Olumiant ® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Incidence of Asthma in the Atopic Dermatitis Clinical Trial Program

Asthma was reported in 1.6% in patients treated with baricitinib in the atopic clinical trials. There were 4 serious adverse events of asthma and no permanent discontinuations due to asthma reported.

Asthma in Atopic Dermatitis Patients

Atopic dermatitis can impact quality of life and is associated with a number of allergic and non-allergic comorbidities. Allergic-related comorbidities can include asthma, a chronic inflammatory disorder of the respiratory system, especially in patients with moderate to severe AD.1

Asthma in the BREEZE-AD Clinical Development Program

BREEZE-AD Phase 3 Clinical Trial Exclusion Criteria

In the BARI AD clinical trial program, patients were excluded if they had any serious concomitant illness that would

  • require the use of systemic corticosteroids

  • interfere with study participation, or

  • require active frequent monitoring.2

Patients were also excluded if have a history or presence of respiratory disorders such as unstable chronic asthma or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.2

Incidence of Asthma in Atopic Dermatitis Clinical Development Program

The integrated datasets used to evaluate cases of asthma are described in Table 2.

The incidence of asthma in the BARI AD clinical trial program are summarized in Table 1.

Table 1. Summary of the Incidence of Asthma From the Atopic Dermatitis Clinical Program2

 

 

 

 

 

 

 

 

 

 

 

BARI 2 mg Placebo-Controlleda
n (adj %)
b

BARI 4 mg Placebo-Controlleda
n (adj %)
b

BARI 2 mg vs 4 mgan (adj %)b

BARI 2 mg vs 4 mg ext
n (adj %)
b [adj IR]

All BARI AD
n (%) [IR]


Placebo
n=889

BARI 2 mg
n=721

Placebo
n=743

BARI 4 mg
n=489

BARI 2 mg
n=576

BARI 4 mg
n=489

BARI 2 mg
n=576

BARI 4 mg
n=489

All doses
N=2531

Asthma

8 (1.1)

8 (1.1)

6 (0.9)

3 (0.5)

6 (0.8)

3 (0.5)

11 (1.5) [2.5]

8 (1.3) [1.7]

41 (1.6) [1.8]

Asthmatic crisis 

0

1 (0.1)

0

0

1 (0.1)

0

1 (0.1) [0.2]

0

1 (0) [0]

Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; ext = extended; IR = incidence rate.

a Data through 16-week placebo-controlled period.

b For 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.

Placebo-Controlled Datasets

In the 16-week placebo-controlled period, temporary interruption of treatment was reported in

  • 1 (0.1%) of BARI 2 mg treated patients due to asthmatic crisis, and

  • 1 (0.2%) of placebo treated patients due to asthma.2

In the BARI 4 mg arm, permanent discontinuation due to asthma was reported in 1 (0.1%) due to a SAE.2

All BARI AD Dataset

In the ALL BARI AD dataset, evaluating 2531 patients treated across all BARI doses studied in AD, temporary interruption of BARI was reported in

  • 6 (0.2%) due to asthma, and

  • 1 (0.0%) due to asthmatic crisis.2

Of all the asthma cases, 4 (0.2%) were reported as SAEs with no cases leading to permanent discontinuation of BARI.2

Atopic Dermatitis Integrated Safety Datasets

Table 2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials2

Analysis Set

Description

BARI 2 mg Placebo-Controlled

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, BREEZE- AD5, and BREEZE-AD7

Compares BARI 2 mg vs placebo

Includes patients with AD from 1 phase 2 and 5 phase 3 studies who were randomized to

  • BARI 2 mg (n=721, PYE=210.6), or

  • placebo (n=889, PYE=252.7).

Treatment period was 0 to 16 weeks.

BARI 4 mg Placebo-Controlled

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, and BREEZE-AD7

Compares BARI 4 mg vs placebo

Includes patients with AD from 1 phase 2 and 4 phase 3 studies who were randomized to

  • BARI 4 mg (n=489, PYE=147.1), or

  • placebo (n=743, PYE=211.8).

Treatment period was 0 to 16 weeks.

BARI 2 mg vs 4 mg

Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7

Compares BARI 2 mg vs BARI 4 mg through 16 weeks

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), or

  • BARI 4 mg (n=489, PYE=147.1).

Treated for 0 to 16 weeks during the placebo-controlled period.

BARI 2 mg vs 4 mg Extended

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=576, PYE=425.5), or

  • BARI 4 mg (n=489, PYE=459.3).

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-AD6

No between-group comparisons

Includes 2531 (total PYE=2247.4) 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=538, PYE=245.9)

  • BARI 2 mg (n=1580, PYE=1129.5), and

  • BARI 4 mg (n=914, PYE=872.8).

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.

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.

References

1. Silverberg JI, Gelfand JM, Margolis DJ, et al. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. http://dx.doi.org/10.1016/j.anai.2018.07.006

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

Glossary

AD = atopic dermatitis

AE = adverse event

BARI = baricitinib

SAE = serious adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: July 21, 2020


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