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Efficacy and Patient Reported Outcomes

Olumiant® (baricitinib), the first JAK inhibitor approved for RA in the EU with head-to-head data vs. adalimumab + MTX3,6

Olumiant is a selective, reversible JAK inhibitor of JAK1 and JAK2,1,2 and is the first JAK inhibitor approved for rheumatoid arthritis (RA) in the EU.3


Olumiant was studied in a robust Phase Ill clinical trial programme of moderate-to-severe RA patients. Overall, from all the clinical studies more than 3,400 patients were tested, with a total of more than 4,200 combined years of exposure.10 More than 90% of patients who completed the clinical trials are participating in the on-going, long-term extension study.11

Professor Peter Taylor gives an overview of the phase 3 clinical trial program and RA BEAM trial design

RA-BEAM6


Taylor PC, et al. New England Journal of Medicine, 2017


The 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).

Study inclusion/exclusion criteria6


Key inclusion criteria were adult patients with active RA (≥6 tender joints of 68 examined, ≥6 swollen joints of 66 examined, and a hsCRP of ≥6 mg/l [>2 x ULN]) who had an inadequate response to MTX following ≥12 weeks of therapy. At baseline, patients had ≥3 joint erosions or 1-2 erosions plus seropositivity for RF or ACPA.


The criteria for exclusion included previous biologic DMARD therapy, selected laboratory abnormalities and recent clinically serious infection.


RA-BEAM study endpoints6


The primary study endpoint was ACR20 response at Week 12. Secondary endpoints included:

  • Change from baseline in:
    • mTSS at Week 24
    • HAQ-DI at Week 12
    • DAS28 hsCRP at Week 12
  • SDAI

  • Patient-reported outcomes (including daily electronic patient diaries up to Week 12)

RA-BEAM endpoint overview


The primary endpoint of the RA-BEAM study was superiority of Olumiant + MTX vs. placebo + MTX in ACR20 at 12 weeks. In the statistical plan for multiple comparisons, if non-inferiority was demonstrated for Olumiant + MTX vs. placebo + MTX, then superiority of Olumiant + MTX vs. adalimumab + MTX would be evaluated.6,8


Primary and Key Secondary Endpoints6,8

Hear from Professor Peter Taylor talk through the results from the RA BEAM study

RA-BEAM results6


Olumiant 4 mg plus MTX demonstrated superior ACR20 response and mean change in DAS28 hsCRP compared with placebo + MTX and adalimumab + MTX at 12 weeks.

Once-daily Olumiant demonstrated statistically significant improvements vs. adalimumab in ACR20, ACR50 and ACR70 responses across multiple timepoints. The proportion of patients attaining ACR50 and ACR70 responses was statistically significantly greater than adalimumab by Week 8.6,8


Improvements in ACR20 responses were observed as early as Week 1, and maintained over 52 weeks.6


By Week 52, both ACR20 and ACR50 responses were significantly greater than with the adalimumab group. Significant ACR70 responses with Olumiant were maintained to Week 40, and over a third of patients attained an ACR70 response by Week 52.6,8

RA-BEAM Patient-Reported Outcomes8,9


Olumiant + MTX provides significantly greater improvements compared with placebo and adalimumab + MTX in most of the prespecified PROs, including physical function, pain, fatigue, duration and severity of MJS and some HRQOL measures at week 12.


In addition, baricitinib + MTX produced rapid improvements in the diary PROs vs placebo and adalimumab + MTX, with significant differences vs placebo appearing within days of initiating treatment. Improvements were maintained to week 52 compared with adalimumab in physical function, pain, fatigue and some HRQOL measures.


Patients showed statistically significant improvements vs. placebo as early as week 1 in HAQ-DI, PtGA and the patient’s assessment of pain, and these results were maintained until the end of the trial at week 52. When compared with adalimumab, statistically significant improvements in HAQ-DI were seen as early as week 4 and at week 2 for PtGA and pain, respectively; these improvements were maintained at week 12 and through week 52.


The improvements in the FACIT-F score were sustained to week 24 for both baricitinib and adalimumab vs placebo + MTX and were significant for Olumiant + MTX at weeks 20, 28 and 52 vs adilimumab + MTX.


Baricitinib treatment resulted in significant improvements versus placebo + MTX and adalimumab + MTX for duration and severity of MJS, worst tiredness and worst joint pain measures at the primary time point of the study, week 12. Improvements versus placebo were significant from week 1 for severity of MJS, Worst Tiredness and Worst Joint Pain and from week 2 for the duration of MJS.


Patients treated with Olumiant and background MTX showed significant improvements in most of the eight SF-36 domains at Week 12 vs placebo + MTX. Compared with adalimumab, Olumiant patients showed significant improvements in most domains at Week 52.

Watch Professor Peter Taylor discuss the patient reported outcomes from RA BEAM

RA-BEACON4


Genovese MC, et al. New England Journal of Medicine 2016


RA-BEACON was a Phase III study of Olumiant in patients with moderately to severely active RA who had an inadequate response to biologic DMARDs, or had unacceptable side effects associated with ≥1 TNF inhibitors, other biologic DMARDs, or both. A total of 527 patients were randomised to receive either Olumiant (2 mg or 4 mg daily) or placebo for 24 weeks.


In RA patients with an inadequate response to biologic DMARDs, Olumiant 4 mg was associated with clinical improvement at 12 weeks, with significantly more patients achieving an ACR20 response vs. placebo (55% vs. 27%, p < 0.001). Differences were also significant for HAQ-DI scores and DAS28 hsCRP, but not for SDAI remission.


RA-BUILD5


Dougados M, et al. Annals of the Rheumatic Diseases 2017


RA-BUILD was a Phase III study of Olumiant in patients with inadequate response or intolerance to ≥1 csDMARDs who were also naïve to biologic DMARDs. A total of 684 patients were randomised to receive either Olumiant (2 mg or 4 mg daily) or placebo for 24 weeks.


Olumiant was associated with a significant clinical improvement, with more patients achieving an ACR20 response at Week 12 vs. placebo (62% vs 39%, p≤0.001). In addition, Olumiant patients demonstrated significant improvements in DAS28, SDAI remission, HAQ-DI, and morning joint stiffness.


In a supportive analysis, radiographic progression of structural joint damage was reduced with Olumiant vs. placebo at 24 weeks.


RA-BEYOND7


The long-term follow-up RA-BEYOND study is currently ongoing, comprising all patients who have previously completed an Olumiant study for RA. RA-BEYOND is designed to investigate the long-term safety of Olumiant, and will provide 5 years of additional treatment data. The study is expected to complete in 2022.

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. Genovese MC, et al. N Engl J Med 2016;374:1243-52.
  5. Dougados M, et al. Ann Rhuem Dis 2017;76(1):88-95.
  6. Taylor PC, et al. N Engl J Med 2017;376(7):652-62.
  7. ClinTrials.gov. Available at clinicaltrials.gov/ct2/show/NCT01885078 [Accessed September 2017].
  8. Taylor PC, et al. N Engl J Med 2017;376(7):652-62 (supplementary appendix).
  9. Keystone EC, et al. Ann Rheum Dis 2017;76(11):1853-61.
  10. Smolen JS, et al. Ann Rheum Dis 2016;75:243-4
  11. Lilly DoF Patient Disposition 2016

©2017 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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