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What is Olumiant?

For adult patients with moderate to severe rheumatoid arthritis insufficiently responding, or intolerant, to conventional DMARDs (cDMARDs)1

Olumiant® (baricitinib) is a once-daily tablet indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Olumiant may be used as monotherapy or in combination with MTX.1


Olumiant is a selective and reversible JAK1/JAK2 inhibitor 1,2 and is the first JAK inhibitor approved for RA in the EU.3 By inhibiting intracellular JAK1 and JAK2, Olumiant directly modulates signalling in a number of cytokines implicated in RA.1,2,4


Olumiant is also the first JAK inhibitor to receive positive published guidance from NICE and an advice statement from the SMC,5,6 making it now available to treat patients in your RA practice.

Watch Professor Chris Edwards share a summary of Olumiants key features

Olumiant was studied in a robust Phase III clinical trial programme in adult patients with moderate-to-severe active RA and background MTX. In total, these trials included over 2500 patients who had an inadequate response to, or were intolerant to DMARDs.7,8,9

RA-BEAM study9


The pivotal Phase III RA-BEAM study was a 52-week, double-blind, and placebo- and active-controlled trial. In total, 1305 patients with active RA receiving background therapy with MTX were randomly assigned to either Olumiant 4 mg daily, adalimumab 40 mg every other week, or placebo (switched to Olumiant after 24 weeks).9


The primary endpoint in the RA-BEAM study was ACR20 response at Week 12.9 Secondary endpoints included changes in DAS28 hsCRP at Week 12, ACR20/50/70 responses up to 52 weeks, and patient-reported outcome parameters.9


Olumiant 4 mg with stable background MTX demonstrated superiority vs adalimumab + MTX as measured by ACR20 at week 12, and superior mean change in DAS28 hsCRP compared with placebo and adalimumab (with background MTX) at 12 weeks.9


A copy of the RA-BEAM clinical paper is available by clicking the download link on the right hand side of this page.

Olumiant + MTX was superior to adalimumab in ACR20 response at Week 12, and demonstrated significant improvements in ACR20/50/70 responses vs. adalimumab + MTX at multiple time points from Week 12 to Week 52.9,10 24% of Olumiant + MTX patients achieved remission as defined by DAS28hsCRP by Week 12 and 40% by Week 52 of treatment.10


In patients receiving background MTX, Olumiant also provides significantly greater improvements in multiple Patient Reported Outcomes, including physical function, pain, and fatigue, when compared with adalimumab and placebo. Olumiant demonstrated significant improvements in many patient reported outcomes vs. placebo, appearing within days of initiating treatment.11


Pill and Packaging


For patients with dexterity challenges, the tablet has an indented centre, allowing patients to rock the pill or moisten their finger or hand to easily it pick up. The newly designed blister pack offers more space between the tablets. Olumiant can be taken at any time of the day and should be swallowed whole with a glass of water with or without food.1

Watch this video to see how the Olumiant pill and packaging was designed with the patient in mind

References

  1. Olumiant (baricitinib) Summary of product characteristics, January 2018.
  2. Shi JG, et al. J Clin Pharmacol 2014;54(12):1345-61.
  3. European Medicines Agency. Available at ema.europa.eu [Accessed September 2017].
  4. Shuai K, et al. Nat Rev Immunol 2003;3(11):900-11.
  5. © NICE (2017) TA466: Baricitinib for moderate to severe rheumatoid arthritis, August 2017. Available from www.nice.org.uk/guidance/ta466 [Accessed September 2017]. All rights reserved. Subject to notice of rights.
  6. Scottish Medicines Consortium – baricitinib 2mg and 4mg film-coated tablet (Olumiant®). SMC No 1265/17, August 2017. Available from scottishmedicines.org.uk/SMC_Advice/Advice/1265_17_baricitinib_Olumiant/baricitinib_Olumiant [Accessed September 2017].
  7. Genovese MC, et al. N Engl J Med 2016;374:1243-52.
  8. Dougados M, et al. Ann Rhuem Dis 2017;76(1):88-95.
  9. Taylor PC, et al. N Engl J Med 2017;376(7):652-62.
  10. Taylor PC, et al. N Engl J Med 2017;376(7):652-62 (supplementary appendix).
  11. Keystone EC, et al. Ann Rheum Dis 2017. doi: 10.1136/annrheumdis-2017-211259 [Epub ahead of print].
  12. Lilly DoF Patient Disposition 2016

©2018 Eli Lilly and Company. All rights reserved. The Olumiant mark and Olumiant design are the trademarks of Eli Lilly and Company.


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