0:00-0:04
[Title, Olumiant logo, and safety directional appear onscreen. The safety directional text and Olumiant logo remain at the bottom of the screen throughout the video.]
Caption: [title] Safety Results and Lab Monitoring Considerations with Olumiant
Descriptive Clue: The Olumiant logo includes the text Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg
Caption: [Safety directional text]
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis and full Prescribing Information on this site.
[background music]
0:04-0:26
[Title fades out and the indication and limitations of use text appear on a white background]
Caption:
INDICATION: Olumiant is a Janus kinase (JAK) inhibitor 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.
Narrator: Indication: Olumiant is a Janus kinase, or JAK, inhibitor indicated for the treatment of adult patients with severe alopecia areata. Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
0:26-1:12
[Previous text fades and warning text displayed on the 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.
Narrator: Warning: serious infections, mortality, malignancy, major adverse cardiovascular events, or 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, or 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.
1:12-1:39
[Text fades out and new safety information fades in]
Caption: 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.
Narrator: Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase, or JAK, inhibitor vs. tumor necrosis factor, or TNF, blockers in rheumatoid arthritis, or 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.
1:39-2:08
[Text fades out and new safety information fades in]
Caption: 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.
Additional safety information will be presented later in this video.
Narrator: 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.
Additional safety information will be presented later in this video.
2:08-2:14
[Conflict of interest statement appears on the screen]
Caption: Dr. Cheshana Kindred is a Consultant for or member of the Advisory Board for AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharmaceuticals, and UCB.
[background music]
2:14-2:34
[Dr. Chesahna Kindred appears on the screen speaking to the camera]
Caption: Dr. Chesahna Kindred
MD, MBA, FAAD. Chair, Dermatology, National Medical Association and Associate Professor, Howard University
Dr. Kindred: Hello, my name is Dr. Cheshana Kindred. I would like to discuss some important safety and lab monitoring assessments to consider while prescribing Olumiant, a JAK inhibitor therapy. Olumiant is the first FDA-approved systemic treatment for adults with severe alopecia areata.
2:34-2:39
[Olumiant logo and text question appear on screen]
Caption: What were some of the key safety results reported in clinical trials?
[background music]
2:39-2:45
[Dr. Kindred appears on the screen speaking to the camera]
Dr. Kindred: Patients with severe alopecia areata want to begin a treatment with confidence.
2:45-2:52
[Scene transitions to a ¾ view of Dr. Kindred speaking]
Dr. Kindred: For this reason, I’d like to take a moment to discuss…
2:49-2:52
[Scene transitions to Dr. Kindred speaking to the camera]
Dr. Kindred: …Olumiant’s demonstrated safety profile…
2:52-3:30
[Dr. Kindred fades out, replaced with a scrolling table on a white background with footnotes.]
Caption: [table title] BRAVE-AA1 and BRAVE-AA2: Adverse Reactions That Occurred in ≥1% of Patients on Olumiant and More Frequently Than Placebo.
Descriptive Clue: The table starts scrolling. Across the top is the description that these occurred in the 36-week placebo-controlled period.* In order, the four columns list adverse reactions, and the percentage of patients who experienced each reaction separated by those who were given placebo (N=371), Olumiant 2 mg/day (N=365), and Olumiant 4 mg/day (N=540).
Upper respiratory tract infections† were seen in 19.9%, 18.4%, and 21.3% of patients.
Headache was seen in 5.4%, 5.5%, and 6.6%.
Acne‡ was seen in 2.2%, 5.8%, and 5.9%.
Hyperlipidemia§ was seen in 3.0%, 3.6%, and 5.9%.
Blood creatine phosphokinase increased in 1.3%, 0.8%, and 4.3%.
Urinary tract infections‖ occurred in 2.2%, 3.8%, and 3.7%.
Liver enzyme elevations¶ occurred in 2.4%, 1.1%, and 3.0%.
Folliculitis# occurred in 0.8%, 1.4%, and 2.2%.
Fatigue was seen in 1.1%, 0.8%, and 2.2%
Lower respiratory tract infections** were seen in 0.8% 2.2%, and 2.0%.
Nausea was seen in 1.6%, 2.7%, and 2.0%.
Genital Candida infections†† were seen in 0.3%, 2.2%, and 1.3%.
Anemia was seen in 0.3%, 0.3%, and 1.3%.
Neutropenia‡‡ was seen in 0.8%, 0.3%, and 1.3%.
Abdominal pain§§ was seen in 2.2%, 3.8%, and 0.9%.
Herpes zoster was seen in 0.5%, 1.4%, and 0.9%.
Weight increased in 0.3%, 1.6%, and 0.9%.
Caption:
[footnotes]
*%-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.
Dr. Kindred: …in two phase 3 clinical trials, BRAVE-AA1 and BRAVE-AA2.
Shown here are the most common adverse reactions, which were reported in 1 percent or more patients on Olumiant compared to the placebo-controlled group over 36 weeks.
Olumiant also carries a Boxed Warning for serious infections, mortality, malignancy, MACE and thrombosis, which should be reviewed prior to prescribing therapy.
3:30-3:44
[Table fades out and a new table fades in]
Caption: [Table title] BRAVE-AA1 and BRAVE-AA2 (Pooled Results): AEs of Special Interest
Descriptive Clue: From weeks 0-36, during the placebo-controlled period, this table 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 and 1 patient (0.2%) in the Olumiant 4 mg/day group, 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 and 1 patient in the Olumiant 4 mg/day group experienced a malignancy other than NMSC†. No one reported NMSC. One patient (0.3%) in the Olumiant 2 mg/day group experienced a MACE (adjudicated)‡. No one in the study reported VTE (adjudicated).
Caption:
[footnotes]
*The extended safety analysis of Olumiant includes all patients with AA who received at least 1 dose of Olumiant 2 mg/day or 4 mg/day in BRAVE-AA1 and BRAVE-AA2, with a median exposure of 532 days.
†Weeks 0-36 includes the event of prostate cancer (placebo) and event of B-cell lymphoma (Olumiant 4 mg/day). Extended safety analysis includes the event of chronic lymphocytic leukemia (Olumiant 2 mg/day) and events of B-cell lymphoma and breast cancer (Olumiant 4 mg/day).
‡MACE was defined as adjudicated events of cardiovascular death, myocardial infarction, or stroke. The reported event was myocardial infarction (also adjudicated as arterial thromboembolism) in a patient with pre-existing cardiovascular risk factors.
§An additional patient on Olumiant 2 mg/day not included in the extended safety analysis experienced both DVT and PE.
Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk.
Data cut-off dates for BRAVE-AA1 and BRAVE-AA2 (weeks 0-36) were February 2021 and January 2021, respectively. Data cut-off date for BRAVE-AA1 and BRAVE-AA2 (extended safety analysis) was November 2021.
Patients considered at high risk of VTE, with significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.
[abbreviations]
DVT= deep vein thrombosis; IR=incidence rate; MACE=major adverse cardiovascular event;
NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure;
VTE=venous thromboembolism.
Dr. Kindred: Shown here are the adverse events of special interest assessed during the 36-week placebo-controlled period of the clinical trials. Adverse events of special interest were also assessed in an extended…
3:44-4:12
[Table extends to show results from the extended safety analysis.]
Descriptive Clue: The new column is titled Extended Safety Analysis* and measures n [IR/100 PYE] for Olumiant 2 mg/day (N=595; PYE=640.16) and Olumiant 4 mg/day (N=996; PYE=1217.76). Four patients in the 2 mg/day group [0.6] and twelve in the 4 mg/day group [1.0] experienced a serious infection. One person in the 2 mg/day group experienced an opportunistic infection [0.1]. One person in the 2 mg/day group [0.1] and 2 people in the 4 mg/day group experienced a malignancy other than NMSC†. Two people in the 2 mg/day group [0.3] were diagnosed with NMSC. One person in the 2 mg/day group [0.1] reported a MACE (adjudicated),‡ and one person in the 2 mg/day group [0.1]§ had a VTE (adjudicated).
Caption: [footnotes]
[footnotes]
*The extended safety analysis of Olumiant includes all patients with AA who received at least 1 dose of Olumiant 2 mg/day or 4 mg/day in BRAVE-AA1 and BRAVE-AA2, with a median exposure of 532 days.
†Weeks 0-36 includes the event of prostate cancer (placebo) and event of B-cell lymphoma (Olumiant 4 mg/day). Extended safety analysis includes the event of chronic lymphocytic leukemia (Olumiant 2 mg/day) and events of B-cell lymphoma and breast cancer (Olumiant 4 mg/day).
‡MACE was defined as adjudicated events of cardiovascular death, myocardial infarction, or stroke. The reported event was myocardial infarction (also adjudicated as arterial thromboembolism) in a patient with pre-existing cardiovascular risk factors.
§An additional patient on Olumiant 2 mg/day not included in the extended safety analysis experienced both DVT and PE.
Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk.
Data cut-off dates for BRAVE-AA1 and BRAVE-AA2 (weeks 0-36) were February 2021 and January 2021, respectively. Data cut-off date for BRAVE-AA1 and BRAVE-AA2 (extended safety analysis) was November 2021.
Patients considered at high risk of VTE, with significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.
[abbreviations]
DVT= deep vein thrombosis; IR=incidence rate; MACE=major adverse cardiovascular event;
NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure;
VTE=venous thromboembolism.
Dr. Kindred: …safety analysis of Olumiant which included all patients with alopecia areata who received at least 1 dose of Olumiant 2 mg a day or 4 mg a day in BRAVE-AA1 and -AA2, with a median exposure of 532 days.
Incidence rates per 100 patient years of exposure are shown for selected adverse events of special interest.
4:12-4:21
[Transition to Dr. Kindred speaking to the camera]
Dr. Kindred: For some adverse events, longer observation periods and larger patient exposure is needed to ascertain risks.
4:21-4:29
[Transition to a ¾ view of Dr. Kindred speaking]
Dr. Kindred: Since each patient is unique, risks and benefits of starting or continuing Olumiant therapy should be carefully considered.
4:29-4:37
[Transition to Dr. Kindred speaking to the camera]
Dr. Kindred: Therefore, performing the following laboratory evaluations to help ensure patient safety is key.
4:37-4:41
[A subsection title card appears]
Caption: Which lab assessments are recommended for patients prior to and during Olumiant therapy?
[Background music]
4:41-4:53
[Dr. Kindred appears speaking to the camera on the left-hand side of the screen. On the right side, a virtual white-board appears with a checklist.]
Caption:
[title] Prior to Starting Olumiant
[subtitle with checkmark] Patient evaluations
[list of evaluations to assess] complete blood count, hepatic function, renal function
Dr. Kindred: Prior to starting Olumiant, a complete blood count and hepatic and renal function at baseline should be evaluated for all patients.
4:53-4:58
[Dr. Kindred continues to speak to the camera. Additional text appears on the virtual whiteboard]
Caption: [additional sub-bullets appear under subtitle] active and latent TB, viral hepatitis
Dr. Kindred: Patients should also be assessed for active and latent TB and viral hepatitis, …
4:58-5:03
[Dr. Kindred continues to speak to the camera. Additional text appears on the virtual whiteboard]
Caption: [additional subtitle appears on list with checkmark] Update immunizations
Dr. Kindred: … and immunizations should be updated.
5:03-5:13
[Dr. Kindred continues to speak to the camera. Additional text appears on the virtual whiteboard]
Caption: [appears on whiteboard marked with a warning explaimation point] Avoid use of Olumiant in patients with active, serious, or opportunistic infections, including localized infections Dr. Kindred: Olumiant therapy should not be initiated in patients with active, serious, or opportunistic infections, including localized infections.
5:13-5:23
[A ¾ view of Dr. Kindred appears on the left-hand side of the screen. A clean virtual whiteboard appears on the right-hand side and text builds with the narration. For emphasis, the text enlarges when the corresponding word is spoken]
Caption: [table title] Lab Assessments and Select Treatment Considerations with Olumiant
Lab Parameter: [column one] Neutrophils, Lymphocytes, Hemoglobin, Liver Enzymes, Lipids.
Assessment: [column two] Evaluate prior to starting treatment and thereafter according to routine patient management. [Matched with the first 4 parameters]
Evaluate at approximately 12 weeks. If hyperlipedemia is observed, manage patients according to hyperlipidemia guidelines. [matched with parameter: lipids]
Dr. Kindred: Lab assessments for patients on Olumiant therapy should include a complete blood count to evaluate neutrophil and lymphocyte counts and hemoglobin levels, …
5:23-5:31
[The scene shifts to Dr. Kindred speaking directly to the camera on the left-hand side of the screen. The table remains on the screen]
Dr. Kindred: … as well as liver enzymes, periodically thereafter following routine patient management.
5:31-5:36
[The assessment for lipids briefly pulses.]
Dr. Kindred: Lipids should be evaluated at approximately 12 weeks.
5:36-6:08
[The table slides from the right to the left, bringing with it a white background. Additional text appears on the right, adding in a third column. To the right of the graph, additional text explanations appear]
Caption:
[Expanded table]
[third column title] Avoid initiation or interrupt treatment with Olumiant if:
ANC <1000 cells/mm3 [on Neutrophil line]
ALC <500 cells/mm3 [on Lymphocyte line]
Hgb <8 g/dl [on Hemoglobin line]
Elevated ALT or AST and suspected drug-induced liver injury [on liver enzymes line]
[text underneath table]
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.
[Additional text on right-hand side]
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 Treatment Considerations:
Hepatic and Renal Impairment – Evaluate baseline hepatic and renal function prior to initiating treatment with Olumiant. Olumiant is not recommended in 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. Avoid initiation or interrupt treatment with Olumiant if patient has active serious infections, including localized infections.
Tuberculosis - Evaluate and test patients for latent or active infection prior to administration of Olumiant. 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 infection prior to initiating therapy.
Viral Reactivation - If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant. Patients should be monitored for viral reactivation.
Immunizations – Update immunizations in agreement with current guidelines prior to initiating Olumiant.
[definitions appear underneath table]
ALC=absolute lymphocyte count; ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; HDL=high-density lipoprotein; Hgb=hemoglobin; LDL=low-density lipoprotein; TB=tuberculosis; ULN=upper limit of normal.
Dr. Kindred: If neutrophils, lymphocytes, or hemoglobin levels fall below specified values, patients should not start or continue treatment with Olumiant. Treatment can be reinitiated once these levels return above the specified values. Treatment with Olumiant should be interrupted in patients with elevated AST and ALT and suspected drug-induced liver injury until this diagnosis is excluded.
6:08-6:18
[Scene transitions to a ¾ view of Dr. Kindred speaking]
Dr. Kindred: Olumiant offers a treatment option with a demonstrated safety profile for adult patients living with severe alopecia areata.
6:18-6:32
[Transition to a scene with Dr. Kindred speaking directly to the camera on the left-hand side of the screen, a blurred office background behind her. The caption and the Olumiant logo appear overlaid on to the right-hand side
Caption: Step into possibility.
Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg
For more information, visit Lilly Play and Olumiant.com/HCP
Dr. Kindred: Step into possibility and discover Olumiant. Review other resources on Lilly Play and visit Olumiant.com/HCP for more information.
6:32-7:21
[Image fades to white. Additional safety information text appears onscreen].
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.
Narrator: 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, or ANC, less than 1000 cells per cubic millimeter, absolute lymphocyte count, or ALC, less than 500 cells per cubic millimeter, or hemoglobin level less than 8 grams per deciliter.
7:21-7:55
[Previous text fades out and is replaced]
Caption: 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 guideline
Avoid use of live vaccines with Olumiant. Update immunizations prior to initiating therapy.
Narrator: If liver enzyme elevation (alanine aminotransferase, or ALT, or aspartate aminotransferase, or 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.
7:56-8:46
[Previous text fades out and is replaced]
Caption: 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.
Narrator: Most common adverse reactions in alopecia areata trials (greater than or equal to 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.
8:46-9:09
[Previous text fades out and is replaced with a bolded paragraph]
Caption: 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.
BA HCP MSR AA 13JUN2022
Narrator: 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 or adjacent to this video.
9:10-9:15
[An introduction and the credentials of Dr. Kindred appear on screen]
Caption: Dr. Cheshana Kindred, MD, MBA, FAAD is a board-certified dermatologist practicing in Columbia, MD. She was recently named Physician of the Year by Maryland’s Daily Record. She is the founder of Kindred Hair & Skin Center, Chair of the Dermatology section at the National Medical Association, Associate Professor at Howard University, and founder and President of Onyx Medical Society. Dr. Kindred specializes in alopecia and is the first dermatologist in the nation to have an in-house full-service hair salon and nail salon for her practice.
[background music]
9:15-9:19
[Previous text fades out and references appear]
Caption: References
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Olumiant. Prescribing Information. Lilly USA, LLC.
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Data on file. Lilly USA, LLC. DOF-BA-US-0075.
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Data on file. Lilly USA, LLC. DOF-BA-US-0076.
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Data on file. Lilly USA, LLC. DOF-BA-US-0087.
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Data on file. Lilly USA, LLC. DOF-BA-US-0090.
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Data on file. Lilly USA, LLC. DOF-BA-US-0089.
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Data on file. Lilly USA, LLC. DOF-BA-US-0078.
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Data on file. Lilly USA, LLC. DOF-BA-US-0091.
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Data on file. Lilly USA, LLC. DOF-BA-US-0093.
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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.
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Important Safety Information (ISI) for Olumiant (baricitinib) tablets.
[background music]
9:19-9:22
[Previous text fades out and an abbreviation list appears]
Caption: Abbreviations
AA Alopecia areata
AE Adverse event
ALT Alanine aminotrasnferase
AST Aspartate aminotransferase
FDA Food and Drug Administration
JAK Janus kinase
MACE Major adverse cardiovascular events
RA Rheumatoid arthritis
TB Tuberculosis
TNF Tumor necrosis factor
[background music]
9:22-9:27
[Text fades to white. Lilly logo appears and grows]
Caption: Lilly
PP-BA-US-1833 10/2022 © LILLY USA, LLC 2022. ALL RIGHTS RESERVED.
[silence]