TY - JOUR
T1 - Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19)
T2 - A multicenter, single-blind, randomized controlled trial
AU - Cao, Yang
AU - Wei, Jia
AU - Zou, Liang
AU - Jiang, Tiebin
AU - Wang, Gaoxiang
AU - Chen, Liting
AU - Huang, Liang
AU - Meng, Fankai
AU - Huang, Lifang
AU - Wang, Na
AU - Zhou, Xiaoxi
AU - Luo, Hui
AU - Mao, Zekai
AU - Chen, Xing
AU - Xie, Jungang
AU - Liu, Jing
AU - Cheng, Hui
AU - Zhao, Jianping
AU - Huang, Gang
AU - Wang, Wei
AU - Zhou, Jianfeng
N1 - Publisher Copyright:
© 2020 American Academy of Allergy, Asthma & Immunology
PY - 2020/7
Y1 - 2020/7
N2 - Background: Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation. Objective: This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019. Methods: We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019. Results: Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P =.0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group. Conclusions: Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.
AB - Background: Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation. Objective: This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019. Methods: We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019. Results: Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P =.0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group. Conclusions: Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.
KW - COVID-19
KW - Ruxolitinib
KW - cytokine storm
KW - efficacy
KW - randomized controlled trial
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=85086647427&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85086647427&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2020.05.019
DO - 10.1016/j.jaci.2020.05.019
M3 - Article
C2 - 32470486
AN - SCOPUS:85086647427
SN - 0091-6749
VL - 146
SP - 137-146.e3
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 1
ER -