Gastrointestinal
Perforations in the Baricitinib Clinical Development Program
Gastrointestinal
Perforations in Rheumatoid Arthritis Clinical Trials
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, 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 01 September 2019.1,2
In
the All BARI RA dataset, 6 patients treated with BARI had a confirmed
GI perforation event occur after the randomized controlled period.
The IR (95% CI) in the All BARI RA dataset was 0.04 (0.016-0.098).1,3
The
cases of GI perforation included
perforated
appendix in 2 patients
perforated
diverticulum in 2 patients
intestinal
perforation, and
upper
GI tract perforation after knee surgery.3,4
Five
of the patients were receiving background MTX, 4 of the patients were
receiving background NSAIDs, and 4 patients were receiving
concomitant prednisone.3,5
References
1.
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.
http://scientific.sparx-ip.net/archiveeular/?c=a&view=4&item=2020FRI0123
2.
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.
3.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4.
Genovese MC, Smolen JS, Tsutomu 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
5.
Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of
baricitinib for the treatment of rheumatoid arthritis up to 6 years:
an updated integrated safety analysis. Poster presented at: Annual
Meeting of the American College of Rheumatology (ACR); October 20-24,
2018; Chicago, IL.
Glossary
AD =
atopic dermatitis
AE =
adverse event
BARI
= baricitinib
GI =
gastrointestinal
IR =
incidence rate
MTX
= methotrexate
NSAID
= nonsteroidal anti-inflammatory drug
PYE
= patient-years of exposure
RA =
rheumatoid arthritis
▼ 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.