Baricitinib: Use as Monotherapy in Patients With Rheumatoid Arthritis

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