Table 5d. Janus Kinase Inhibitors: Selected Clinical Data
Last Updated: August 8, 2022
The clinical trials described in this table do not represent all the trials that the Panel reviewed while developing the recommendations for kinase inhibitors. The studies summarized below are those that have had the greatest impact on the Panel’s recommendations.
The information in this table may include data from preprints or articles that have not been peer reviewed. This section will be updated as new information becomes available. Please see ClinicalTrials.gov for more information on clinical trials evaluating kinase inhibitors.
Methods | Results | Limitations and Interpretation |
---|---|---|
RECOVERY: Open-Label RCT of Baricitinib Versus Usual Care in the United Kingdom1 | ||
Key Inclusion Criterion
Key Exclusion Criteria
Interventions
Primary Endpoint
Key Secondary Endpoints
| Participant Characteristics
Primary Outcome
Secondary Outcomes
| Key Limitation
Interpretation
|
COV-BARRIER: Double-Blind, Placebo-Controlled, Randomized Trial of Baricitinib in Hospitalized Adults in 12 Countries in Asia, Europe, North America, and South America2 | ||
Key Inclusion Criteria
Key Exclusion Criteria
Interventions
Primary Endpoint
Key Secondary Endpoint
| Participant Characteristics
Primary Outcome
Secondary Outcomes
| Key Limitation
Interpretation
|
COV-BARRIER Addendum: Double-Blind, Placebo-Controlled, Randomized Trial of Baricitinib in Hospitalized Adults on Mechanical Ventilation or Extracorporeal Membrane Oxygenation in Argentina, Brazil, Mexico, and the United States3 | ||
Key Inclusion Criteria
Key Exclusion Criteria
Interventions
Key Endpoints
| Participant Characteristics
Outcomes
| Key Limitations
Interpretation
|
ACTT-2: Double-Blind, Placebo-Controlled, Randomized Trial of Baricitinib Plus Remdesivir in Hospitalized Adults With COVID-19 in 8 Countries in Europe, North America, and Asia4 | ||
Key Inclusion Criteria
Key Exclusion Criteria
Interventions
Primary Endpoint
Key Secondary Endpoints
| Participant Characteristics
Primary Outcomes
Secondary Outcomes
| Key Limitations
Interpretation
|
ACTT-4: Double-Blind, Placebo-Controlled, Randomized Trial of Remdesivir With Baricitinib Versus Dexamethasone for Hospitalized Patients Requiring Supplemental Oxygen in Japan, Mexico, Singapore, South Korea, and the United States5 | ||
Key Inclusion Criteria
Key Exclusion Criterion
Interventions
Primary Endpoint
Key Secondary Endpoints
Key Safety Endpoints
| Participant Characteristics
Primary Outcome
Secondary Outcomes
Safety Outcomes
| Key Limitations
Interpretation
|
STOP-COVID: Double-Blind, Placebo-Controlled, Randomized Trial of Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia in Brazil6 | ||
Key Inclusion Criteria
Key Exclusion Criteria
Interventions
Primary Endpoint
Key Secondary Endpoint
| Participant Characteristics
Primary Outcome
Secondary Outcome
| Key Limitations
Interpretation
|
Key: AE = adverse event; ALC = absolute lymphocyte count; ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate transaminase; BAR = baricitinib; CCP = COVID-19 convalescent plasma; CRP = C-reactive protein; CT = computed tomography; CXR = chest X-ray; DEX = dexamethasone; ECMO = extracorporeal membrane oxygenation; eGFR = estimated glomerular filtration rate; HFNC = high-flow nasal cannula; IVIG = intravenous immunoglobulin; LDH = lactate dehydrogenase; MV = mechanical ventilation; NIV = noninvasive ventilation; OS = ordinal scale; the Panel = the COVID-19 Treatment Guidelines Panel; PCR = polymerase chain reaction; PO = orally; RCT = randomized controlled trial; RDV = remdesivir; SAE = serious adverse event; SOC = standard of care; SpO2 = oxygen saturation; TB = tuberculosis; ULN = upper limit of normal |
References
- RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet. 2022;400(10349):359-368. Available at: https://pubmed.ncbi.nlm.nih.gov/35908569.
- Marconi VC, Ramanan AV, de Bono S, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled Phase 3 trial. Lancet Respir Med. 2021;9(12):1407-1418. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34480861.
- Ely EW, Ramanan AV, Kartman CE, et al. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022;10(4):327-336. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35123660.
- Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384(9):795-807. Available at: https://www.ncbi.nlm.nih.gov/pubmed/33306283.
- Wolfe CR, Tomashek KM, Patterson TF, et al. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial. Lancet Respir Med. 2022;10(9):888-899. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35617986.
- Guimaraes PO, Quirk D, Furtado RH, et al. Tofacitinib in patients hospitalized with COVID-19 pneumonia. N Engl J Med. 2021;385(5):406-415. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34133856.