Baricitinib
Phase 3 Program
Patients
with a history or presence of GI disorders that, in the opinion of
the investigator, could constitute a risk when taking BARI or could
interfere with the interpretation of data were excluded from the
phase 3 clinical development program.1
Each
of the 4 phase 3 studies in the clinical program evaluated a distinct
treatment population of patients with moderate-to-severe RA.
RA-BEGIN compared
BARI 4 mg monotherapy, BARI 4 mg plus MTX, and MTX monotherapy in
patients who had limited or no prior treatment with MTX and were
naïve to other DMARDs.2
RA-BEAM compared
BARI 4 mg vs placebo or adalimumab, with background MTX, in patients
with inadequate response to MTX.3
RA-BUILD compared
BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in
patients with inadequate response to csDMARDs.4
RA-BEACON compared
BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy,
in patients with an inadequate response to at least one TNF
inhibitor, who may also have had an inadequate response to one or
more non-TNF inhibitor biologic DMARDs.5
The
study population of DMARD-naïve patients from the RA-BEGIN study
is not included in the approved label. However, the RA-BEGIN study is
supportive for the target population of patients with an inadequate
response to, or intolerance to, other DMARDs.6
Patients
With Medical History of GI Perforations in the Baricitinib Phase 3
Program
Medical
history, including GI perforation, was recorded upon enrollment into
each of the BARI phase 3 clinical studies.
In
the 4 phase 3 BARI clinical trials in patients with RA, 4 patients
treated with BARI had a pre-existing condition or historical
diagnosis of GI perforation.1
Patients
With Medical History of Diverticulitis in the Baricitinib Phase 3
Program
Medical
history, including diverticulitis, was recorded upon enrollment into
each of the BARI phase 3 clinical studies.
In
the 4 phase 3 BARI clinical trials in patients with RA, 11 patients
treated with BARI had a pre-existing condition or historical
diagnosis of diverticulitis.1
The
individual phase 3 clinical trials were not designed to detect
differences in the efficacy and safety of BARI for the treatment of
moderate to severe RA in patients with or without a GI disorders. Due
to the small numbers of patients with a medical history of GI
perforation or diverticulitis in the BARI phase 3 clinical program
for RA, an analysis of the efficacy and safety of BARI in these
patients was not conducted.
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib,
methotrexate, or combination in patients with rheumatoid arthritis
and no or limited prior disease-modifying antirheumatic drug
treatment. Arthritis Rheumatol. 2017;69(3):506-517.
http://dx.doi.org/10.1002/art.39953
3.
Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus
placebo or adalimumab in rheumatoid arthritis. N Engl J Med.
2017;376(7):652-662. http://dx.doi.org/10.1056/NEJMoa1608345
4.
Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in
patients with inadequate response or intolerance to conventional
synthetic DMARDs: results from the RA-BUILD study [published
correction appears in Ann Rheum Dis. 2017;76(9):1634.
http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1
]. Ann Rheum Dis. 2017;76(1):88-95.
http://dx.doi.org/10.1136/annrheumdis-2016-210094
5.
Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with
refractory rheumatoid arthritis. N Engl J Med.
2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247
6.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Glossary
BARI
= baricitinib
csDMARD
= conventional synthetic disease-modifying antirheumatic drug
DMARD
= disease-modifying antirheumatic drug
GI =
gastrointestinal
MTX
= methotrexate
RA =
rheumatoid arthritis
TNF
= tumor necrosis factor
▼ 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.