Atopic
Dermatitis Clinical Trial Criteria Related to Tuberculosis
Patients
were excluded from participation in phase 3 AD studies if they had
evidence of
active
TB, documented by
a
positive skin test or in vitro immunoassay
medical
history
clinical
symptoms, and
abnormal
chest x-ray at screening, or
latent
TB, documented by
a
positive skin test or in vitro immunoassay
no
clinical symptoms, and
a
normal chest x-ray at screening.1
Patients
could participate in the studies if they had
latent
TB with at least 4 weeks of appropriate treatment completed prior to
randomization, and agreed to complete the remainder of treatment
while in the study, or
a
history of active or latent TB with documented evidence of completed
appropriate treatment, no history of reexposure since treatment, and
a normal chest x-ray at screening.1
Tuberculosis
in Atopic Dermatitis Clinical Trials
Incidence
of Tuberculosis
There
were no cases of TB in the AD clinical trial program among the
2531
(total PYE=2247.4) patients who received at least 1 dose of BARI, or
889
(total PYE=252.7) patients who received placebo.1,2
Safety
Datasets
The
All BARI AD safety dataset 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).1
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. There was no censoring of data at dose change.1
Placebo
dataset includes 889 (PYE=252.7) patients with AD from 1 phase 2 and
5 phase 3 studies who were randomized to placebo during weeks 0 to
16.1
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.
Warnings
and Precautions Related to Tuberculosis
Patients
should be screened for tuberculosis (TB) before starting baricitinib
therapy.3
Baricitinib
should not be given to patients with active TB.3
Anti-TB
therapy should be considered prior to initiation of Baricitinib in
patients with previously untreated latent TB.3
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.
Published online September 14, 2020.
https://doi.org/10.1111/jdv.16948
3.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Glossary
AD =
atopic dermatitis
BARI
= baricitinib
PYE
= patient-years of exposure
TB =
tuberculosis
▼ 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.