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Olumiant ® (baricitinib) tabletter
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The effect of baricitinib on progression of structural joint damage was evaluated radiographically in studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.1
Each phase 3 study in the clinical program evaluated a distinct treatment population of patients with moderate-to-severe RA.
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.1
Patients who completed RA-BEAM, RA-BUILD, or RA-BEGIN could enter into the phase 3 LTE study, RA-BEYOND. After completing the originating study, patients either
As of the data cut-off date, September 1, 2016, 2125 (82.6%) patients entered into the RA-BEYOND long-term extension study. Radiographic assessments were performed on 1893 (89.1%) patients over the first 2 years of this extension study. After this time, 1846 (71.7%) patients had at least 1 radiograph collected after 2 years and were included in the 5-year analysis.5,6
RA-BEAM evaluated radiographically assessed joint damage as a major gated secondary endpoint against a placebo control.2
Patients treated with BARI 4 mg exhibited significantly less progression of joint damage compared with placebo at
At week 52, the proportion of patients who showed no progression of joint damage, defined as a change in mTSS ≤0, was
After 52 weeks in RA-BEAM, patients who entered into the LTE study either
All patients continued on background MTX.5
Radiographically assessed joint damage was an exploratory efficacy measure in RA-BUILD.3
Significantly less progression of joint damage was observed for patients treated with BARI administered as 2 mg or 4 mg daily compared with placebo at week 24 (BARI 2 mg vs placebo, p≤.05; BARI 4 mg vs placebo, p≤.01).3
After 24 weeks in RA-BUILD, patients who entered into the LTE study either
All patients continued on background csDMARDs.5
Compared to patients who started on placebo, patients who started on BARI 4 mg exhibited significantly less progression of joint damage at weeks 48 and 96 (p≤.05 for both). There was no statistically significant difference between the BARI 2-mg group and placebo group.5
Additionally, a small difference in mTSS was noted in patients who started on BARI 4 mg compared to patients who started on BARI 2 mg. 8
RA-BEGIN evaluated radiographically assessed joint damage as a major gated secondary endpoint against an active comparator (MTX monotherapy), but without a placebo-control group.4
Patients treated with BARI plus MTX, but not BARI monotherapy, had statistically significantly less progression of joint damage than MTX monotherapy (change in mTSS; 0.40 vs 1.02, p≤.01).4
After 52 weeks in RA-BEGIN, patients who entered into the LTE study continued or switched to BARI 4 mg monotherapy. The investigating physician at any point could add MTX treatment during the LTE study. Results include radiographs at baseline, 1 year, and 2 year analyzed in a new reading campaign.5
For patients on initial BARI 4 mg + MTX or initial BARI 4-mg monotherapy,
Compared to patients who started on initial MTX, significantly greater proportion of patients who started on BARI 4 mg or BARI 4 mg + MTX had no radiographic progression (change in mTSS of ≤0.5).8
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-662. http://dx.doi.org/10.1056/NEJMoa1608345
3Dougados 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(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1
4Fleischmann 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
5van der Heijde, Schiff M, Tanaka Y, et al. Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis [published correction appears in RMD Open. 2019;5(2):e000898corr1. https://dx.doi.org/10.1136/rmdopen-2019-000898corr1 ]. RMD Open. 2019;5(1):e000898. https://dx.doi.org/10.1136/rmdopen-2019-000898
6van der Heijde D, Kartman CE, Xie L et al. Radiographic progression of structural joint damage over 5 years of Baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND. Poster presented at: Annual Meeting of American College of Rheumatology Virtual Congress; November 5-9, 2020.
7van der Heijde D, Schiff M, Tanaka R, et al. Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis. Poster presented at: European League Against Rheumatism (EULAR) Annual Meeting; June 14-17, 2017; Madrid, Spain.
8van der Heijde D, Kartman CE, Xie L, et al. Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: results from RA-BEYOND. Paper presented at: Annual Meeting of American College of Rheumatology (ACR Virtual); November 5-9, 2020. Accessed November 10, 2020. https://acrabstracts.org/abstract/radiographic-progression-of-structural-joint-damage-over-5-years-of-baricitinib-treatment-in-patients-with-rheumatoid-arthritis-results-from-ra-beyond/
ADA = adalimumab
BARI = baricitinib
csDMARD = conventional synthetic disease-modifying antirheumatic drug
DMARD = disease-modifying antirheumatic drug
LTE = long-term extension
mTSS = modified Total Sharp Score
MTX = methotrexate
RA = rheumatoid arthritis
Datum fӧr senaste ӧversyn 2020 M09 23