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.

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 adalimumab, 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, 01 September 2016, 2125 (82.6%) of patients entered into RA-BEYOND and 1893 patients had the radiographic assessments required for these analyses.5

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

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).5,6 

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 (change in mTSS; 0.44 vs 1.09, p≤.05), and

  • week 96 (0.68 vs 1.42, p≤.05).5

There was no statistically significant difference between the BARI 2-mg group and placebo group.5

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 methotrexate treatment during the LTE study.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).5,6

Last Reviewed: 30 July 2019

References

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

2. Taylor 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

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 [published correction appears in Ann Rheum Dis. 2017;76(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1 ]. Ann Rheum Dis. 2017;76(1):88-95. http://dx.doi.org/10.1136/annrheumdis-2016-210094

4. 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

5. van 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

6. van 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.

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

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 M07 30

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