Incidence
of Folliculitis
Treatment-Emergent
Adverse Events
A
TEAE is an adverse event that either occurred or worsened in severity
after the first dose of study treatment and did not necessarily have
a causal relationship to study treatment.1
7-Study
Placebo-Controlled Dataset
Description
The
7-study pooled dataset included patients with RA randomized to BARI 4
mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2
studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and
RA-BALANCE). Patients could have been taking background MTX or other
conventional DMARDs. Evaluation time periods included through
the
12-week placebo-controlled period in phase 2 studies
16
weeks of assigned treatment before any opportunity for rescue
therapy in phase 3 studies, and
24
weeks of assigned treatment or until rescue in phase 3 studies.2
Data
from BARI 2 mg (N=479, PYE=185.8) were derived from 4 of these
studies in which both BARI 2 mg and BARI 4 mg were options during
randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).2
Incidence
of Folliculitis
In
this safety analysis, through 24 weeks of treatment, the TEAE of
folliculitis
was reported in
3
(0.3%) patients in the BARI 4 mg group,
3
(0.6%) patients in the BARI 2 mg group, and
0
patients in the placebo group.1
All
Baricitinib Rheumatoid Arthritis Analysis Set
Description
The
All BARI RA analysis set included 3770 patients with RA who received
BARI at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3
studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE).
Data includes a long-term extension study (RA-BEYOND) with
13,148
PYE
median
exposure of 4.2 years
maximum
exposure of 8.4 years, and
data
through September 1, 2019.3,4
Incidence
of Folliculitis
In
the All BARI RA analysis dataset through September 1, 2019, a TEAE of
folliculitis
was reported in 27 (0.7%, [EAIR=0.2]) patients.1
Of
these 27 TEAEs of folliculitis,
0
were reported as serious adverse events
4
resulted in temporary interruption of BARI, and
0
resulted in permanent discontinuation of BARI.1
Information
From the Label
Folliculitis
is not listed as an adverse drug reaction in the BARI Summary of
Product Characteristics.5
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of
baricitinib for the treatment of rheumatoid arthritis over a median
of 3 years of treatment: an updated integrated safety analysis.
Lancet Rheumatol. 2020;2(6):E347-E357.
https://doi.org/10.1016/S2665-9913(20)30032-1
3.
Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of
baricitinib for the treatment of rheumatoid arthritis up to 8.4
years: an updated integrated safety analysis [abstract]. Ann Rheum
Dis. 2020;79(suppl 1):638.
https://ard.bmj.com/content/79/Suppl_1/642.1
4.
Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of
baricitinib for the treatment of rheumatoid arthritis up to 8.4
years: an updated integrated safety analysis. Poster presented at:
European League Against Rheumatism Virtual Congress; June 3-6, 2020.
5.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Glossary
BARI
= baricitinib
DMARD
= disease-modifying antirheumatic drug
EAIR
= exposure-adjusted incidence rate
MTX
= methotrexate
PYE
= patient-years of exposure
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.