Children with pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) who are treated with intravenous (IV) methylprednisolone do not have a statistically significant change in the length of their hospitalization vs those treated with IV immunoglobulin therapy. These study results were published in The Lancet Child & Adolescent Health.
Researchers conducted an open-label, randomized, 2-arm trial between May 21, 2021, and April 15, 2022, of children hospitalized with PIMS-TS at 10 pediatric hospitals in Switzerland. Participants were included in the study if they had fever and inflammation, organ dysfunction, no other probable disease, andwere suspected of having COVID-19.
The study participants (N=75) were randomly assigned in a 1:1 ratio to the IV methylprednisolone cohort (n=37; 10 mg/kg per day for 3 days) or the IV immunoglobulin cohort (n=38; 2 g/kg as a single dose via long infusion). The primary objective was to determine the length of hospitalization in each cohort. The researchers compared the log-transformed time from admission to discharge for both cohorts through a two-sided t-test. They also performed a Bayesian analysis of the primary outcome.
Participants in the methylprednisolone cohort had a median age of 8.9 years, while the immunoglobulin cohort had a median age of 9.4 years. Those in the methylprednisolone cohort were primarily 78% boys and 84% White. Kawasaki disease (41%), followed by an undifferentiated phenotype (32%), and shock (27%) were the main types of PIMS-ST noted in the methylprednisolone cohort. Participants in the immunoglobulin cohort were predominantly boys (71%) and White (74%). In this cohort, Kawasaki disease (42%), an undifferentiated phenotype (32%), and shock (26%) were the main types of PIMS-ST.
The medium length of hospitalization was 6.0 days (IQR, 4.0-8.0) in the methylprednisolone cohort and 6.0 days (IQR, 5.0-8.8) in the immunoglobulin cohort. No participants died from either cohort (95% CI, -0.13 to 0.065; P =0.42). Overall, those in the methylprednisolone cohort needed less respiratory support than those in the immunoglobulin cohort (27% vs 55%, respectively). There was no statistical difference between cohorts for major bleeding, thrombotic events, or intensive care unit admission rates.
Limitations of the study include the limited sample size and the open-label nature of the research. Some participants also did not give consent for comparison.
The researchers conclude, “Given the scarce availability of intravenous immunoglobulins around the world, our findings add to evidence that intravenous methylprednisolone could be an acceptable first-line treatment in children with PIMS-TS, in addition to supportive care, considering that it is more affordable and more widely available globally than intravenous immunoglobulins.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Welzel T, Atkinson A, Schöbi N, et al. Methylprednisolone versus intravenous immunoglobulins in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-COV-2 (PIMS-TS): An open-label, multicentre, randomised trial. The Lanc Child & Adoles Health. Published online February 3, 2023. doi:10.1016/s2352-4642(23)00020-2