Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Användning som monoterapi hos patienter med reumatoid artrit

Baricitinib administrerades som monoterapi vid två fas 3-studier, RA-BEGIN och RA-build.

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

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.2

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.3

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.3,4

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.3,4

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. Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3. 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

4. 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

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.

Datum fӧr senaste ӧversyn 2019 M05 01


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