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Olumiant ® ▼ (baricitinib)
Olumiant® ▼ (baricitinib): Incidence of Alopecia in Atopic Dermatitis
There was no significant difference between the baricitinib and placebo group or between baricitinib doses in the incidence of alopecia.
Incidence of Alopecia in the BREEZE-AD Clinical Development Program
Dataset Description
The integrated datasets used to evaluate incidence of alopecia are described in more detail in .
Incidence of Treatment-Emergent Alopecia Adverse Events
Alopecia, diffuse alopecia, alopecia areata, and androgenetic alopecia were reported as TEAEs in patients who received BARI.
There were no statistically significant differences (p<.05) in the incidence of alopecia between the BARI and placebo group or between BARI doses.1
Table 1. Summary of Alopecia Treatment-Emergent Adverse Events From the Atopic Dermatitis Clinical Program1
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BARI
2 mg Placebo-Controlleda |
BARI
4 mg Placebo-Controlleda |
BARI
2 mg vs 4 mga |
BARI
2 mg vs 4 mg ext |
All
BARI AD |
||||
|
|
Placebo |
BARI
2 mg |
Placebo |
BARI
4 mg |
BARI
2 mg |
BARI
4 mg |
BARI
2 mg |
BARI
4 mg |
All
doses |
|
Alopecia |
6 (0.7) |
3 (0.5) |
5 (0.6) |
2 (0.4) |
3 (0.5) |
2 (0.4) |
4 (0.7) [1.0] |
3 (0.6) [0.7] |
11 (0.4) [0.5] |
|
Diffuse Alopecia |
0 |
3 (0.3) |
0 |
0 |
2 (0.2) |
0 |
2 (0.2) [0.3] |
0 (0) [0] |
6 (0.2) [0.3] |
|
Alopecia Areata |
1 (0.1) |
1 (0.2) |
1 (0.1) |
2 (0.4) |
1 (0.2) |
2 (0.4) |
1 (0.2) [0.3] |
2 (0.4) [0.4] |
5 (0.2) [0.2] |
|
Androgenetic Alopecia |
0 |
1 (0.1) |
0 |
0 |
1 (0.1) |
0 |
1 (0.1) [0.2] |
0 (0) [0] |
1 (0.0) [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.
Integrated Safety Datasets Description
Table 2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials1,2
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Analysis Set |
Description |
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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. |
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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. |
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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.
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
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: February 04, 2021
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