Independent masked adjudication of intercurrent events of additional anti-inflammatory treatment according to three clinical phenotypes of Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS)
| IVMP | IVIG | P value | |||
| Entire trial cohort, n=75 | n=37 | n=38 | 0.04 | ||
| ICE | None | 13 (35%) | 21 (55%) | ||
| Indicated | 13 (35%) | 14 (37%) | |||
| Non-indicated | 11 (30%) | 3 (8%) | |||
| Shock-like, n=20 | n=10 | n=10 | 0.77 | ||
| ICE | None | 2 (20%) | 3 (30%) | ||
| Indicated | 6 (60%) | 6 (60%) | |||
| Non-indicated | 2 (20%) | 1 (10%) | |||
| Kawasaki disease-like, n=31 | n=15 | n=16 | 0.10 | ||
| ICE | None | 9 (60%) | 8 (50%) | ||
| Indicated | 2 (13%) | 7 (44%) | |||
| Non-indicated | 4 (27%) | 1 (6%) | |||
| Undifferentiated, n=24 | n=12 | n=12 | 0.004 | ||
| ICE | None | 2 (16%) | 10 (84%) | ||
| Indicated | 5 (42%) | 1 (8%) | |||
| Non-indicated | 5 (42%) | 1 (8%) | |||
Considering the non-indicated ICEs among patients classified as having Kawasaki disease-like and undifferentiated PIMS-TS at baseline, all were considered to be Kawasaki disease-like at the time of ICE; among patients with undifferentiated PIMS-TS at baseline and non-indicated ICEs, three episodes were reclassified as Kawasaki disease-like PIMS-TS at the time of the ICE, one was considered to be Shock-like PIMS-TS with improvement and one was considered undifferentiated PIMS-TS.
ICE, intercurrent event; IVIG, intravenous immunoglobulin; IVMP, intravenous methylprednisolone.