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Efficacy outcomes and long-term patient expectations with Olumiant

Featuring Natasha Mesinkovska, MD, PhD

00:00-00:05

[Olumiant logo, video title, and disclaimer appear on screen. The Disclaimer and logo remain visible for the duration of the video. A bar animates in from the side with three Olumiant branding colors]

Descriptive Clue:
The Olumiant Logo includes the text Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg.

Caption:
[title] EFFICACY OUTCOMES AND LONG-TERM PATIENT EXPECTATIONS WITH OLUMIANT

Caption:
[disclaimer footer]
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis and full Prescribing Information on the site.

00:05-00:26

[Indication and limitations of use appear on screen]

Caption:
Video to begin after brief Safety Information

INDICATION:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.¹

LIMITATIONS OF USE:
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.¹

00:26-02:06

[Warning information appears on screen]

Caption:
SELECT IMPORTANT SAFETY INFORMATION:
Warning: serious infections, mortality, malignancy, major adverse cardiovascular events (mace), and thrombosis.

SERIOUS INFECTIONS:
Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

MORTALITY:
Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.

Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.

Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.

Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.

02:06-02:10

[Dr. Mesinkovska's credential information appears on screen]

Caption:
Dr. Natasha Mesinkovska, MD, PhD., is an Associate Professor of Dermatology and Vice Chair of Clinical Research in the UCI School of Medicine's Department of Dermatology in Irvine, California, specializing in the diagnosis and treatment of skin disorders, including skin cancer. Her clinical interests include hair loss, dermatitis, and integrative dermatology. Her research interests include alopecia and dermatitis, and she is the author or co-author of many articles in peer-reviewed publications. In addition, she is an investigator on several current clinical trials involving alopecia, atopic dermatitis, psoriasis, and skin laxity. She also served as the Chief Scientific Officer of the National Alopecia Areata Foundation.

02:10-02:24

[Dr. Mesinkovska appears on screen with credentials animating below her]

Caption:
Dr. Natasha Mesinkovska
MD, PhD, Associate Professor of Dermatology and Vice Chair of Clinical Research, UCI School of Medicine

02:24-02:28

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[Title] What results can patients expect from initial treatment?

02:28-02:41

[Dr. Mesinkovska appears on screen and speaks directly to the viewer. There is an eyebrow on the top left in orange color: “FOR ADULTS WITH SEVERE ALOPECIA AREATA”]

02:41-02:44

[Dr. Mesinkovska appears to the left of the screen, speaking directly to the viewer, while a graphic appears to the right of the screen]

Caption:
[figure title] The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata (AA)^2,3

[Graphic description]
SALT score 100: complete hair loss
SALT score 0: no hair loss

Caption:
[Image disclaimer]
Image for illustrative purposes only and is not representative of specific patients or efficacy data.
[footnote]
SALT is a clinically validated tool used to measure scalp hair loss in AA.^2,3

02:54-03:05

[Closeup of Dr. Mesinkovska]

03:05-03:23

[Dr. Mesinkovska off screen, trial design appears on screen]

Caption:
[title] BRAVE-AA1 and BRAVE-AA2 Clinical Trial Design^1,4

Descriptive Clue:
A schematic shows that BRAVE-AA1 (N=654) and BRAVE-AA2 (N=546) assigned patients to one of the following groups: placebo, Olumiant 2 mg/day or Olumiant 4 mg/day. The primary endpoint was the proportion of patients achieving a SALT ≤20 at week 36. Patients were randomized 2:2:3 (placebo:2 mg:4 mg) at week 0.

Caption:
[footnotes]
Olumiant was studied in two randomized, double-blind, placebo-controlled clinical trials in adults with a baseline SALT score >50 and a current AA episode lasting >6 months and <8 years in duration.
BRAVE-AA1 was a phase 2/3 trial that enrolled 654 patients in the phase 3 portion. BRAVE-AA2 was a phase 3 trial that enrolled 546 patients.
Patients were randomized 2:2:3 to placebo, Olumiant 2 mg, or Olumiant 4 mg once daily. The primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36.
[abbreviations]
SALT=Severity of Alopecia Tool; AA=alopecia areata.

03:23-04:29

[Dr. Mesinkovska appears on screen, speaking directly to the viewer and is then replaced with two graphs appearing on screen with Dr. Mesinkovska narrating]

Caption:
[slide title]
Complete or near-complete hair regrowth (SALT ≤20) by week 36 and continued through week 52^1,4-9,*

[graph titles]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRI^a

Descriptive Clue:
The two graphs build along the screen and stop at week 36. Across the top is the description that some patients achieved a SALT score ≤20 as early as week 16.

In BRAVE-AA1, 7%, 11%, and 22% of patients on Olumiant 2 mg/day (N=184), and 19%, 27%, and 35% of patients on Olumiant 4 mg/day (N=281), at weeks 16, 24, and 36 respectively, achieved a SALT score ≤20 versus 4%, 5%, and 5% of patients on placebo (N=189) at weeks 16, 24 and 36 (p≤0.05 for Olumiant 4 mg at week 16 vs placebo and for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, and 17% of patients on Olumiant 2 mg/day (N=156), and 17%, 28%, and 32% of patients on Olumiant 4 mg/day (N=234), at weeks 16, 24, and 36 respectively, achieved a SALT score ≤20 versus 1%, 1%, and 3% of patients on placebo (N=156) at weeks 16, 24, and 36 respectively (p≤0.05 for Olumiant 2 mg at week 36 vs placebo and Olumiant 4 mg at weeks 24 and 36 vs placebo). The placebo-controlled period ended at week 36.

Caption:
[footnotes] The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
^*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their same dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
^†In BRAVE-AA1, statistical significance was seen at week 16 in the 4 mg/day arm, but not in the other treatment arms; statistical conclusions cannot be made.
^aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
^bp≤0.05 vs placebo.

[abbreviations]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

04:29-05:05

Caption:
[slide title]
Complete or near-complete hair regrowth (SALT ≤20) by week 36 and continued through week 52^1,4-9,*

[graph titles]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRI^a

Descriptive Clue:
The two graphs continue to build to week 52. Across the top is a description that some patients achieved a SALT score ≤20 as early as week 16.

In BRAVE-AA1, 7%, 11%, 22%, and 21% of patients on Olumiant 2 mg/day (N=184), and 19%, 27%, 35%, and 41% of patients on Olumiant 4 mg/day (N=281), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 4%, 5%, and 5% of patients on placebo (N=189) at weeks 16, 24 and 36 (p≤0.05 for Olumiant 4 mg at week 16 vs placebo and for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, 17%, and 24% of patients on Olumiant 2 mg/day (N=156), and 17%, 28%, 32%, and 37% of patients on Olumiant 4 mg/day (N=234), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 1%, 1%, and 3% of patients on placebo (N=156) at weeks 16, 24 and 36 respectively (p≤0.05 for Olumiant 2 mg at week 36 vs placebo and Olumiant 4 mg at weeks 24 and 36 vs placebo). The placebo-controlled period ended at week 36.

Caption:
[footnotes]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
^*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their same dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
^†In BRAVE-AA1, statistical significance was seen at week 16 in the 4 mg/day arm, but not in the other treatment arms; statistical conclusions cannot be made.
^aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
^bp≤0.05 vs placebo.
[abbreviations]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

05:05-06:05

Caption:
[slide title]
Complete or near-complete hair regrowth (SALT score ≤10) by week 36 and continued through week 52^1,4-9,*

[graph titles]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤10 Through Week 52, NRI^a

Descriptive Clue:
The two graphs build up to week 36.

In BRAVE-AA1, 8%, 13%, and 14% of patients on Olumiant 2 mg/day (N=184), and 18%, 26%, and 30% of patients on Olumiant 4 mg/day (N=281), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 3% and 4% of patients on placebo (N=189) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.

In BRAVE-AA2, 8%, 11%, and 17% of patients on Olumiant 2 mg/day (N=156), and 19%, 24%, and 28% of patients on Olumiant 4 mg/day (N=234), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 1% of patients on placebo (N=156) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.

Caption:
[footnotes] The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
^*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
^aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
^bp≤0.05 vs placebo.

[abbreviations]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

06:05-06:34

Caption:
[slide title]
Complete or near-complete hair regrowth (SALT score ≤10) by week 36 and continued through week 52^1,4,6-9,*

[graph titles]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤10 Through Week 52, NRI^a

Descriptive Clue:
The two graphs continue to build to week 52.

Caption:
[footnotes]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
^*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
^aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
^bp≤0.05 vs placebo.
See BRAVE-AA trial designs.

[abbreviations]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

06:34-06:39

[Dr. Mesinkovska appears on the left side of the screen with a title on the right]

Caption:
[title]
See the difference Olumiant can make in your adult patients with severe AA

06:39-06:48

[Dr. Mesinkovska appears on screen and is then replaced by images of the patient's hair regrowth over 36 weeks]

Caption:
[image title]
See the difference Olumiant can make through week 36^1,10-12

Descriptive Clue:
Images of the patient's hair at baseline, Week 12 on Olumiant 2 mg/day, and Week 36 on Olumiant 2 mg/day appear. Images show hair regrowth across time points. At baseline, the patient had a SALT Score of 51, and at Week 36, a SALT Score of 14. There is a description above the images indicating that patient hairstyles may influence the appearance of SALT scores depicted.

Image footnote:
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.^a

Caption:
[footnotes]
^aBased on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score ≤20 at week 36) in BRAVE-AA1 and BRAVE-AA2, the observed mean SALT score at week 36 was 8.6 (SD: 6.7) among patients treated with Olumiant 2 mg/day (N=67).
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
See BRAVE-AA1 and BRAVE-AA2 trial designs.

[abbreviations]
SALT=Severity of Alopecia Tool; SD=standard deviation.

06:48-06:52

Caption:
[image title]
See the difference Olumiant can make through week 36

Descriptive Clue:
Images of the patient's hair at baseline, Week 12 on Olumiant 4 mg/day, and Week 36 on Olumiant 4 mg/day appear. Images show hair regrowth across time points. At baseline, the patient had a SALT Score of 100, and at Week 36, a SALT Score of 8. There is a description above the images indicating that patient hairstyles may influence the appearance of SALT scores depicted.

Image footnote:
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.^a

Caption:
[footnotes]
^aBased on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score ≤20 at week 36) in BRAVE-AA1 and BRAVE-AA2, the observed mean SALT score at week 36 was 6.4 (SD: 6.5) among patients treated with Olumiant 4 mg/day (N=175).
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
See BRAVE-AA1 and BRAVE-AA2 trial designs.

[abbreviations]
SALT=Severity of Alopecia Tool; SD=standard deviation.

06:52-06:56

[Title fades in from gradient background. A bar animated in from the side with three Olumiant branding colors]

Caption:
[title]
Subgroup analysis

06:56-07:27

[Dr. Mesinkovska appears on screen and then narrates while graphs appear and replace her on screen]

Caption:
[slide title]
Earlier treatment with Olumiant (AA episode <4 years resulted in more patients achieving ≥80% scalp coverage)^1,13

[graph title]
BRAVE-AA Trials (Pooled Results): SALT Score ≤20 Response Rates Through Week 52 Based on Duration of Current Episode in Patients with baseline SALT Score 50 to 94, NRI

Descriptive Clue:
SALT score ≤20 response rates based on duration of current AA episode in patients with a baseline SALT score 50 to 94 treated with Olumiant 2 mg/day through week 52.

At 36 weeks on Olumiant 2 mg/day, 39% of patients with an AA episode <4 years (N=105) achieved ≥80% scalp coverage compared to 17% of patients who had an AA episode ≥4 years (N=42). At 52 weeks, 41% of patients with an AA episode <4 years achieved ≥80% scalp coverage compared to 24% of patients who had an AA episode ≥4 years.

At 36 weeks on Olumiant 4 mg/day, 52% of patients with an AA episode <4 years (N=165) achieved ≥80% scalp coverage compared to 40% of patients who had an AA episode ≥4 years (N=83). At 52 weeks, 56% of patients with an AA episode <4 years achieved ≥80% scalp coverage compared to 41% of patients who had an AA episode ≥4 years.

07:27-07:31

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
Eyebrow and eyelash efficacy

07:31-07:35

[Dr. Mesinkovska appears on screen speaking directly to the audience]

07:35-07:43

[Dr. Mesinkovska narrates while a stylized eye and eyebrow and table appear on screen]

Caption:
[slide title]
With Oluminant 4 mg/day, an improvement in eyebrow and eyelash coverage was observed at week 36^{1,4,5,14-16,*}

[figure title]
Percentage of Patients Who Achieved EB ClinROTM 0,1 or EL ClinROTM 0,1 With ≥2-Point Improvement From Baseline at Week 36, NRI^†

Descriptive Clue:
An image of an eyebrow above an eye appears on the left side of the screen. There is a description at the top to indicate the results presented below are shown for patients with substantial eyebrow and eyelash hair loss at baseline. There is a table to the right, anchored to the eyebrow, that reads:
BRAVE-AA1: 31% of patients on Olumiant 4 mg/day (59/188 patients) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (4/124 patients) (p≤0.05)
BRAVE-AA2: 35% of patients on Olumiant 4 mg/day (56/161 patients) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 4% on placebo (5/112 patients) (p≤0.05)

There is a table to the right, anchored to the eye, that reads:
BRAVE-AA1: 34% of patients on Olumiant 4 mg/day (56/167 patients) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (3/96 patients) (p≤0.05)
BRAVE-AA2: 34% of patients on Olumiant 4 mg/day (48/140 patients) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 6% on placebo (5/90 patients) (p≤0.05)

Caption:
[footnotes]
^*The EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
^†Data collected after permanent study drug discontinuation or data collected at remote visits due to the COVID-19 pandemic were excluded.
^‡p≤0.05 vs placebo.

[abbreviations]
EB ClinRO= Clinician-Reported Outcome Measure for Eyebrow Hair Loss; EL ClinRO= Clinician-Reported Outcome Measure for Eyelash Hair Loss; NRI=nonresponder imputation.

07:43-07:54

[Previous images are replaced by an iconized image of a half face and statistics]

Caption:
[slide title]
Demonstrated improvement in scalp, eyebrow, and eyelash coverage through week 52^{1,4,7,8,14-16}

[image title]
BRAVE-AA Trials (Pooled Results): Proportion of Patients on Olumiant Who Achieved a Response at Week 52, NRI^a

Descriptive Clue:
An iconized image of half a face appears on the left side with four statistics anchored to the icon: 2 to the scalp region, one to the eyebrow region, and one to the eyelash region. The statistics show scalp hair loss: 22.6% achieved SALT score ≤20 at week 52 with Olumiant 2 mg/day (N=340), scalp hair loss: 39% achieved SALT score ≤20 at week 52 with Olumiant 4 mg/day (N=515), eyebrow hair loss: 44.1% achieved EB ClinRO 0,1 with a ≥2-point improvement at week 52 with Olumiant 4 mg/day (N=349)b, eyelash hair loss: 45.3% achieved EL ClinRO 0,1 with a ≥2-point improvement at week 52 with Olumiant 4 mg/day (N=307)^b

In BRAVE-AA trials, the primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36. These prespecified analyses included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dosage through week 52. Data after week 36 were not placebo-controlled.

^aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
^bThe EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.

See BRAVE-AA trial designs.

[abbreviations]
EB ClinRO= Clinician-Reported Outcome Measure for Eyebrow Hair Loss; EL ClinRO= Clinician-Reported Outcome Measure for Eyelash Hair Loss; SALT=Severity of Alopecia Tool.

07:54-07:58

[Dr. Mesinkovska appears on screen as title fades in]

Caption:
[title]
See the difference Olumiant can make in your adult patients with severe AA

07:58-08:10

ACTION:
Patient photos build on screen.

Caption:
[title]
See the difference Olumiant can make through week 36^1,10-12,14

Descriptive Clue:
Images of a patient's eyebrow regrowth from baseline to week 36 show an improvement in EB ClinRO from 3 to 1, and images of a different patient's eyelash regrowth from baseline to week 36 show an improvement in EL ClinRO from 3 to 1. There is a description above indicating how the ClinRO^™ measures were developed.

Caption:
[disclaimer]
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.

08:10-08:14

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
When can patients expect hair regrowth?

08:14-08:44

[Dr. Mesinkovska appears on the left side of the screen as a schematic shows early, gradual, and late responders]

Caption:
[title]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Onset of Improvement Groups

Descriptive Clue:
Early responders are defined as those who responded ≤12 weeks, gradual responders: >12 weeks to ≤36 weeks, and late responders: >36 to 52 weeks.

08:44-09:00

[Onset of improvement graphic and text transitions to full screen and continues to build on]

Caption:
[title]
Onset of improvement (≥30% regrowth) within 1 year is driven by baseline severity¹⁷

[schematic title]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Onset of Improvement Groups

Descriptive There is a description above the schematic to indicate that patients were categorized as improvers or non-improvers based on the achievement of >30% improvement in SALT score at any point within 1 year of treatment. Early responders are defined as those who responded ≤12 weeks, gradual responders: >12 weeks to ≤36 weeks, and late responders: >36 to 52 weeks. Patients with a baseline severity 50-94 were more likely to be early improvers.* Patients with a baseline severity 95-100 were more likely to be gradual or late improvers.^*

Caption
[footnotes]
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.

^*Early improvers were more likely to have less severe SALT scores at baseline. Olumiant 2 mg: 81% of early responders had a SALT score 50-94 at baseline compared to 44% and 34% of gradual and late improvers, respectively. Olumiant 4 mg: 73% of early responders had a SALT score 50-94 at baseline compared to 47% and 34% of gradual and late improvers, respectively.
On Olumiant 2 mg, 51% (174/340) of patients were improvers (20% early, 23% gradual, and 9% late).
On Olumiant 4 mg, 69% (355/515) were improvers (33% early, 28% gradual, 8% late).

[abbreviations]
AA=alopecia areata, SALT=Severity of Alopecia Tool.

09:00-09:15

Caption:
[slide title]
Onset of improvement may indicate the likelihood of achieving 80% or more scalp hair coverage by 1 year^17,18

[graph title]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percent of Patients Achieving a SALT Score ≤20 Based on Timing of Onset of Improvement

Descriptive Clue:
A graph displaying Olumiant 2 mg group results appears. The graph shows that within the Olumiant 2 mg group (N=340), a SALT score <20 was reached by 70% (47/67) of early, 40% (31/78) of gradual, and 14% (4/29) of late improvers.

Caption:
[footnotes]
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
Onset of improvement was categorized based on timing of achievement of ≥30% improvement in SALT score within 1 year of treatment.
On Olumiant 2 mg (N=340), a SALT score <20 was reached by 70% (47/67) of early, 40% (31/78) of gradual, and 14% (4/29) of late improvers.
On Olumiant 4 mg (N=515), a SALT score <20 was reached by 78% (131/168) of early, 51% (75/146) of gradual, and 20% (8/41) of late improvers.

Early improvers were more likely to have less severe SALT scores at baseline. Olumiant 2 mg: 81% of early improvers had a SALT score 50-94 at baseline compared to 44% and 34% of gradual and late improvers, respectively. Olumiant 4 mg: 73% of early improvers had a SALT score 50-94 at baseline compared to 47% and 34% of gradual and late improvers, respectively.

[abbreviations]
SALT=Severity of Alopecia Tool.

09:15-09:30

Caption:
[slide title]
Onset of improvement may indicate the likelihood of achieving 80% or more scalp hair coverage by 1 year

[graph title]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percent of Patients Achieving a SALT Score ≤20 Based on Timing of Onset of Improvement

Descriptive Clue:
A graph displaying Olumiant 4 mg group results appears beside Olumiant 2 mg group. The graph shows that within the Olumiant 4 mg group (N=515), a SALT score <20 was reached by 78% (131/168) of early, 51% (75/146) of gradual, 20% (8/41) of late improvers.

[abbreviations]
SALT=Severity of Alopecia Tool.

09:30-09:35

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
What can patients expect with long-term treatment?

09:35-09:50

[Dr. Mesinkovska appears on screen speaking directly to the audience]

09:50-10:00

[Dr. Mesinkovska stays on screen speaking directly to the audience]

Caption:
[title]
BRAVE-AA1 and BRAVE-AA2: Long-term Extension Study Design^19-21

10:00-10:48

Caption:
[slide title] Long-term extension study design: responders (SALT score ≤20) at week 52 were eligible for re-randomization^19,*

[figure title]
BRAVE-AA1 and BRAVE-AA2: Long-term Extension Study Design^19-21

Descriptive Clue:
A schematic indicating that participants who achieved a SALT score ≤20 at week 52 of BRAVE-AA1 and BRAVE-AA2 were re-randomized to receive a placebo, 2 mg/day, or 4 mg/day up to 104 weeks for a long-term extension. Participants were either withdrawing with placebo, maintaining or down-titrating to 2 mg/day, or maintaining 4 mg/day, according to their prior randomization.

[abbreviations]
PBO=placebo; QD=once daily; SALT=Severity of Alopecia Tool.

10:48-10:53

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
What happened to scalp coverage for patients who continued treatment through 3 years?

10:53-10:58

[Dr. Mesinkovska appears on screen]

10:58-11:16

Caption:
[graph title]
BRAVE-AA Trials (Pooled Results): Percentage of Responders Who Sustained a SALT Score ≤20 Through Week 152, LOCF^a

Descriptive Clue:
The graph indicates that BRAVE-AA1 and BRAVE-AA2 (Pooled Results) showed 84% of responders on Olumiant 2 mg/day (N=67) and 89% of responders on Olumiant 4 mg/day (N=129) sustained a SALT score ≤20 from week 52 to week 152.

91% of responders on Olumiant 2 mg/day (N=67) and 88% of responders on Olumiant 4 mg/day (N=129) sustained a SALT score ≤20 from week 52 to week 104.

Caption:
[footnotes]
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day when an adequate response has been achieved.
Study Design: In the BRAVE-AA trials, patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52. At week 52, responders (SALT score ≤20; N=278) were re-randomized to either: treatment continuation (both trials), withdrawal to placebo (BRAVE-AA1) or down-titration from 4 mg to 2 mg (BRAVE-AA2).
Down-Titration Efficacy: In BRAVE-AA2, 59% of patients (N=42) on Olumiant who achieved a SALT score ≤20 at week 52 sustained ≥80% scalp coverage through week 152 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day.
*,aLOCF analysis excludes study drug discontinuation or dose change after week 52.
The long-term extension data of BRAVE-AA trials were not placebo-controlled.

[abbreviations]
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.

11:16-11:20

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
What happened when patients increased their dose?

11:21-11:27

[Dr. Mesinkovska appears on screen and speaks directly to the audience]

11:28-11:39

Caption:
[page title]
Up-titration: SALT score ≤20 response rates after increasing the treatment dose for nonresponders²³

[graph title]
BRAVE-AA1 and BRAVE-AA2 Up-titration Period (Pooled analysis): Percentage of Patients Who Achieved a SALT Score ≤20 (Week 52 to 76), NRI^23,*

Descriptive Clue:
Among patients on Olumiant 2 mg/day who were non-responders at week 52, 3%, 13%, and 26% achieved a SALT score ≤20 at week 56, 64, and 76, respectively, after the treatment dose was increased to Olumiant 4 mg/day (N=212).

Caption:
[footnotes]
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.¹

Eligible nonresponders (SALT score >20) in the Olumiant 2 mg/day treatment arm were transitioned to Olumiant 4 mg/day at week 52 and continue through week 76.²³

^*Excludes data collected after permanent study drug discontinuation.²³

The long-term extension data of BRAVE-AA1 and BRAVE-AA2 were not placebo-controlled.^19,20

[abbreviations]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

11:39-11:43

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
What happened when patients decreased their dose?

11:43-11:49

[Cut to close up of Dr. Mesinkovska]

11:49-11:59

Caption:
[graph title]
BRAVE-AA2 Down-Titration Period (Weeks 52-152): Percentage of Responders Who Sustained a SALT Score ≤20, LOCF^*

Descriptive Clue:
There is a description above the graph to indicate that 59% of patients (N=42) on Olumiant who achieved a SALT score ≤20 at week 52 sustained >80% scalp coverage through week 152 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day, LOCF.^*
The graph indicates that within BRAVE-AA2, 66% of responders (N=42) sustained a SALT score ≤20 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day up to week 104 and 59% sustained a SALT score ≤20 at week 152.

Caption:
[footnotes]
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.

Patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52, and then responders (SALT score ≤20) on Olumiant 4 mg (N=85) either continued treatment or down-titrated to 2 mg.

^*LOCF excludes study drug discontinuation or dose change after week 52.

The long-term extension data of BRAVE-AA2 were not placebo-controlled.

[abbreviations]
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.

11:59-12:04

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
What happened when patients discontinued treatment?

12:04-12:17

Caption:
[graph title]
BRAVE-AA1: Percentage of Responders Who Sustained a SALT Score ≤20 From Week 52 to Week 104 After Discontinuing Treatment, MI+NRI^a

Descriptive Clue:
The graph shows that in BRAVE-AA1, 10% of responders who switched from 2 mg/day to placebo (N=10) and 20% of responders who switched from 4 mg/day to placebo (N=30) sustained a SALT score ≤20 from week 52 to week 104.

Caption:
[footnotes] ^*,aMI+NRI analysis excludes data after permanent study drug discontinuation, treatment switch after week 52 visit, or collected at remote visits due to the COVID-19 pandemic. Missing data due to COVID-19 were imputed by MI; data missing for other reasons were imputed as nonresponse.
These analyses included BRAVE-AA1 responders (SALT score ≤20) at week 52 who were randomized from Olumiant 2 mg/day and Olumiant 4 mg/day to placebo withdrawal.
The study population sample size should be taken into consideration when evaluating these data.
See BRAVE-AA1 Long-Term Extension study design.

12:17-12:21

[Dr. Mesinkovska appears on screen speaking directly to the audience]

12:21-12:25

[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors]

Caption:
[title]
Summary

12:25-12:40

Caption:
[title]
Olumiant offers the possibility of complete or near-complete hair regrowth that is sustained with an established safety profile in a once-daily tablet^1,6,7,19-22

Descriptive Clue:
There is an icon of a hair follicle to represent complete or near-complete hair regrowth. Olumiant has been proven to help patients achieve ≥80% scalp coverage by week 36.
There is an icon of a calendar and an arrow around a checkmark to indicate sustained efficacy. Among responders (≥80% scalp coverage) at 1 year, most sustained the response through 3 years with Olumiant treatment.

12:40-12:47

[Dr. Mesinkovska appears on the left side of the screen and claim transitions to inset]

Caption:
[title]
Olumiant offers the possibility of complete or near-complete hair regrowth that is sustained with an established safety profile in a once-daily tablet^1,6,7,19-22

12:48-12:53

[SSI appears on screen]

Caption:
[title]
SELECT SAFETY INFORMATION

[copy]
Olumiant has a Boxed Warning for serious infetions, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Consider the risks and beenfits of treatment prior to initiating or continuing therapy with Olumiant. 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.

12:53-13:00

[Dr. Mesinkovska appears on screen speaking directly to the audience to provide closing remarks]

13:01-13:05

[Dr. Mesinkovska’s conflict of interest statement appears]

Caption:
[copy]
Dr. Natasha Mesinkovska, MD., PhD., is a speaker for Eli Lilly and Pfizer. She is a member of the Advisory Board for Eli Lilly, Pfizer, Sun Pharma, Abbvie, L'Oréal, and Nutrafol.

13:05-15:45

[Dr. Mesinkovska’s conflict of interest statement is replaced with the ISI for Olumiant (baricitinib) tablets. The ISI scrolls slowly through the remaining ISI details]

Caption:
[title]
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets

[copy]
Serious hypersensitivity reactions, gastrointestinal perforations, and laboratory abnormalities have been reported in Olumiant-treated patients.

Discontinue Olumiant if a serious hypersensitivity reaction occurs while evaluating the potential causes.

Monitor patients who may be at increased risk for gastrointestinal perforations. Promptly evaluate those presenting with new onset abdominal symptoms.

Avoid initiation or interrupt treatment in patients with an absolute neutrophil count (ANC) <1000 cells/mm³, absolute lymphocyte count (ALC) <500 cells/mm³, or hemoglobin level <8 g/dL.

If liver enzyme elevation (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) is observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Assess lipid parameters approximately 12 weeks following Olumiant initiation and manage patients according to clinical hyperlipidemia guidelines.

Avoid use of live vaccines with Olumiant. Update immunizations prior to initiating therapy.

Most common adverse reactions in alopecia areata trials (≥1%) 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.

Advise pregnant women and women of reproductive potential of the potential risk of fetal harm. Advise women not to breastfeed during Olumiant treatment and for 4 days after the last dose.

Olumiant is not recommended in patients with severe hepatic or severe renal impairment.

This is not the complete safety information for Olumiant. For additional information, please see the full Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, and Major Adverse Cardiovascular Events, and Thrombosis, and the full Prescribing Information on this site.

[footnote]
BA HCP MSR AA 13JUN2022

15:45-15:53

[References appear on screen]

Caption:
[title]
References

Olumiant. Prescribing Information. Lilly USA, LLC.
Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines-part II. J Am Acad Dermatol. 2004;51(3):440-447.
Data on file. Lilly USA, LLC. DOF-BA-US-0065.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(suppl 1):1-77.
Data on file. Lilly USA, LLC. DOF-BA-US-0075.
Data on file. Lilly USA, LLC. DOF-BA-US-0076.
Data on file. Lilly USA, LLC. DOF-BA-US-0074.
Data on file. Lilly USA, LLC. DOF-BA-US-0122.
Data on file. Lilly USA, LLC. DOF-BA-US-0084.
Data on file. Lilly USA, LLC. DOF-BA-US-0086.
Data on file. Lilly USA, LLC. DOF-BA-US-0092.
Data on file. Lilly USA, LLC. DOF-BA-US-0117.
Wyrwich K, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. Am J Clin Dermatol. 2020;21(5):725-732.
Data on file. Lilly USA, LLC. DOF-BA-US-0063.
Data on file. Lilly USA, LLC. DOF-BA-US-0064.
King B, Shapiro J, Ohyama M, et al. When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials. Br J Dermatol. 2023;189(6):666-673.
Data on file. Lilly USA, LLC. DOF-BA-US-0121.
Data on file. Lilly USA, LLC. DOF-BA-US-0078.
Data on file. Lilly USA, LLC. DOF-BA-US-0090.
Data on file. Lilly USA, LLC. DOF-BA-US-0105.
Data on file. Lilly USA, LLC. DOF-BA-US-0111.
Data on file. Lilly USA, LLC. DOF-BA-US-0102.
Data on file. Lilly USA, LLC. DOF-BA-US-0101.
Data on file. Lilly USA, LLC. DOF-BA-US-0100.

15:53-15:54

[The Eli Lilly logo and disclaimers appear on a white background]

Caption:
Lilly logo and Veeva code.
PP-BA-US-2331 10/2024 ©Lilly USA, LLC 2024. All rights reserved.
ClinRO Measure for Eyebrow Hair Loss^™ and ClinRO Measure for Eyelash Hair Loss^™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Olumiant^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Safety Profile and treatment considerations with Olumiant

Featuring Omer Ibrahim, MD, FAAD

00:00-00:03

[Olumiant logo, video title, and disclaimer appear on screen. The disclaimer and logo remain visible for the duration of the video.]

Descriptive Clue:
The Olumiant logo includes the text Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg

Caption:
[Title]
SAFETY PROFILE AND TREATMENT CONSIDERATIONS WITH OLUMIANT

Caption:
[Disclaimer footer]
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis and full Prescribing Information on the site.

00:04-00:27

[Indication and limitations of use appear on screen.]

Caption:
Video to begin after brief Safety Information.

INDICATION:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.¹

LIMITATIONS OF USE:
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.¹

00:28-02:06

[Warning information appears on screen.]

Caption:
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS.
Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use.

Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.

Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.

Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.

Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.

02:07-02:09

[Dr. Omer Ibrahim’s credential information appears on screen.]

Caption:
Dr. Omer Ibrahim is a Co-director of Chicago Cosmetic and Dermatologic Research. He has published numerous peer-reviewed articles, book chapters, and editorials on general, surgical, and cosmetic dermatology. Dr. Ibrahim has participated in numerous research trials covering topics ranging from hair loss to innovative laser anti-aging treatments. He serves as an adjunct faculty at Cleveland Clinic, Chicago, where he teaches residents the fundamentals of cosmetic dermatology.

02:10-02:21

[Dr. Ibrahim appears on screen with credentials animating below him. He introduces himself and the video.]

Caption:
Dr. Omer Ibrahim
MD, FAAD, Co-director of Research, Chicago Cosmetic Surgery and Dermatology, Clinical Instructor, RUSH University Medical Center

02:22-02:25

[Dr. Ibrahim disappears, and section title appears on screen.]

Caption:
How many patients have experience on Olumiant?

02:26-02:35

[Dr. Ibrahim appears on screen and speaks directly to the viewer.]

02:36-02:55

[Dr. Ibrahim disappears, and patient exposure data appears on screen.]
[On all claim-related screens, there is an eyebrow on top left in orange color: “FOR ADULTS WITH SEVERE ALOPECIA AREATA”]

Caption:
[Figure title]
Extensive Patient Exposure Over 9 Years1-4^*

Descriptive Clue:
Olumiant has been well studied and is approved across two immunologic diseases, rheumatoid arthritis (2018) and alopecia areata (2022).
Unrivaled total exposure in adults with severe AA across clinical trials and real-world use. 1,303 patients have been treated with Olumiant for up to 4 years in the AA clinical trial program.a Post-approval: Over 11,000 patients have been treated with Olumiant.b

Caption:
[Footer]
^*Exposure in adults: RA over 9 years and AA up to 4 years.
^aAs of May 2023, median exposure of 825 days and maximum exposure of 4.0 years across two randomized AA clinical trials (N=1,303).
^bData cutoff was 04/2024.

AA=alopecia areata; RA=rheumatoid arthritis.

02:56-03:06

[Alopecia areata and rheumatoid arthritis indications and limitations of use appear on screen side by side.]

Caption:
[Figure Title]
Alopecia Areata
Indication:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.¹
Limitations of use:
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.¹

[Figure Title]
Rheumatoid Arthritis
Indication:
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.¹
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.¹

03:07-03:10

[Section title appears on screen.]

Caption:
What is the safety profile of Olumiant, including long-term safety?

03:11-03:33

[Camera angle changes back to front-facing angle as Dr. Ibrahim continues speaking and introduces the next section.]

03:34-03:38

[Dr. Ibrahim disappears, and section title appears on screen.]

Caption:
What key safety results were reported in clinical trials?

03:39-03:41

[Dr. Ibrahim appears on screen.]

03:41-04:04

[Dr. Ibrahim disappears while continuing to speak, and adverse reactions table appears on screen. Adverse events and data values scroll in time with voice-over.]

Caption:
[Table title]
Adverse reactions (≥1%) through week 361
Descriptive Clue:
The table starts scrolling. Across the top is the description that is BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Adverse Reactions That Occurred in ≥1% of Patients on Olumiant and More Frequently Than Placebo Over a 36-Week Period.^* In order, the three columns list Placebo (N=371), Olumiant 2 mg/day (N=365), and Olumiant 4 mg/day (N=540).
Upper respiratory tract infections^† seen in 19.9%, 18.4%, 21.3%.
Headache seen in 5.4%, 5.5%, 6.6%.
Acne‡ seen in 2.2%, 5.8%, 5.9%.
Hyperlipidemia^§ seen in 3.0%, 3.6%, 5.9%.
Blood creatine phosphokinase increased seen in 1.3%, 0.8%, 4.3%.
Urinary tract infections^‖ seen in 2.2%, 3.8%, 3.7%.
Liver enzyme elevations^¶ seen in 2.4%, 1.1%, 3.0%.
Folliculitis^# seen in 0.8%, 1.4%, 2.2%.
Fatigue seen in 1.1%, 0.8%, 2.2%.
Lower respiratory tract infections^** seen in 0.8%, 2.2%, 2.0%.
Nausea seen in 1.6%, 2.7%, 2.0%.
Genital Candida infections^†† seen in 0.3%, 2.2%, 1.3%.
Anemia seen in 0.3%, 0.3%, 1.3%.
Neutropenia^‡‡ seen in 0.8%, 0.3%, 1.3%.
Abdominal pain^§§ seen in 2.2%, 3.8%, 0.9%.
Herpes zoster seen in 0.5%, 1.4%, 0.9%.
Weight increased seen in 0.3%, 1.6%, 0.9%.

Caption:
[Footer]
^*%-study size adjusted percentages.
^†Includes acute sinusitis, influenza, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, respiratory tract infection viral, rhinovirus infection, and adenoiditis.
^‡Includes acne and dermatitis acneiform.
^§Includes hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, lipids increased, low density lipoprotein increased, blood cholesterol increased, and blood triglycerides increased.
^‖Includes cystitis, urinary tract infection, white blood cells urine positive, urinary tract infection bacterial, and pyelonephritis.
^¶Includes transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, gamma-glutamyl transferase increased, and hepatic function abnormal.
^#Was most commonly localized in the scalp region associated with hair regrowth.
^**Includes bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection.
^††Includes vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital infection fungal.
^‡‡Includes neutropenia and neutrophil count decreased.
^§§Includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.

04:05-04:08

[Section title appears on screen.]

Caption:
What are the 3-year safety results?

04:09-04:14

[Dr. Ibrahim appears on screen introducing the section.]

04:15-05:00

[Dr. Ibrahim disappears while continuing to speak, and adverse events of special interest table appears on screen. Data is populated and/or emphasized in time with the voice-over.]

Caption:
[Table title]
AEs of special interest: 3-year safety update^5-11

Descriptive Clue:
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): adverse events of Special Interest.^*

Table with 3 subsections. Column section one, from weeks 0-36, during the placebo-controlled period, shows the adverse events experienced by the 371 patients given placebo, 365 patients given Olumiant 2 mg/day, and 540 patients given Olumiant 4 mg/day. Serious infections were experienced by 2 patients (0.5%) in the Olumiant 2 mg/day group [0.8] and 1 patient (0.2%) in the Olumiant 4 mg/day group [0.3], but not by anyone in the placebo group. No one in the study experienced an opportunistic infection. One patient (0.3%) in the placebo group [0.4] and 1 patient in the Olumiant 4 mg/day group [0.3] experienced a malignancy other than NMSC.^a No one reported NMSC. One patient (0.3%) in the Olumiant 2 mg/day group [0.4] experienced a MACE (adjudicated).^b No one in the study reported DVT/PE (adjudicated). Column section two, from weeks 0-152, is titled Extended Safety Analysisb and measures n [IR/100 PYE] for Olumiant 2 mg/day (N=383 PYE=523.25) and Olumiant 4 mg/day (N=565; PYE=1106.70). Two patients in the 2 mg/day group [0.4] and six in the 4 mg/day group [0.5] experienced a serious infection. No opportunistic infections were reported. Three people in the 4 mg/day group [0.3] experienced a malignancy other than NMSC.^a One person in the 2 mg/day group [0.2] were diagnosed with NMSC. One person in the 2 mg/day group [0.2] reported a MACE (adjudicated),^b and one person in the 2 mg/day group [0.2] had a DVT/PE (adjudicated). Column section three is titled All BARI AAc and measures n [IR/100 PYE] for All Doses (N=1303; PYE=2789.69). 16 patients [6.0] experienced serious infection, one patient [<0.1] experienced opportunistic infections, 7 patients [0.2] experienced Malignancies other than NMSCa, three patients [0.1] were diagnosed with NMSC, one patient [<0.1] reported a MACE (adjudicated),^b and two patients [0.1]^d had a DVT/PE (adjudicated).

Caption:
[Footer]
^*Data includes patients from the BRAVE-AA1 (Phase 2/3) and BRAVE-AA2 (Phase 3) trials, and from a study addendum.
^aAll BARI includes the events of prostate cancer (placebo), B-cell lymphoma (Olumiant 4 mg/day), breast cancers (Olumiant 4 mg/day & 2 mg/day), chronic lymphocytic leukemia (Olumiant 2 mg/day), malignant melanoma in situ (Olumiant 2 mg/day), malignant melanoma (Olumiant 4 mg/day), and endometrial cancer (Olumiant 4 mg/day).
^bThe extended safety analysis includes patients who were treated continuously on either Olumiant 2 mg/day or 4 mg/day from randomization through data cut-off. Data is censored after any dose or treatment change.
^cAll BARI AA includes all patients who received a dose of baricitinib at any time during the BRAVE-AA studies. Median exposure for All BARI AA was 825 days.
^dOne patient had a DVT and one patient had a DVT/PE.

Certain adverse events, such as MACE and malignancy, require longer observation periods to ascertain risk.
Patients with high risk of DVT/PE, significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.
Data cut-off dates for BRAVE-AA trials from weeks 0-36 by February 2021, weeks 0-152 by May 2023.

BARI=baricitinib; DVT=deep vein thrombosis; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure.

05:01-05:04

[Section title appears on screen.]

Caption:
What were adverse event rates in patients with and without risk factors?

05:05-05:28

[Claim headers and required text build with the 46.0% statistic and outer circle. Surrounding data then build sequentially in time with the voice-over.]

Caption:
[Figure title]
Proportion of patients with risk factors for select AEs of special interest at baseline^5,12,13

Descriptive Clue:
About 46% of patients with severe AA had at least one risk factor for select AEs of special interest at baseline.^*

Circles of various sizes that scale proportionally to the percentage of patients with selected AEs are themselves placed in a circle around a statistic of at least one risk factor.

At least one risk factor: 46.0%
BMI ≥30 kg/m2: 20.4%
History of smokinga: 17.0%
Hypertension: 11.1%
HDL <40 mg/dL: 8.9%
Diabetes mellitus: 3.1%
History of malignancy: 1.3%
ASCVD: 0.9%
Age ≥65 yearsb: 2.5%
Severe mobility impairment (EQ-5D)c: 0.3%

Unrivaled total exposure in adults with severe AA across clinical trials and real-world use. 1,303 patients have been treated with Olumiant for up to 4 years in the AA clinical trial program.a Post-approval: Over 11,000 patients have been treated with Olumiant.^b

Caption:
[Footer]
AEs of special interest included MACE, malignancies, VTE, serious infections, and mortality.

Individual disease burden, risk factors, and response to treatment should be considered to make an informed decision for individual patients treated with Olumiant.

The risk factors presented are those relevant for the selected AEs of special interest and were assessed as part of an analysis to address questions on JAK inhibitor safety from the EMA.

^*In AA analysis set, data were pooled from BRAVE-AA1 (phase 2/3) and BRAVE-AA2 (phase 3), and all patients who were exposed to any Olumiant dose.
^aCurrent or past smoking.
^bThe age of participants in the AA clinical trials was limited to ≤60 years for men and ≤70 years for women to reduce concomitant androgenic alopecia.
^cSevere mobility impairment indicated by a response of either “I have severe problems in walking about” or “I am unable to walk about.”

AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; EMA=European Medicines Agency; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; JAK=Janus kinase; MACE=major adverse cardiovascular event; VTE=venous thromboembolism.

05:29-05:33

[Dr. Ibrahim appears on screen introducing the next safety table.]

05:34-05:50

[Dr. Ibrahim disappears. Table with illustrations and required text build initially. Data points populate in time with voice-over.]

Caption:
[Figure title]
An integrated safety analysis across BRAVE-AA clinical trials^12,13

Descriptive Clue:
Incidence rates of adverse events of special interest in patients with and without specified risk factors* in BRAVE-AA Clinical Trials.a Two columns, No specified risk factors (N=704) and ≥1 specified risk factor (N=599), measured in IR/100 PYE (n).

MACE^b seen as 0 (0) and 0.12 (1).
Malignancies Excluding NMSCs seen as 0 (0) and 0.35 (3).
VTE^c seen as 0 (0) and 0.12 (1).
Serious Infections seen as 0.57 (6) and 1.17 (10).
All-Cause Mortality seen as 0 (0) and 0 (0).

Caption:
[Footer]
^*The risk factors were ASCVD, diabetes mellitus, age ≥65 years, hypertension, history of smoking, HDL <40 mg/dL, BMI ≥30 kg/m2, severe mobility impairment as indicated by EQ-5D, or history of malignancy, also including factors only documented in case narrative, such as past smoking.
Individual disease burden, risk factors, and response to treatment should be considered to make informed decisions for individual patients treated with Olumiant.
^aPooled data from BRAVE-AA1 and BRAVE-AA2 clinical trials. Total patient-years of exposure was 1868.
^bMACE was defined as positively adjudicated events of myocardial infarction, stroke, and cardiovascular deaths combined.
^cVTE was defined as DVT or PE.

AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; DVT=deep vein thrombosis; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC= nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure; VTE=venous thromboembolism.

05:51-05:54

[Section title appears on screen.]

Caption:
Which lab assessments are recommended for patients on Olumiant?

05:55-06:02

[Dr. Ibrahim appears on screen in a medium shot.]

06:03-06:08

[Dr. Ibrahim appears in a close-up.]

06:09-07:26

[Dr. Ibrahim disappears. Table with lab assessment recommendations builds initially. Data points populate and are emphasized in time with voice-over.]

Caption: [Table title] Lab assessments and select treatment considerations with Olumiant¹

Descriptive Clue: Lab monitoring table that describes when to avoid initiation or interrupt treatment with Olumiant for the following lab parameters:

Lab results before treatment include: tuberculosis screening, hepatitis screeninga (active, serious, or opportunistic infection), complete blood count (CBC) with differential on absolute neutrophil count (ANC)b (<1000 cell/uL), absolute lymphocyte count (ALC)b (<500 cells/uL), and hemoglobin (Hgb)b (<8 g/uL), hepatic transaminases (ALT, AST)b (liver enzyme elevations and suspected drug-induced liver injury), glomerular filtration rate (GFR) (estimated GFR of less than 30 mL/min/1.73m3), evaluate for immunization screenings.^d

Lab results at week 12: lipids.^c

Caption:
[Footer]
Treatment can be initiated or restarted after ANC, ALC, or Hgb levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.
Laboratory Abnormalities - Treatment with Olumiant was associated with an increased risk of neutropenia (ANC <1000 cells/mm3). ALC <500 cells/mm3 and Hgb <8 g/dL were reported in Olumiant clinical trials. Treatment with Olumiant was associated with increased incidence of liver enzyme elevation. Increases of ALT ≥5 times the ULN and increases of AST ≥10 times the ULN were observed in patients taking Olumiant.
Treatment with Olumiant was also associated with increases in lipid parameters, including total cholesterol, LDL, and HDL.
Other Considerations During Routine Treatment:
Hepatic and Renal Impairment - Olumiant is not recommended for patients with severe renal or severe hepatic impairment. Dosage should be reduced in patients with moderate renal impairment.
Serious Infections - Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant.
Tuberculosis - If positive, treat for latent TB prior to Olumiant use. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
Viral Reactivation - If a patient develops herpes zoster, interrupt Olumiant treatment until episode resolves. Patients should be monitored for viral reactivation.

^aPerform hepatitis screening in accordance with clinical guidelines.
^bIn addition to evaluation before starting treatment, evaluate thereafter according to routine patient management.
^cPatients should be managed according to clinical guidelines for hyperlipidemia.
^dUpdate immunizations in agreement with current guidelines prior to initiating Olumiant.

ALC=absolute lymphocyte count; ALT=alanine aminotransferase; AST=aspartate aminotransferase; HDL=high-density lipoprotein; LDL=low-density lipoprotein; TB=tuberculosis; ULN=upper limit of normal.

07:27-07:30

[Table fades off screen, and next section title appears.]

Caption:
Summary

07:31-07:37

[Dr. Ibrahim speaks directly to viewer.]

07:38-07:47

[Dr. Ibrahim appears in a close-up view with text emphasized on screen in time to voice-over.]

Caption:
[Visual title]
Olumiant offers extensive exposure and an established, long-term safety profile^1,3-7,14-18*

Descriptive Clue:
Icon of a shield with the following bullets:
• 12,000+ severe AA patients have been treated with Olumiant^†
• Safety profile established in 1,303 severe AA patients up to 4 years

Caption:
[Footer] ^*Data as of 04/2024
^†12,000+ is inclusive of 1,303 (clinical trials) and 11,000+ (real-world use).

07:48-07:52

[Dr. Ibrahim disappears and select safety information appears on screen.]

Caption:
Select Safety Information
Olumiant has a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Consider the risks and benefits of treatment prior to initiating or continuing therapy with Olumiant. 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.

07:53-07:59

[Dr. Ibrahim appears back on screen.]

08:00-08:03

[Dr. Ibrahim’s conflict of interest statement appears on screen.]

Caption:
Dr. Omer Ibrahim is a consultant for Eli Lilly.

08:04-10:43

[Additional safety information text appears on screen and is scrolled.]

Caption:
ADDITIONAL SAFETY INFORMATION
Serious hypersensitivity reactions, gastrointestinal perforations, and laboratory abnormalities have been reported in Olumiant-treated patients.

Discontinue Olumiant if a serious hypersensitivity reaction occurs while evaluating the potential causes.

Monitor patients who may be at increased risk for gastrointestinal perforations. Promptly evaluate those presenting with new onset abdominal symptoms.

Avoid initiation or interrupt treatment in patients with an absolute neutrophil count (ANC) <1000 cells/mm³, absolute lymphocyte count (ALC) <500 cells/mm³, or hemoglobin level <8 g/dL.

Assess lipid parameters approximately 12 weeks following Olumiant initiation and manage patients according to clinical hyperlipidemia guidelines.

Avoid use of live vaccines with Olumiant. Update immunizations prior to initiating therapy.

Advise pregnant women and women of reproductive potential of the potential risk of fetal harm. Advise women not to breastfeed during Olumiant treatment and for 4 days after the last dose.

Olumiant is not recommended in patients with severe hepatic or severe renal impairment.

BA HCP MSR AA 13JUN2022

10:44-10:50

Caption: References

Olumiant. Prescribing Information. Lilly USA, LLC.
Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2021;81(3):335-343.
King B, Mostaghimi A, Shimomura Y, et al. Safety analysis of baricitinib in adult patients with severe alopecia areata from 2 randomized clinical trials over a median of 2.3 years and up to 4 years of exposure. Poster presented at the American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 51436.
Data on file. Lilly USA, LLC. DOF-BA-US-0118.
Data on file. Lilly USA, LLC. DOF-BA-US-0075.
Data on file. Lilly USA, LLC. DOF-BA-US-0090.
Data on file. Lilly USA, LLC. DOF-BA-US-0078.
Data on file. Lilly USA, LLC. DOF-BA-US-0094.
Data on file. Lilly USA, LLC. DOF-BA-US-0112.
Data on file. Lilly USA, LLC. DOF-BA-US-0113.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699.
Taylor PC, Bieber T, Alten R, et al. Baricitinib safety for events of special interest in populations at risk: analysis from randomised trial data across rheumatologic and dermatologic indications. Adv Ther. 2023;40(4):1867-1883.
Data on file. Lilly USA, LLC. DOF-BA-US-0116.
Data on file. Lilly USA, LLC. DOF-BA-US-0076.
Data on file. Lilly USA, LLC. DOF-BA-US-0105.
Data on file. Lilly USA, LLC. DOF-BA-US-0111.
Data on file. Lilly USA, LLC. DOF-BA-US-0095.
Data on file. Lilly USA, LLC. DOF-BA-US-0119.

10:51-10:52

[Text fades to white. Lilly A MEDICINE COMPANY logo appears.]

An Actual Patient Story

Meet Laura

"There wasn't a day that went by that I didn't wish for my hair back."

- Laura, an actual patient with severe alopecia areata.^*

Watch Laura's journey with Olumiant below.

*Laura was compensated for her time. Individual results may vary.

Olumiant patient Laura patient story video thumbnail — 0:00:00 - 1:24:20
Unknown
Having been a performing artist for almost my entire life, I spent so much time in the spotlight after I lost my hair. I didn't want people to look at me. My name is Laura. I was diagnosed with severe alopecia areata in 2008.

1:24:22 - 01:58:18
Unknown
As a performer, your hairstyle is part of the character that you play. I would put it up into a bun, usually for a classical role, or it would be free and flowing if I were doing a more contemporary dance. Not having that part of me and having that identity taken away was devastating. I remember distinctly being in bed one morning, rolling over and just laying on my arm and my hand randomly felt a perfectly bare, smooth spot of skin.

1:58:20 - 2:26:27
Unknown
I would be in the shower and clumps of hair would be falling out. I noticed a lot more hair than usual on my hairbrush, and I was scared. There was a lot of confusion. There was blaming myself. I didn't know what I did to cause this. I had lost all my eyebrows. I had lost all my eyelashes. So getting ready in the morning, not only would I have to, you know, put my bandana on and put my wig on, if I was getting dressed up.

2:26:29 - 2:52:02
Unknown
I would have to find solutions to also look like I had eyebrows and eyelashes. It was really time to come out of hiding, to share what was going on with me. And despite the fact of embracing who I was, there really wasn't a day that went by that I didn't wish for my hair back. I tried many different treatments.

2:52:04 - 3:00:03
Unknown
Nothing really gave me the result that I wanted.

3:00:06 - 3:24:17
Unknown
Once I had seen that halloumi it had been FDA approved for the treatment of severe alopecia areata in adults, I went to my dermatologist. I actually found out that I was going to be her first patient with alopecia areata that she would be treating with a Lumia. So I was very excited that we could learn together and we could see the possibilities of what a Lumia could do for me.

3:24:19 - 3:48:05
Unknown
I obtained my prescription in August of 2022, and that's when I began my whole limited journey. I've been taking a limit for a while now. I could feel some sprouts of eyebrows and eyelashes growing, and it's so amazing to have a hair again, to run my fingers through it, to feel it flowing in the breeze.

3:48:08 - 4:33:04
Unknown
Serious hypersensitivity reactions. Gastrointestinal perforations and laboratory abnormalities have been reported in the gloomiest treated patients. Discontinue illuminate if a serious hypersensitivity reaction occurs while evaluating the potential causes. Monitor patients who may be at increased risk for gastrointestinal perforations promptly evaluate those presenting with new onset abdominal symptoms. Avoid initiation or interrupt treatment in patients with an absolute neutrophil count or ANC less than 1000 cells per cubic millimeter absolute lymphocyte count or RLC less than 500 cells per cubic millimeter or hemoglobin level less than eight grams per deciliter.

4:33:07 - 5:06:0
Unknown
If liver enzyme elevation alanine aminotransferase or alt or aspartate aminotransferase or ast is observed and drug induced liver injury is suspected. Interrupt illuminates until this diagnosis is excluded, assess lipid parameters approximately 12 weeks following a lumi into initiation and manage patients according to clinical hyperlipidemia guidelines. Avoid use of live vaccines with illuminate. Update immunizations prior to initiating therapy.

5:06:03 - 5:43:06
Unknown
Most common adverse reactions in alopecia areata trials greater than or equal to 1% were upper respiratory tract infections, headache, acne hyperlipidemia creatine phosphate kinase 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. Advise pregnant women and women of reproductive potential of the potential risk of fetal harm.

5:43:08 - 6:19:04
Unknown
Advise women not to breastfeed during illuminated treatment and for four days after the last dose. Aluminum is not recommended in patients with severe hepatic or severe renal impairment. This is not the complete safety information for illuminate. For additional information, please see the full important safety information, including boxed warning about serious infections, mortality, malignancy and major adverse cardiovascular events and thrombosis and the full prescribing information on this site.

6:19:06 - 7:26:12
Unknown
I know that when people are looking at me, they're not seeing the thing that makes me stand out and makes me so different. They're seeing who are truly feel like I am.

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).