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 Headache in the Atopic Dermatitis Clinical Trial Program

Headache is a common adverse drug reaction (≥1/100 to <1/10) with baricitinib treatment.

BREEZE-AD Phase 3 Clinical Trial Exclusion Criteria Related to Headache

Headache was not a specific exclusion criterion in the AD clinical trials. However, patients who had a history or presence of a serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data were excluded.1 

Incidence of Headache in the Atopic Dermatitis Clinical Development Program

The integrated datasets used to evaluate headache TEAEs in patients with AD are described in more detail in Table 2.

The incidence rates of headache across the integrated safety datasets are presented in Table 1.

Table 1. Headache Treatment-Emergent Adverse Events From the Atopic Dermatitis Clinical Program1,2

 

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

Headache

30 (3.5)

40 (6.3)c

28 (3.3)

35 (6.3)d

37 (5.9)

35 (6.3)

43 (6.9) [10.8]

46 (8.3) [10.6]

166 (6.6) [7.6]

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. 

c p<.05 BARI 2 mg vs placebo.

d p<.01 BARI 4 mg vs placebo.

Placebo-Controlled Datasets

In the 16-week placebo controlled period of the AD clinical trials, patients treated with BARI 4 mg (p<.01) and BARI 2 mg (p<.05) had significantly more headache TEAEs compared to placebo (see Table 1); there was no difference (p>.05) between BARI 2 mg and BARI 4 mg.1

In the 16-week placebo controlled period of the AD clinical trials, the severity of headache TEAEs in patients treated with BARI 4 mg were

  • mild in 74% of 35 events

  • moderate in 26% of 35 events, and

  • severe in 0% events.1

In the 16-week placebo controlled period of the AD clinical trials, the severity of headache TEAEs in patients treated with BARI 2 mg were

  • mild in 67.5% of 40 events

  • moderate in 32.5% of 40 events, and

  • severe in 0% events.1

All BARI AD Dataset

One hundred sixty-six patients (6.6%; IR=7.6) reported headache with any dose of BARI during the AD clinical trial program (see Table 1).1,2

A total of 216 TEAEs of headache were reported by these 166 patients, with a time of onset from start of BARI of 138.4 days (median 57 days).1 Headaches were mostly mild and the median event duration was 1 day.2

Of these TEAEs of headache, the severity was

  • mild in 68.1% of events

  • moderate in 29.6% events, and

  • severe in 2.3% events.1

Of these 216 TEAEs of headache, 

  • none were serious

  • 5 (2.3%) patients had temporary interruption of treatment, and

  • 2 (0.9%) patients had permanent discontinuation of treatment.1 

Forty-nine (22.7%) of these 216 TEAEs of headache were considered related to BARI by the investigator.1

Integrated Safety Dataset Table

Table 2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials1

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 is 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 is 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).

Treatment is 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).

Treatment period is 0 to 16 weeks.

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

2. Bieber 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

AD = atopic dermatitis

BARI = baricitinib

IR = incidence rate

TEAE = treatment-emergent 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: August 04, 2020


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