Safety of baricitinib in vaccinated patients with severe and
critical COVID-19 sub study of the randomised Bari-SolidAct
trial

J 2025

Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial

VIERMYR, Hans-Kittil; Kristian TONBY; Erica PONZI; Sophie TROUILLET-ASSANT; Julien POISSY et al.

Základní údaje

Originální název

Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial

Autoři

VIERMYR, Hans-Kittil; Kristian TONBY; Erica PONZI; Sophie TROUILLET-ASSANT; Julien POISSY; Jose R ARRIBAS; Virginie DYON-TAFANI; Maude BOUSCAMBERT-DUCHAMP; Lambert ASSOUMOU; Bente HALVORSEN; Nuriye Basdag TEKIN; Alpha DIALLO; De Gastines LUCIE; Ludvig A MUNTHE; Sarah Louise MURPHY; Thor UELAND; Annika E MICHELSEN; Fridtjof LUND-JOHANSEN; Pal AUKRUST; Joy MOOTIEN; Benjamin DERVIEUX; Yoann ZERBIB; Jean-Christophe RICHARD; Renaud PREVEL; Denis MALVY; Jean-Francois TIMSIT; Nathan PEIFFER-SMADJA; Damien ROUX; Lionel PIROTH; Hafid AIT-OUFELLA; Cesar VIEIRA; Olav DALGARD; Lars HEGGELUND; Karl Erik MULLER; Jannicke Horjen MOLLER; Anders Benjamin KILDAL; Vegard SKOGEN; Saad ABALLI; Jonas Daniel Sjoberg OGAARD; Anne Ma DYRHOL-RIISE; Anders TVEITA; Amin ALIREZAYLAVASANI; Dominique COSTAGLIOLA; Yazdan YAZDANPANAH; Inge Christoffer OLSEN; Tuva Borresdatter DAHL; Hassen KARED; Aleksander Rygh HOLTEN a Marius TROSEID

Vydání

EBioMedicine, Amsterdam, Elsevier Science BV, 2025, 2352-3964

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Bari-SolidAct

Impakt faktor

Impact factor: 10.800 v roce 2024

Organizační jednotka

CZECRIN IV

DOI

https://doi.org/10.1016/j.ebiom.2024.105511

UT WoS

001405593800001

Klíčová slova česky

SARS-CoV-2 vaccination; COVID-19; Serious adverse events; JAK/STAT-inhibitor; Immunomodulation; Baricitinib; Inflammation

Klíčová slova anglicky

SARS-CoV-2 vaccination; COVID-19; Serious adverse events; JAK/STAT-inhibitor; Immunomodulation; Baricitinib; Inflammation

Štítky

Excelence Science, RIV, user, článek v časopise

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 19. 1. 2026 14:13, Bc. Hana Vladíková, BBA

Anotace

V originále

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-2vaccinated 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 fl ow 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). Copyright (c) 2024 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

Návaznosti

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

@article{2548378,
   author = {Viermyr, HansandKittil and Tonby, Kristian and Ponzi, Erica and TrouilletandAssant, Sophie and Poissy, Julien and Arribas, Jose R and DyonandTafani, Virginie and BouscambertandDuchamp, Maude and Assoumou, Lambert and Halvorsen, Bente and Tekin, Nuriye Basdag and Diallo, Alpha and Lucie, De Gastines and Munthe, Ludvig A and Murphy, Sarah Louise and Ueland, Thor and Michelsen, Annika E and LundandJohansen, Fridtjof and Aukrust, Pal and Mootien, Joy and Dervieux, Benjamin and Zerbib, Yoann and Richard, JeanandChristophe and Prevel, Renaud and Malvy, Denis and Timsit, JeanandFrancois and PeifferandSmadja, Nathan and Roux, Damien and Piroth, Lionel and AitandOufella, Hafid and Vieira, Cesar and Dalgard, Olav and Heggelund, Lars and Muller, Karl Erik and Moller, Jannicke Horjen and Kildal, Anders Benjamin and Skogen, Vegard and Aballi, Saad and Ogaard, Jonas Daniel Sjoberg and DyrholandRiise, Anne Ma and Tveita, Anders and Alirezaylavasani, Amin and Costagliola, Dominique and Yazdanpanah, Yazdan and Olsen, Inge Christoffer and Dahl, Tuva Borresdatter and Kared, Hassen and Holten, Aleksander Rygh and Troseid, Marius},
   article_location = {Amsterdam},
   article_number = {na},
   doi = {https://doi.org/10.1016/j.ebiom.2024.105511},
   keywords = {SARS-CoV-2 vaccination; COVID-19; Serious adverse events; JAK/STAT-inhibitor; Immunomodulation; Baricitinib; Inflammation},
   language = {eng},
   issn = {2352-3964},
   journal = {EBioMedicine},
   title = {Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial},
   url = {https://www.sciencedirect.com/science/article/pii/S2352396424005474?pes=vor&utm_source=clarivate&getft_integrator=clarivate},
   volume = {111},
   year = {2025}
}

TY  - JOUR
ID  - 2548378
AU  - Viermyr, Hans-Kittil - Tonby, Kristian - Ponzi, Erica - Trouillet-Assant, Sophie - Poissy, Julien - Arribas, Jose R - Dyon-Tafani, Virginie - Bouscambert-Duchamp, Maude - Assoumou, Lambert - Halvorsen, Bente - Tekin, Nuriye Basdag - Diallo, Alpha - Lucie, De Gastines - Munthe, Ludvig A - Murphy, Sarah Louise - Ueland, Thor - Michelsen, Annika E - Lund-Johansen, Fridtjof - Aukrust, Pal - Mootien, Joy - Dervieux, Benjamin - Zerbib, Yoann - Richard, Jean-Christophe - Prevel, Renaud - Malvy, Denis - Timsit, Jean-Francois - Peiffer-Smadja, Nathan - Roux, Damien - Piroth, Lionel - Ait-Oufella, Hafid - Vieira, Cesar - Dalgard, Olav - Heggelund, Lars - Muller, Karl Erik - Moller, Jannicke Horjen - Kildal, Anders Benjamin - Skogen, Vegard - Aballi, Saad - Ogaard, Jonas Daniel Sjoberg - Dyrhol-Riise, Anne Ma - Tveita, Anders - Alirezaylavasani, Amin - Costagliola, Dominique - Yazdanpanah, Yazdan - Olsen, Inge Christoffer - Dahl, Tuva Borresdatter - Kared, Hassen - Holten, Aleksander Rygh - Troseid, Marius
PY  - 2025
TI  - Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial
JF  - EBioMedicine
VL  - 111
IS  - na
SP  - 1-15
EP  - 1-15
PB  - Elsevier Science BV
SN  - 23523964
KW  - SARS-CoV-2 vaccination
KW  - COVID-19
KW  - Serious adverse events
KW  - JAK/STAT-inhibitor
KW  - Immunomodulation
KW  - Baricitinib
KW  - Inflammation
UR  - https://www.sciencedirect.com/science/article/pii/S2352396424005474?pes=vor&utm_source=clarivate&getft_integrator=clarivate
N2  - 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-2vaccinated 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 fl ow 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). Copyright (c) 2024 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
ER  -

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