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Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.

Publication ,  Journal Article
Kalil, AC; Patterson, TF; Mehta, AK; Tomashek, KM; Wolfe, CR; Ghazaryan, V; Marconi, VC; Ruiz-Palacios, GM; Hsieh, L; Kline, S; Tapson, V ...
Published in: N Engl J Med
March 4, 2021

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 4, 2021

Volume

384

Issue

9

Start / End Page

795 / 807

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sulfonamides
  • Respiration, Artificial
  • Pyrazoles
  • Purines
  • Oxygen Inhalation Therapy
  • Middle Aged
  • Male
  • Janus Kinase Inhibitors
  • Humans
 

Citation

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Kalil, A. C., Patterson, T. F., Mehta, A. K., Tomashek, K. M., Wolfe, C. R., Ghazaryan, V., … ACTT-2 Study Group Members. (2021). Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med, 384(9), 795–807. https://doi.org/10.1056/NEJMoa2031994
Kalil, Andre C., Thomas F. Patterson, Aneesh K. Mehta, Kay M. Tomashek, Cameron R. Wolfe, Varduhi Ghazaryan, Vincent C. Marconi, et al. “Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.N Engl J Med 384, no. 9 (March 4, 2021): 795–807. https://doi.org/10.1056/NEJMoa2031994.
Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, et al. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795–807.
Kalil, Andre C., et al. “Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.N Engl J Med, vol. 384, no. 9, Mar. 2021, pp. 795–807. Pubmed, doi:10.1056/NEJMoa2031994.
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, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH, ACTT-2 Study Group Members. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795–807.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 4, 2021

Volume

384

Issue

9

Start / End Page

795 / 807

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sulfonamides
  • Respiration, Artificial
  • Pyrazoles
  • Purines
  • Oxygen Inhalation Therapy
  • Middle Aged
  • Male
  • Janus Kinase Inhibitors
  • Humans