Skip to main content
Olumiant home
  • Prescribing Information
  • Medication Guide
Menu closed
Olumiant home
  • Prescribing Information
  • Medication Guide
Globe Loading... Reveal available languages
  • For Consumers
  • House For Healthcare Providers
      • Alopecia Areata Home
      • Olumiant Patient Profile and MOA
      • Efficacy
      • Safety
      • Getting Started
      • Efficacy
      • Dosing
      • Safety
      • Patient Profile & Mechanism of Action (MOA)
      • About Olumiant
      • Efficacy
        • ACTT-2
        • COV-BARRIER
        • COV-BARRIER OS 7 Addendum
      • Dosage & Administration
      • Safety
      • Access
    • Support Resources
Ask Lilly

We're here to help.

Phone Call:
1-800-LillyRX
(1-800-545-5979)
Expand contact lilly

COVID-19 Clinical Data

The efficacy and safety of Olumiant were assessed in two phase 3, randomized, double-blind, placebo-controlled clinical trials1:

  • ACTT-2 (COVID I, NCT04401579), which evaluated the combination of Olumiant 4 mg and remdesivir compared to placebo and remdesivir.
  • COV-BARRIER (COVID II, NCT04421027), which evaluated Olumiant 4 mg compared to placebo. Patients could remain on background therapy, as defined per local guidelines. An additional exploratory sub-study in patients requiring invasive mechanical ventilation or ECMO at baseline was also conducted under this protocol and analyzed separately.

ACTT-2=Adaptive COVID-19 Treatment Trial 2.

NIAID Ordinal Scale used in ACTT-2 and COV-BARRIER1

1 Not hospitalized; no limitations on activities
2 Not hospitalized; limitation on activities and/or requiring home oxygen
3 Hospitalized; no longer requires ongoing medical care; not requiring supplemental oxygen
4 Hospitalized; requiring ongoing medical care; not requiring supplemental oxygen
5 Hospitalized; requiring supplemental oxygen
6 Hospitalized; on non-invasive ventilation or high-flow oxygen devices
7 Hospitalized; on invasive mechanical ventilation or ECMO
8 Death

ACTT-2=Adaptive COVID-19 Treatment Trial 2.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS

The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant. Closely monitor patients for development of infections during and after Olumiant treatment. In COVID-19 patients, consider the risks and benefits of treatment with OLUMIANT with other concurrent infections.

ACTT-2 Data Overview

ACTT-2 (COVID I) Study Design

The Adaptive COVID-19 Treatment Trial 2 (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 Olumiant 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 or ECMO.1-3

There was no limit to the duration of symptoms prior to enrollment.3

Patients treated with the combination received the following regimen1,2:

  • Olumiant 4 mg once daily (orally) for 14 days or until hospital discharge, whichever was first
  • 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, whichever was first

In this study prophylaxis for venous thromboembolic event (VTEs) was recommended for all patients unless a major contraindication was noted.1,2

The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization.
Recovery was defined as1-3:

  • 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).1-3

*Laboratory-confirmed SARS-CoV-2 infection was determined by RT-PCR assay.3

ECMO=extracorporeal membrane oxygenation; RT-PCR=reverse transcription, polymerase-chain-reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SpO2=peripheral oxygen saturation.

View the Ordinal Scale used in ACTT-2

Patient Characteristics for ACTT-2

All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Age1,2
Mean, years (SD) All subjects (N=1033): 55.4 (15.7) Olumiant + RDV (N=515): 55.0 (15.4) Placebo + RDV (N=518): 55.8 (16.0)
Distribution, n (%)
<40 years All subjects (N=1033): 173 (16.7) Olumiant + RDV (N=515): 87 (16.9) Placebo + RDV (N=518): 86 (16.6)
40-64 years All subjects (N=1033): 555 (53.7) Olumiant + RDV (N=515): 281 (54.6) Placebo + RDV (N=518): 274 (52.9)
≥65 years All subjects (N=1033): 305 (29.5) Olumiant + RDV (N=515): 147 (28.5) Placebo + RDV (N=518): 158 (30.5)
All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Sex, n (%)1,2
Male All subjects (N=1033): 652 (63.1) Olumiant + RDV (N=515): 319 (61.9) Placebo + RDV (N=518): 333 (64.3)
Female All subjects (N=1033): 381 (36.9) Olumiant + RDV (N=515): 196 (38.1) Placebo + RDV (N=518): 185 (35.7)
All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Race, n (%)1,2a
Asian All subjects (N=1033): 101 (9.8) Olumiant + RDV (N=515): 49 (9.5) Placebo + RDV (N=518): 52 (10.0)
Black All subjects (N=1033): 156 (15.1) Olumiant + RDV (N=515): 77 (15.0) Placebo + RDV (N=518): 79 (15.3)
White All subjects (N=1033): 496 (48.0) Olumiant + RDV (N=515): 251 (48.7) Placebo + RDV (N=518): 245 (47.3)
Other or Unknown All subjects (N=1033): 280 (27.1) Olumiant + RDV (N=515): 138 (26.8) Placebo + RDV (N=518): 142 (27.4)
Ethnic group, n (%)1,2a
Hispanic or Latino All subjects (N=1033): 531 (51.4) Olumiant + RDV (N=515): 263 (51.1) Placebo + RDV (N=518): 268 (51.7)
Not Hispanic or Latino All subjects (N=1033): 486 (47.0) Olumiant + RDV (N=515): 246 (47.8) Placebo + RDV (N=518): 240 (46.3)
Not reported or unknown All subjects (N=1033): 16 (1.5) Olumiant + RDV (N=515): 6 (1.2) Placebo + RDV (N=518): 10 (1.9)

aRace and ethnic group were reported by the patients. With respect to "other" race, the categories that were used when data on race were reported included American Indian or Alaska Native and Native Hawaiian or other Pacific Islander.

All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Geographic region, n (%)2
Asia All subjects (N=1033): 67 (6.5) Olumiant + RDV (N=515): 33 (6.4) Placebo + RDV (N=518): 34 (6.6)
Europe All subjects (N=1033): 13 (1.3) Olumiant + RDV (N=515): 6 (1.2) Placebo + RDV (N=518): 7 (1.4)
North America All subjects (N=1033): 953 (92.3) Olumiant + RDV (N=515): 476 (92.4) Placebo + RDV (N=518): 477 (92.1)
All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Time from symptom onset to randomization2
Median days (IQR) All subjects (N=1033): 8 (5-10) Olumiant + RDV (N=515): 8 (5-10) Placebo + RDV (N=518): 8 (5-11)
All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Ordinal scale score, n (%)1,2
4 All subjects (N=1033): 142 (13.7) Olumiant + RDV (N=515): 70 (13.6) Placebo + RDV (N=518): 72 (13.9)
5 All subjects (N=1033): 564 (54.6) Olumiant + RDV (N=515): 288 (55.9) Placebo + RDV (N=518): 276 (53.3)
6 All subjects (N=1033): 216 (20.9) Olumiant + RDV (N=515): 103 (20.0) Placebo + RDV (N=518): 113 (21.8)
7 All subjects (N=1033): 111 (10.7) Olumiant + RDV (N=515): 54 (10.5) Placebo + RDV (N=518): 57 (11.0)
All subjects (N=1033)
Olumiant + RDV (N=515)
Placebo + RDV (N=518)
Comorbidities at baseline, n (%)1,3b
Obesity All subjects (N=1033): 567 (56) Olumiant + RDV (N=515): 295 (58) Placebo + RDV (N=518): 272 (53)
Hypertension All subjects (N=1033): 522 (52) Olumiant + RDV (N=515): 258 (51) Placebo + RDV (N=518): 264 (52)
Type 2 diabetes All subjects (N=1033): 370 (37) Olumiant + RDV (N=515): 195 (39) Placebo + RDV (N=518): 175 (35)
Coronary artery disease All subjects (N=1033): 101 (10) Olumiant + RDV (N=515): 50 (10) Placebo + RDV (N=518): 51 (10)
Asthma All subjects (N=1033): 97 (10) Olumiant + RDV (N=515): 53 (10) Placebo + RDV (N=518): 44 (9)
Chronic respiratory disease All subjects (N=1033): 69 (7) Olumiant + RDV (N=515): 39 (8) Placebo + RDV (N=518): 30 (6)
Chronic kidney disease All subjects (N=1033): 64 (6) Olumiant + RDV (N=515): 31 (6) Placebo + RDV (N=518): 33 (7)
Congestive heart failure All subjects (N=1033): 62 (6) Olumiant + RDV (N=515): 31 (6) Placebo + RDV (N=518): 31 (6)
Cancer All subjects (N=1033): 37 (4) Olumiant + RDV (N=515): 20 (4) Placebo + RDV (N=518): 17 (3)
Immune deficiency All subjects (N=1033): 30 (3) Olumiant + RDV (N=515): 17 (3) Placebo + RDV (N=518): 13 (3)
Chronic liver disease All subjects (N=1033): 28 (3) Olumiant + RDV (N=515): 13 (3) Placebo + RDV (N=518): 15 (3)
Any history of DVT or PE All subjects (N=1033): 22 (2) Olumiant + RDV (N=515): 11 (2) Placebo + RDV (N=518): 11 (2)
Cardiac valvular disease All subjects (N=1033): 22 (2) Olumiant + RDV (N=515): 10 (2) Placebo + RDV (N=518): 12 (2)
Chronic oxygen requirement All subjects (N=1033): 17 (2) Olumiant + RDV (N=515): 8 (2) Placebo + RDV (N=518): 9 (2)
Type 1 diabetes All subjects (N=1033): 10 (1) Olumiant + RDV (N=515): 5 (1) Placebo + RDV (N=518): 5 (1)
Coagulopathy All subjects (N=1033): 7 (1) Olumiant + RDV (N=515): 3 (1) Placebo + RDV (N=518): 4 (1)
Summary of coexisting conditions, n/total n (%)2
None All subjects (N=1033): 155/994 (15.6) Olumiant + RDV (N=515): 64/496 (12.9) Placebo + RDV (N=518): 91/498 (18.3)
One All subjects (N=1033): 270/994 (27.2) Olumiant + RDV (N=515): 148/496 (29.8) Placebo + RDV (N=518): 122/498 (24.5)
Two or more All subjects (N=1033): 569/994 (57.2) Olumiant + RDV (N=515): 284/496 (57.3) Placebo + RDV (N=518): 285/498 (57.2)

bPercentages are based on the number of subjects with data available for the individual comorbidity.

ACTT-2=Adaptive COVID-19 Treatment Trial 2; DVT=deep vein thrombosis; IQR=interquartile range; PE=pulmonary embolism; RDV=remdesivir.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS

Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.

ACTT-2 Primary Endpoint and Subgroup Analyses - Recovery Outcomes

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 Olumiant and remdesivir compared to 8 days for placebo and remdesivir [hazard ratio: 1.16 (95% CI 1.01, 1.33); p=0.035].1

ACTT-2: Recovery Outcomes in the ITT Population According to Baseline Ordinal Scale Score2

4a
Not requiring supplemental oxygen

Recoveries, n
Olumiant + RDV (n=70): 67
Placebo + RDV (n=72): 69

Median time to recovery, days (95% CI)
Olumiant + RDV (n=70): 5 (4-6)
Placebo + RDV (n=72): 4 (4-6)

HR (95% CI)
0.88 (0.63-1.23)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1


5
Low-flow oxygen

Recoveries, n
Olumiant + RDV (n=288): 262
Placebo + RDV (n=276): 243

Median time to recovery, days (95% CI)
Olumiant + RDV (n=288): 5 (5-6)
Placebo + RDV (n=276): 6 (5-6)

HR (95% CI)
1.17 (0.98-1.39)


6
High-flow oxygen/NIMV

Recoveries, n
Olumiant + RDV (n=103): 82
Placebo + RDV (n=113): 73

Median time to recovery, days (95% CI)
Olumiant + RDV (n=103): 10 (9-13)
Placebo + RDV (n=113): 18 (13-21)

HR (95% CI)
1.51 (1.10-2.08)


7
Mechanical ventilation/ECMO

Recoveries, n
Olumiant + RDV (n=54): 22
Placebo + RDV (n=57): 21

Median time to recovery, days (95% CI)
Olumiant + RDV (n=54): NE (25-NE)
Placebo + RDV (n=57): NE (26-NE)

HR (95% CI)
1.08 (0.59-1.97)

  4a
Not requiring supplemental oxygen
5
Low-flow oxygen
6
High-flow oxygen/NIMV
7
Mechanical ventilation/ECMO
  Olumiant + RDV (n=70) Placebo + RDV (n=72) Olumiant + RDV (n=288) Placebo + RDV (n=276) Olumiant + RDV (n=103) Placebo + RDV (n=113) Olumiant + RDV (n=54) Placebo + RDV (n=57)
Recoveries, n 67 69 262 243 82 73 22 21
Median time to recovery, days (95% CI) 5 (4-6) 4 (4-6) 5 (5-6) 6 (5-6) 10 (9-13) 18 (13-21) NE (25-NE) NE (26-NE)
HR (95% CI) 0.88 (0.63-1.23) 1.17 (0.98-1.39) 1.51 (1.10-2.08) 1.08 (0.59-1.97)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1

Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.

View the ACTT-2 Study Design

View the Ordinal Scale used in ACTT-2

ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; HR=hazard ratio; ITT=intent-to-treat; NE=not possible to estimate; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.

ACTT-2 Secondary Endpoint and Subgroup Analyses - OS Score at Day 15

In the overall population, patients assigned to Olumiant 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].1

Ordinal Scale Score at Day 15 According to Baseline Score2:

4a
Not requiring supplemental oxygen

Ordinal scale score at Day 15: 1
Olumiant + RDV (n=70) n (%): 33 (47.1)
Placebo + RDV (n=72) n (%): 44 (61.1)

Ordinal scale score at Day 15: 2
Olumiant + RDV (n=70) n (%): 25 (35.7)
Placebo + RDV (n=72) n (%): 20 (27.8)

Ordinal scale score at Day 15: 3
Olumiant + RDV (n=70) n (%): 5 (7.1)
Placebo + RDV (n=72) n (%): 2 (2.8)

Ordinal scale score at Day 15: 4
Olumiant + RDV (n=70) n (%): 7 (10.0)
Placebo + RDV (n=72) n (%): 6 (8.3)

Ordinal scale score at Day 15: 5
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)

Ordinal scale score at Day 15: 6
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)

Ordinal scale score at Day 15: 7
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)

Ordinal scale score at Day 15: 8
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)

OR (95% CI)
0.6 (0.3-1.1)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1


5
Low-flow oxygen

Ordinal scale score at Day 15: 1
Olumiant + RDV (n=288) n (%): 114 (39.6)
Placebo + RDV (n=276) n (%): 101 (36.6)

Ordinal scale score at Day 15: 2
Olumiant + RDV (n=288) n (%): 120 (41.7)
Placebo + RDV (n=276) n (%): 115 (41.7)

Ordinal scale score at Day 15: 3
Olumiant + RDV (n=288) n (%): 2 (0.7)
Placebo + RDV (n=276) n (%): 1 (0.4)

Ordinal scale score at Day 15: 4
Olumiant + RDV (n=288) n (%): 14 (4.9)
Placebo + RDV (n=276) n (%): 7 (2.5)

Ordinal scale score at Day 15: 5
Olumiant + RDV (n=288) n (%): 18 (6.2)
Placebo + RDV (n=276) n (%): 27 (9.8)

Ordinal scale score at Day 15: 6
Olumiant + RDV (n=288) n (%): 9 (3.1)
Placebo + RDV (n=276) n (%): 1 (0.4)

Ordinal scale score at Day 15: 7
Olumiant + RDV (n=288) n (%): 8 (2.8)
Placebo + RDV (n=276) n (%): 19 (6.9)

Ordinal scale score at Day 15: 8
Olumiant + RDV (n=288) n (%): 3 (1.0)
Placebo + RDV (n=276) n (%): 5 (1.8)

OR (95% CI)
1.2 (0.9-1.6)


6
High-flow oxygen/NIMV

Ordinal scale score at Day 15: 1
Olumiant + RDV (n=103) n (%): 27 (26.2)
Placebo + RDV (n=113) n (%): 17 (15.0)

Ordinal scale score at Day 15: 2
Olumiant + RDV (n=103) n (%): 30 (29.1)
Placebo + RDV (n=113) n (%): 24 (21.2)

Ordinal scale score at Day 15: 3
Olumiant + RDV (n=103) n (%): 0 (0)
Placebo + RDV (n=113) n (%): 0 (0)

Ordinal scale score at Day 15: 4
Olumiant + RDV (n=103) n (%): 7 (6.8)
Placebo + RDV (n=113) n (%): 3 (2.7)

Ordinal scale score at Day 15: 5
Olumiant + RDV (n=103) n (%): 15 (14.6)
Placebo + RDV (n=113) n (%): 20 (17.7)

Ordinal scale score at Day 15: 6
Olumiant + RDV (n=103) n (%): 7 (6.8)
Placebo + RDV (n=113) n (%): 16 (14.2)

Ordinal scale score at Day 15: 7
Olumiant + RDV (n=103) n (%): 15 (14.6)
Placebo + RDV (n=113) n (%): 28 (24.8)

Ordinal scale score at Day 15: 8
Olumiant + RDV (n=103) n (%): 2 (1.9)
Placebo + RDV (n=113) n (%): 5 (4.4)

OR (95% CI)
2.2 (1.4-3.6)


7
Mechanical ventilation/ECMO

Ordinal scale score at Day 15: 1
Olumiant + RDV (n=54) n (%): 3 (5.6)
Placebo + RDV (n=57) n (%): 3 (5.3)

Ordinal scale score at Day 15: 2
Olumiant + RDV (n=54) n (%): 2 (3.7)
Placebo + RDV (n=57) n (%): 4 (7.0)

Ordinal scale score at Day 15: 3
Olumiant + RDV (n=54) n (%): 1 (1.9)
Placebo + RDV (n=57) n (%): 0 (0)

Ordinal scale score at Day 15: 4
Olumiant + RDV (n=54) n (%): 3 (5.6)
Placebo + RDV (n=57) n (%): 2 (3.5)

Ordinal scale score at Day 15: 5
Olumiant + RDV (n=54) n (%): 10 (18.5)
Placebo + RDV (n=57) n (%): 3 (5.3)

Ordinal scale score at Day 15: 6
Olumiant + RDV (n=54) n (%): 4 (7.4)
Placebo + RDV (n=57) n (%): 2 (3.5)

Ordinal scale score at Day 15: 7
Olumiant + RDV (n=54) n (%): 25 (46.3)
Placebo + RDV (n=57) n (%): 36 (63.2)

Ordinal scale score at Day 15: 8
Olumiant + RDV (n=54) n (%): 6 (11.1)
Placebo + RDV (n=57) n (%): 7 (12.3)

OR (95% CI)
1.7 (0.8-3.4)

  4a
Not requiring supplemental oxygen
5
Low-flow oxygen
6
High-flow oxygen/NIMV
7
Mechanical ventilation/ECMO
Ordinal scale score at Day 15 Olumiant + RDV (n=70)
n (%)
Placebo + RDV (n=72)
n (%)
Olumiant + RDV (n=288)
n (%)
Placebo + RDV (n=276)
n (%)
Olumiant + RDV (n=103)
n (%)
Placebo + RDV (n=113)
n (%)
Olumiant + RDV (n=54)
n (%)
Placebo + RDV (n=57)
n (%)
1 33 (47.1) 44 (61.1) 114 (39.6) 101 (36.6) 27 (26.2) 17 (15.0) 3 (5.6) 3 (5.3)
2 25 (35.7) 20 (27.8) 120 (41.7) 115 (41.7) 30 (29.1) 24 (21.2) 2 (3.7) 4 (7.0)
3 5 (7.1) 2 (2.8) 2 (0.7) 1 (0.4) 0 (0) 0 (0) 1 (1.9) 0 (0)
4 7 (10.0) 6 (8.3) 14 (4.9) 7 (2.5) 7 (6.8) 3 (2.7) 3 (5.6) 2 (3.5)
5 0 (0) 0 (0) 18 (6.2) 27 (9.8) 15 (14.6) 20 (17.7) 10 (18.5) 3 (5.3)
6 0 (0) 0 (0) 9 (3.1) 1 (0.4) 7 (6.8) 16 (14.2) 4 (7.4) 2 (3.5)
7 0 (0) 0 (0) 8 (2.8) 19 (6.9) 15 (14.6) 28 (24.8) 25 (46.3) 36 (63.2)
8 0 (0) 0 (0) 3 (1.0) 5 (1.8) 2 (1.9) 5 (4.4) 6 (11.1) 7 (12.3)
OR (95% CI) 0.6 (0.3-1.1) 1.2 (0.9-1.6) 2.2 (1.4-3.6) 1.7 (0.8-3.4)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1

Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.

The ordinal score at Day 15 (±2 days visit window) is the patient's worst score on the ordinal scale during the previous day.2

View the ACTT-2 Study Design

View the Ordinal Scale used in ACTT-2

ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.

ACTT-2 Secondary Endpoint - Progression by Day 29

The proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29 was lower in Olumiant 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 non-invasive 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.1

View the ACTT-2 Study Design

View the Ordinal Scale used in ACTT-2

ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation.

ACTT-2 Secondary Endpoint & Subgroup Analyses - Mortality

In the overall population, the proportion of patients who died by Day 29 was 4.7% (24/515) for Olumiant and remdesivir compared to 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%); hazard ratio=0.65 (95% CI: 0.39, 1.09)].1

Mortality According to Baseline Ordinal Scale Score2:

4a
Not requiring supplemental oxygen

Mortality over first 14 daysb

HR (95% CI)
NE

No. of deaths
Olumiant + RDV (n=70): 0
Placebo + RDV (n=72): 0

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=70): 0 (NE-NE)
Placebo + RDV (n=72): 0 (NE-NE)

Mortality over first 28 daysb

HR (95% CI)
NE

No. of deaths
Olumiant + RDV (n=70): 0
Placebo + RDV (n=72): 0

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=70): 0 (NE-NE)
Placebo + RDV (n=72): 0 (NE-NE)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1


5
Low-flow oxygen

Mortality over first 14 daysb

HR (95% CI)
0.73 (0.16-3.26)

No. of deaths
Olumiant + RDV (n=288): 3
Placebo + RDV (n=276): 4

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=288): 1.1 (0.4-3.4)
Placebo + RDV (n=276): 1.5 (0.6-3.9)

Mortality over first 28 daysb

HR (95% CI)
0.40 (0.14-1.14)

No. of deaths
Olumiant + RDV (n=288): 5
Placebo + RDV (n=276): 12

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=288): 1.9 (0.8-4.4)
Placebo + RDV (n=276): 4.7 (2.7-8.1)


6
High-flow oxygen/NIMV

Mortality over first 14 daysb

HR (95% CI)
0.21 (0.02-1.80)

No. of deaths
Olumiant + RDV (n=103): 1
Placebo + RDV (n=113): 5

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=103): 1.0 (0.1-6.7)
Placebo + RDV (n=113): 4.6 (2.0-10.8)

Mortality over first 28 daysb

HR (95% CI)
0.55 (0.22-1.38)

No. of deaths
Olumiant + RDV (n=103): 7
Placebo + RDV (n=113): 13

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=103): 7.5 (3.6-15.2)
Placebo + RDV (n=113): 12.9 (7.7-21.3)


7
Mechanical ventilation/ECMO

Mortality over first 14 daysb

HR (95% CI)
0.69 (0.19-2.44)

No. of deaths
Olumiant + RDV (n=54): 4
Placebo + RDV (n=57): 6

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=54): 7.6 (2.9-19.1)
Placebo + RDV (n=57): 11.3 (5.3-23.5)

Mortality over first 28 daysb

HR (95% CI)
1.00 (0.45-2.22)

No. of deaths
Olumiant + RDV (n=54): 12
Placebo + RDV (n=57): 12

Kaplan-Meier estimate of mortality, % (95% CI)
Olumiant + RDV (n=54): 23.1 (13.8-37.1)
Placebo + RDV (n=57): 22.6 (13.5-36.4)

  4a
Not requiring supplemental oxygen
5
Low-flow oxygen
6
High-flow oxygen/NIMV
7
Mechanical ventilation/ECMO
Ordinal scale score at Day 15 Olumiant + RDV (n=70) Placebo + RDV (n=72) Olumiant + RDV (n=288) Placebo + RDV (n=276) Olumiant + RDV (n=103) Placebo + RDV (n=113) Olumiant + RDV (n=54) Placebo + RDV (n=57)
Mortality over first 14 daysb
HR (95% CI) NE 0.73 (0.16-3.26) 0.21 (0.02-1.80) 0.69 (0.19-2.44)
No. of deaths 0 0 3 4 1 5 4 6
Kaplan-Meier estimate of mortality, % (95% CI) 0 (NE-NE) 0 (NE-NE) 1.1 (0.4-3.4) 1.5 (0.6-3.9) 1.0 (0.1-6.7) 4.6 (2.0-10.8) 7.6 (2.9-19.1) 11.3 (5.3-23.5)
Mortality over first 28 daysb
HR (95% CI) NE 0.40 (0.14-1.14) 0.55 (0.22-1.38) 1.00 (0.45-2.22)
No. of deaths 0 0 5 12 7 13 12 12
Kaplan-Meier estimate of mortality, % (95% CI) 0 (NE-NE) 0 (NE-NE) 1.9 (0.8-4.4) 4.7 (2.7-8.1) 7.5 (3.6-15.2) 12.9 (7.7-21.3) 23.1 (13.8-37.1) 22.6 (13.5-36.4)

aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1

bDays post-randomization noted as "over first 14 days/over 28 days" correspond to study Days 15 and 29, respectively.

Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.

View the ACTT-2 Study Design

View the Ordinal Scale used in ACTT-2

ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; HR=hazard ratio; NE=not possible to estimate; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO VIRAL REACTIVATION

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant.

COV-BARRIER Data Overview

COV-BARRIER (COVID II) Study Design

COV-BARRIER was a randomized, double-blind, placebo-controlled clinical trial of hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with Olumiant 4 mg once daily (n=764) with placebo (n=761). Olumiant was administered for 14 days or until hospital discharge, whichever came first. Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. In this study prophylaxis for venous thromboembolic event (VTE) was required for all patients unless contraindicated. The most frequently used therapies at baseline were1:

  • corticosteroids (79% of patients, mostly dexamethasone)
  • remdesivir (19% of patients)

Patients had to have laboratory-confirmed SARS-CoV-2 infection, at least one instance of elevation in at least one inflammatory marker (CRP, D-dimer, LDH, ferritin), and at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2 <94% on room air, evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/min) or requirement for supplemental oxygen. Patients requiring invasive mechanical ventilation or ECMO at baseline were enrolled in an exploratory addendum study of COV-BARRIER. These patients were not included in the main COV-BARRIER study population and were analyzed separately.1

The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28 days of the study. Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.1

A key secondary endpoint was all-cause mortality by Day 28.1

CRP=C-reactive protein; ECMO=extracorporeal membrane oxygenation; LDH=lactate dehydrogenase; SpO2=oxygen saturation as measured by pulse oximetry.

View the Ordinal Scale used in COV-BARRIER

Patient Characteristics for COV-BARRIER

All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
Age1,4
Years, mean (SD) All subjects (N=1525): 57.6 (14.1) Olumiant + SOC (N=764): 57.8 (14.3) Placebo + SOC (N=761): 57.5 (13.8)
Distribution, n (%)
<65 years All subjects (N=1033): 1026 (67.3) Olumiant + RDV (N=515): 508 (66.5) Placebo + RDV (N=518): 518 (68.1)
≥65 years All subjects (N=1033): 499 (32.7) Olumiant + RDV (N=515): 256 (33.5) Placebo + RDV (N=518): 243 (31.9)
All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
Sex, n (%)1,4
Male All subjects (N=1525): 963 (63.1) Olumiant + SOC (N=764): 490 (64.1) Placebo + SOC (N=761): 473 (62.2)
Female All subjects (N=1525): 562 (36.9) Olumiant + SOC (N=764): 274 (35.9) Placebo + SOC (N=761): 288 (37.8)
All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
Race, n (%)1,4
American Indian or Alaska Nativea All subjects (N=1525): 316 (20.7) Olumiant + SOC (N=764): 148 (19.4) Placebo + SOC (N=761): 168 (22.1)
Asian All subjects (N=1525): 174 (11.4) Olumiant + SOC (N=764): 80 (10.5) Placebo + SOC (N=761): 94 (12.4)
Black or African American All subjects (N=1525): 75 (4.9) Olumiant + SOC (N=764): 39 (5.1) Placebo + SOC (N=761): 36 (4.7)
Native Hawaiian or other Pacific Islander All subjects (N=1525): 5 (0.3) Olumiant + SOC (N=764): 3 (0.4) Placebo + SOC (N=761): 2 (0.3)
White All subjects (N=1525): 920 (60.3) Olumiant + SOC (N=764): 480 (62.8) Placebo + SOC (N=761): 440 (57.8)
Multiple All subjects (N=1525): 3 (0.2) Olumiant + SOC (N=764): 2 (0.3) Placebo + SOC (N=761): 1 (0.1)
Missing All subjects (N=1525): 32 (2.1) Olumiant + SOC (N=764): 12 (1.6) Placebo + SOC (N=761): 20 (2.6)

aIncludes participants from Mexico and Latin America.

All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
Geographic region, n (%)1,4
Europeb All subjects (N=1525): 143 (9.4) Olumiant + SOC (N=764): 73 (9.6) Placebo + SOC (N=761): 70 (9.2)
United States including Puerto Rico All subjects (N=1525): 320 (21.0) Olumiant + SOC (N=764): 162 (21.2) Placebo + SOC (N=761): 158 (20.8)
Rest of Worldc All subjects (N=1525): 1062 (69.6) Olumiant + SOC (N=764): 529 (69.2) Placebo + SOC (N=761): 533 (70.0)

bIncludes Germany, Italy, Spain, and the United Kingdom.

cIncludes Argentina, Brazil, India, Japan, Korea (Republic of), Mexico, and Russian Federation.

All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
BMI kg/m2, mean (SD)4 All subjects (N=1525): 30.5 (6.5) Olumiant + SOC (N=764): 30.4 (6.4) Placebo + SOC (N=761): 30.6 (6.6)
All subjects (N=1518)
Olumiant + SOC (N=762)
Placebo + SOC (N=756)
Disease duration of symptoms prior to enrollment, n (%)4
<7 days All subjects (N=1518): 253 (16.7) Olumiant + SOC (N=762): 137 (18.0) Placebo + SOC (N=756): 116 (15.3)
≥7 days All subjects (N=1518): 1265 (83.3) Olumiant + SOC (N=762): 625 (82.0) Placebo + SOC (N=756): 640 (84.7)
All subjects (N=1518)
Olumiant + SOC (N=762)
Placebo + SOC (N=756)
Ordinal Scale Score, n (%)1,4
4 All subjects (N=1518): 186 (12.3) Olumiant + SOC (N=762): 89 (11.7) Placebo + SOC (N=756): 97 (12.8)
5 All subjects (N=1518): 962 (63.4) Olumiant + SOC (N=762): 490 (64.3) Placebo + SOC (N=756): 472 (62.4)
6 All subjects (N=1518): 370 (24.4) Olumiant + SOC (N=762): 183 (24.0) Placebo + SOC (N=756): 187 (24.7)
All subjects (N=1518)
Olumiant + SOC (N=762)
Placebo + SOC (N=756)
Concomitant medications of interest, n (%)1,4
Remdesivir All subjects (N=1518): 287 (18.9) Olumiant + SOC (N=762): 140 (18.4) Placebo + SOC (N=756): 147 (19.4)
Systemic corticosteroids All subjects (N=1518): 1204 (79.3) Olumiant + SOC (N=762): 612 (80.3) Placebo + SOC (N=756): 592 (78.3)
   Dexamethasone    All subjects (N=1518): 1099/1204 (91.3)    Olumiant + SOC (N=762): 566/612 (92.5)    Placebo + SOC (N=756): 533/592 (90.0)
All subjects (N=1525)
Olumiant + SOC (N=764)
Placebo + SOC (N=761)
Comorbidities at baseline, n (%)1,4
Obesity All subjects (N=1525): 503 (33.0) Olumiant + SOC (N=764): 250 (32.7) Placebo + SOC (N=761): 253 (33.2)
Diabetes (Type I & Type II) All subjects (N=1525): 457 (30.0) Olumiant + SOC (N=764): 224 (29.3) Placebo + SOC (N=761): 233 (30.6)
Hypertension All subjects (N=1525): 731 (47.9) Olumiant + SOC (N=764): 365 (47.8) Placebo + SOC (N=761): 366 (48.1)

BMI=body mass index; OS=ordinal scale; SD=standard deviation; SOC=standard of care.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO MORTALITY

In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.

COV-BARRIER Primary Endpoint

The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28 days of the study. Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.1

Olumiant + SOC (n=764)
Placebo + SOC (n=761)
Estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 Olumiant + SOC (n=764): 27.8% Placebo + SOC (n=761): 30.5%
Comparison with placebo
OR (95% CI)
0.85 (0.67, 1.08)
p-value 0.180

The difference between the treatment groups was not statistically significant.

View the COV-BARRIER Study Design

OR=odds ratio; SOC=standard of care.

COV-BARRIER All-Cause Mortality

Mortality by Day 28

In the overall population, the proportion of patients who died by Day 28 was 8.1% (62/764) for Olumiant plus standard of care vs 13.3% (101/761) for placebo plus standard of care (estimated difference in Day 28 probability of mortality = -4.9% [95% CI: -8.0%, -1.9%]; HR = 0.56 [95% CI: 0.41, 0.77]). This corresponds to a 39.1% relative reduction in mortality and a number needed to treat of 20. This data includes one death in the placebo arm that is not reflected in the figure shown below.1

This was a prespecified analysis that was not type-I error controlled. Therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

Kaplan-Meier Estimates of 28-Day All-Cause Mortality in the Overall Population5

Kaplan-Meier graph of 28-day all-cause mortality in the overall population for COV-BARRIER

A Kaplan-Meier graph of 28-day all-cause mortality for patients in the overall population of the COV-BARRIER study is shown.

In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 764. At Day 7, the number at risk was 725. At Day 14, the number at risk was 684. At Day 21, the number at risk was 664. At Day 27, the number at risk was 648.

In the placebo plus SOC arm, the number at risk at Day 0 was 761. At Day 7, the number at risk was 717. At Day 14, the number at risk was 679. At Day 21, the number at risk was 639. At Day 27, the number at risk was 617.

The hazard ratio was 0.57 with a 95% confidence interval of 0.41 to 0.78.

The number at risk at Day 27 represents the number of participants with available data at Day 28.

HR=hazard ratio; SOC=standard of care.

All-Cause Mortality by Day 60

Kaplan-Meier Estimates of 60-Day All-Cause Mortality in the Overall Population5

Kaplan-Meier graph of 60-day all-cause mortality in the overall population for COV-BARRIER

A Kaplan-Meier graph of 60-day all-cause mortality for patients in the overall population of the COV-BARRIER study is shown.

In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 764. At Day 7, the number at risk was 728. At Day 14, the number at risk was 687. At Day 21, the number at risk was 668. At Day 28, the number at risk was 647. At Day 59, the number at risk was 241.

In the placebo plus SOC arm, the number at risk at Day 0 was 761. At Day 7, the number at risk was 718. At Day 14, the number at risk was 681. At Day 21, the number at risk was 642. At Day 28, the number at risk was 613. At Day 59, the number at risk was 234.

The hazard ratio was 0.62 with a 95% confidence interval of 0.47 to 0.83.

This was a prespecified analysis that was not type-I error controlled. Therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

The visit at Day 60 was added as a protocol amendment. Results should be interpreted with caution due to the limited patient information available for this analysis.

The number at risk at Day 59 represents the number of participants with available data at Day 60.

View the COV-BARRIER Study Design

HR=hazard ratio; SOC=standard of care.

28-day all-cause mortality by baseline OS score

In COV-BARRIER, 63% of the overall population required supplemental oxygen (OS 5) at randomization.

Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Baseline Severity OS 55

Kaplan-Meier graph of 28-day all-cause mortality for participants with a baseline OS score of 5 in COV-BARRIER

A Kaplan-Meier graph of 28-day all-cause mortality for patients with a baseline ordinal scale score of 5 in the COV-BARRIER study is shown.

In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 490. At Day 7, the number at risk was 468. At Day 14, the number at risk was 448. At Day 21, the number at risk was 439. At Day 27, the number at risk was 429.

In the placebo plus SOC arm, the number at risk at Day 0 was 472. At Day 7, the number at risk was 452. At Day 14, the number at risk was 435. At Day 21, the number at risk was 418. At Day 27, the number at risk was 411.

The hazard ratio was 0.72 with a 95% confidence interval of 0.45 to 1.16.

HR=hazard ratio; OS=ordinal scale; SOC=standard of care

In COV-BARRIER, 24% of the overall population required non-invasive ventilation or high-flow oxygen (OS 6) at randomization.1

Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Baseline Severity OS 65

Kaplan-Meier graph of 28-day all-cause mortality for participants with a baseline OS score of 6 in COV-BARRIER

A Kaplan-Meier graph of 28-day all-cause mortality for patients with a baseline OS score of 6 in the COV-BARRIER study is shown. The figure shows a hazard ratio of 0.52 with a 95% CI of 0.33 to 0.80.

These were prespecified subgroup analyses that were not type-I error-controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

The number at risk at Day 27 represents the number of participants with available data at Day 28.

View the COV-BARRIER All-Cause Mortality Data

View the COV-BARRIER Study Design

HR=hazard ratio; OS=ordinal scale; SOC=standard of care.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS

Malignancies were observed in clinical studies with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) and a higher rate of lymphomas were observed in patients treated with the JAK inhibitor compared with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy in patients with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

COV-BARRIER OS 7 Addendum Data Overview

COV-BARRIER OS 7 Addendum Study Design

The COV-BARRIER OS 7 addendum study was an exploratory, randomized, double-blind, placebo-controlled substudy of COV-BARRIER of hospitalized adults with confirmed SARS-CoV-2 infection requiring invasive mechanical ventilation or ECMO at baseline. All eligibility criteria were the same as the main COV-BARRIER study, with the exception that patients required invasive mechanical ventilation or ECMO to be enrolled. This substudy compared treatment with Olumiant 4 mg once daily plus standard of care (n=51) with placebo plus standard of care (n=50). All patients received standard of care in keeping with local clinical practice for COVID-19 management, which could include concomitant medications such as corticosteroids, antivirals, and other treatments. In this study prophylaxis for venous thromboembolic event (VTE) was required for all patients unless contraindicated. Olumiant was administered for 14 days or until hospital discharge, whichever occurred first.6

All endpoints in this substudy are considered exploratory. Select prespecified endpoints included all-cause mortality by Day 28 and Day 60.6

COVID-19=coronavirus disease 2019; ECMO=extracorporeal membrane oxygenation; OS=ordinal scale; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Patient Characteristics for COV-BARRIER OS 7 Addendum Study

All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Age, mean (SD)7
Years All subjects (N=101): 58.6 (13.8) Olumiant + SOC (N=51): 58.4 (12.4) Placebo + SOC (N=50): 58.8 (15.2)
All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Sex, n (%)7
Male All subjects (N=101): 55 (54.5) Olumiant + SOC (N=51): 25 (49.0) Placebo + SOC (N=50): 30 (60.0)
Female All subjects (N=101): 46 (45.5) Olumiant + SOC (N=51): 26 (51.0) Placebo + SOC (N=50): 20 (40.0)

aIncludes participants from Mexico and Latin America.

All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Race, n (%)7
American Indian or Alaska Nativea All subjects (N=101): 32 (31.7) Olumiant + SOC (N=51): 15 (29.4) Placebo + SOC (N=50): 17 (34.0)
Asian All subjects (N=101): 1 (1.0) Olumiant + SOC (N=51): 0 (0.0) Placebo + SOC (N=50): 1 (2.0)
Black or African American All subjects (N=101): 2 (2.0) Olumiant + SOC (N=51): 1 (2.0) Placebo + SOC (N=50): 1 (2.0)
Multiple All subjects (N=101): 2 (2.0) Olumiant + SOC (N=51): 2 (3.9) Placebo + SOC (N=50): 0 (0.0)
White All subjects (N=101): 62 (61.4) Olumiant + SOC (N=51): 32 (62.7) Placebo + SOC (N=50): 30 (60.0)
Missing All subjects (N=101): 2 (2.0) Olumiant + SOC (N=51): 1 (2.0) Placebo + SOC (N=50): 1 (2.0)
All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Country, n (%)7
Argentina All subjects (N=101): 21 (20.8) Olumiant + SOC (N=51): 12 (23.5) Placebo + SOC (N=50): 9 (18.0)
Brazil All subjects (N=101): 29 (28.7) Olumiant + SOC (N=51): 15 (29.4) Placebo + SOC (N=50): 14 (28.0)
Mexico All subjects (N=101): 31 (30.7) Olumiant + SOC (N=51): 14 (27.5) Placebo + SOC (N=50): 17 (34.0)
United States All subjects (N=101): 20 (19.8) Olumiant + SOC (N=51): 10 (19.6) Placebo + SOC (N=50): 10 (20.0)
All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
BMI kg/m2, mean (SD)7 All subjects (N=101): 33.2 (7.1) Olumiant + SOC (N=51): 34.3 (7.8) Placebo + SOC (N=50): 32.1 (6.3)
All subjects (N=99)
Olumiant + SOC (N=51)
Placebo + SOC (N=48)
Disease duration of symptoms prior to enrollment, n (%)7
<7 days All subjects (N=99): 6 (6.1) Olumiant + SOC (N=51): 2 (3.9) Placebo + SOC (N=48): 4 (8.3)
≥7 days All subjects (N=99): 93 (93.9) Olumiant + SOC (N=51): 49 (96.1) Placebo + SOC (N=48): 44 (91.7)
All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Concomitant medications of interest, n (%)7
Remdesivir use All subjects (N=101): 2 (2.0) Olumiant + SOC (N=51): 0 (0.0) Placebo + SOC (N=50): 2 (4.0)
Corticosteroid use All subjects (N=101): 87 (86.1) Olumiant + SOC (N=51): 43 (84.3) Placebo + SOC (N=50): 44 (88.0)
All subjects (N=101)
Olumiant + SOC (N=51)
Placebo + SOC (N=50)
Comorbidities at baseline, n (%)7
Obesity All subjects (N=101): 57 (56.4) Olumiant + SOC (N=51): 28 (54.9) Placebo + SOC (N=50): 29 (58.0)
Diabetes (Type I & Type II) All subjects (N=101): 36 (35.6) Olumiant + SOC (N=51): 20 (39.2) Placebo + SOC (N=50): 16 (32.0)
Hypertension All subjects (N=101): 55 (54.5) Olumiant + SOC (N=51): 31 (60.8) Placebo + SOC (N=50): 24 (48.0)

BMI=body mass index; OS=ordinal scale; SD=standard deviation; SOC=standard of care.

SELECT IMPORTANT SAFETY INFORMATION RELATED TO MAJOR ADVERSE CARDIOVASCULAR EVENTS

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of MACE (defined as cardiovascular death, non-fatal MI, and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.

COV-BARRIER OS 7 Addendum Study All-Cause Mortality

COV-BARRIER OS 7 Addendum Study Mortality by Day 28

The proportion of patients who died by Day 28 was 39.2% (20/51) for Olumiant compared to 58.0% (29/50) for placebo [estimated difference in Day 28 risk of mortality = -18.8% (95% CI: -36.3%, 0.6%); hazard ratio = 0.54 (95% CI: 0.31, 0.96)].1

This corresponds to a 32.4% relative reduction in mortality and a number needed to treat of 6.

This was a prespecified exploratory analysis that was not type-I error controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Patients in OS 7 at Baseline6

Kaplan-Meier graph of 28-day all-cause mortality for patients in OS 7 at baseline

A Kaplan-Meier graph of 28-day all-cause mortality for patients in ordinal scale 7 at baseline for the COV-BARRIER OS 7 addendum study is shown.

In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 51. At Day 7, the number at risk was 47. At Day 14, the number at risk was 38. At Day 21, the number at risk was 32. At Day 27, the number at risk was 29.

In the placebo plus SOC arm, the number at risk at Day 0 was 50. At Day 7, the number at risk was 39. At Day 14, the number at risk was 28. At Day 21, the number at risk was 20. At Day 27, the number at risk was 19.

The hazard ratio was 0.54 with a 95% confidence interval of 0.31 to 0.96.

The number at risk at Day 27 represents the number of participants with available data at Day 28.

HR=hazard ratio; OS=ordinal scale; SOC=standard of care.

COV-BARRIER OS 7 Addendum Study Mortality by Day 60

Kaplan-Meier Estimates of 60-Day All-Cause Mortality for Patients in OS 7 at Baseline1

Kaplan-Meier graph of 60-day all-cause mortality for patients in OS7 at baseline

A Kaplan-Meier graph of 60-day all-cause mortality for patients in ordinal scale 7 at baseline for the COV-BARRIER OS 7 addendum study is shown.

In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 51. At Day 7, the number at risk was 48. At Day 14, the number at risk was 40. At Day 21, the number at risk was 34. At Day 27, the number at risk was 31. At Day 59, the number at risk was 25.

In the placebo plus SOC arm, the number at risk at Day 0 was 50. At Day 7, the number at risk was 39. At Day 14, the number at risk was 28. At Day 21, the number at risk was 20. At Day 27, the number at risk was 19. At Day 59, the number at risk was 16.

The hazard ratio was 0.56 with a 95% confidence interval of 0.33 to 0.97.

This was a prespecified exploratory analysis that was not type-I error controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

The numbers at risk at Days 27 and 59 represent the numbers of participants with available data at Days 28 and 60, respectively.

View the COV-BARRIER OS 7 Addendum Study Design

HR=hazard ratio; OS=ordinal scale; SOC=standard of care.

References

  1. Olumiant. Prescribing information. Lilly USA, LLC.
  2. 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. doi: 10.1056/NEJMoa2031994
  3. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. N Engl J Med. 2021;384(suppl):1-55. doi:10.1056/NEJMoa2031994
  4. Data on File. Lilly USA, LLC. DOF-BA-US-0081.
  5. 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. doi: 10.1016/S2213-2600(21)00331-3
  6. 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. Published online February 3, 2022. doi:10.1016/S2213-2600(22)00006-6
  7. Data on file. Lilly USA, LLC. DOF-BA-US-0082.

IMPORTANT SAFETY INFORMATION

WARNING:

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS -

Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
  • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.

The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.

Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MORTALITY

In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

MAJOR ADVERSE CARDIOVASCULAR EVENTS

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction [MI], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

THROMBOSIS

Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.

HYPERSENSITIVITY

Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia - Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.

Lymphopenia - Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.

Anemia - Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.

Liver Enzyme Elevations - Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations - Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS

Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.

ADVERSE REACTIONS

In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.

In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.

PREGNANCY AND LACTATION

Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.

HEPATIC AND RENAL IMPAIRMENT

Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2).

Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.

BA HCP ISI ALL 14SEP2022

Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.

INDICATIONS

Alopecia Areata

Olumiant is indicated for the treatment of adult patients with severe alopecia areata.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Rheumatoid Arthritis

Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.

COVID-19

Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap
 

This site is intended for US healthcare professionals only.

PP-BA-US-1703 09/2022 ©Lilly USA, LLC 2022. All rights reserved.

Olumiant® is a registered trademark of Eli Lilly and Company, its subsidiaries, or affiliates. Olumiant Together™, Companion in Care™, and Lilly Together™ are trademarks of Eli Lilly and Company. Other product/company names mentioned herein are the trademarks of their respective owners.

Facebook
Terms of Use Privacy Statement Accessibility Statement Sitemap
Lilly.com