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Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

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Harvard

Kalil, AC, Patterson, TF, Mehta, AK, Tomashek, KM, Wolfe, CR, Ghazaryan, V, Marconi, VC, Ruiz-Palacios, GM, Hsieh, L, Kline, S, Tapson, V, Iovine, NM, Jain, MK, Sweeney, DA, El Sahly, HM, Branche, AR, Regalado Pineda, J, Lye, DC, Sandkovsky, U, Luetkemeyer, AF, Cohen, SH, Finberg, RW, Jackson, PEH, Taiwo, B, Paules, CI, Arguinchona, H, Erdmann, N, Ahuja, N, Frank, M, Oh, M-D, Kim, E-S, Tan, SY, Mularski, RA, Nielsen, H, Ponce, PO, Taylor, BS, Larson, L, Rouphael, NG, Saklawi, Y, Cantos, VD, Ko, ER, Engemann, JJ, Amin, AN, Watanabe, M, Billings, J, Elie, M-C, Davey, RT, Burgess, TH, Ferreira, J, Green, M, Makowski, M, Cardoso, A, Bono, de, S, Bonnett, T, Proschan, M, Deye, GA, Dempsey, W, Nayak, SU, Dodd, LE, Beigel, JH, ACTT-2 Study Group Members, Lundgren, JD, Murray, DD & Østergaard Jensen, T 2021, 'Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19', The New England journal of medicine, bind 384, nr. 9, s. 795-807. https://doi.org/10.1056/NEJMoa2031994

APA

Kalil, A. C., Patterson, T. F., Mehta, A. K., Tomashek, K. M., Wolfe, C. R., Ghazaryan, V., Marconi, V. C., Ruiz-Palacios, G. M., Hsieh, L., Kline, S., Tapson, V., Iovine, N. M., Jain, M. K., Sweeney, D. A., El Sahly, H. M., Branche, A. R., Regalado Pineda, J., Lye, D. C., Sandkovsky, U., ... Østergaard Jensen, T. (2021). Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. The New England journal of medicine, 384(9), 795-807. https://doi.org/10.1056/NEJMoa2031994

CBE

Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh M-D, Kim E-S, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie M-C, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, Bono, de S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH, ACTT-2 Study Group Members, Lundgren JD, Murray DD, Østergaard Jensen T. 2021. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. The New England journal of medicine. 384(9):795-807. https://doi.org/10.1056/NEJMoa2031994

MLA

Vancouver

Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V o.a. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. The New England journal of medicine. 2021 mar 4;384(9):795-807. https://doi.org/10.1056/NEJMoa2031994

Author

Kalil, Andre C ; Patterson, Thomas F ; Mehta, Aneesh K ; Tomashek, Kay M ; Wolfe, Cameron R ; Ghazaryan, Varduhi ; Marconi, Vincent C ; Ruiz-Palacios, Guillermo M ; Hsieh, Lanny ; Kline, Susan ; Tapson, Victor ; Iovine, Nicole M ; Jain, Mamta K ; Sweeney, Daniel A ; El Sahly, Hana M ; Branche, Angela R ; Regalado Pineda, Justino ; Lye, David C ; Sandkovsky, Uriel ; Luetkemeyer, Anne F ; Cohen, Stuart H ; Finberg, Robert W ; Jackson, Patrick E H ; Taiwo, Babafemi ; Paules, Catharine I ; Arguinchona, Henry ; Erdmann, Nathaniel ; Ahuja, Neera ; Frank, Maria ; Oh, Myoung-Don ; Kim, Eu-Suk ; Tan, Seow Y ; Mularski, Richard A ; Nielsen, Henrik ; Ponce, Philip O ; Taylor, Barbara S ; Larson, LuAnn ; Rouphael, Nadine G ; Saklawi, Youssef ; Cantos, Valeria D ; Ko, Emily R ; Engemann, John J ; Amin, Alpesh N ; Watanabe, Miki ; Billings, Joanne ; Elie, Marie-Carmelle ; Davey, Richard T ; Burgess, Timothy H ; Ferreira, Jennifer ; Green, Michelle ; Makowski, Mat ; Cardoso, Anabela ; Bono, de, Stephanie ; Bonnett, Tyler ; Proschan, Michael ; Deye, Gregory A ; Dempsey, Walla ; Nayak, Seema U ; Dodd, Lori E ; Beigel, John H ; ACTT-2 Study Group Members ; Lundgren, Jens Dilling ; Murray, Daniel D. ; Østergaard Jensen, Tomas. / Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. I: The New England journal of medicine. 2021 ; Bind 384, Nr. 9. s. 795-807.

Bibtex

@article{a53f210241c14ccebf80dd551776c352,
title = "Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19",
abstract = "BACKGROUND: Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.METHODS: We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.RESULTS: A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).CONCLUSIONS: Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).",
keywords = "Adenosine Monophosphate/adverse effects, Adult, Aged, Alanine/adverse effects, Antiviral Agents/adverse effects, Azetidines/adverse effects, COVID-19/drug therapy, Double-Blind Method, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Janus Kinase Inhibitors/adverse effects, Male, Middle Aged, Oxygen Inhalation Therapy, Purines/adverse effects, Pyrazoles/adverse effects, Respiration, Artificial, Sulfonamides/adverse effects, Treatment Outcome",
author = "Kalil, {Andre C} and Patterson, {Thomas F} and Mehta, {Aneesh K} and Tomashek, {Kay M} and Wolfe, {Cameron R} and Varduhi Ghazaryan and Marconi, {Vincent C} and Ruiz-Palacios, {Guillermo M} and Lanny Hsieh and Susan Kline and Victor Tapson and Iovine, {Nicole M} and Jain, {Mamta K} and Sweeney, {Daniel A} and {El Sahly}, {Hana M} and Branche, {Angela R} and {Regalado Pineda}, Justino and Lye, {David C} and Uriel Sandkovsky and Luetkemeyer, {Anne F} and Cohen, {Stuart H} and Finberg, {Robert W} and Jackson, {Patrick E H} and Babafemi Taiwo and Paules, {Catharine I} and Henry Arguinchona and Nathaniel Erdmann and Neera Ahuja and Maria Frank and Myoung-Don Oh and Eu-Suk Kim and Tan, {Seow Y} and Mularski, {Richard A} and Henrik Nielsen and Ponce, {Philip O} and Taylor, {Barbara S} and LuAnn Larson and Rouphael, {Nadine G} and Youssef Saklawi and Cantos, {Valeria D} and Ko, {Emily R} and Engemann, {John J} and Amin, {Alpesh N} and Miki Watanabe and Joanne Billings and Marie-Carmelle Elie and Davey, {Richard T} and Burgess, {Timothy H} and Jennifer Ferreira and Michelle Green and Mat Makowski and Anabela Cardoso and {Bono, de}, Stephanie and Tyler Bonnett and Michael Proschan and Deye, {Gregory A} and Walla Dempsey and Nayak, {Seema U} and Dodd, {Lori E} and Beigel, {John H} and {ACTT-2 Study Group Members} and Lundgren, {Jens Dilling} and Murray, {Daniel D.} and {{\O}stergaard Jensen}, Tomas",
note = "Copyright {\textcopyright} 2020 Massachusetts Medical Society.",
year = "2021",
month = mar,
day = "4",
doi = "10.1056/NEJMoa2031994",
language = "English",
volume = "384",
pages = "795--807",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "9",

}

RIS

TY - JOUR

T1 - Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

AU - Kalil, Andre C

AU - Patterson, Thomas F

AU - Mehta, Aneesh K

AU - Tomashek, Kay M

AU - Wolfe, Cameron R

AU - Ghazaryan, Varduhi

AU - Marconi, Vincent C

AU - Ruiz-Palacios, Guillermo M

AU - Hsieh, Lanny

AU - Kline, Susan

AU - Tapson, Victor

AU - Iovine, Nicole M

AU - Jain, Mamta K

AU - Sweeney, Daniel A

AU - El Sahly, Hana M

AU - Branche, Angela R

AU - Regalado Pineda, Justino

AU - Lye, David C

AU - Sandkovsky, Uriel

AU - Luetkemeyer, Anne F

AU - Cohen, Stuart H

AU - Finberg, Robert W

AU - Jackson, Patrick E H

AU - Taiwo, Babafemi

AU - Paules, Catharine I

AU - Arguinchona, Henry

AU - Erdmann, Nathaniel

AU - Ahuja, Neera

AU - Frank, Maria

AU - Oh, Myoung-Don

AU - Kim, Eu-Suk

AU - Tan, Seow Y

AU - Mularski, Richard A

AU - Nielsen, Henrik

AU - Ponce, Philip O

AU - Taylor, Barbara S

AU - Larson, LuAnn

AU - Rouphael, Nadine G

AU - Saklawi, Youssef

AU - Cantos, Valeria D

AU - Ko, Emily R

AU - Engemann, John J

AU - Amin, Alpesh N

AU - Watanabe, Miki

AU - Billings, Joanne

AU - Elie, Marie-Carmelle

AU - Davey, Richard T

AU - Burgess, Timothy H

AU - Ferreira, Jennifer

AU - Green, Michelle

AU - Makowski, Mat

AU - Cardoso, Anabela

AU - Bono, de, Stephanie

AU - Bonnett, Tyler

AU - Proschan, Michael

AU - Deye, Gregory A

AU - Dempsey, Walla

AU - Nayak, Seema U

AU - Dodd, Lori E

AU - Beigel, John H

AU - ACTT-2 Study Group Members

A2 - Lundgren, Jens Dilling

A2 - Murray, Daniel D.

A2 - Østergaard Jensen, Tomas

N1 - Copyright © 2020 Massachusetts Medical Society.

PY - 2021/3/4

Y1 - 2021/3/4

N2 - BACKGROUND: Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.METHODS: We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.RESULTS: A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).CONCLUSIONS: Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

AB - BACKGROUND: Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.METHODS: We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.RESULTS: A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).CONCLUSIONS: Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

KW - Adenosine Monophosphate/adverse effects

KW - Adult

KW - Aged

KW - Alanine/adverse effects

KW - Antiviral Agents/adverse effects

KW - Azetidines/adverse effects

KW - COVID-19/drug therapy

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Female

KW - Hospital Mortality

KW - Hospitalization

KW - Humans

KW - Janus Kinase Inhibitors/adverse effects

KW - Male

KW - Middle Aged

KW - Oxygen Inhalation Therapy

KW - Purines/adverse effects

KW - Pyrazoles/adverse effects

KW - Respiration, Artificial

KW - Sulfonamides/adverse effects

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85102545545&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2031994

DO - 10.1056/NEJMoa2031994

M3 - Journal article

C2 - 33306283

VL - 384

SP - 795

EP - 807

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 9

ER -

ID: 64084993