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Olumiant ® ▼ (baricitinib)
Olumiant® ▼ (baricitinib): Switching from a Biologic DMARD to Barcitinib
Patients were switched from a bDMARD (adalimumab) to baricitinib without a washout.
Over the course of the phase 3 clinical development program, patients were able to switch from a bDMARD to BARI in 2 different scenarios, described below.
A 52-week study, RA-BEAM, evaluated the efficacy and safety of BARI 4 mg once daily vs placebo or adalimumab 40 mg every 2 weeks, with background MTX, in patients with
moderate-to-severe RA, and
an inadequate response to MTX.3
The study was conducted using innovator adalimumab as the active comparator.3
As early as week 16, patients treated with adalimumab were eligible for rescue treatment with BARI 4 mg based on predefined criteria for inadequate response at both week 14 and week 16.3
RA-BEAM to RA-BEYOND
RA-BEYOND was a long-term extension study designed to evaluate the efficacy and safety of patients with moderate-to-severe RA enrolled from the phase 2 and phase 3 clinical studies. RA-BEYOND includes patients from RA-BEAM who switched treatment from adalimumab (52 weeks before enrolling into RA-BEYOND) to BARI 4 mg daily upon study entry.2
Patients Stopped Biologic DMARD Therapy Prior to Randomization in Phase 3 Study RA-BEACON
RA-BEACON evaluated BARI vs placebo, with background csDMARD therapy, in patients with
moderate-to-severe RA, and
an inadequate response to TNF inhibitors, a type of bDMARD therapy.4
Study Inclusion Criteria Related to Prior Biologic DMARD Therapy: RA-BEACON
In order to participate in RA-BEACON, patients stopped their bDMARD therapy at least 28 days prior to planned randomization. Biologic DMARDs included
Patients previously treated with rituximab could not have had a dose within 6 months of randomization.1
Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.5
2. Tanaka Y, Fautrel B, Keystone EC, et al. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019;78(7):890‐898. http://dx.doi.org/10.1136/annrheumdis-2018-214529
3. 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
4. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247
BARI = baricitinib
bDMARD = biologic disease-modifying antirheumatic drug
csDMARD = conventional synthetic disease-modifying antirheumatic drug
DMARD = disease-modifying antirheumatic drug
MTX = methotrexate
RA = rheumatoid arthritis
TNF = tumor necrosis factor
▼ 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.
Date of Last Review: May 15, 2020