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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.

When should Olumiant® (baricitinib) treatment be interrupted and what are the effects of treatment interruption?

In AA trials, the majority of treatment interruptions of baricitinib were due to adverse events, with infections being the most common AE. Patients with treatment interruptions ≤4 weeks long had similar efficacy results than patients with no interruption.

US_cFAQ_BAR014C_TREATMENT_INTERRUPTION_AA

en-US

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

Olumiant® (baricitinib) Prescribing Information

Recommendations Regarding Baricitinib Treatment Interruption

Recommendations for Baricitinib Treatment Interruption1
If...	Then...
an infection develops	monitor carefully and interrupt baricitinib treatment if the patient is not responding to standard therapy. Interrupt treatment if the patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume baricitinib treatment until the infection resolves.
a patient develops herpes zoster	interrupt treatment with baricitinib until the episode resolves.
clinical features of DVT/PE occur	interrupt baricitinib, evaluate promptly, and institute appropriate treatment.a
increases in ALT or AST are observed, and drug-induced liver injury is suspected	interrupt baricitinib treatment until this diagnosis is excluded.
a patient has an absolute neutrophil count <1.0 billion cells/L (1000 cells/mm³)	interrupt baricitinib treatment until ANC ≥1000 cells/μL.
a patient has an absolute lymphocyte count <0.5 billion cells/L (500 cells/mm³)	interrupt baricitinib treatment until ALC ≥500 cells/μL.
hemoglobin is less than 8 g/dL	interrupt baricitinib treatment until hemoglobin is ≥8 g/dL.

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; DVT = deep vein thrombosis; PE = pulmonary embolism.

aBaricitinib should be used with caution in patients with risk factors for DVT and PE.

Individuals of Reproductive Potential

Based on the findings from animal reproduction studies, baricitinib may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with baricitinib exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy. There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy. Consider the risks and benefits with chronic use of baricitinib during pregnancy.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 Trials

The efficacy and safety of baricitinib have been evaluated in the following pivotal, phase 3, placebo-controlled trials in adult patients with severe alopecia areata (AA)

BRAVE-AA1 (N=654) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss, and
BRAVE-AA2 (N=546) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss.2

Temporary Interruption of Treatment in Alopecia Areata Clinical Trials

Assessments of temporary interruptions 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 cut-off, 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.3

Safety data were integrated from the BRAVE-AA1 phases 2 and 3 cohorts (data cut-off May 22, 2023) and from BRAVE-AA2 (data cut-off May 8, 2023). Data cut-off represents all patients who either completed 152 weeks of the study or discontinued from the trial.4

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.

Overall Treatment Interruptions

Summary of Temporary Interruptions of Study Drug From Alopecia Areata Clinical Trials presents an overview of temporary interruptions including reasons for interruption and duration of interruptions across the integrated datasets.

Overall,

the percentage of patients with ≥1 temporary interruption was similar between placebo, baricitinib 2 mg, and baricitinib 4 mg during the placebo-controlled period
adverse events (AEs) were the reason for temporary interruption in most patients irrespective of treatment group across datasets
>90% of patients resumed study treatment after temporary interruption, and
duration of treatment interruption was similar with a mean of approximately 2 weeks.4

Summary of Temporary Interruptions of Study Drug From Alopecia Areata Clinical Trials4
	36-Week Placebo-Controlled BARI AA			Extended BARI AA		All BARI AA
	Placebo N=371	BARI 2 mg N=365	BARI 4 mg N=540	BARI 2 mg N=383	BARI 4 mg N=565	All Doses N=1303
Total number of study drug interruptions	33	30	44	73	159	377
With resumption of study drug	31	30	43	73	152	369
Without resumption of study drug	2	0	1	0	7	8
Number of patients with study drug interruption, n (%)
≥1	26 (7.0)	24 (6.6)	39 (7.2)	49 (12.8)	111 (19.6)	262 (20.1)
≥2	7 (1.9)	4 (1.1)	4 (0.7)	14 (3.7)	26 (4.6)	71 (5.4)
≥3	0	2 (0.5)	1 (0.2)	6 (1.6)	13 (2.3)	28 (2.1)
Duration of dose interruptions (days), mean (SD)	13.3 (22.9)	14.6 (16.3)	14.8 (18.2)	13.1 (18.5)	17.3 (35.1)	15.2 (26.1)
Top Reasons for study drug interruption, n (%)
Adverse event	20 (5.4)	18 (4.9)	25 (4.6)	38 (9.9)	89 (15.8)	212 (16.3)
Abnormal laboratory results	2 (0.5)	2 (0.5)	6 (1.1)	2 (0.5)	13 (2.3)	24 (1.8)
Per protocol	1 (0.3)	2 (0.5)	0	3 (0.8)	0	4 (0.3)
Suspected pregnancy	1 (0.3)	0	2 (0.4)	0	2 (0.4)	3 (0.2)
Investigator decision	1 (0.3)	2 (0.5)	6 (1.1)	5 (1.3)	11 (1.9)	26 (2.0)

Abbreviations: AA = alopecia areata; BARI = baricitinib.

BRAVE-AA1 data cut-off May 22, 2023 and BRAVE-AA2 data cut-off May 8, 2023.

Treatment Interruptions Due to Adverse Events

Adverse events leading to temporary treatment interruption by Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) are presented in Summary of Adverse Events Leading to Temporary Interruptions of Study Drug From Alopecia Areata Clinical Trials.

Overall,

the incidence rates (IRs) for ≥1 temporary interruption were similar between placebo, baricitinib 2 mg, and baricitinib 4 mg during the placebo-controlled period
in the extended period, IR was slightly higher in the baricitinib 4 mg (9.1) than baricitinib 2 mg (7.4), but similar to the IR for placebo-controlled period, and
AEs in the infections and infestations SOC were responsible for most of the temporary interruptions across all datasets.4

Summary of Adverse Events Leading to Temporary Interruptions of Study Drug From Alopecia Areata Clinical Trialsa 3,4
System Organ Class	36-Week Placebo-Controlled BARI AA			Extended BARI AA		All BARI AA
System Organ Class	Placebo N=371	BARI 2 mg N=365	BARI 4 mg N=540	BARI 2 mg N=383	BARI 4 mg N=565	All Doses N=1303
	n (%) [IR]			n [IR]		n [IR]
Patients with ≥1 AE leading to temporary interruption	21 (5.7) [8.8]	18 (4.9) [7.6]	28 (5.2) [7.9]	38 [7.4]	94 [9.1]	237 [9.2]
Infections and infestations	10 (2.7) [4.1]	12 (3.3) [5.0]	11 (2.0) [3.0]	25 [4.7]	53 [4.9]	151 [5.6]
Investigationsb	3 (0.8) [1.2]	1 (0.3) [0.4]	5 (0.9) [1.4]	4 [0.7]	12 [1.1]	27 [1.0]
Blood and lymphatic disorders	0	0	3 (0.6) [0.8]	1 [0.2]	8 [0.7]	12 [0.4]
General disorders and administration site conditionsc	0	0	2 (0.4) [0.5]	0	4 [0.4]	6 [0.2]
Injury, poisoning, and procedural complications	0	1 (0.3) [0.4]	2 (0.4) [0.5]	3 [0.5]	4 [0.4]	10 [0.4]
Gastrointestinal disorders	1 (0.3) [0.4]	1 (0.3) [0.4]	1 (0.2) [0.3]	1 [0.2]	3 [0.3]	8 [0.3]
Musculoskeletal and connective tissue disorders	2 (0.5) [0.8]	1 (0.3) [0.4]	1 (0.2) [0.3]	1 [0.2]	3 [0.3]	5 [0.2]
Nervous system disorders	2 (0.5) [0.8]	0	1 (0.2) [0.3]	0	2 [0.2]	5 [0.2]
Psychiatric disorders	0	0	1 (0.2) [0.3]	1 [0.2]	2 [0.2]	4 [0.1]
Respiratory, thoracic, and mediastinal disorders	0	2 (0.5) [0.8]	1 (0.2) [0.3]	2 [0.4]	2 [0.2]	5 [0.2]
Skin and subcutaneous tissue disorders	2 (0.5) [0.8]	0	1 (0.2) [0.3]	1 [0.2]	3 [0.3]	5 [0.2]
Surgical and medical procedures	0	1 (0.3) [0.4]	1 (0.2) [0.3]	1 [0.2]	2 [0.2]	8 [0.3]
Cardiac disorders	0	1 (0.3) [0.4]	0	1 [0.2]	3 [0.3]	5 [0.2]
Reproductive system and breast disorders	1 (0.3) [0.4]	0	0	0	0	3 [0.1]

Abbreviations: AA = alopecia areata; AE = adverse event; BARI = baricitinib; IR = incidence rate.

Note: IRs are calculated based on patient-years at risk.

BRAVE-AA1 data cut-off May 22, 2023 and BRAVE-AA2 data cut-off May 8, 2023.

aPresenting system organ classes that had >1 adverse event (per treatment arm) that led to temporary interruption.

bBlood creatine phosphokinase increased and transaminases increased (various preferred terms) were event terms that led to higher frequencies of treatment-emergent adverse events in the investigations system organ class in the BARI 4-mg group compared to placebo in the 36-week placebo-controlled period and led to higher IRs in the BARI 4-mg compared to BARI 2-mg group in the extended BARI AA analysis set.

cFatigue was the event term that led to higher frequencies of treatment-emergent adverse events in the general disorders and administration site conditions system organ class in the BARI 4-mg group compared to placebo in the 36-week placebo-controlled period and led to higher IRs in the BARI 4-mg compared to BARI 2-mg group in the extended BARI AA analysis set.

Integrated Safety Analysis Datasets

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials3,4
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.

Impact of Temporary Treatment Interruption on Efficacy

In patients receiving baricitinib 2-mg and 4-mg treatments, the effect of temporary interruption was analyzed to assess the impact on

achievement of response during the first 52-week period, and
status of clinical response in responder patients from week 52 to 152.4

Treatment Interruption Impact on Achieving Response: 0 to 52 Weeks

Efficacy Results at Week 52 in Patients With and Without Treatment Interruption presents the number of patients achieving Severity of Alopecia Tool (SALT) ≤20 (80% scalp coverage with hair) and SALT₅₀(at least 50% improvement in SALT from baseline) at week 52 in patients with and without treatment interruption.4

Efficacy Results at Week 52 in Patients With and Without Treatment Interruption4
n/N-obs (%)	No Tx Interruption		Tx Interruption Lasting ≤4 wks		Tx Interruption Lasting >4 to ≤8 wks		Tx Interruption Lasting >8 wks
n/N-obs (%)	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg
SALT ≤20	71/296 (24.0)	196/459 (42.7)	9/27 (33.3)	18/40 (45.0)	1/2 (50)	0/5 (0)	1/6 (16.7)	0/4 (0)
SALT₅₀	105/296 (35.5)	261/459 (56.9)	15/27 (55.6)	22/40 (55.0)	2/2 (100)	2/5 (40)	2/6 (33.3)	0/4 (0)

Abbreviations: n = number of patients with endpoint; N-obs = number of patients observed in each group; SALT = Severity of Alopecia Tool; SALT₅₀ = at least 50% improvement from baseline in SALT score; SALT ≤20 = 80% scalp coverage with hair; Tx = treatment; wks = weeks.

Based on available data in patients with a SALT score assessment within 4 weeks prior to and after treatment interruption, mean SALT scores improved despite treatment interruption. The mean improvement in SALT score from before to after treatment interruption was

-11.6 (min -57, max 0) in the baricitinib 2-mg group (n=10), and
-3.28 (min -18, max 3) in the baricitinib 4-mg group (n=18).4

Treatment Interruption Impact on Responder Patients: 52 to 152 Weeks

Loss of Treatment Benefit at Week 152 in Responder Patients With and Without Treatment Interruption presents the number of responder patients (achieved ≤SALT 20 at week 52) who lost treatment benefit at week 152 by interruption status. A loss of treatment benefit was defined as a >20-point worsening from week 52.4

Loss of Treatment Benefit at Week 152 in Respondera Patients With and Without Treatment Interruption
n/N-obs	No Tx Interruption		Tx Interruption Lasting ≤4 wks		Tx Interruption Lasting >4 to ≤8 wks		Tx Interruption Lasting >8 wks
n/N-obs	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg	Baricitinib 2 mg	Baricitinib 4 mg
Loss of benefit at 152 weeksb	4/53	5/96	1/11	2/28	0/1	0/1	0/2	2/4

Abbreviations: n = number of patients with endpoint; N-obs = number of patients observed in each group; SALT = Severity of Alopecia Tool; Tx = treatment.

aResponders are patients who achieved SALT≤20 at week 52.

bA loss of treatment benefit was defined as a >20-point worsening from week 52.

Effect of Treatment Withdrawal on Scalp Hair

The BRAVE-AA1 trial included a randomized withdrawal substudy, patients were eligible for inclusion in the substudy if they had

remained on the same dose of baricitinib 4 mg or 2 mg from initial randomization, and
reached a SALT score ≤20 at week 52.2,5

A majority of patients maintained treatment results through weeks 4 and 8 after switching to placebo (see Proportion of Patients With SALT≤20 After Switch to Placebo in Withdrawal Substudy Through Week 12).

Proportion of Patients With SALT≤20 After Switch to Placebo in Withdrawal Substudy Through Week 124
Maintained SALT ≤20 After Switch, n (%)	Baricitinib 2 mg → Placebo n=10	Baricitinib 4 mg → Placebo n=30
Week 4	9 (90)	22 (73)
Week 8	8 (80)	19 (63)
Week 12	6 (60)	15 (50)
Week 16	3 (30)	12 (40)

Abbreviation: SALT = Severity of Alopecia Tool.

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

3King 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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5King B, Ko J, Kwon O, et al. Outcomes of treatment withdrawal in patients with severe alopecia areata treated with baricitinib: week 104 data from phase 3 BRAVE-AA1. Poster presented at: World Congress of Dermatology; July 3-8, 2023; Singapore.

Date of Last Review: November 06, 2023

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