Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context
Summary: Background: The Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-stu...
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2025-01-01
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| author | Hans-Kittil Viermyr Kristian Tonby Erica Ponzi Sophie Trouillet-Assant Julien Poissy José R. Arribas Virginie Dyon-Tafani Maude Bouscambert-Duchamp Lambert Assoumou Bente Halvorsen Nuriye Basdag Tekin Alpha Diallo Lucie De Gastines Ludvig A. Munthe Sarah Louise Murphy Thor Ueland Annika E. Michelsen Fridtjof Lund-Johansen Pål Aukrust Joy Mootien Benjamin Dervieux Yoann Zerbib Jean-Christophe Richard Renaud Prével Denis Malvy Jean-François Timsit Nathan Peiffer-Smadja Damien Roux Lionel Piroth Hafid Ait-Oufella Cesar Vieira Olav Dalgard Lars Heggelund Karl Erik Müller Jannicke Horjen Møller Anders Benjamin Kildal Vegard Skogen Saad Aballi Jonas Daniel Sjøberg Øgaard Anne Ma Dyrhol-Riise Anders Tveita Amin Alirezaylavasani Dominique Costagliola Yazdan Yazdanpanah Inge Christoffer Olsen Tuva Børresdatter Dahl Hassen Kared Aleksander Rygh Holten Marius Trøseid |
| author_facet | Hans-Kittil Viermyr Kristian Tonby Erica Ponzi Sophie Trouillet-Assant Julien Poissy José R. Arribas Virginie Dyon-Tafani Maude Bouscambert-Duchamp Lambert Assoumou Bente Halvorsen Nuriye Basdag Tekin Alpha Diallo Lucie De Gastines Ludvig A. Munthe Sarah Louise Murphy Thor Ueland Annika E. Michelsen Fridtjof Lund-Johansen Pål Aukrust Joy Mootien Benjamin Dervieux Yoann Zerbib Jean-Christophe Richard Renaud Prével Denis Malvy Jean-François Timsit Nathan Peiffer-Smadja Damien Roux Lionel Piroth Hafid Ait-Oufella Cesar Vieira Olav Dalgard Lars Heggelund Karl Erik Müller Jannicke Horjen Møller Anders Benjamin Kildal Vegard Skogen Saad Aballi Jonas Daniel Sjøberg Øgaard Anne Ma Dyrhol-Riise Anders Tveita Amin Alirezaylavasani Dominique Costagliola Yazdan Yazdanpanah Inge Christoffer Olsen Tuva Børresdatter Dahl Hassen Kared Aleksander Rygh Holten Marius Trøseid |
| author_sort | Hans-Kittil Viermyr |
| collection | DOAJ |
| description | Summary: Background: The Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-study aimed to investigate whether vaccination influences the safety profile of baricitinib in patients with severe COVID-19. Methods: Biobanked samples from 146 participants (55 vaccinated vs. 91 unvaccinated) were analysed longitudinally for inflammation markers, humoral responses, tissue viral loads, and plasma viral antigens on days 1, 3, and 8. High-dimensional analyses, including RNA sequencing and flow cytometry, were performed on available samples. Mediation analyses were used to assess relationships between SAEs, baseline-adjusted biomarkers, and treatment-vaccination status. Findings: Vaccinated participants were older, more frequently hospitalized, had more comorbidities, and exhibited higher nasopharyngeal viral loads. Baricitinib treatment did not affect antibody responses or viral clearance, but reduced markers of T-cell and monocyte activation compared to placebo (sCD25, sCD14, sCD163, sTIM-3). Age, baseline levels of plasma viral antigen, and several inflammatory markers, as well as IL-2, IL-6, Neopterin, CXCL16, sCD14, and suPAR on day 8 were associated with the occurrence of SAEs. However, mediation analyses of markers linked to SAEs, baricitinib treatment, or vaccination status did not reveal statistically significant interactions between vaccination status and SAEs. Interpretation: This sub-study did not identify any virus- or host-related biomarkers significantly associated with the interaction between SARS-CoV-2 vaccination status and the safety of baricitinib. However, caution should be exercised due to the moderate sample size. Funding: EU Horizon 2020 (grant number 101015736). |
| format | Article |
| id | doaj-art-9801e7aeb3ca4aaca9fc85f927c59f12 |
| institution | Kabale University |
| issn | 2352-3964 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj-art-9801e7aeb3ca4aaca9fc85f927c59f122024-12-29T04:47:28ZengElsevierEBioMedicine2352-39642025-01-01111105511Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in contextHans-Kittil Viermyr0Kristian Tonby1Erica Ponzi2Sophie Trouillet-Assant3Julien Poissy4José R. Arribas5Virginie Dyon-Tafani6Maude Bouscambert-Duchamp7Lambert Assoumou8Bente Halvorsen9Nuriye Basdag Tekin10Alpha Diallo11Lucie De Gastines12Ludvig A. Munthe13Sarah Louise Murphy14Thor Ueland15Annika E. Michelsen16Fridtjof Lund-Johansen17Pål Aukrust18Joy Mootien19Benjamin Dervieux20Yoann Zerbib21Jean-Christophe Richard22Renaud Prével23Denis Malvy24Jean-François Timsit25Nathan Peiffer-Smadja26Damien Roux27Lionel Piroth28Hafid Ait-Oufella29Cesar Vieira30Olav Dalgard31Lars Heggelund32Karl Erik Müller33Jannicke Horjen Møller34Anders Benjamin Kildal35Vegard Skogen36Saad Aballi37Jonas Daniel Sjøberg Øgaard38Anne Ma Dyrhol-Riise39Anders Tveita40Amin Alirezaylavasani41Dominique Costagliola42Yazdan Yazdanpanah43Inge Christoffer Olsen44Tuva Børresdatter Dahl45Hassen Kared46Aleksander Rygh Holten47Marius Trøseid48Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, NorwayFaculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, NorwayDepartment of Research Support for Clinical Trials, Oslo University Hospital, Oslo, NorwayCentre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, Lyon, France; Joint Research Unit Hospices Civils de Lyon-bioMerieux S.A., Hôpital Lyon Sud, Pierre-Bénite, FranceUniversité Lille, Inserm U1285, CHU Lille, Pôle de Médecine Intensive-Réanimatin, CNRS, UMR 8576, France; Université Lille, Unité de Glycobiologie Structurale et Fonctionnelle (UGSF), F-59000, Lille, FranceInfectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, IdiPAZ, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, SpainCentre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, Lyon, FranceHospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des Virus Respiratoires France Sud, F-69317, Lyon, France; Université Claude Bernard Lyon 1, Virpath, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372, Lyon, FranceSorbonne Université, INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP), Paris, FranceResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, FranceANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, FranceDepartment of Immunology, Oslo University Hospital, Oslo, Norway; KG Jebsen Centre for B Cell Malignancies, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Thrombosis Research Center (TREC), Division of Internal Medicine, University Hospital of North Norway, Tromsø, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of Immunology, Oslo University Hospital, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayIntensive Care Unit, Antibiotic Stewardship Team, Groupe Hospitalier Région Mulhouse et Sud Alsace, Mulhouse, FranceInfectious Diseases Unit, Groupe Hospitalier Région Mulhouse et Sud Alsace, Mulhouse, FranceIntensive Care Department, Amiens-Picardie University Hospital, Amiens, FranceMedical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital - Université Lyon 1, Lyon, France; CREATIS INSERM 1044 CNRS 5220, Villeurbanne, FranceCHU Bordeaux, Medical Intensive Care Unit, Bordeaux, France; Univ Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, Inserm UMR 1045, Bordeaux, FranceDepartment of Infectious and Tropical Diseases, University Hospital, UMR 1219 Inserm/EMR 271 IRD, University of Bordeaux, Bordeaux, FranceAP-HP, Bichat Hospital, Medical and Infectious Diseases ICU (MI2), F-75018, Paris, France; Université Paris-Cité, INSERM, F-75018, Paris, France; OUCTOME REA Research Network, FranceUniversité Paris Cité, Inserm, IAME, Paris, 75018, France; Service de Maladies Infectieuses et Tropicales, Hôpital Bichat Claude Bernard, AP-HP, Paris, 75018, FranceUniversité Paris Cité, AP-HP, Hôpital Louis Mourier, DMU ESPRIT, Service de Médecine Intensive Réanimation, Colombes, FranceInfectious Diseases Department, University Hospital, Dijon, France; INSERM CIC 1432, University of Burgundy, Dijon, FranceService de Médecine Intensive-Réanimation, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, Paris, F-75012, FranceCentro Hospitalar Universitário de Lisboa Central, Hospital Curry Cabral, Department of Intensive Care Medicine - Lisbon, PortugalDepartment of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway; Department of Infectious Diseases, Akershus University Hospital, NorwayDepartment of Internal Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Norway; Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen, Bergen, NorwayDepartment of Internal Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Norway; Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen, Bergen, NorwayDepartment of Intensive Care Medicine, Stavanger University Hospital, Stavanger, NorwayDepartment of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UIT The Arctic University of Norway, NorwayDepartment of Infectious Diseases, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UIT The Arctic University of Norway, NorwayDepartment of Infectious Diseases, Østfold Hospital Kalnes, Grålum, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayFaculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway; Department of Internal Medicine, Bærum Hospital, Vestre Viken Hospital Trust, 1346, Gjettum, NorwayDepartment of Immunology, Oslo University Hospital, Oslo, NorwaySorbonne Université, INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP), Paris, FranceInfectious and Tropical Diseases Department, Bichat - Claude Bernard Hospital, AP-HP Nord-Université Paris Cité, Paris, France; IAME INSERM UMR 1137, Université Paris Cité, Paris, France; ANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, FranceDepartment of Research Support for Clinical Trials, Oslo University Hospital, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of Immunology, Oslo University Hospital, Oslo, Norway; KG Jebsen Centre for B Cell Malignancies, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway; Department of Acute Medicine, Oslo University Hospital, Oslo, NorwayResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway; Corresponding author. Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.Summary: Background: The Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-study aimed to investigate whether vaccination influences the safety profile of baricitinib in patients with severe COVID-19. Methods: Biobanked samples from 146 participants (55 vaccinated vs. 91 unvaccinated) were analysed longitudinally for inflammation markers, humoral responses, tissue viral loads, and plasma viral antigens on days 1, 3, and 8. High-dimensional analyses, including RNA sequencing and flow cytometry, were performed on available samples. Mediation analyses were used to assess relationships between SAEs, baseline-adjusted biomarkers, and treatment-vaccination status. Findings: Vaccinated participants were older, more frequently hospitalized, had more comorbidities, and exhibited higher nasopharyngeal viral loads. Baricitinib treatment did not affect antibody responses or viral clearance, but reduced markers of T-cell and monocyte activation compared to placebo (sCD25, sCD14, sCD163, sTIM-3). Age, baseline levels of plasma viral antigen, and several inflammatory markers, as well as IL-2, IL-6, Neopterin, CXCL16, sCD14, and suPAR on day 8 were associated with the occurrence of SAEs. However, mediation analyses of markers linked to SAEs, baricitinib treatment, or vaccination status did not reveal statistically significant interactions between vaccination status and SAEs. Interpretation: This sub-study did not identify any virus- or host-related biomarkers significantly associated with the interaction between SARS-CoV-2 vaccination status and the safety of baricitinib. However, caution should be exercised due to the moderate sample size. Funding: EU Horizon 2020 (grant number 101015736).http://www.sciencedirect.com/science/article/pii/S2352396424005474SARS-CoV-2 vaccinationCOVID-19Serious adverse eventsJAK/STAT-inhibitorImmunomodulationBaricitinib |
| spellingShingle | Hans-Kittil Viermyr Kristian Tonby Erica Ponzi Sophie Trouillet-Assant Julien Poissy José R. Arribas Virginie Dyon-Tafani Maude Bouscambert-Duchamp Lambert Assoumou Bente Halvorsen Nuriye Basdag Tekin Alpha Diallo Lucie De Gastines Ludvig A. Munthe Sarah Louise Murphy Thor Ueland Annika E. Michelsen Fridtjof Lund-Johansen Pål Aukrust Joy Mootien Benjamin Dervieux Yoann Zerbib Jean-Christophe Richard Renaud Prével Denis Malvy Jean-François Timsit Nathan Peiffer-Smadja Damien Roux Lionel Piroth Hafid Ait-Oufella Cesar Vieira Olav Dalgard Lars Heggelund Karl Erik Müller Jannicke Horjen Møller Anders Benjamin Kildal Vegard Skogen Saad Aballi Jonas Daniel Sjøberg Øgaard Anne Ma Dyrhol-Riise Anders Tveita Amin Alirezaylavasani Dominique Costagliola Yazdan Yazdanpanah Inge Christoffer Olsen Tuva Børresdatter Dahl Hassen Kared Aleksander Rygh Holten Marius Trøseid Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context EBioMedicine SARS-CoV-2 vaccination COVID-19 Serious adverse events JAK/STAT-inhibitor Immunomodulation Baricitinib |
| title | Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context |
| title_full | Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context |
| title_fullStr | Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context |
| title_full_unstemmed | Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context |
| title_short | Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trialResearch in context |
| title_sort | safety of baricitinib in vaccinated patients with severe and critical covid 19 sub study of the randomised bari solidact trialresearch in context |
| topic | SARS-CoV-2 vaccination COVID-19 Serious adverse events JAK/STAT-inhibitor Immunomodulation Baricitinib |
| url | http://www.sciencedirect.com/science/article/pii/S2352396424005474 |
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