1. 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 trialResearch in context
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Maya C. Andre, Carlos Sanchez, Sabrina Bressieux-Degueldre, Marie-Helene Perez, Daniela Wütz, Geraldine Blanchard-Rohner, Serge Grazioli, Nina Schöbi, Johannes Trück, Tatjana Welzel, Andrew Atkinson, Luregn J. Schlapbach, Julia Bielicki, Henrik Koehler, Spyridoula Gysi, Indra Janz, Andreas Bieri, Birgit Donner, Jürg Hammer, Ulrich Heininger, Clemens von Kalckreuth, Malte Kohns, Nicole Mettauer, Alexandra Meyer, Diana Reppucci, Chloé Schlaeppi, Daniel Trachsel, Nina Vaezipour, Andreas Woerner, Andreas Zutter, Federica Vanoni, Lisa Kottanattu, Calogero Mazzara, Alessia Severi Conti, Christoph Aebi, Philipp Agyeman, Andrea Duppenthaler, Martin Glöckler, Sabine Pallivathukal, Thomas Riedel, Petra Zimmermann, Hong-Phuc Cudré-Cung, Mladen Pavlovic, Alice Bordessoule, Anne-Laure Martin, Angelo Polito, Noemie Wagner, Marie Rohr, Arnaud L'Huillier, Vivianne Amiet, Thomas Ferry, David Longchamp, Julia Natterer, Rebecca Oppenheim, Michael Hofer, Michael Buettcher, Katharina Wechselberger, Alex Donas, Sara Germann, Michaela Lütolf Erni, Daniela Kaiser, Katharina Schwendener Scholl, Hans Peter Kuen, Katja Hrup, Janine Stritt, Douggl G.N. Bailey, Tanja Wachinger, Ingrid Beck, André Birkenmaier, Bjarte Rogdo, Philip Lorenz, Ivo Iglowstein, Konstanze Zöhrer, Martin Flade, Seraina Prader, Jana Pachlopnik Schmid, Michelle Seiler, Patrick Meyer Sauteur, Barbara Brotschi, Kathrin Weber, Elizabeth Whittaker, and Saul N. Faust
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Children ,Immunoglobulins ,PIMS-TS ,Methylprednisolone ,RCT ,Coronary artery aneurysm ,Medicine (General) ,R5-920 - Abstract
Summary: 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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- 2024
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