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Olumiant ^® (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

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

The most common adverse events ≥2% in the alopecia areata clinical trials were upper respiratory tract infections, nasopharyngitis, headache, acne, increased CPK, and urinary tract infections.

UK_cFAQ_BAR101C_COMMON_SIDE_EFFECTS_AA

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Content Overview

What are the common adverse drug reactions with baricitinib?
What are the Common treatment-emergent adverse events in the alopecia areata clinical trials?
Description of the Integrated safety datasets
References

What are the common adverse drug reactions with baricitinib?

The most commonly reported adverse drug reactions with baricitinib are1

increased LDL cholesterol (26.0 %),
upper respiratory tract infections (16.9 %)
headache (5.2 %)
herpes simplex (3.2 %), and
urinary tract infections (2.9 %).

Serious pneumonia and serious herpes zoster occurred uncommonly in patients with rheumatoid arthritis.1

Please refer to section 4.8 of the Olumiant Summary of Product Characteristics for the tabulated list of adverse reactions and description of selected adverse reactions.

Please note that the frequencies of the adverse reactions are based on integrated data from1

clinical trials and/or
postmarketing setting

across

rheumatoid arthritis,
atopic dermatitis, and
alopecia areata

indications unless stated otherwise.1

For full prescribing information including warnings and precautions please refer to the Summary of Product Characteristics.

What are the Common treatment-emergent adverse events in the alopecia areata clinical trials?

What are the data that have been evaluated?

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 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.5

Safety data were integrated from the BRAVE-AA1 Phase 2 and 3 cohorts (data cut-off May 24, 2022) and from BRAVE-AA2 (data cut-off May 10, 2022). Data cut-off represents all patients who either completed 104 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.

Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.

Which events have been observed in teh alopecia areata clinical trials? (Common TEAE)

A TEAE (treatment-emergent adverse event) is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.6

Common TEAEs are defined as those reported at a frequency of ≥2% before the rounding of patients in any treatment group, including placebo.6

Across all analysis sets, the most common TEAEs were

upper respiratory tract infection
nasopharyngitis
headache
acne
blood creatine phosphokinase (CPK) increased, and
urinary tract infection (UTI).5,6

The most common TEAEs reported in ≥2% of any group in the baricitinib AA clinical trial program can be seen in 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=470.2	BARI 4 mg N=565 PYE=913.0	All Doses N=1303 PYE=2217.9
Upper respiratory tract infection	26 (7.0) [11.2]	24 (6.6) [10.3]	41 (7.6) [11.8]	46 (12.0) [10.2]	60 (10.6) [7.0]	142 (10.9) [6.8]
Nasopharyngitis	19 (5.1) [8.0]	16 (4.4) [6.8]	37 (6.9) [10.7]	26 (6.8) [5.5]	48 (8.5) [5.5]	89 (6.8) [4.2]
Headache	20 (5.4) [8.4]	20 (5.5) [8.5]	36 (6.7) [10.4]	29 (7.6) [6.2]	53 (9.4) [6.1]	107 (8.2) [5.0]
Acne	4 (1.1) [1.6]	21 (5.8) [9.0]a	30 (5.6) [8.5]b	26 (6.8) [5.6]	36 (6.4) [4.1]	87 (6.7) [4.1]
Blood CPK increased	5 (1.3) [2.0]	3 (0.8) [1.2]	23 (4.3) [6.4]c d	6 (1.6) [1.2]	41 (7.3) [4.6]d	69 (5.3) [3.1]
Urinary tract infection	6 (1.6) [2.5]	14 (3.8) [5.9]	18 (3.3) [5.0]	23 (6.0) [4.8]	31 (5.5) [3.4]	80 (6.1) [3.7]
Hypertension	9 (2.4) [3.7]	2 (0.5) [0.8]	14 (2.6) [3.9]	3 (0.8) [0.6]	18 (3.2) [2.0]	36 (2.8) [1.6]
Influenza	7 (1.9) [2.9]	6 (1.6) [2.5]	14 (2.6) [3.9]	7 (1.8) [1.4]	21 (3.7) [2.3]	33 (2.5) [1.5]
Pruritus	8 (2.2) [3.3]	1 (0.3) [0.4]	13 (2.4) [3.6]	6 (1.6) [1.2]	17 (3.0) [1.8]	32 (2.5) [1.4]
Cough	7 (1.9) [2.9]	5 (1.4) [2.1]	12 (2.2) [3.3]	7 (1.8) [1.4]	16 (2.8) [1.7]	33 (2.5) [1.5]
Weight Increased	1 (0.3) [0.4]	6 (1.6) [2.5]	5 (0.9) [1.4]	12 (3.1) [2.5]	13 (2.3) [1.4]	31 (2.4) [1.4]
Hypercholesterolemia	3 (0.8) [1.2]	5 (1.4) [2.1]	7 (1.3) [1.9]	8 (2.1) [1.6]	9 (1.6) [1.0]	29 (2.2) [1.3]
Oropharyngeal pain	3 (0.8) [1.2]	5 (1.4) [2.1]	8 (1.5) [2.2]	9 (2.3) [1.9]	11 (1.9) [1.2]	29 (2.2) [1.3]
Blood cholesterol increased	2 (0.5) [0.8]	4 (1.1) [1.7]	7 (1.3) [1.9]	9 (2.3) [1.8]	15 (2.7) [1.6]	28 (2.1) [1.3]
Hyperlipidemia	2 (0.5) [0.8]	3 (0.8) [1.2]	5 (0.9) [1.4]	5 (1.3) [1.0]	11 (1.9) [1.2]	26 (2.0) [1.2]
Pyrexia	2 (0.5) [0.8]	4 (1.1) [1.7]	4 (0.7) [1.1]	6 (1.6) [1.2]	10 (1.8) [1.1]	28 (2.1) [1.2]
Fatigue	4 (1.1) [1.6]	3 (0.8) [1.2]	12 (2.2) [3.3]	4 (1.0) [0.8]	16 (2.8) [1.7]	25 (1.9) [1.1]
Post vaccination syndrome	0	0	0	2 (0.5) [0.4]	6 (1.1) [0.6]	26 (2.0) [1.2]
Dizziness	3 (0.8) [1.2]	4 (1.1) [1.7]	5 (0.9) [1.4]	8 (2.1) [1.6]	7 (1.2) [0.7]	22 (1.7) [1.0]
Folliculitis	3 (0.8) [1.2]	5 (1.4) [2.1]	12 (2.2) [3.3]	10 (2.6) [2.1]	19 (3.4) [2.1]	42 (3.2) [1.9]
Nausea	6 (1.6) [2.5]	10 (2.7) [4.2]	11 (2.0) [3.1]	12 (3.1) [2.5]	15 (2.7) [1.6]	41 (3.1) [1.9]
Back pain	12 (3.2) [5.0]	6 (1.6) [2.5]	10 (1.9) [2.8]	8 (2.1) [1.6]	22 (3.9) [2.4]	37 (2.8) [1.7]
Arthralgia	8 (2.2) [3.3]	7 (1.9) [2.9]	9 (1.7) [2.5]	14 (3.7) [2.9]	18 (3.2) [2.0]	46 (3.5) [2.1]
Herpes zoster	2 (0.5) [0.8]	5 (1.4) [2.1]	5 (0.9) [1.4]	10 (2.6) [2.1]	15 (2.7) [1.6]	44 (3.4) [2.0]
Diarrhea	8 (2.2) [3.3]	2 (0.5) [0.8]	9 (1.7) [2.5]	7 (1.8) [1.4]	12 (2.1) [1.3]	21 (1.6) [0.9]
Viral upper respiratory tract infection	6 (1.6) [2.5]	8 (2.2) [3.4]	8 (1.5) [2.2]	8 (2.1) [1.6]	10 (1.8) [1.1]	21 (1.6) [0.9]
Oral herpes	9 (2.4) [3.7]	6 (1.6) [2.5]	7 (1.3) [1.9]	7 (1.8) [1.4]	13 (2.3) [1.4]	25 (1.9) [1.1]
Vulvovaginal candidiasise	0	6 (2.6) [4.0]	4 (1.2) [1.8]	6 (2.5) [1.9]	7 (2.0) [1.2]	19 (2.4) [1.4]
Menstruation irregular	0	0	4 (1.2) [1.8]	0	7 (2.0) [1.2]	8 (1.0) [0.6]
COVID-19	2 (0.5) [0.8]	1 (0.3) [0.4]	1 (0.2) [0.3]	15 (3.9) [3.1]	49 (8.7) [5.4]d	143 (11.0) [6.5]
Asymptomatic COVID-19	0	0	0	3 (0.8) [0.6]	14 (2.5) [1.5]	38 (2.9) [1.7]
Dermatitis contact	4 (1.1) [1.6]	7 (1.9) [2.9]	4 (0.7) [1.1]	8 (2.1) [1.6]	13 (2.3) [1.4]	26 (2.0) [1.2]
Dyslipidemia	3 (0.8) [1.2]	0	9 (1.7) [2.5]	0	14 (2.5) [1.5]	19 (1.5) [0.8]
Rhinorrhea	0	5 (1.4) [2.1]f	4 (0.7) [1.1]	8 (2.1) [1.6]	7 (1.2) [0.7]	19 (1.5) [0.8]
Gastroenteritis	6 (1.6) [2.5]	6 (1.6) [2.5]	4 (0.7) [1.1]	10 (2.6) [2.0]	9 (1.6) [1.0]	25 (1.9) [1.1]

Abbreviations: AA = alopecia areata; BARI = baricitinib; COVID-19 = coronavirus disease 2019; CPK = creatine phosphokinase; IR = incidence rate; PYE = patient-years of exposure; PYR = patient-years at risk.

Note: IRs are calculated based on PYR.

ap<0.001 for BARI 2-mg versus PBO

bp<0.001 for BARI 4-mg versus PBO.

cp<0.05 for BARI 4-mg versus PBO.

dp<0.05 for BARI 4-mg versus BARI 2-mg.

eDenominator and IR adjusted because event is gender specific.

fp<0.05 for BARI 2-mg versus PBO.

Results from the 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

Results from the Extended BARI AA analysis set

Higher incidence rates (IRs) observed for the baricitinib 4-mg group compared with the baricitinib 2-mg group included

CPK increased
coronavirus disease 2019 (COVID-19)
asymptomatic COVID-19
hypertension
influenza
fatigue
back pain
pruritus
cough
hyperlipidemia
post vaccination syndrome
menstruation irregular, and
dyslipidemia, see Common Treatment-Emergent Adverse Events Occurring in ≥2% in Any Group.6

Results from the All-BARI-AA Analysis Set

With longer exposure, most IRs of TEAEs were similar or decreased in the All-BARI-AA analysis set compared with the placebo-controlled period.6

Description of the 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=912.9), or BARI 2 mg (n=383, PYE=470.2). Evaluation time period included randomization up to data cutoff, May 10, 2022 for BRAVE-AA2 and May 24, 2022 for BRAVE-AA1. Data were censored after a patient was switched to another dose or treatment.
All BARI AA	No between-group assessments. Includes 1303 (total PYE=2217.9) 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=996, PYE=1478.7) BARI 2 mg (n=595, PYE=734.4), 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.

References

1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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 January 26, 2022. Accessed March 1, 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 March 30, 2023. Accessed March 1, 2023. https://clinicaltrials.gov/ct2/show/study/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://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljac059/6821292

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

Date of Last Review: 01 November 2022

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Olumiant ® (baricitinib)