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)

What Was the Incidence of Acne in the Olumiant®▼(baricitinib) BREEZE-AD Clinical Program?

74 (2.9%) of 2531 patients across all baricitinib doses studied in All BARI AD dataset reported acne as treatment emergent adverse event.

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Relevant Information from the SmPC

Acne was reported as a common (≥ 1/100 to < 1/10) adverse drug reaction. This frequency was based on the pooled rheumatoid arthritis and atopic dermatitis clinical trials.1

Acne in Atopic Dermatitis

The use of topical steroids for the treatment of skin conditions such as atopic dermatitis (AD) can lead to acne or worsening of acne.2,3

Treatment-Emergent Adverse Events Related to Acne in the BREEZE-AD Clinical Development Program

Incidence of Treatment-Emergent Acne in the Atopic Dermatitis Clinical Trials

The integrated datasets used to evaluate safety in the AD clinical trials are described in detail in Treatment-Emergent Adverse Events of Acne From the Atopic Dermatitis Clinical Program.

The HLT cluster and treatment emergent adverse events  (TEAEs) by preferred term related to acne reported in the baricitinib (BARI) AD clinical trial program are reported in Treatment-Emergent Adverse Events of Acne From the Atopic Dermatitis Clinical Program.

Treatment-Emergent Adverse Events of Acne From the Atopic Dermatitis Clinical Program4

 

 

 

 

 

 

 

 

 

 

 

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

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

BARI 2 mg vs 4 mga
n (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

Acne HLT

7 (0.7)

11 (1.5)

7 (0.7)

10 (1.5)

9 (1.3)

10 (1.5)

16 (2.3) [3.6]

19 (3.0) [4.2]

79 (3.1) [3.5]

Acne

7 (0.7)

10 (1.4)

7 (0.7)

9 (1.4)

8 (1.2)

9 (1.4)

15 (2.2) [3.3]

17 (2.7) [3.8]

74 (2.9) [3.3]

Acne varioliformis

0

1 (0.1)

0

0

1 (0.1)

0

1 (0.1) [0.2]

0

1 (0.0) [0.0]

Dermatitis acneiform

0

0

0

1 (0.1)

0

1 (0.1)

0

2 (0.3) [0.4]

4 (0.2) [0.2]

Acne pustular

0

0

0

1 (0.1)

0

1 (0.1)

1 (0.1) [0.2]

1 (0.1) [0.2]

3 (0.1) [0.1]

Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; ext = extended; HLT = high-level term; IR = incidence rate.

aData through 16-week placebo-controlled period.

bFor 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 (eg, 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 Dataset

In the 16-week placebo-controlled period, TEAEs in the acne HLT cluster were reported more frequently in the BARI-treated group compared to placebo. Within the acne HLT cluster, acne was the most frequently reported event term with

  • 1.2% in the BARI 2 mg group
  • 1.4% in the BARI 4 mg group, and
  • 0.7% in the placebo group.4

The study-size adjusted percentages were calculated for the adverse events (AEs) to provide appropriate direct comparisons between treatment groups.4

The differences between treatment groups were not significant, and there were no treatment interruptions or permanent discontinuations reported due to acne-related AEs.4

All BARI Dataset

In the All BARI AD dataset of the 74 (2.9%) TEAEs of acne reported

  • 61 (2.4%) were mild
  • 13 (0.5%) were moderate, and
  • no cases were reported as severe.4

There were no treatment interruptions or permanent discontinuations from the BREEZE-AD studies reported due to acne-related AEs.4

Integrated Safety Datasets

Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials4,5

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

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

2Common risks of topical corticosteroids. National Eczema Association. Updated 2020. Accessed August 18, 2020. https://nationaleczema.org/risks-of-topical-corticosteriods/

3Topical corticosteroids. UK National Health Service. Updated January 15, 2020. Accessed August 18, 2020. https://www.nhs.uk/conditions/topical-steroids/

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

5Bieber 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

Glossary

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: January 27, 2021


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