RA-BEGIN
Summary
In
study RA-BEGIN, patients who had limited or no prior treatment with
MTX and were naïve to other DMARDs were randomized to receive
MTX
monotherapy
BARI
4 mg monotherapy, or
BARI
4 mg plus MTX.1
Efficacy
Summary
Baricitinib
monotherapy met the prespecified 12% margin and was non-inferior to
MTX monotherapy with respect to ACR20 response at week 24.1
Baricitinib
monotherapy was also statistically significantly superior to MTX
monotherapy at week 24, as measured by ACR20 response (77% vs 62%,
p≤.01).1
Safety
Summary
Through
52 weeks, TEAEs were reported by
72%
of patients in the MTX monotherapy group
71%
of patients in the BARI 4 mg monotherapy group, and
78%
of patients in the BARI 4 mg plus MTX group.1
Rates
of serious adverse events, including serious infections, were similar
across treatment groups.1
RA-BUILD
Summary
In
study RA-BUILD, 7% of study population received study drug as
monotherapy with
18
patients randomized to BARI 2 mg daily, and
13
patients randomized to BARI 4 mg daily.2
Subgroups
for this analysis were defined by background csDMARD therapy and
included,
no
background csDMARDs
MTX
only
non-MTX
csDMARDs, and
MTX
plus other csDMARDs.2,3
There
was no evidence for any consistent significant qualitative or
quantitative interactions by background csDMARD subgroups based
on ACR20, ACR50, DAS28-hsCRP ≤3.2 response rates, and change
from baseline in physical function at 24 weeks.2,3
References
1.
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
2.
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. Ann Rheum Dis.
2017;76(1):88-95. http://dx.doi.org/10.1136/annrheumdis-2016-210094
3.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
ACR20
= 20% improvement in American College of Rheumatology criteria
ACR50
= 50% improvement in American College of Rheumatology criteria
BARI
= baricitinib
csDMARD
= conventional synthetic disease-modifying antirheumatic drug
DAS28-hsCRP
= Disease Activity Score based on high-sensitivity C-reactive protein
DMARD
= disease-modifying antirheumatic drug
MTX
= methotrexate
TEAE
= treatment-emergent adverse event