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Clinical Data

Scientific Evidence Supporting this EUA

ACTT-2 (Adaptive COVID-19 Treatment Trial 2) Study in Hospitalized Adults Diagnosed with COVID-19 Infection

The ACTT-2 study was a randomized, double-blind, placebo-controlled clinical trial of hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with baricitinib and remdesivir (combination group; n=515) to treatment with placebo and remdesivir (placebo group; n=518). Patients had to have laboratory-confirmed SARS-CoV-2 infection, as well as at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2 ≤94% on room air, a requirement for supplemental oxygen, or a requirement for mechanical ventilation.

Patients treated with the combination received the following regimen:

  • Baricitinib 4 mg once daily (orally) for 14 days or until hospital discharge
  • Remdesivir 200 mg on Day 1 and 100 mg once daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge

The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization. Recovery was defined as:

  • Being discharged from the hospital without limitations on activities,
  • Being discharged from the hospital with limitations on activities and/or requiring home oxygen, or
  • Hospitalized but not requiring supplemental oxygen and no longer requiring medical care.

The key secondary endpoint was clinical status on Day 15, as assessed on an 8-point ordinal scale (OS).

ACTT-2 Ordinal Scale

acct 2 ordinal scale acct 2 ordinal scale acct 2 ordinal scale

Patient Characteristics for ACTT-2

At randomization, mean age was 55 years (with 30% of patients aged 65 or older); 63% of patients were male, 51% were Hispanic or Latino; 48% were White, 15% were Black or African American, and 10% were Asian. At the time of randomization, 14% did not require supplemental oxygen, 55% required supplemental oxygen, 21% required noninvasive ventilation or high-flow oxygen, and 11% required invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The most common comorbidities were obesity (56%), hypertension (52%), and type 2 diabetes (37%). Demographics and disease characteristics were balanced across the combination group and the placebo group.

ACTT-2 Primary and Key Secondary Efficacy Analysesa

For the overall population, the median time to recovery (defined as discharged from hospital or hospitalized but not requiring supplemental oxygen or ongoing medical care) was 7 days for baricitinib and remdesivir compared to 8 days for placebo and remdesivir [hazard ratio: 1.15 (95% CI 1.00, 1.31); p=0.047]. Patients assigned to baricitinib and remdesivir were more likely to have a better clinical status (according to an 8-point ordinal scale) at Day 15 compared to patients assigned to placebo and remdesivir [odds ratio: 1.26 (95% CI 1.01, 1.57); p=0.044].

The proportion of patients who died or progressed to noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29 was lower in baricitinib and remdesivir (23%) compared to placebo and remdesivir (28%) [odds ratio: 0.74 (95% CI 0.56, 0.99); p=0.039]. Patients who required noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.

The proportion of patients who died by Day 29 was 4.7% (24/515) for baricitinib and remdesivir vs. 7.1% (37/518) for placebo and remdesivir [Kaplan Meier estimated difference in Day 29 probability of mortality: -2.6% (95% CI -5.8%, 0.5%)].

Data on deaths, serious adverse events (SAEs), AEs leading to discontinuation, infections, and VTEs are summarized below.

Comparisons and Confidence Intervals for Adverse Events in the As-Treated Populationa

Patients with at least 1 Placebo + remdesivir
(N=509)
n (%)
Baricitinib + remdesivir
(N=507)
n (%)
Risk difference
% (95% CI)
Patients with at least 1: AE Placebo + remdesivir (N=509)
n (%):
242 (48)

Baricitinib + remdesivir (N=507)
n (%):
210 (41)

Risk difference, % (95% CI):
-6 (-12, 0)
Patients with at least 1: Grade 3-4 AE Placebo + remdesivir (N=509)
n (%):
238 (47)

Baricitinib + remdesivir (N=507)
n (%):
207 (41)

Risk difference, % (95% CI):
-6 (-12, 0)
Patients with at least 1: SAE Placebo + remdesivir (N=509)
n (%):
103 (20)

Baricitinib + remdesivir (N=507)
n (%):
77 (15)

Risk difference, % (95% CI):
-5 (-10, 0)
Patients with at least 1: SAE with fatal outcome Placebo + remdesivir (N=509)
n (%):
31 (6)

Baricitinib + remdesivir (N=507)
n (%):
19 (4)

Risk difference, % (95% CI):
-2 (-5, 0)
Patients with at least 1: AE leading to discontinuation of study drug Placebo + remdesivir (N=509)
n (%):
59 (12)

Baricitinib + remdesivir (N=507)
n (%):
34 (7)

Risk difference, % (95% CI):
-5 (-8, -1)
Patients with at least 1: Infections Placebo + remdesivir (N=509)
n (%):
50 (10)

Baricitinib + remdesivir (N=507)
n (%):
32 (6)

Risk difference, % (95% CI):
-4 ( -7, 0)
Patients with at least 1: VTE Placebo + remdesivir (N=509)
n (%):
16 (3)

Baricitinib + remdesivir (N=507)
n (%):
21 (4)

Risk difference, % (95% CI):
1 (-1, 3)
Patients with at least 1: Pulmonary Embolism Placebo + remdesivir (N=509)
n (%):
2 (0.4)

Baricitinib + remdesivir (N=507)
n (%):
5 (1)

Risk difference, % (95% CI):
0.6 (-0.4, 1.6)

AE=adverse event; CI=confidence interval; N=number of patients in the as-treated population; n=number of patients reporting at least 1 event; SAE=serious adverse event; VTE=venous thromboembolic events.

aPatients are counted for each category regardless of the number of events.

AUTHORIZED USE

Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

  • Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.
  • Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Under the EUA, baricitinib is available as 1 mg and 2 mg tablets.

IMPORTANT SAFETY INFORMATION

The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization.

WARNINGS

Serious Infections: Serious infections have occurred in patients receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis. Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections.

Thrombosis: In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.

Abnormal Laboratory Values: Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines.

Vaccinations: Avoid use of live vaccines with baricitinib.

Hypersensitivity: If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction.

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib.

Serious Side Effects: Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.

There are limited clinical data available for baricitinib use in COVID-19. Additional safety information regarding baricitinib may be found in the full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

USE IN SPECIFIC POPULATIONS

Pregnancy: Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

Renal Impairment: There are limited data for baricitinib in patients with severe renal impairment. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury.

Hepatic Impairment: Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk.

Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).

BC HCP EUA ISI 19NOV2020

Fact Sheet for Healthcare Providers
Fact Sheet for Patients, Parents and Caregivers (English)
Fact Sheet for Patients, Parents and Caregivers (Spanish)
FDA Letter of Authorization
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