Olumiant ® (baricitinib)

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What is the incidence of acne in patients treated with Olumiant® (baricitinib) for atopic dermatitis?

101 (3.8%) of 2636 patients across all baricitinib doses studied in All BARI AD dataset reported acne as treatment emergent adverse event.

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en-GB

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

Incidence of acne in the baricitinib atopic dermatitis clinical trials

The integrated datasets used to evaluate safety in the atopic dermatitis (AD) clinical trials are described in detail in Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials.

A high-level term (HLT) cluster analysis was performed to assess acne and related terms associated with acne which included acne, acne varioliformis, and dermatitis acneiform.2 The HLT cluster and treatment-emergent adverse events (TEAEs) by preferred term related to acne reported in the baricitinib AD clinical trial program are described in Treatment-Emergent Adverse Events of Acne From the Atopic Dermatitis Clinical Program.

Treatment-Emergent Adverse Events of Acne From the Atopic Dermatitis Clinical Program2

 

Placebo-Controlled
(to week 16)
n (adj %)a

BARI 2 mg vs 4 mg Extended
(up to 3.9 years)
n (adj %)a [adj IR]

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

All Doses
N=2636

Acne HLT

7 (0.7)

9 (1.3)

10 (1.5)

20 (2.7) [2.7]

26 (4.2) [3.4]

112 [2.5]

Acne

7 (0.7)

8 (1.2)

9 (1.4)

18 (2.5) [2.5]

23 (3.8) [3.0]

101 [2.2]

Acne varioliformis

0

1 (0.1)

0

1 (0.1) [0.1]

0

1 [0.0]

Dermatitis acneiform

0

0

1 (0.1)

1 (0.1) [0.1]

3 (0.4) [0.3]

10 [0.2]

Acne pustular

0

0

1 (0.1)

1 (0.1) [0.1]

1 (0.1) [0.1]

4 [0.1]

Abbreviations: AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; HLT = high-level term; 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 (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 baricitinib-treated group compared to placebo. Within the acne HLT cluster, acne was the most frequently reported event term with

  • 1.2% in the baricitinib 2-mg group
  • 1.4% in the baricitinib 4-mg group, and
  • 0.7% in the placebo group.3

The study-size adjusted percentages were calculated for the adverse events to provide appropriate direct comparisons between treatment groups.2

The differences between treatment groups were not significant, and there were no treatment interruptions or permanent discontinuations reported due to acne-related adverse events.2

All baricitinib-treated patients with extended data

In the All BARI AD dataset evaluating 2636 patients treated across all baricitinib doses studied in AD, there were 101 (3.8%; incidence rate (IR) = 2.2) TEAEs of acne reported, of which

  • 82 (3.1%) were mild
  • 19 (0.7%) were moderate, and
  • no cases were reported as severe.2

There were no treatment interruptions or permanent discontinuations from the BREEZE-AD studies reported due to acne-related adverse events.2

In a previous analysis of TEAEs of acne that were reported by 74 (IR=2.9) patients, the median time to onset was 146.0 days and median duration was 82.5 days.3

BREEZE-AD Clinical Trial Exclusion Criteria Related to Acne

In the BREEZE-AD phase 3 trials, patients were excluded from enrollment if they had

  • a history or current concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD
  • a skin infection that required treatment with topical or systemic antibiotics, or
  • any other active or recent infection within 4 weeks of randomization that, in the opinion of the investigator, would pose an unacceptable risk to patients if participating in the study.2

There were no treatment recommendations specified in the protocol of the BREEZE-AD trials for patients reporting acne.2

Baricitinib Safety Profile Information Related Acne

Based on the integrated safety data from the rheumatoid arthritis clinical development program, acne has been included as an adverse drug reaction associated with baricitinib.2

In patients treated with baricitinib in the atopic dermatitis (AD) clinical trials, acne was a commonly reported adverse drug reaction, which included

  • acne
  • dermatitis acneiform, and
  • acne varioliformis.2

Acne in Atopic Dermatitis

Acne is a common inflammatory skin disorders centered around the pilosebaceous unit and frequently affects adolescents and adults. The innate immunity and inflammation play a key role in acne, which manifests as comedones and inflammatory skin lesions.4

The use of topical steroids for the treatment of skin conditions such as AD can lead to acne or worsening of acne.5,6

Integrated Safety Datasets

Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials2,7-9

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

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.

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

3Kircik L, Brinker D, Katoh N, et al. Pooled analysis of baricitinib tolerability in patients with atopic dermatitis in relation to acne, headache, and gastrointestinal events from 8 clinical trials. Poster presented at: 30th Annual Meeting of the European Academy of Dermatology and Venereology (EADV Virtual); September 29-October 2, 2021.

4Layton AM, Thiboutot D, Tan J. Reviewing the global burden of acne: how could we improve care to reduce the burden? Br J Dermatol. Published online August 8, 2020. https://doi.org/10.1111/bjd.19477

5Common risks of topical corticosteroids. National Eczema Association. Updated 2020. Accessed August 18, 2020. https://nationaleczema.org/risks-of-topical-corticosteriods/

6Topical corticosteroids. UK National Health Service. Updated January 15, 2020. Accessed August 18, 2020. https://www.nhs.uk/conditions/topical-steroids/

7Bieber 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

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

9Bieber 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.

Date of Last Review: 14 September 2022


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