Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome
Introduction: COVID-19 morbimortality is mainly associated with development of severe acute respiratory syndrome (SARS), which has been related to an augmented immune response of the host with elevated circulating cytokines. Methods: In this is a prospective, multicenter, single arm (compared with a...
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Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
2021
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| Acceso en línea: | https://revistas.unc.edu.ar/index.php/med/article/view/32800 |
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I10-R10-article-32800 |
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Universidad Nacional de Córdoba |
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Revistas de la UNC |
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Inglés |
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Artículo revista |
| topic |
coronavirus infections Janus kinase inhibitors respiratory distress syndrome, adult infecciones por coronavirus inhibidores de las cinasas Janus síndrome de dificultad respiratoria del adulto infecções por coronavirus inibidores de janus quinases síndrome do desconforto respiratório do adulto |
| spellingShingle |
coronavirus infections Janus kinase inhibitors respiratory distress syndrome, adult infecciones por coronavirus inhibidores de las cinasas Janus síndrome de dificultad respiratoria del adulto infecções por coronavirus inibidores de janus quinases síndrome do desconforto respiratório do adulto Iastrebner, Marcelo Castro, Joaquín García Espina, Edgardo Lettieri, Carolina Payaslian, Silvio Cuesta, María Celia Gutiérrez Fernández, Pablo Mandrile, Araceli Contreras, Angela Paola Gervasoni, Sebastián Verde, Gabriel Galetti, Cayetano Minoldo, Estefanía Caruso, Vanesa Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| topic_facet |
coronavirus infections Janus kinase inhibitors respiratory distress syndrome, adult infecciones por coronavirus inhibidores de las cinasas Janus síndrome de dificultad respiratoria del adulto infecções por coronavirus inibidores de janus quinases síndrome do desconforto respiratório do adulto |
| author |
Iastrebner, Marcelo Castro, Joaquín García Espina, Edgardo Lettieri, Carolina Payaslian, Silvio Cuesta, María Celia Gutiérrez Fernández, Pablo Mandrile, Araceli Contreras, Angela Paola Gervasoni, Sebastián Verde, Gabriel Galetti, Cayetano Minoldo, Estefanía Caruso, Vanesa |
| author_facet |
Iastrebner, Marcelo Castro, Joaquín García Espina, Edgardo Lettieri, Carolina Payaslian, Silvio Cuesta, María Celia Gutiérrez Fernández, Pablo Mandrile, Araceli Contreras, Angela Paola Gervasoni, Sebastián Verde, Gabriel Galetti, Cayetano Minoldo, Estefanía Caruso, Vanesa |
| author_sort |
Iastrebner, Marcelo |
| title |
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| title_short |
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| title_full |
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| title_fullStr |
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| title_full_unstemmed |
Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome |
| title_sort |
ruxolitinib in severe covid-19: results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with covid-19 and severe acute respiratory syndrome |
| description |
Introduction: COVID-19 morbimortality is mainly associated with development of severe acute respiratory syndrome (SARS), which has been related to an augmented immune response of the host with elevated circulating cytokines. Methods: In this is a prospective, multicenter, single arm (compared with a historical control), add-on, experimental phase 2 study, ruxolitinib 5 mg BID was added to standard of care in COVID-19 patients. Main objective was to determine efficacy and safety of ruxolitinib in patients with COVID-19-related SARS. Results: Even though we could not show a significant reduction of COVID-19 pneumonia patients requiring intensive care unit admission and mechanical ventilation (primary endpoint), a trend to a lower mortality rate in critical ill patients receiving ruxolitinib was reported. Administered ruxolitinib dose had to be increased according to protocol in 32% of patients, without additional toxicity. Conclusion: Side effects profile was manageable, and no direct organ injury was caused by the study drug. Ruxolitinib had a fast anti-inflammatory effect, and one-third of patients felt well immediately after starting treatment. |
| publisher |
Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología |
| publishDate |
2021 |
| url |
https://revistas.unc.edu.ar/index.php/med/article/view/32800 |
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I10-R10-article-328002021-12-30T12:19:16Z Ruxolitinib in severe COVID-19: Results of a multicenter, prospective, single arm, open-label clinical study to investigate the efficacy and safety of ruxolitinib in patients with COVID-19 and severe acute respiratory syndrome Ruxolitinib en COVID-19 grave: Resultados de un estudio multicéntrico, prospectivo, de brazo único y diseño abierto para evaluar la eficacia y seguridad del ruxolitinib en pacientes con COVID-19 y síndrome respiratorio agudo grave Ruxolitinibe em COVID-19 grave: Resultados de um estudo aberto, multicêntrico, prospectivo, de braço único para avaliar a eficácia e segurança de ruxolitinibe em pacientes com COVID-19 e síndrome respiratória aguda grave Iastrebner, Marcelo Castro, Joaquín García Espina, Edgardo Lettieri, Carolina Payaslian, Silvio Cuesta, María Celia Gutiérrez Fernández, Pablo Mandrile, Araceli Contreras, Angela Paola Gervasoni, Sebastián Verde, Gabriel Galetti, Cayetano Minoldo, Estefanía Caruso, Vanesa coronavirus infections Janus kinase inhibitors respiratory distress syndrome, adult infecciones por coronavirus inhibidores de las cinasas Janus síndrome de dificultad respiratoria del adulto infecções por coronavirus inibidores de janus quinases síndrome do desconforto respiratório do adulto Introduction: COVID-19 morbimortality is mainly associated with development of severe acute respiratory syndrome (SARS), which has been related to an augmented immune response of the host with elevated circulating cytokines. Methods: In this is a prospective, multicenter, single arm (compared with a historical control), add-on, experimental phase 2 study, ruxolitinib 5 mg BID was added to standard of care in COVID-19 patients. Main objective was to determine efficacy and safety of ruxolitinib in patients with COVID-19-related SARS. Results: Even though we could not show a significant reduction of COVID-19 pneumonia patients requiring intensive care unit admission and mechanical ventilation (primary endpoint), a trend to a lower mortality rate in critical ill patients receiving ruxolitinib was reported. Administered ruxolitinib dose had to be increased according to protocol in 32% of patients, without additional toxicity. Conclusion: Side effects profile was manageable, and no direct organ injury was caused by the study drug. Ruxolitinib had a fast anti-inflammatory effect, and one-third of patients felt well immediately after starting treatment. Introducción: La morbimortalidad por COVID-19 se asocia principalmente con el síndrome respiratorio agudo severo (SARS), relacionado con una respuesta inmunitaria aumentada del huésped con aumento de los niveles circulantes de citoquinas. Métodos: En este estudio prospectivo, multicéntrico, de un solo brazo (en comparación con un control histórico), en fase 2, se agregó ruxolitinib 5 mg dos veces al día al estándar de tratamiento en pacientes con COVID-19. El objetivo principal fue determinar la eficacia y seguridad de ruxolitinib en pacientes con SARS relacionado con COVID-19. Resultados: aunque no fue posible demostrar una reducción significativa de la proporción de pacientes con neumonía por COVID-19 que requerían ingreso en la unidad de cuidados intensivos y ventilación mecánica (criterio de valoración principal), se observó una tendencia a una menor tasa de mortalidad en los pacientes críticos que recibieron ruxolitinib. La dosis de ruxolitinib administrada tuvo que aumentarse de acuerdo con el protocolo en el 32% de los pacientes, sin toxicidad adicional. Conclusión: El perfil de efectos secundarios fue manejable y el fármaco en estudio no causó lesiones orgánicas directas. El ruxolitinib tuvo un efecto antiinflamatorio rápido y un tercio de los pacientes manifestó bienestar inmediatamente después de comenzar el tratamiento. Introdução: A morbidade e mortalidade por COVID-19 estão principalmente associadas à síndrome respiratória aguda grave (SARS), relacionada a um aumento da resposta imune do hospedeiro com aumento dos níveis circulantes de citocinas. Métodos: Neste estudo prospectivo, multicêntrico, de braço único (comparado a um controle histórico), na fase 2, ruxolitinibe 5 mg duas vezes ao dia foi adicionado ao padrão de tratamento em pacientes com COVID-19. O objetivo principal foi determinar a eficácia e segurança de ruxolitinibe em pacientes com SARS relacionada ao COVID-19. Resultados: Embora não tinha sido possível demonstrar uma redução significativa na proporção de pacientes com pneumonia pela COVID-19 que requereram admissão na unidade de terapia intensiva e ventilação mecânica (desfecho primário), uma tendência a uma taxa de mortalidade mais baixa foi observada em pacientes gravemente enfermos que receberam ruxolitinibe. A dose administrada teve que ser aumentada de acordo com o protocolo em 32% dos pacientes, sem toxicidade adicional. Conclusão: O perfil de efeitos colaterais foi controlável e o medicamento do estudo não causou dano orgânico direto. O ruxolitinibe teve um efeito anti-inflamatório rápido e um terço dos pacientes relatou bem-estar imediatamente após o início do tratamento. Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2021-09-07 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf text/html https://revistas.unc.edu.ar/index.php/med/article/view/32800 Revista de la Facultad de Ciencias Médicas de Córdoba.; Vol. 78 No. 3 (2021); 294-302 Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 78 Núm. 3 (2021); 294-302 Revista da Faculdade de Ciências Médicas de Córdoba; v. 78 n. 3 (2021); 294-302 1853-0605 0014-6722 10.31053/1853.0605.v78.n3 eng https://revistas.unc.edu.ar/index.php/med/article/view/32800/35159 https://revistas.unc.edu.ar/index.php/med/article/view/32800/35160 Derechos de autor 2021 Universidad Nacional de Córdoba http://creativecommons.org/licenses/by-nc/4.0 |