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Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized
Yang Cao1, Jia Wei1, Liang Zou2
1Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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 After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study.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.
Insights
Ruxolitinib, a Janus-associated kinase (JAK) inhibitor, showed promising trends for coronavirus disease 2019 (COVID-19) patients. While not statistically significant, it led to faster clinical and CT scan improvements, reduced cytokine levels, and no deaths in the treatment group.
Area of Science:
- Immunology
- Pharmacology
- Virology
Background:
- Janus-associated kinase (JAK) inhibitors are emerging as potential therapeutic targets for various conditions.
- Investigating JAK inhibitors for coronavirus disease 2019 (COVID-19) is crucial given the disease's inflammatory nature.
Purpose of the Study:
- To evaluate the efficacy and safety of ruxolitinib, a selective JAK1/2 inhibitor, in patients with severe COVID-19.
- To assess the impact of ruxolitinib on clinical outcomes, computed tomography (CT) findings, and cytokine profiles.
Main Methods:
- A prospective, multicenter, single-blind, randomized controlled phase II trial was conducted.
- Severe COVID-19 patients were randomized to receive either ruxolitinib plus standard-of-care or placebo plus standard-of-care.
- Clinical improvement, CT scan results, mortality, cytokine levels, and safety were monitored.
Main Results:
- Ruxolitinib treatment did not achieve statistically significant accelerated clinical improvement but showed a numerically faster recovery.
- Significant improvement in chest CT scans was observed in the ruxolitinib group (90%) compared to the control group (61.9%).
- Ruxolitinib recipients experienced reduced cytokine levels, faster recovery from lymphopenia, and zero mortality, with a favorable safety profile.
Conclusions:
- Ruxolitinib demonstrated encouraging trends in improving clinical and radiological outcomes for severe COVID-19 patients.
- The drug was well-tolerated, with no new safety concerns identified.
- Further investigation in larger populations is warranted to confirm the efficacy of ruxolitinib in treating COVID-19.
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