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
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
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
|
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.
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.