Olumiant® (Baricitinib)

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Baricitinib: Use as Monotherapy in Patients With Rheumatoid Arthritis

Baricitinib was administered as monotherapy in two phase 3 studies, RA-BEGIN and RA-BUILD.

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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

1Fleischmann 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

2Dougados 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

3Data 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

Fecha de la última revisión: 2019 M05 01


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