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Cardiac assessment and inflammatory markers in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV2 (PIMS-TS) treated with methylprednisolone versus intravenous immunoglobulins: 6-month follow-up outcomes of the randomised controlled Swissped RECOVERY trial.
Andre, Maya C; Sanchez, Carlos; Bressieux-Degueldre, Sabrina; Perez, Marie-Helene; Wütz, Daniela; Blanchard-Rohner, Geraldine; Grazioli, Serge; Schöbi, Nina; Trück, Johannes; Welzel, Tatjana; Atkinson, Andrew; Schlapbach, Luregn J; Bielicki, Julia.
Afiliación
  • Andre MC; Division of Respiratory and Critical Care Medicine, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
  • Sanchez C; Department of Pediatric Haematology and Oncology, University Children's Hospital, Eberhard Karls University, Tuebingen, Germany.
  • Bressieux-Degueldre S; Paediatric Research Centre, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
  • Perez MH; Paediatric Cardiology Unit, Department of Women-Mother-Child, University Hospital of Lausanne and Lausanne University, Lausanne, Switzerland.
  • Wütz D; Paediatric Intensive and Intermediate Care Units, Department of Women-Mother-Child, University Hospital of Lausanne and Lausanne University, Lausanne, Switzerland.
  • Blanchard-Rohner G; Division of Pediatric Cardiology, Pediatric Heart Center, University Children's Hospital Zurich, Zurich, Switzerland.
  • Grazioli S; Pediatric Immunology and Vaccinology Unit, Division of General Pediatrics, Department of Child, Woman and Adolescent Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
  • Schöbi N; Division of Neonatal and Pediatric Intensive Care, Department of Child, Woman and Adolescent Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
  • Trück J; Division of Pediatric Infectious Diseases, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Welzel T; Divisions of Allergy and Immunology and Children's Research Center, University Children's Hospital Zurich, University of Zurich (UZH), Zurich, Switzerland.
  • Atkinson A; Paediatric Research Centre, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
  • Schlapbach LJ; Pediatric Rheumatology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
  • Bielicki J; Paediatric Research Centre, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
EClinicalMedicine ; 67: 102358, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38107550
ABSTRACT

Background:

Previous findings from the Swissped RECOVERY trial showed that patients with Pediatric Inflammatory Multisystem Syndrome-Temporally Associated with SARS-CoV-2 (PIMS-TS) who were randomly assigned to intravenous immunoglobulins or methylprednisolone have a comparable length of hospital stay. Here, we report the 6-month follow-up outcomes of cardiac pathologies and normalisation of clinical or laboratory signs of inflammation from this study population.

Methods:

This pre-planned follow-up of patients with PIMS-TS included the Swissped RECOVERY Trial reports on the 6-month outcomes of the cohort after randomisation, with a focus on cardiac, haematological, and biochemical findings. The trial was an investigator-initiated randomised multicentre open-label two-arm trial in children and adolescents hospitalised with PIMS-TS at ten hospitals in Switzerland. Cardiological assessments and laboratory analyses were prospectively collected in the intention-to-treat analysis on pre-defined intervals after hospital discharge. Differences between randomised arms were investigated using Chi-square test for categorical and Wilcoxon test for continuous variables. The trial is registered with the Swiss National Clinical Trials Portal (SNCTP000004720) and ClinicalTrials.gov (NCT04826588).

Findings:

Between May 21, 2021 and April 15, 2022, 75 patients with a median age of 9.1 years (IQR 6.2-12.2) were included in the intention-to-treat population (37 in the methylprednisolone group and 38 in the intravenous immunoglobulin group). During follow-up, the incidence of abnormal left ventricular systolic function, coronary artery aneurysms (CAA), and other signs of inflammation were comparable in both groups. However, we detected cardiac abnormalities with low incidence and a mild degree grade of pathology. CAAs were observed in 2/38 children (5.3%) in the IVIG group and 1/37 children (2.7%) in the methylprednisolone group at 6-month follow-up (difference proportion 0.75; 95% confidence interval (CI) -0.05 to 1.0; p = 0.39).

Interpretation:

Methylprednisolone alone may be an acceptable first-line treatment as left ventricular systolic dysfunction and clinical/laboratory evidence for inflammation quickly resolved in all children. However, our findings need further confirmation through larger studies as our sample size is likely to be of insufficient power to address rare clinically relevant adverse outcomes.

Funding:

NOMIS, Vontobel, and Gaydoul Foundation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EClinicalMedicine Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EClinicalMedicine Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido