Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Radiografisk progression av strukturell ledskada

Baricitinib visade statistiskt signifikant hämning av strukturell ledskada jämfört med kontrollen i 3 pivotala fas 3-studier.

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Phase 3 Studies That Assessed Radiographic Joint Damage

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.

  • RA-BEAM was a 52-week study that compared BARI 4 mg vs placebo or ADA, with background MTX, in patients with inadequate response to MTX. Patients in the placebo group switched to BARI 4-mg treatment at 24 weeks.2
  • RA-BUILD was a 24-week study that compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with inadequate response to csDMARDs.3
  • RA-BEGIN was a 52-week study that compared BARI 4-mg monotherapy, BARI 4 mg plus MTX, and MTX monotherapy in patients who had limited or no prior treatment with MTX and were naïve to other DMARDs.4

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

  • continued on their initial or rescued BARI dose, or
  • switched from placebo or active comparator to BARI treatment.5

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 

Radiographic Joint Damage Results in Phase 3 Trials

Results in Methotrexate Inadequate Responders from RA-BEAM and RA-BEYOND

RA-BEAM: 0 to 24 and 52 Week Results

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

  • week 24 (change in mTSS; 0.41 vs 0.90, p≤.001), and
  • week 52 (0.71 vs 1.80, p≤.001).2

At week 52, the proportion of patients who showed no progression of joint damage, defined as a change in mTSS ≤0, was

  • 79% in the BARI 4-mg group
  • 81% in the ADA group, and
  • 70% in the placebo group.2

RA-BEAM to RA-BEYOND: 0 to 100 Week Results

0 to 100 Week Results

After 52 weeks in RA-BEAM, patients who entered into the LTE study either

  • continued on BARI 4 mg, or
  • were switched from ADA to BARI 4 mg.5

All patients continued on background MTX.5

At week 100, patients who started on BARI exhibited significantly less progression of joint damage than patients who started on placebo (change in mTSS; 1.13 vs 2.20, p≤.001).5,7 

0 to 244 Week Results

As shown in Inhibition of Radiographic Progression of Structural Joint Damage (mTSS) in MTX-IR Patients From 0 to 244 Weeks, patients on initial BARI 4 mg had

  • statistically significantly lower radiographic progression at years 2 and 3 (p<.05) than patients on initial PBO
  • numerically lower radiographic progression at years 4 and 5 than patients on initial PBO, and
  • similar radiographic progression (mTSS) at years 2, 3, 4, and 5 than patients on initial ADA.6
Inhibition of Radiographic Progression of Structural Joint Damage (mTSS) in MTX-IR Patients From 0 to 244 Weeks6

Abbreviations: LS = least squares, PBO = placebo, BARI = baricitinib, ADA = adalimumab, Q2W = every 2 weeks, QD = once daily, MTX-IR = inadequate response to methotrexate, mTSS = modified Total Sharp Score.

* p<.05.

Note: Data analysis includes patients randomized and treated who had radiographs at baseline and at least 1 radiograph collected after 2 years.

Results in csDMARD Inadequate Responders from RA-BUILD and RA-BEYOND

RA-BUILD: 0 to 24 Week Results

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

RA-BUILD to RA-BEYOND

0 to 48 and 96 Week Results

After 24 weeks in RA-BUILD, patients who entered into the LTE study either

  • continued on BARI 2 mg or BARI 4 mg, or
  • were switched from placebo to BARI 4 mg.5

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 

0 to 240 Week Results

As shown in Inhibition of Radiographic Progression of Structural Joint Damage (mTSS) in csDMARD-IR Patients From 0 to 240 Weeks , at years 3, 4, and 5, patients initially treated with BARI 4 mg had numerically lower scores compared to patients on initial placebo for

  • radiographic progression (mTSS)
  • bone erosion, and
  • joint space narrowing.6

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

Inhibition of Radiographic Progression of Structural Joint Damage (mTSS) in csDMARD-IR Patients From 0 to 240 Weeks6

Abbreviations: LS = least squares, PBO = placebo, BARI = baricitinib, QD = once daily, csDMARD = conventional synthetic disease-modifying antirheumatic drug, csDMARD-IR = inadequate response or intolerant to csDMARD treatment; mTSS = modified Total Sharp Score.

Note: Data analysis includes patients randomized and treated who had radiographs at baseline and at least 1 radiograph collected after 2 years.

Results in DMARD Naïve Patients from RA-BEGIN and RA-BEYOND

RA-BEGIN: 0 to 52 Week

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

RA-BEGIN to RA-BEYOND

0 to 100 Weeks

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

At week 100, patients who started on BARI 4 mg plus MTX, but not patients who started on BARI monotherapy, exhibited significantly less progression of joint damage than patients who started on MTX monotherapy (change in mTSS; 0.61 vs 1.97, p≤.001).5,7 

0 to 244 Weeks

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

Inhibition of Radiographic Progression of Structural Joint Damage (mTSS) in DMARD-IR Patients From 0 to 244 Weeks6

Abbreviations: LS = least squares, PBO = placebo, BARI = baricitinib, QD = once daily, DMARD-IR = inadequate responders to disease-modifying antirheumatic drug, mTSS = modified Total Sharp Score, MTX = methotrexate.

Note: Data analysis includes patients randomized and treated who had radiographs at baseline and at least 1 radiograph collected after 2 years.

References

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/

Glossary

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


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