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Baricitinib

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 were the common adverse events reported in Olumiant® (baricitinib) alopecia areata clinical trials?

The most common adverse events occurring ≥5% in the alopecia areata clinical trials were COVID-19, upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infection, and blood CPK increased.

US_cFAQ_BAR101C_COMMON_SIDE_EFFECTS_AA

en-US

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

Olumiant® (baricitinib) Prescribing Information Related to Adverse Events

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.1

Please see US prescribing information for adverse reactions that occurred in ≥1% during the 36-week placebo-controlled period of the baricitinib alopecia areata trials.

Common Treatment-Emergent Adverse Events in the Alopecia Areata Clinical Trials

The baricitinib alopecia areata (AA) clinical trial program includes

BRAVE-AA1, an adaptive phase 2/3 study (NCT03570749), and
BRAVE-AA2, a phase 3 study (NCT03899259).2-4

Assessments of common treatment-emergent adverse events (TEAEs) in the BRAVE-AA trials were reported in 3 integrated safety datasets including the

36-week placebo-controlled BARI AA dataset with patients exposed to placebo, baricitinib 2 mg, and baricitinib 4 mg from randomization to week 36
extended BARI AA dataset with patients exposed to baricitinib 2 mg or 4 mg from randomization to dose or treatment change, or data cutoff, and
All-BARI-AA dataset with all patients exposed to any baricitinib dose (1-mg, 2-mg, or 4-mg) at any time during the studies.5

Safety data were integrated from the BRAVE-AA1 phases 2 and 3 cohorts (data cutoff May 22, 2023) and from BRAVE-AA2 (data cutoff May 8, 2023). Data cutoff represents all patients who either completed at least 152 weeks of the study or discontinued from the trial.6

More details on patient exposure and censoring rules in each dataset are provided in Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials.

The most common (≥5%) TEAEs reported in the All BARI AA analyses set were

coronavirus disease 2019 (COVID-19)
upper respiratory tract infection
headache
nasopharyngitis
acne
urinary tract infection (UTI), and
blood creatine phosphokinase (CPK) increase.6

Common TEAEs are defined as those reported at a frequency of greater than or equal to 2%, before rounding of patients in any treatment group, including placebo (see Common Treatment-Emergent Adverse Events Occurring in ≥2% in Any Group).

Common Treatment-Emergent Adverse Events Occurring in ≥2% in Any Group5,6
	36-Week Placebo-Controlled BARI AA			Extended BARI AA		All BARI AA
Treatment-emergent adverse event, n (%) [IR]	Placebo N=371 PYE=243.2	BARI 2 mg N=365 PYE=240.6	BARI 4 mg N=540 PYE=363.4	BARI 2 mg N=383 PYE=523.3	BARI 4 mg N=565 PYE=1106.7	All Doses N=1303 PYE=2789.7
COVID-19	2 (0.5) [0.8]	1 (0.3) [0.4]	1 (0.2) [0.3]	36 (9.4) [6.9]	93 (16.5) [8.9]	294 (22.6) [11.4]
Upper respiratory tract infection	26 (7.0) [11.2]	24 (6.6) [10.3]	41 (7.6) [11.8]	48 (12.5) [9.8]	66 (11.7) [6.4]	161 (12.4) [6.2]
Headache	20 (5.4) [8.4]	20 (5.5) [8.5]	36 (6.7) [10.4]	30 (7.8) [5.8]	55 (9.7) [5.2]	113 (8.7) [4.3]
Nasopharyngitis	19 (5.1) [8.0]	16 (4.4) [6.8]	37 (6.9) [10.7]	26 (6.8) [5.0]	53 (9.4) [5.0]	103 (7.9) [3.8]
Acne	4 (1.1) [1.6]	21a (5.8) [9.0]	30b (5.6) [8.5]	26 (6.8) [5.0]	38 (6.7) [3.6]	94 (7.2) [3.5]
Urinary tract infection	6 (1.6) [2.5]	14 (3.8) [5.9]	18 (3.3) [5.0]	25 (6.5) [4.8]	36 6.4) [3.3]	89 (6.8) [3.3]
Blood CPK increased	5 (1.3) [2.0]	3 (0.8) [1.2]	23c d (4.3) [6.4]	6 (1.6) [1.1]	44 (7.8) [4.1]	76 (5.8) [2.8]
Herpes zoster	2 (0.5) [0.8]	5 (1.4) [2.1]	5 (0.9) [1.4]	11 (2.9) [2.0]	18 (3.2) [1.6]	53 (4.1) [1.9]
Arthralgia	8 (2.2) [3.3]	7 (1.9) [2.9]	9 (1.7) [2.5]	14 (3.7) [2.6]	18 (3.2) [1.6]	49 (3.8) [1.8]
Folliculitis	3 (0.8) [1.2]	5 (1.4) [2.1]	12 (2.2) [3.3]	11 (2.9) [2.0]	19 (3.4) [1.7]	45 (3.5) [1.6]
Nausea	6 (1.6) [2.5]	10 (2.7) [4.2]	11 (2.0) [3.1]	12 (3.1) [2.2]	18 (3.2) [1.6]	45 (3.5) [1.6]
Back pain	12 (3.2) [5.0]	6 (1.6) [2.5]	10 (1.9) [2.8]	10 (2.6) [1.9]	23 (4.1) [2.1]	43 (3.3) [1.5]
Cough	7 (1.9) [2.9]	5 (1.4) [2.1]	12 (2.2) [3.3]	8 (2.1) [1.5]	18 (3.2) [1.6]	42 (3.2) [1.5]
Influenza	7 (1.9) [2.9]	6 (1.6) [2.5]	14 (2.6) [3.9]	7 (1.8) [1.3]	25 (4.4) [2.3]	41 (3.1) [1.5]
Hypertension	9 (2.4) [3.7]	2 (0.5) [0.8]	14 (2.6) [3.9]	4 (1.0) [0.7]	19 (3.4) [1.7]	40 (3.1) [1.4]
Hypercholesterolemia	3 (0.8) [1.2]	5 (1.4) [2.1]	7 (1.3) [1.9]	10 (2.6) [1.9]	13 (2.3) [1.2]	37 (2.8) [1.3]
Weight increased	1 (0.3) [0.4]	6 (1.6) [2.5]	5 (0.9) [1.4]	12 (3.1) [2.2]	13 (2.3) [1.2]	36 (2.8) [1.3]
Pruritus	8 (2.2) [3.3]	1 (0.3) [0.4]	13 (2.4) [3.6]	6 (1.6) [1.1]	17 (3.0) [1.5]	32 (2.5) [1.1]
Blood cholesterol increased	2 (0.5) [0.8]	4 (1.1) [1.7]	7 (1.3) [1.9]	9 (2.3) [1.7]	17 (3.0) [1.5]	32 (2.5) [1.1]
Sinusitis	6 (1.6) [2.5]	4 (1.1) [1.7]	5 (0.9) [1.4]	7 (1.8) [1.3]	25 (4.4) [2.3]	31 (2.4) [1.1]
Pyrexia	2 (0.5) [0.8]	4 (1.1) [1.7]	4 (0.7) [1.1]	6 (1.6) [1.1]	11 (1.9) [1.0]	31 (2.4) [1.1]
Oropharyngeal pain	3 (0.8) [1.2]	5 (1.4) [2.1]	8 (1.5) [2.2]	9 (2.3) [1.7]	12 (2.1) [1.1]	30 (2.3) [1.1]
Hyperlipidemia	2 (0.5) [0.8]	3 (0.8) [1.2]	5 (0.9) [1.4]	5 (1.3) [0.9]	13 (2.3) [1.2]	29 (2.2) [1.0]
Gastroenteritis	6 (1.6) [2.5]	6 (1.6) [2.5]	4 (0.7) [1.1]	10 (2.6) [1.8]	13 (2.3) [1.2]	29 (2.2) [1.0]
Alanine aminotransferase increased	3 (0.8) [1.2]	2 (0.5) [0.8]	6 (1.1) [1.6]	2 (0.5) [0.4]	13 (2.3) [1.2]	28 (2.1) [1.0]
Eczema	5 (1.3) [2.1]	3 (0.8) [1.2]	4 (0.7) [1.1]	8 (2.1) [1.5]	11 (1.9) [1.0]	28 (2.1) [1.0]
Post vaccination syndrome	0	0	0	2 (0.5) [0.4]	6 (1.1) [0.5]	28 (2.1) [1.0]
Oral herpes	9 (2.4) [3.7]	6 (1.6) [2.5]	7 (1.3) [1.9]	7 (1.8) [1.3]	14 (2.5) [1.2]	27 (2.1) [1.0]
Dermatitis contact	4 (1.1) [1.6]	7 (1.9) [2.9]	4 (0.7) [1.1]	8 (2.1) [1.5]	13 (2.3) [1.2]	27 (2.1) [1.0]
Fatigue	4 (1.1) [1.6]	3 (0.8) [1.2]	12 (2.2) [3.3]	4 (1.0) [0.7]	16 (2.8) [1.4]	26 (2.0) [0.9]
Dizziness	3 (0.8) [1.2]	4 (1.1) [1.7]	5 (0.9) [1.4]	8 (2.1) [1.5]	9 (1.6) [0.8]	25 (1.9) [0.9]
Hypertriglyceridemia	2 (0.5) [0.8]	1 (0.3) [0.4]	4 (0.7) [1.1]	3 (0.8) [0.5]	13 (2.3) [1.2]	23 (1.8) [0.8]
Dyspepsia	4 (1.1) [1.6]	4 (1.1) [1.7]	8 (1.5) [2.2]	5 (1.3) [0.9]	12 (2.1) [1.1]	23 (1.8) [0.8]
Diarrhea	8 (2.2) [3.3]	2 (0.5) [0.8]	9 (1.7) [2.5]	7 (1.8) [1.3]	13 (2.3) [1.2]	23 (1.8) [0.8]
Dyslipidemia	3 (0.8) [1.2]	0	9 (1.7) [2.5]	1 (0.3) [0.2]	16 (2.8) [1.4]	22 (1.7) [0.8]
Viral upper respiratory tract infection	6 (1.6) [2.5]	8 (2.2) [3.4]	8 (1.5) [2.2]	8 (2.1) [1.5]	10 (1.8) [0.9]	22 (1.7) [0.8]
Vulvovaginal candidiasise	0	6 (2.6) [4.0]	4 (1.2) [1.8]	7 (2.9) [2.0]	7 (2.0) [1.0]	20 (2.5) [1.1]
Rhinorrhea	0	5f (1.4) [2.1]	4 (0.7) [1.1]	8 (2.1) [1.5]	7 (1.2) [0.6]	19 (1.5) [0.7]
Menstruation irregular^e	0	0	4 (1.2) [1.8]	0	7 (2.0) [1.0]	8 (1.0) [0.5]

Abbreviations: AA = alopecia areata; BARI = baricitinib; COVID-19 = coronavirus disease 2019; CPK = creatine phosphokinase; IR = incidence rate; PBO = placebo; PYE = patient-years of exposure; PYR = patient-years at risk.
Note: IRs are calculated based on PYR.
Data cutoff: May 22, 2023 for BRAVE-AA1 and May 8, 2023 for BRAVE-AA2.

ap<.001 for BARI 2-mg versus PBO

bp<.001 for BARI 4-mg versus PBO.

cp<.05 for BARI 4-mg versus BARI 2-mg.

dp<.05 for BARI 4-mg versus PBO.

eDenominator and IR adjusted because event is gender specific.

fp<.05 for BARI 2-mg versus PBO.

36-Week Placebo-Controlled Period

Treatment-emergent adverse events that were more frequent in the baricitinib 2-mg and baricitinib 4-mg group compared with placebo were

acne
UTI, and
vulvovaginal candidiasis.5,6

The TEAEs that were reported more frequently in baricitinib 4-mg compared with placebo were

blood CPK increased
fatigue, and
folliculitis.6

All-BARI-AA Analysis Set

With longer exposure, no clinically relevant increases in adverse event incidence rates were observed compared to rates during the placebo-controlled period, except for COVID-19, representing the conduct of the studies during the pandemic.6

Integrated Safety Datasets

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials5,6
Analysis Set	Description
36-Week placebo-controlled BARI AA	Assesses BARI 4 mg, BARI 2 mg, and placebo. Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to BARI 4 mg (n=540, PYE=363.4) BARI 2 mg (n=365, PYE=240.6), or placebo (n=371, PYE=243.2). Evaluation time period included randomization to week 36.
Extended BARI AA	Assesses BARI 4 mg and BARI 2 mg including extended evaluations. Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to BARI 4 mg (n=565, PYE=1106.70), or BARI 2 mg (n=383, PYE=523.25). Evaluation time period included randomization up to data cutoff, May 22, 2023 for BRAVE-AA1, and May 8, 2023 for BRAVE-AA2. Data were censored after a patient was switched to another dose or treatment.
All BARI AA	No between-group assessments. Includes 1303 (total PYE=2789.69) patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were exposed to any BARI dose, including BARI 4 mg (n=1001, PYE=1912.55) BARI 2 mg (n=595, PYE=887.69), or BARI 1 mg (n=28, PYE=14.6). Evaluation time period included any time points during the studies either from randomization or from switch or rescue from placebo.

Abbreviations: AA = alopecia areata; BARI = baricitinib; PYE = patient-years of exposure.

Enclosed Prescribing Information

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

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

2King B, Ohyama M, Kwon O, et al; BRAVE-AA Investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699. https://doi.org/10.1056/nejmoa2110343

3A study of baricitinib (LY3009104) in adults with severe or very severe alopecia areata (BRAVE-AA2). ClinicalTrials.gov identifier: NCT03899259. Updated July 21, 2023. Accessed November 27, 2023. https://clinicaltrials.gov/ct2/show/NCT03899259

4A study of baricitinib (LY3009104) in participants with severe or very severe alopecia areata (BRAVE-AA1). ClinicalTrials.gov identifier: NCT03570749. Updated October 24, 2023. Accessed November 27, 2023. https://clinicaltrials.gov/ct2/show/NCT03570749

5King B, Mostaghimi A, Shimomura Y, et al. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Br J Dermatol. 2023;188(2):218-227. https://doi.org/10.1093/bjd/ljac059

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: January 30, 2024

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