The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata^1,2

The SALT measures scalp hair loss on a scale of 0 to 100

SALT measurement scale of scalp hair loss — The SALT score, which ranges from 0-100, can be used to assess scalp hair loss. A SALT score of 100 indicates complete hair loss and a SALT score of 0 indicates no hair loss.

Interpretation of SALT scores:
SALT score of 100: Complete hair loss
SALT score of 50: 50% hair loss
SALT score of ≤20: 20% or less hair loss
SALT score of 0: No hair loss

See Scalp Hair Results

Olumiant was studied as monotherapy in two phase 3 trials for adults with severe alopecia areata^1,2

The primary endpoint was the proportion of patients achieving a SALT score of ≤20 at week 36

BRAVE-AA1 and BRAVE-AA2 Clinical Trial Design^*

BRAVE-AA1 Study Design — Olumiant was studied in 2 clinical trials. BRAVE-AA1 enrolled 654 patients in the phase 3 portion. BRAVE-AA1 was a phase 2/3 trial and BRAVE-AA2 was a phase 3 clinical trial. BRAVE-AA2 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 of ≤20 at week 36.

Olumiant was studied in adults with a baseline SALT score of ≥50 and a current alopecia areata (AA) episode lasting >6 months and <8 years in duration.

Select inclusion criteria

Males (18 to 60 years of age) and females (18 to 70 years of age)
No spontaneous improvement over the past 6 months
Patients with severe AA lasting ≥8 years were eligible only if episodes of regrowth were observed on affected areas over the past 8 years

SALT=Severity of Alopecia Tool.

Patients in the clinical trials had severe alopecia areata, with a mean scalp hair loss of 85% at baseline³

Patient Baseline Characteristics—Pooled Analysis From BRAVE-AA1 and BRAVE-AA2

	Placebo (n=345)	Olumiant 2 mg/day (n=340)	Olumiant 4 mg/day (n=515)
Age (years), mean (SD)	Placebo (n=345): 37 (13)	Olumiant 2 mg/day (n=340): 38 (13)	Olumiant 4 mg/day (n=515): 37 (13)
Female	Placebo (n=345): 60%	Olumiant 2 mg/day (n=340): 62%	Olumiant 4 mg/day (n=515): 60%
Race
White	Placebo (n=345): 49%	Olumiant 2 mg/day (n=340): 55%	Olumiant 4 mg/day (n=515): 52%
Asian	Placebo (n=345): 38%	Olumiant 2 mg/day (n=340): 37%	Olumiant 4 mg/day (n=515): 35%
Black or African descent	Placebo (n=345): 10%	Olumiant 2 mg/day (n=340): 6%	Olumiant 4 mg/day (n=515): 9%
Duration since AA onset (years), mean (SD)	Placebo (n=345): 12 (11)	Olumiant 2 mg/day (n=340): 13 (11)	Olumiant 4 mg/day (n=515): 12 (11)
Duration of current AA episode (years), mean (SD)	Placebo (n=345): 4 (5)	Olumiant 2 mg/day (n=340): 4 (5)	Olumiant 4 mg/day (n=515): 4 (3)
<4 years	Placebo (n=345): 66%	Olumiant 2 mg/day (n=340): 68%	Olumiant 4 mg/day (n=515): 64%
≥4 years	Placebo (n=345): 34%	Olumiant 2 mg/day (n=340): 32%	Olumiant 4 mg/day (n=515): 36%
Patients with universalis	Placebo (n=345): 41%	Olumiant 2 mg/day (n=340): 45%	Olumiant 4 mg/day (n=515): 46%
Patients with atopic background^*	Placebo (n=345): 41%	Olumiant 2 mg/day (n=340): 38%	Olumiant 4 mg/day (n=515): 36%
SALT score, mean (SD)	Placebo (n=345): 85 (18)	Olumiant 2 mg/day (n=340): 86 (18)	Olumiant 4 mg/day (n=515): 85 (18)

^*Atopic background is defined as medical history of or ongoing atopic dermatitis, allergic rhinitis, allergic conjunctivitis, or allergic asthma.

See Study Designs

Understanding SALT Scores

SALT=Severity of Alopecia Tool; SD=standard deviation.

DOSING INFORMATION

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 once patients achieve an adequate response with 4 mg/day.

For adults with severe alopecia areata

Olumiant can help patients regrow their hair resulting in meaningful scalp coverage at week 36^1-4*

Some patients on Olumiant 4 mg/day achieved a SALT score of ≤20 as early as week 24

BRAVE-AA1: Percentage of Patients Who Achieved a SALT score of ≤20 Over Time, NRI^†

BRAVE-AA1 SALT ≤20 results through week 36 — In BRAVE-AA1, 22% of patients at week 36 and 11% at week 24 achieved a SALT score of ≤20 with Olumiant 2 mg/day (N=184) and 35% of patients at week 36 and 27% of patients at week 24 achieved a SALT score of ≤20 with Olumiant 4 mg/day (N=281) vs 5% of patients on placebo (N=189) (p≤0.05 for all comparisons vs. placebo).

BRAVE-AA2: Percentage of Patients Who Achieved a SALT score of ≤20 Over Time, NRI^†

	Week 16	Week 24	Week 36
Placebo (N=156)	Week 16: 1%	Week 24: 1%	Week 36: 3%
Olumiant 2 mg/day (N=156)	Week 16: 8%	Week 24: 11%	Week 36: 17%^‡
Olumiant 4 mg/day (N=234)	Week 16: 18%	Week 24: 28%^‡	Week 36: 32%^‡

^*Primary endpoint was the proportion of patients achieving a SALT score of ≤20 at week 36.
^†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.

See Study Designs

Understanding SALT Scores

SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS
Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Test patients for latent TB and if positive, treat with standard antimycobacterial therapy before initiating Olumiant. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.

NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

For adults with severe alopecia areata

SALT score of ≤20 response rates were higher in patients with a baseline SALT score of 50-94 vs 95-100^1,5

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percentage of Patients Who Achieved a SALT Score of ≤20 at Week 36 by Baseline Severity, NRI^*

SALT <20 Baseline by Severity bar chart — In a pooled subgroup analysis of BRAVE-AA1 and BRAVE-AA2, patients were stratified by a baseline SALT score of 50-94 and 95-100. In patients with a baseline SALT score of 50-94, 33% of patients on Olumiant 2 mg/day (N=147) and 48% of patients on Olumiant 4 mg/day (N=248) achieved a SALT score of ≤20 at week 36 vs 8% on placebo (N=166). In patients with a baseline SALT score of 95-100, 10% of patients on Olumiant 2 mg/day (N=193) and 21% of patients on Olumiant 4 mg/day (N=267) achieved a SALT score of ≤20 at week 36 vs 1% on placebo (N=178). All analyses were NRI.

These pooled subgroup analyses were not controlled for multiplicity; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.

^*Data collected after permanent study drug discontinuation or data collected at remote visits due to the COVID-19 pandemic were excluded.

See Study Designs

Understanding SALT Scores

SELECT IMPORTANT SAFETY INFORMATION RELATED TO THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was observed at an increased incidence in Olumiant-treated patients compared to patients treated with placebo. Arterial thrombosis events in the extremities have also reported in clinical studies with Olumiant. 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, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. If clinical features of DVT/PE or arterial thrombosis occur, discontinue Olumiant and promptly evaluate and appropriately treat patients. Avoid Olumiant in patients that may be at increased risk for thrombosis.

NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

For adults with severe alopecia areata

Olumiant provided sustained response rates of a SALT score of ≤20 at week 52^1-3,6,7

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percentage of Patients Who Achieved a SALT Score of ≤20 at Week 52, NRI^*

Pooled BRAVE-AA1 and BRAVE-AA2 SALT ≤20 results through week 52 — Study participants were treated with Olumiant 4 mg/day (N=515) or Olumiant 2 mg/day (N=340) from 0 to 52 weeks in the BRAVE clinical trial program. 39% of patients on Olumiant 4 mg/day and 23% of patients on Olumiant 2 mg/day achieved a SALT score of ≤20 at week 52. All analyses were NRI.

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

These prespecified analyses included pooled data from the BRAVE-AA1 and BRAVE-AA2 trials that were not adjusted for multiplicity.

^*Data collected after permanent study drug discontinuation or data collected at remote visits due to COVID-19 pandemic were excluded.

In BRAVE-AA1 and BRAVE-AA2, the primary endpoint was the proportion of patients achieving SALT ≤20 at week 36. These analyses included patients randomized to Olumiant 4 mg/day at baseline who remained on this dose through week 52.

See Study Designs

Understanding SALT Scores

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

NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.

For adults with severe alopecia areata

With Olumiant 4 mg/day, an improvement in eyebrow and eyelash coverage was observed at week 36^1-3,8-10*

Results shown for patients with substantial eyebrow and eyelash hair loss at baseline

EB and EL ClinRO for eyelash and eyebrow hair regrowth at 36 weeks — In BRAVE-AA1, 31% of patients on Olumiant 4 mg/day (N=188) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=124) (p≤0.05). In BRAVE-AA2, 35% of patients on Olumiant 4 mg/day (N=161) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 4% on placebo (N=112) (p≤0.05).

In BRAVE-AA1, 34% of patients on Olumiant 4 mg/day (N=167) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=96) (p≤0.05). In BRAVE-AA2, 34% of patients on Olumiant 4 mg/day (N=140) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 6% on placebo (N=90) (p≤0.05).

All analyses were NRI.

^*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.

See Study Designs

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

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.

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

For adults with severe alopecia areata

Visible results with Olumiant through week 36^1,11-13

See the difference Olumiant can make

Scalp Hair Results

Patient 1

Scalp photos of alopecia areata patient at baseline and at week 36

Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.^*

Patient 2

Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.^*

Patient 3

Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.^*

Patient 4

Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.^*

Patient hairstyles may influence appearance of SALT scores depicted.

^*Based on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score of ≤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) and the observed mean SALT score at week 36 was 6.4 (SD: 6.5) among patients treated with Olumiant 4 mg/day (N=175).¹²

See Study Designs

Understanding SALT Scores

Eyebrow and Eyelash Results

Eyebrow photos of alopecia areata patient at baseline and at week 36

Eyelash photos of alopecia areata patient at baseline and at week 36

Clinical trial patients treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.

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.⁸

Explore Efficacy Data

See Study Designs

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

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; SD=standard deviation.

For adults with severe alopecia areata

BRAVE-AA2: Most responders on Olumiant maintained a SALT score of ≤20 even after their dose was lowered^1,14,15

75% of responders who were switched from Olumiant 4 mg/day to Olumiant 2 mg/day at week 52 maintained a SALT score of ≤20 at week 76

BRAVE-AA2 Dose-Titration Period (Weeks 52-76): Percentage of Patients Who Sustained a SALT Score of ≤20, NRI^*

BRAVE-AA2 SALT≤20 Results for Dose-Titration Period (Weeks 52-76) — In BRAVE-AA2, during the dose-titration period from weeks 52-76, 75% of responders who were switched from Olumiant 4 mg/day to Olumiant 2 mg/day at week 52 maintained a SALT score of ≤20 at week 76. All analyses were NRI.

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

^*Data collected after permanent study drug discontinuation or data collected at remote visits due to COVID-19 pandemic were excluded.

These prespecified subgroup analyses were not adjusted for multiplicity.

Eligible responders (SALT score of ≤20) in the Olumiant 4 mg/day treatment arm were rerandomized to continue Olumiant 4 mg/day or transition to Olumiant 2 mg/day at week 52. Patients rerandomized to Olumiant 2 mg/day at week 52 who experienced a loss of treatment response (>20-point worsening in SALT score) were retreated with Olumiant 4 mg/day.

Explore Efficacy Data

See Study Designs

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

References:

Olumiant. Prescribing Information. Lilly USA, LLC.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386:1687-1699. doi:10.1056/NEJMoa2110343.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(suppl):1-76.
Data on file. Lilly USA, LLC. DOF-BA-US-0075.
Data on file. Lilly USA, LLC. DOF-BA-US-0070.
Data on file. Lilly USA, LLC. DOF-BA-US-0076.
Data on file. Lilly USA, LLC. DOF-BA-US-0074.
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.
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-0078.
Data on file. Lilly USA, LLC. DOF-BA-US-0079.

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).

The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata1,2

Olumiant was studied as monotherapy in two phase 3 trials for adults with severe alopecia areata1,2

The primary endpoint was the proportion of patients achieving a SALT score of ≤20 at week 36

Patients in the clinical trials had severe alopecia areata, with a mean scalp hair loss of 85% at baseline3

Olumiant can help patients regrow their hair resulting in meaningful scalp coverage at week 361-4*

Some patients on Olumiant 4 mg/day achieved a SALT score of ≤20 as early as week 24

SALT score of ≤20 response rates were higher in patients with a baseline SALT score of 50-94 vs 95-1001,5

Olumiant provided sustained response rates of a SALT score of ≤20 at week 521-3,6,7

BRAVE-AA2: Most responders on Olumiant maintained a SALT score of ≤20 even after their dose was lowered1,14,15

75% of responders who were switched from Olumiant 4 mg/day to Olumiant 2 mg/day at week 52 maintained a SALT score of ≤20 at week 76

IMPORTANT SAFETY INFORMATION

WARNING:

SERIOUS INFECTIONS -

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

VACCINATIONS

ADVERSE REACTIONS

PREGNANCY AND LACTATION

HEPATIC AND RENAL IMPAIRMENT

INDICATIONS

The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata^1,2

Olumiant was studied as monotherapy in two phase 3 trials for adults with severe alopecia areata^1,2

Patients in the clinical trials had severe alopecia areata, with a mean scalp hair loss of 85% at baseline³

Olumiant can help patients regrow their hair resulting in meaningful scalp coverage at week 36^1-4*

SALT score of ≤20 response rates were higher in patients with a baseline SALT score of 50-94 vs 95-100^1,5

Olumiant provided sustained response rates of a SALT score of ≤20 at week 52^1-3,6,7

BRAVE-AA2: Most responders on Olumiant maintained a SALT score of ≤20 even after their dose was lowered^1,14,15