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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 is the risk of infections in Olumiant® (baricitinib) patients with atopic dermatitis or alopecia areata?

Monitor carefully patients who develop an infection. Temporarily interrupt baricitinib if patients do not respond to standard therapy. Do not restart baricitinib until infection resolution.

UK_cFAQ_BAR122_INFECTIONS_AD_AA

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Content overview

How should I monitor a patient with an active infection under baricitinib?
Special warnings and precautions regarding baricitinib and infections
Incidence of infections in placebo-controlled trials and long-term exposure
Incidence of infections based on real-world data
References
Appendix 1: Integrated safety datasets table atopic dermatitis clinical trials
Appendix 2: Integrated safety datasets table alopecia areata clinical trials

How should I monitor a patient with an active infection under baricitinib?

Screen for active, chronic, or recurrent infections

Serious and sometimes fatal infections have been reported in patients receiving other JAK inhibitors.1

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.1

The risks and benefits of treatment should be carefully considered prior to initiating baricitinib in patients with active, chronic or recurrent infections.1

If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.1

As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age, baricitinib should only be used if no suitable treatment alternatives are available.1

Screen for tuberculosis

Patients should be screened for tuberculosis (TB) before starting therapy.1

Baricitinib should not be given to patients with active TB.1
Anti-TB therapy should be considered prior to initiation of treatment in patients with previously untreated latent TB.1

Screen for herpes zoster

If a patient develops herpes zoster, treatment should be temporarily interrupted until the episode resolves.1

Screen for viral hepatitis

Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with baricitinib.1

Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate.
Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.

Special warnings and precautions regarding baricitinib and infections

The most commonly reported infection-related adverse drug reactions with baricitinib are1

upper respiratory tract infections (16.9 %)
herpes simplex (3.2 %), and
urinary tract infections (2.9 %).1

Please find the frequency of infections and infestations reported in clinical trials or in the postmarketing setting or both for patients with rheumatoid arthritis, atopic dermatitis, or alopecia areata in Infections and infestations reported in clinical trials or in the postmarketing setting or both for patients with rheumatoid arthritis, atopic dermatitis, or alopecia areata. from the summary of product characteristics (SmPC), and an overview of treatment emergent infections from the All-BARI datasets in Overview of treatment-emergent infections from the All-BARI datasets.

Infections and infestations reported in clinical trials or in the postmarketing setting or both for patients with rheumatoid arthritis, atopic dermatitis, or alopecia areata.1
System Organ Class	Very commona	Commonb	Uncommon
Infections and infestations	Upper respiratory tract infections	Herpes zoster^c Herpes simplex Gastroenteritis Urinary tract infections Pneumonia^d Folliculitis e	Pneumoniaf

The full information on infection adverse drug reaction can be found in the SmPC

a≥1/10

b≥1/100 to <1/10

cFrequency for herpes zoster is based on rheumatoid arthritis clinical trials.

dIn atopic dermatitis and alopecia areata clinical trials, the frequency of pneumonia was uncommon.

eFolliculitis was observed in alopecia areata clinical trials. It was usually localized in the scalp region associated with hair regrowth.

fIn atopic dermatitis and alopecia areata clinical trials

Overview of treatment-emergent infections from the All-BARI datasets2-5
	All-BARI-RA	All BARI AD	All BARI AA
n [EAIR]a	N=3770 PYE=15114.1	N=2636 PYE=4628.4	N=1303 PYE=2217.9
All TE infection	2590 [17.1]	1519 [67.2]	624 [42.5]
Led to temporary interruption of study treatment	827 [5.5]	264 [6.0]	108 [4.9]
Led to permanent discontinuation	185 [1.2]	33 [0.7]	3b [0.1]

Abbreviations: AA = alopecia areata; AD = atopic dermatitis; BARI = baricitinib; EAIR = exposure-adjusted incidence rate; PYE = patient-years of exposure; RA = rheumatoid arthritis; TE = treatment emergent.

aExposure-adjusted incidence rate in 100 patient years. Incidence rate in the All BARI-AD dataset.

b1 patient with lower respiratory tract infection, 1 patient with of COVID-19, and 1 patient with herpes zoster.

Incidence of infections in placebo-controlled trials and long-term exposure

Atopic dermatitis clinical trials

Baricitinib was evaluated for up to 4628 patient-years of exposure and up to 3.9 years to treat atopic dermatitis. Please find an overview of treatment emergent adverse event (TEAEs) infections from the atopic dermatitis (AD) clinical trials in Summary of Infections in the Atopic Dermatitis Clinical Trials. Appendix 1: Integrated safety datasets table atopic dermatitis clinical trials provides details about the corresponding studies.3,6

In the AD clinical trials, 1373 of the 2636 patients were considered patients at-risk, defined as ≥65 years, or with at least one of the following risk factors: atherosclerotic cardiovascular disease, diabetes mellitus, hypertension, current smoking, high-density lipoprotein cholesterol less than 40 mg/dL, body mass index at least 30, poor mobility on EuroQol-5 Dimension, and history of malignancy.7

55 of the 82 serious infections were reported by patients at-risk.7

Summary of Infections in the Atopic Dermatitis Clinical Trials3,6
	16-week Placebo-Controlled Period n [adj IR]a			BARI 2 mg and 4 mg Extended (up to 3.9 years) n [adj IR]a		All BARI AD (up to 3.9 years) n [IR]
	Placebo N=743	BARI 2 mg N=576	BARI 4 mg N=489	BARI 2 mg N=584	BARI 4 mg N=497	N=2636
Infections	216 [100.3]	212 [128.0]	183 [134.5]	326 [99.7]	312 [96.0]	1519 [67.2]
Serious infectionsb	5 [2.1]	3 [1.0]	3 [1.9]	12 [1.4]	20 [2.7]	82 [1.8]
Opportunistic infections	1 [0.4]	1 [0.3]	0	5 [0.6]	3 [0.5]	14c[0.3]
Infections leading to temporary interruption	4 [1.3]	17 [7.5]	15 [9.3]	52 [7.1]	54 [7.9]	264 [6.0]
Infections leading to permanent discontinuation	2 [0.7]	2 [1.0]	2 [1.3]	6 [0.7]	11 [1.6]	33 [0.7]
Skin infections requiring antibiotics	38 [15.7]	31 [16.6]	18 [11.4]	31 [4.5]	19 [2.5]	76 [1.7]

Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; HZ = herpes zoster; IR = incidence rate.

aFor the integrated controlled analysis sets where the randomized ratio of patients receiving BARI to placebo or BARI to active control is not the same across all the integrated studies (example 2:1:1:1 vs 1:1:1:1), the study-size adjusted percentages were calculated for the adverse events to provide appropriate direct comparisons between treatment groups.

bMost frequent serious infections: eczema herpeticum (IR=0.3), cellulitis (IR=0.2), erysipelas (IR=0.1), pneumonia (IR=0.1) and COVID-19 pneumonia (IR=0.1).

cOpportunistic infections include 11 cases of HZ, 1 case of herpes ophthalmic, 1 case of HZ disseminated, and 1 case of typhoid fever.

Alopecia areata clinical trials

In the AA clinical trials, 659 of the 1303 patients were considered patients at-risk, defined as ≥65 years, or with at least one of the following risk factors: atherosclerotic cardiovascular disease, diabetes mellitus, hypertension, current smoking, high-density lipoprotein cholesterol less than 40 mg/dL, body mass index at least 30, poor mobility on EuroQol-5 Dimension, and history of malignancy.7

Baricitinib was evaluated for up to 2218 patient-years of exposure for alopecia areata (AA). Please find an overview of major adverse cardiovascular events from the AA clinical trials in Summary of Infections in the Alopecia Areata Clinical Trials. Appendix 2: Integrated safety datasets table alopecia areata clinical trials provides details about the corresponding studies.5,8

Summary of Infections in the Alopecia Areata Clinical Trials4,5
	36-Week Placebo-Controlled Period			Extended BARI AA		All BARI AA
	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=912.95	All Doses N=1303 PYE=2217.90
	n [IR per 100 patient-years at risk]			n [IR per 100 patient-years at risk]
Patients with ≥1 TEAEa	108 [55.5]	118 [62.9]	165 [57.3]	169 [52.2]	267 [44.1]	624 [42.5]
Serious AEb	0	2 [0.8]	1 [0.3]	2 [0.4]	6 [0.6]	16 [0.7]
Led to temporary interruption	10 [4.1]	12 [5.0]	11 [3.0]	20 [4.2]	38 [4.2]	108 [4.9]
Led to permanent discontinuation	0	1 [0.4]	0	1 [0.2]	1 [0.1]	3c[0.1]

Abbreviations: AA = alopecia areata; AE = adverse event; BARI = baricitinib; IR = incidence rate; COVID-19 = coronavirus disease 2019; PYE = patient-years of exposure; TEAE = treatment-emergent adverse event.

aThe most frequently reported infection terms in BARI-treated patients were upper respiratory tract infection, nasopharyngitis, and urinary tract infection.

bSerious events were: COVID-19 pneumonia, COVID-19, appendicitis, pyelonephritis, appendicitis perforated, diverticulitis, herpes zoster, lyme disease, pneumonia, varicella

c1 patient with lower respiratory tract infection, 1 patient with of COVID-19, and 1 patient with herpes zoster.

10 of the 16 cases of serious infection were reported by patients at-risk.7

Incidence of infections based on real-world data

Best to our knowledge, there are no systematic real-world data in baricitinib patients with atopic dermatitis or alopecia areata.

References

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

2Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022;81(3):335-343. https://doi.org/10.1136/annrheumdis-2021-221276

3Bieber T, Thyssen JP, Reich K, et al. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. J Eur Acad Dermatol Venereol. 2021;35(2):476-485. https://doi.org/10.1111/jdv.16948

4King 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

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Bieber T, Katoh N, Simpson EL, et al. Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 and up to 3.9 years treatment: an updated integrated analysis of 8 clinical trials. Poster presented at: 31st Annual European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy.

7Taylor, P.C., Bieber, T., Alten, R. et al. Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications. Adv Ther (2023). https://doi.org/10.1007/s12325-023-02445-w

8King B, Maari C, Lain E, et al. Extended safety analysis of baricitinib 2 mg in adult patients with atopic dermatitis: an integrated analysis from eight randomized clinical trials. Am J Clin Dermatol. 2021;22(3):395-405. https://doi.org/10.1007/s40257-021-00602-x

9King 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. Published online November 11, 2022. https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljac059/6821292

Appendix 1: Integrated safety datasets table atopic dermatitis clinical trials

Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials3,5,6,8
Analysis Set	Description
16-Week Placebo-Controlled BARI AD Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7	Compares BARI 2 mg, BARI 4 mg and placebo. Includes patients with AD from 1 phase 2 and 4 phase 3 studies who were randomized to BARI 2 mg (n=576, PYE=169.1) BARI 4 mg (n=489, PYE=147.1), or placebo (n=743, PYE=211.8). Treated for 0 to 16 weeks during the placebo-controlled period.
BARI 2 mg and 4 mg Extended ADa Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD7, and extension study BREEZE-AD3	Compares BARI 2 mg vs BARI 4 mg including extended evaluations Includes patients with AD from 1 phase 2 and 4 phase 3 studies and any further exposure for those patients in the phase 3 extension study, BREEZE-AD3, who were randomized to BARI 2 mg (n=584, PYE=727.1), or BARI 4 mg (n=497, PYE=800.1). Data censored at dose or treatment change (rescue, dose switch, or re-randomization to a different BARI dose or placebo) for BREEZE-AD4 and BREEZE-AD3.
All BARI AD Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7, and extension studies BREEZE-AD3, BREEZE-AD6a	No between-group comparisons Includes 2636 (total PYE=4628.4) patients with AD from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received BARI at a variety of doses, including BARI 1 mg (n=605, PYE=441.5) BARI 2 mg (n=1703, PYE=2420.9), and BARI 4 mg (n=1012, PYE=1766.8). Includes all patients who were exposed to any BARI dose at any time during the studies, either from randomization or from switch or rescue from placebo. No censoring of data at dose change.

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; PYE = patient-years of exposure.

aData cut as of November 3, 2021 for BREEZE-AD3 and December 15, 2021 for BREEZE-AD4

Appendix 2: Integrated safety datasets table alopecia areata clinical trials

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials5,9
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.

Date of Last Review: 05 June 2023

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Olumiant ® (baricitinib)