Baricitinib

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What effect did baricitinib treatment have on platelet counts in COVID-19?

In the COVID-19 clinical trials, thrombocytosis (8.2%) was one of the most commonly reported adverse drug reactions of patients treated with baricitinib.

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Baricitinib Emergency Use Authorization for COVID

Baricitinib has not been approved, but has been authorized for emergency use by FDA for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Baricitinib is authorized for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at baricitinibemergencyuse.com.

Baricitinib Fact Sheet for Healthcare Providers

In the COVID-19 clinical trials, thrombocytosis >600,000 cells/mm3 (8.2%) was one of the most commonly reported adverse drug reactions of patients treated with BARI.1

Please refer to the sections below for additional details.

Baricitinib Available Clinical Data

Platelet Effects in Patients With COVID-19

Although COVID-19 is associated with severe inflammation, reactive thrombocytosis has not been demonstrated.2 COVID-19 patients often have mild thrombocytopenia (5%-41.7%) with incidence varying according to disease severity. Mild thrombocytopenia has been detected in 58% to 95% of severe cases of COVID-19.3-6

Summary of Baricitinib Exposure Across COVID-19 Clinical Trial Program

The efficacy and safety of BARI were assessed in 2 phase 3, randomized, double-blind, placebo-controlled clinical trials.

  • COV-BARRIER evaluated BARI 4 mg compared to placebo. Patients could remain on background therapy, as defined per local guidelines.
  • ACTT‑2 evaluated the combination of BARI 4 mg + RDV compared to placebo + RDV.1

Integrated Safety Dataset

In placebo-controlled COVID-19 clinical trials, ACTT-2 and COV-BARRIER, a total of

  • 1257 patients received at least one dose of BARI 4 mg once daily (8.0 days mean exposure, 1442 total patient-weeks of exposure), and
  • 1261 patients received placebo (8.1 days mean exposure, 1465 total patient-weeks of exposure).1,7

Patients received treatment for up to 14 days or hospital discharge, whichever occurred first. Safety data is through study day 29.1

COV-BARRIER Clinical Trial Exposure

In COV-BARRIER, a total of 1502 patients were randomized and received treatment with either

  • BARI 4 mg orally once daily + SOC (n=750, 8.1 days mean exposure, 866 total patient-weeks of exposure), or 
  • placebo + SOC (n=752, 8.3 days mean exposure, 891 total patient-weeks of exposure).7

ACTT-2 Clinical Trial Exposure

In ACTT-2, a total of 1016 were randomized and received treatment with either

  • BARI 4 mg + RDV (n=507, 7.9 days mean exposure, 575 total patient-weeks of exposure), or 
  • placebo + RDV (n=509, 7.9 days mean exposure, 574 total patient-weeks of exposure).7,8

Platelet Changes in COVID-19 Clinical Trials

Integrated Safety Dataset Treatment-Emergent High and Low Platelets

High Platelets

Treatment-emergent high platelets were reported in

  • 510 (45.5%) patients in the BARI treatment group, and
  • 398 (35.3%) patients in the placebo group (p=.001).7

Thombocytosis (>600,000 cells/mm3) was reported in

  • 57 (8.2%) patients in the BARI treatment group, and
  • 30 (4.3%) patients in the placebo group (p=.004).7

Low Platelets

Treatment-emergent low platelets were reported in

  • 66 (6.4%) patients in the BARI treatment group, and
  • 87 (8.4%) patients in the placebo group.7

Thrombocytopenia was reported in

  • 5 (0.4%) patients in the BARI treatment group, and
  • 9 (0.7%) patients in the placebo group.7

Shifts in Platelets in the Integrated Safety Dataset and COV-BARRIER

Platelet shift changes that occurred in the COVID-19 clinical trials are presented in Shifts of Platelets in the Baricitinib COVID-19 Clinical Trials.

Shifts of Platelets in the Baricitinib COVID-19 Clinical Trials7

 

Integrated Safety Dataset

COV-BARRIER

 

Placebo
N=1261
(N-obs=1200)
n (%)

BARI 4 mg
N=1257
(N-obs=1200)
n (%)

Placebo + SOC
N=752
(N-obs=699)
n (%)

BARI 4 mg + SOC
N=750
(N-obs=700)
n (%)

Platelet changes

Decreased

82 (6.8)

93 (7.8)

43 (6.2)

54 (7.7)

Same

1020 (85.0)

1027 (85.6)

584 (83.5)

589 (84.1)

Increased

98 (8.2)

80 (6.7)

72 (10.3)

57 (8.1)

Change from ≤400 to >400 billions/L, n/NAR (%)

196/647 (30.3)

271/646 (42.0)

196/647 (30.3)

271/646 (42.0)

Change from ≤600 to >600 billions/L, n/NAR (%)

30/694 (4.3)

57/698 (8.2)

30/694 (4.3)

57/698 (8.2)

Abbreviations: BARI = baricitinib; COVID-19 = coronavirus disease 2019; NAR = number at risk; N-obs = number observed; SOC = standard of care.

Mean Platelet Changes in ACTT-2

Mean platelet counts at baseline and changes through day 29 are presented in Baseline and Mean Changes in Platelets in ACTT-2.

Baseline and Mean Changes in Platelets in ACTT-27

Platelets (109/L)

Placebo + RDV
N=509

BARI 4 mg + RDV
N=507

Baseline, mean (SD)

231.1 (88.2)

232.8 (88.5)

Mean change (SD) from baseline to

Day 3

52.6 (51.6)

55.9 (54.0)

Day 15

111.6 (134.9)

175.9 (158.8)

Day 29

36.9 (107.9)

16.5 (95.8)

Abbreviations: BARI = baricitinib; RDV = remdesivir.

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1U. S. Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers. Emergency Use Authorization (EUA) of Baricitinib. 2021.

2Battinelli EM. COVID-19 concerns aggregate around platelets. Blood. 2020;136(11):1221-1223. https://doi.org/10.1182/blood.2020007805

3Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020;7(6):e438-e440. https://dx.doi.org/10.1016/S2352-3026(20)30145-9

4Wool GD, Miller JL. The impact of COVID-19 disease on platelets and coagulation. Pathobiology. 2021;88(1):15-27. https://dx.doi.org/10.1159/000512007.

5Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382(18):1708-1720. https://doi.org/10.1056/nejmoa2002032

6Yang X, Yang Q, Wang Y, et al. Thrombocytopenia and its association with mortality in patients with COVID-19. J Thromb Haemost. 2020;18(6):1469-1472. https://dx.doi.org/10.1111/jth.14848.

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8Kalil 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. https://doi.org/10.1056/NEJMoa2031994

Glossary

ACTT-2 = Adaptive COVID-19 Treatment Trial 2

BARI = baricitinib

COVID-19 = coronavirus disease 2019

ECMO = extracorporeal membrane oxygenation

EUA = Emergency Use Authorization

FDA = Food and Drug Administration

RDV = remdesivir

SOC = standard of care

Date of Last Review: July 29, 2021


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