Product Information

Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Olumiant^® (baricitinib) tablets

1mg, 2mg, 4mg

Full Prescribing Information

baricitinib

1mg, 2mg, 4mg

HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter

Olumiant^® (baricitinib) tablets

1mg, 2mg, 4mg

Full Prescribing Information

baricitinib

1mg, 2mg, 4mg

HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What is known about temporary interruption of OLUMIANT® (baricitinib) in pediatric patients with alopecia areata?

In the phase 3 study of baricitinib in adolescent patients with severe alopecia areata (BRAVE-AA-PEDS), temporary interruptions of study intervention were reported across treatment groups; infections were the most common reason for interruption.

US_cFAQ_BAR014C_TREATMENT_INTERRUPTION_AA_PEDS_v0_2

See important safety information, including boxed warning, in the attached prescribing information.

Content Overview

Under what circumstances may baricitinib treatment be temporarily interrupted?
- Clinical Decision
- Baricitinib Alopecia Areata Clinical Trial
What were the reasons for temporary treatment interruption in adolescent patients with severe alopecia areata treated with baricitinib?
What adverse events led to temporary interruption of baricitinib in adolescent patients with severe alopecia areata?
- Placebo-Controlled Period Through Week 36
- Extended Baricitinib Treatment Through Week 52
References

Under what circumstances may baricitinib treatment be temporarily interrupted?

In the circumstances described in Table 1, the baricitinib prescribing information indicates that baricitinib treatment should be interrupted.¹

Table 1. Circumstances Under Which Baricitinib Treatment May Be Temporarily Interrupted¹

If	Then
a serious infection, an opportunistic infection, or sepsis develops	interrupt baricitinib. Do not resume baricitinib until the infection is controlled.
a new infection develops during treatment	the patient should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and baricitinib should be interrupted if the patient is not responding to therapy. Do not resume baricitinib until the infection is controlled.
absolute neutrophil count is <1000 cells/µL	interrupt baricitinib until ANC ≥1000 cells/µL.
absolute lymphocyte count is <500 cells/µL	interrupt baricitinib until ALC ≥500 cells/µL.
hemoglobin is <8 g/dL	interrupt baricitinib until hemoglobin ≥8 g/dL.
the patient develops herpes zoster	interrupt baricitinib treatment until the episode resolves.
increases in ALT or AST are observed and drug-induced liver injury is suspected	interrupt baricitinib until this diagnosis is excluded.

Abbreviations: ALC = absolute lymphocyte count; ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase.

If clinical features of deep venous thrombosis/pulmonary embolism or arterial thrombosis occur, patients should discontinue baricitinib and be evaluated promptly and treated appropriately.¹

Clinical Decision

The treating physician may use the information provided, the patient’s medical information, clinical presentation, and other individual factors in formulating an assessment and approach for individual treatment interruption and restart of therapy. The treating physician should consider potential risks and benefits and use their best clinical judgment regarding treatment.

Baricitinib Alopecia Areata Clinical Trial

BRAVE-AA-PEDS (NCT05723198) is an ongoing phase 3, double-blind, placebo-controlled, randomized study evaluating the efficacy, safety, and pharmacokinetics of baricitinib in children from 6 years to less than 18 years of age with severe or very severe alopecia areata (AA). To be eligible for the study, patients must have severe AA for at least 1 year with a Severity of Alopecia Tool (SALT) score of ≥50% at screening and baseline.²

The study is divided into 4 periods, which include

a 5-week screening period
a 36-week double-blind treatment period
an approximately 2-year long-term extension period, and
a 4-week posttreatment follow-up period.³

An estimated 595 patients will be enrolled in the study. Enrollment will be sequential by age group, with adolescents (12 to <18 years old) enrolling prior to children (6 to <12 years old).³

Most adolescent participants (12 to <18 years) will be randomized to baricitinib high dose, low dose, or placebo in a 1:1:1 ratio. A portion of adolescents will be randomly assigned 1:1 to double-blind treatment with baricitinib low dose or high dose to accumulate additional safety exposures.³

Please note that this statement describes a subgroup analysis of the adolescent patients only. This ongoing study will also include a separate cohort of younger patients (6 to <12 years). This pediatric population is not part of this analysis.

Safety results in the BRAVE-AA-PEDS trial were evaluated using 3 integrated safety datasets

Placebo-controlled BARI AA Adolescents, with patients receiving placebo, baricitinib 2 mg, and 4 mg doses from randomization to week 36 (all participants who completed the 36-week placebo-controlled period were eligible to enter the long-term extension period, up to approximately 2 years of additional treatment).
Extended BARI AA Adolescents includes all participants who were exposed to baricitinib 2 mg or baricitinib 4 mg dose from randomization until dose or treatment change, and
All BARI AA Adolescents includes all participants who were exposed to any baricitinib dose at any time during the study, either from randomization or from switch from placebo.³

The 52-week safety data described in this response are up to the cutoff date of April 15, 2025. The maximal duration of study intervention will be 136 weeks.³

Back to Content Overview

What were the reasons for temporary treatment interruption in adolescent patients with severe alopecia areata treated with baricitinib?

Through the primary placebo-controlled period (week 36), a total of 30 participants reported an interruption of study intervention with no notable difference across treatment arms. The mean duration per group ranged from 8.5 to 31.0 days, with the longest mean duration observed in the placebo arm (see Table 2).³

Table 2. Summary of Temporary Interruptions of Study Drug Through Week 36 and Week 52 in the BRAVE-AA-PEDS Study³

Temporary Interruptions	APSAS			Adolescent Baricitinib Exposure Extended Set^a
Temporary Interruptions	Placebo (N=88)	BARI 2 mg (N=83)	BARI 4 mg (N=85)	BARI 2 mg (N=83)	BARI 4 mg (N=83)
Total number of initiated dose interruptions	13	7	12	21	20
With resumption of study drug	12	7	12	21	19
Without resumption of study drug	1	0	0	0	1
Number of patients with dose interruption, n (%)
≥1	11 (12.5)	7 (8.4)	12 (14.1)	17 (20.5)	17 (20.5)
≥2	2 (2.3)	0	0	4 (4.8)	3 (3.6)
Reasons for dose interruption, n (%)
Adverse event	8 (9.1)	3 (3.6)	8 (9.4)	14 (16.9)	14 (16.9)
Abnormal laboratory result	3 (3.4)	3 (3.6)	1 (1.2)	3 (3.6)	2 (2.4)
Protocol	0	1 (1.2)	1 (1.2)	1 (1.2)	1 (1.2)
Investigator decision	0	0	2 (2.4)	0	0
Duration of dose interruptions, days, mean (SD)	31.0 (51.4)	22.3 (21.8)	8.5 (5.6)	12.9 (8.67)	11.9 (8.93)

Abbreviations: APSAS = Adolescent Placebo-Controlled Safety Analysis Set; BARI = baricitinib; N = number of participants in the analysis population; n = number of participants with non-missing values.

^aData cut as of Apr 15, 2025.

Notes: All BARI AA includes BARI 2-mg and 4-mg doses. Any incomplete interruption at the analysis cutoff was not used for the summary of duration or cumulative duration summary. Percentages are calculated by n/N × 100%.

Back to Content Overview

What adverse events led to temporary interruption of baricitinib in adolescent patients with severe alopecia areata?

Placebo-Controlled Period Through Week 36

Through week 36 in BRAVE-AA-PEDS, the proportion of participants with adverse events (AEs) leading to temporary interruption of study drug in the baricitinib 4 mg group was higher than in the 2 mg group but similar to the placebo group:

Placebo: 9 (10.2%)
Baricitinib 2 mg: 5 (6.0%)
Baricitinib 4 mg: 8 (9.4%)

Infections and infestations were responsible for most of the temporary interruptions across treatment groups:

Placebo: 4 (4.5%)
Baricitinib 2 mg: 3 (3.6%)
Baricitinib 4 mg: 2 (2.4%)

Influenza and neutropenia were the only AEs in the baricitinib-treated groups that led to treatment interruption for more than 1 participant.³

Extended Baricitinib Treatment Through Week 52

In the extended adolescent AA analysis set through week 52 (as initially randomized, censored at dose change),

infections and infestations accounted for most temporary interruptions (baricitinib 2 mg: incidence rate [IR] 7.7; baricitinib 4 mg: IR 5.6)
in the baricitinib 4 mg group, the most frequently reported AE leading to temporary interruption was neutropenia (IR 2.0), and
in all baricitinib AA adolescent set, the most frequently reported AE leading to temporary interruption was influenza (IR 1.0).

System organ class details for both time points are presented in Table 3.³

Table 3. Adverse Events Leading to Temporary Interruption of Study Drug by System Organ Class Through Week 36 and Week 52 in the BRAVE-AA-PEDS Study³

System Organ Class	Week 0 through Week 36^a			Week 0 through Week 52^b
System Organ Class	Placebo (N=88), n (%); PYR [IR]	BARI 2 mg (N=83), n (%); PYR [IR]	BARI 4 mg (N=85), n (%); PYR [IR]	Ext BARI 2 mg (N=166), n (%); PYR [IR]	Ext BARI 4 mg (N=168), n (%); PYR [IR]	All BARI AA (N=415), n (%); PYR [IR]
Participants with ≥1 adverse event leading to interruption	9 (10.2); 54.8 [16.4]	5 (6.0); 54.9 [9.1]	8 (9.4); 54.3 [14.7]	21 (12.7); 162.5 [12.9]	24 (14.3); 187.6 [12.8]	53 (12.8); 445.5 [11.9]
Infections and infestations	4 (4.5); 56.5 [7.1]	3 (3.6); 56.1 [5.3]	2 (2.4); 56.7 [3.5]	13 (7.8); 168.9 [7.7]	11 (6.5); 197.7 [5.6]	26 (6.3); 464.8 [5.6]
Investigations	0; 58.4 [0.0]	2 (2.4); 55.8 [3.6]	1 (1.2); 56.7 [1.8]	7 (4.2); 170.0 [4.1]	4 (2.4); 201.2 [2.0]	13 (3.1); 471.5 [2.8]
Blood and lymphatic system disorders	0; 58.4 [0.0]	0; 57.0 [0.0]	3 (3.5); 55.8 [5.4]	0; 175.5 [0.0]	5 (3.0); 201.0 [2.5]	5 (1.2); 478.9 [1.0]
Nervous system disorders	1 (1.1); 58.2 [1.7]	0; 57.0 [0.0]	0; 57.2 [0.0]	1 (0.6); 174.9 [0.6]	0; 204.9 [0.0]	4 (1.0); 481.6 [0.8]
Gastrointestinal disorders	1 (1.1); 57.9 [1.7]	0; 57.0 [0.0]	1 (1.2); 57.1 [1.8]	1 (0.6); 174.9 [0.6]	2 (1.2); 204.0 [1.0]	3 (0.7); 481.1 [0.6]
General disorders and administration site conditions	2 (2.3); 57.2 [3.5]	0; 57.0 [0.0]	1 (1.2); 56.7 [1.8]	1 (0.6); 175.0 [0.6]	1 (0.6); 203.8 [0.5]	3 (0.7); 481.1 [0.6]
Psychiatric disorders	1 (1.1); 58.1 [1.7]	0; 57.0 [0.0]	0; 57.2 [0.0]	0; 175.5 [0.0]	1 (0.6); 204.1 [0.5]	2 (0.5); 481.9 [0.4]
Eye disorders	NA	NA	NA	0; 175.5 [0.0]	0; 204.9 [0.0]	1 (0.2); 482.6 [0.2]
Skin and subcutaneous tissue disorders	1 (1.1); 58.2 [1.7]	0; 57.0 [0.0]	0; 57.2 [0.0]	1 (0.6); 174.9 [0.6]	0; 204.9 [0.0]	1 (0.2); 482.1 [0.2]
Social circumstances	NA	NA	NA	0; 175.5 [0.0]	0; 204.9 [0.0]	1 (0.2); 482.7 [0.2]
Surgical and medical procedures	NA	NA	NA	0; 175.5 [0.0]	1 (0.6); 204.8 [0.5]	1 (0.2); 482.7 [0.2]
Hepatobiliary disorders	1 (1.1); 58.2 [1.7]	0; 57.0 [0.0]	0; 57.2 [0.0]	NA	NA	NA
Respiratory, thoracic and mediastinal disorders	1 (1.1); 57.8 [1.7]	0; 57.0 [0.0]	0; 57.2 [0.0]	NA	NA	NA

Abbreviations: APSAS = Adolescent Placebo-Controlled Safety Analysis Set; BARI = baricitinib; Ext = extended; IR = incidence rate; N = number of participants in the analysis population; n = number of participants in the specified category; NA = not available; PYR = patient-years at risk.

^a Adolescent Placebo-Controlled Safety Analysis Set (APSAS), Week 0 through Week 36.

^b Adolescent Safety Set through Week 52, data cutoff 15 April 2025. Extended BARI AA Adolescents (Ext BARI 2 mg, Ext BARI 4 mg): participants exposed to that dose from randomization until dose or treatment change. All BARI AA Adolescents: all participants exposed to any baricitinib dose during the study (from randomization or from switch from placebo).

Notes: Percentages (%) are based on the number of subjects in each treatment group (N). Incidence rate (IR) is calculated as n/PYR × 100, where PYR = patient-years at risk (sum of duration for all participants with/without the event, in years). PYR values reflect exposure to Week 36 (APSAS) or through Week 52 (Extended and All Baricitinib Adolescent Safety Sets).

Back to Content Overview

Enclosed Prescribing Information

OLUMIANT® (baricitinib) tablets, for oral use, Lilly

References

Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
A study of baricitinib (LY3009104) in children from 6 years to less than 18 years of age with alopecia areata (BRAVE-AA-PEDS). ClinicalTrials.gov identifier: NCT05723198. Updated July 17, 2026. Accessed September 28, 2026. https://clinicaltrials.gov/study/NCT05723198.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: September 28, 2026

Are you satisfied with this content?