You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
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, 4mgbaricitinib
1mg, 2mg, 4mgOlumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis 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 were the common adverse events reported in the OLUMIANT® (baricitinib) alopecia areata pediatric clinical trial?
The most frequently reported adverse events occurring ≥5% in the BRAVE-AA-PEDS clinical trial were acne, upper respiratory tract infection, nasopharyngitis, influenza, headache, rhinitis, and blood creatine phosphokinase increase.
See important safety information, including boxed warning, in the attached prescribing information.
This document may contain information not fully aligned with local requirements. Please see local labeling for approved indications and further information.
Content Overview
- What was the design of the BRAVE-AA-PEDS clinical trial?
- How were the safety data analyzed in the BRAVE-AA-PEDS clinical trial?
- What treatment-emergent adverse events were reported in the baricitinib alopecia areata clinical trial?
- What adverse drug reactions have been reported in postmarketing experience with baricitinib?
- Which integrated analysis datasets were used to evaluate safety in the baricitinib pediatric alopecia areata clinical trial?
- References
What was the design of the BRAVE-AA-PEDS clinical trial?
BRAVE-AA-PEDS (NCT05723198) is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of baricitinib in children from 6 years to less than 18 years of age with severe alopecia areata (AA).1
The data in this response describe the results in the adolescent population (12 to <18 years). Because the population aged 6 to less than 12 years will be enrolled at a later stage, subsequent results may be disclosed accordingly later.1
Safety results in the BRAVE-AA-PEDS trial were evaluated using the following 3 integrated safety datasets:
- Placebo-controlled baricitinib (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.1
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.1
More details on patient exposure and integrated datasets used to evaluate safety in the baricitinib pediatric alopecia areata clinical trial are presented in Table 3.
How were the safety data analyzed in the BRAVE-AA-PEDS clinical trial?
Safety analyses were conducted in all randomized adolescents who received ≥1 dose of study treatment.
- Extended BARI AA dataset included patients remaining on continuous treatment with baricitinib 2 mg or 4 mg from baseline to data cutoff in the extension period, and
- All-BARI AA dataset included all patients exposed to any baricitinib dose (2 mg or 4 mg) at any time during the studies, including patients with dose or treatment change up to the data cutoff in the extension period.2
What treatment-emergent adverse events were reported in the baricitinib pediatric alopecia areata clinical trial?
The safety findings were consistent with the known safety profile for baricitinib in adolescents.3
- no deaths, opportunistic infection, venous thromboembolism, pulmonary embolism, or major adverse cardiovascular events were reported, and
- a serious infection and a malignancy (myxoid liposarcoma; reported as unrelated to study medication by the investigator) were reported in baricitinib groups.2
Table 1 provides a summary of the adverse events reported in the BRAVE-AA-PEDS clinical trial. Treatment-emergent adverse event (TEAE) is defined as any event that occurred on or after the first dose of study drug administration or any preexisting event that worsened in severity after dosing.2
|
Placebo-Controlled Period |
Extended BARI AA |
All BARI AA |
|||
|---|---|---|---|---|---|---|
n (%) [IR] |
Placebo |
BARI 2 mg |
BARI 4 mg |
BARI 2 mg |
BARI 4 mg |
All Doses |
Patients with ≥1 TEAE |
47 (53.4) [129.1] |
50 (60.2) [160.1] |
60 (70.6) [199.7] |
52 (62.7) [115.2] |
70 (82.4) [168.5] |
156 (62.7) [108.7] |
TEAE severitya |
||||||
Mild |
27 (30.7) [56.3] |
37 (44.6) [96.6] |
43 (50.6) [116.4] |
36 (43.4) [60.4] |
41 (48.2) [58.9] |
95 (38.2) [47.2] |
Moderate |
18 (20.5) [36.3] |
12 (14.5) [23.3] |
15 (17.6) [28.5] |
14 (16.9) [17.2] |
26 (30.6) [27.3] |
53 (21.3) [20.5] |
Severe |
2 (2.3) [3.5] |
1 (1.2) [1.8] |
2 (2.4) [3.6] |
2 (2.4) [2.2] |
3 (3.5) [2.7] |
8 (3.2) [2.7] |
≥1 Serious AE |
3 (3.4) [5.2] |
2 (1.2) [1.8]b |
1 (1.2) [1.1] |
4 (4.7) [3.6] |
9c (3.6) [3.1] |
|
Death |
0 |
0 |
0 |
0 |
0 |
0 |
AE leading to temporary interruption |
9 (10.2) [16.4] |
5 (6.0) [9.1] |
8 (9.4) [14.7] |
7 (8.4) [8.0] |
10 (11.8) [9.5] |
24 (9.6) [8.6] |
AE leading to permanent discontinuation |
2 (2.3) [3.4] |
1 (0.6) [0.9]b |
1 (1.2) [1.1] |
3 (3.5) [2.7] |
5 (2.0) [1.7] |
|
Abbreviations: AA = alopecia areata; AE = adverse event; BARI = baricitinib; IR = incidence rate; MedDRA = Medical Dictionary for Regulatory Activities; PYE = patient-years of exposure; TEAE = treatment-emergent adverse event.
IR represents 100× (the number of participants experiencing the AE divided by the patient-years at risk). Classifications of AEs are based on the MedDRA (version 27.0 Placebo-controlled period and 28.0 Extended BARI AA and All BARI AA).
Data cutoff: September 10, 2024, for placebo-controlled period and April 15, 2025, for Extended BARI AA/All BARI AA.
a Participants with multiple occurrences of the same event were counted under the highest severity.
b This is an ongoing study and remains double-blinded after the week 36 placebo period. Due to the low number of serious AEs and TEAEs reported, it is not possible to provide certain details to maintain the blind.
c In the All BARI AA group: Abdominal pain upper, depression, major depression, suicide attempt, epilepsy, ligament sprain, myxoid liposarcoma, pneumonia, and upper limb fracture.
Most frequently reported TEAEs are summarized in Table 2. The most common TEAEs occurring ≥5% in the BRAVE-AA-PEDS clinical trial were acne, upper respiratory tract infection, nasopharyngitis, influenza, headache, rhinitis, and blood creatine phosphokinase increase.2
|
Placebo-Controlled Period |
Extended BARI AA |
All BARI AA |
|||
|---|---|---|---|---|---|---|
TEAEs Occurring at ≥5% Frequency in Any Treatment Group, n (%) [IR] |
Placebo |
BARI 2 mg |
BARI 4 mg |
BARI 2 mg |
BARI 4 mg |
All Doses |
Acne |
4 (4.5) |
7 (8.4) |
8 (9.4) |
8 (9.6) |
11 (12.9) |
30 (12.0) |
Upper respiratory tract infection |
6 (6.8) |
7 (8.4) |
7 (8.2) |
9 (10.8) |
10 (11.8) |
24 (9.6) |
Nasopharyngitis |
9 (10.2) |
7 (8.4) |
6 (7.1) |
9 (10.8) |
8 (9.4) |
21 (8.4) |
Influenza |
3 (3.4) |
10 (12.0) |
5 (5.9) |
10 (12.0) |
6 (7.1) |
21 (8.4) |
Headache |
5 (5.7) |
4 (4.8) |
7 (8.2) |
4 (4.8) |
10 (11.8) |
17 (6.8) |
Rhinitis |
3 (3.4) |
1 (1.2) |
6 (7.1) |
1 (1.2) |
7 (8.2) |
8 (3.2) |
Blood CPK increase |
2 (2.3) |
5 eventsa |
5 eventsa |
5 (2.0) |
||
Abbreviations: AA = alopecia areata; AE = adverse event; BARI = baricitinib; CPK = creatine phosphokinase; IR = incidence rate; MedDRA = Medical Dictionary for Regulatory Activities; PYE = patient-years of exposure; TEAE = treatment-emergent adverse event.
Note: IR represents 100× (the number of participants experiencing the AE divided by the patient-years at risk). Classifications of AEs are based on the MedDRA (version 27.0 placebo-controlled period and 28.0 Extended BARI AA and All BARI AA).
Data cutoff: September 10, 2024, for placebo-controlled period and April 15, 2025, for Extended BARI AA/All BARI AA.
a This is an ongoing study and remains double-blinded after the week 36 placebo period. Due to the low number of serious AEs and TEAEs reported, it is not possible to provide certain details to maintain the blind.
What adverse drug reactions have been reported in postmarketing experience with baricitinib?
The following adverse reactions have been identified during post-approval use of baricitinib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- immune system disorders: drug hypersensitivity (events such as rash, urticaria, and angioedema have been reported), and
- metabolism and nutrition disorders: hypoglycemia.4
Which integrated analysis datasets were used to evaluate safety in the baricitinib pediatric alopecia areata clinical trial?
Analysis Set |
Description |
|---|---|
36-week placebo-controlled BARI AA Adolescents |
Assesses BARI 4 mg, BARI 2 mg, and placebo.
Evaluation time period included randomization to week 36. Data cut off: September 10, 2024. |
Extended BARI AA Adolescents |
Assesses BARI 4 mg and BARI 2 mg including extended evaluations. Includes patients from the phase 3 BRAVE-AA-PEDS study who were randomized to
Evaluation time period included randomization up to data cutoff, April 15, 2025. Data were censored after a patient was switched to another dose or treatment. |
All BARI AA Adolescents |
No between-group assessments. Includes 249 (total PYE=294.8) patients from the phase 3 BRAVE-AA-PEDS study who were exposed to any BARI dose, including
Evaluation time period included any time points during the studies either from randomization or from switch from placebo. |
Abbreviations: AA = alopecia areata; BARI = baricitinib; PYE = patient-years of exposure.
Date of Last Review: 08-October-2026
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Craiglow B, Arkin L, Saceda-Corralo D, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 52-week efficacy and safety results from a phase 3 randomized, controlled trial. J of Skin. 2025;9(6):s666. https://doi.org/10.25251/rw150t68
- Torrelo A, Rewerska B, Galimberti M, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in paediatric patients with moderate-to-severe atopic dermatitis with an inadequate response to topical corticosteroids: results from a phase III, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS). Br J Dermatol. 2023;189(1):23-32. https://doi.org/10.1093/bjd/ljad096
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: October 08, 2026