventricular dysfunction occurred in 8 percent and 17 percent of the patients, respectively. The incidence of shock resulting in vasopressor use also was lower in the IVIG plus glucocorticoid regimen: 13 percent versus 24 percent with IVIG alone. The use of adjunctive therapy was lower among patients who received IVIG plus glucocorticoids than among those who received IVIG alone (34 percent vs. 70 percent), but the risk for fever was unaffected (31 percent and 40 percent).

Methylprednisolone was the most common glucocorticoid prescribed (353 patients; 68 percent), administered at a dose of 2 mg/kg of body weight per day in 284 of the patients (80 percent), and in pulse doses of 10 mg/kg to 30 mg/kg of body weight per day in 69 patients (20 percent).

The researchers acknowledged earlier studies have shown glucocorticoids and IVIG may be an effective regimen for MIS-C. But in many cases, the studies included fewer patients and less pronounced results. A French study, for example, “suggested” a lower incidence of cardiovascular dysfunction. “In our larger U.S. cohort, we confirmed that cardiovascular function was better, and the incidence of administration of adjunctive treatments was lower” among patients given the combined regimen versus those given IVIG alone.