Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼(baricitinib): Byte från biologisk DMARD till baricitinib i kliniskt program för reumatoid artrit

En studie för att bedöma effektiviteten och säkerheten vid byte från en bDMARD till baricitinib genomfördes inte som en del av baricitinib kliniska utvecklingsprogram.

Switching From Biologic DMARDs to Baricitinib in Phase 3 Studies RA-BEAM and RA-BEYOND

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.

RA-BEAM Rescue

A 52-week study, RA-BEAM, evaluated the efficacy and safety of BARI 4 mg once daily vs PBO or adalimumab 40 mg every 2 weeks, with background MTX, in patients with

  • moderate-to-severe RA, and

  • an inadequate response to MTX.1

The study was conducted using innovator adalimumab as the active comparator.1

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 16.1

RA-BEAM to RA-BEYOND

RA-BEYOND is an ongoing 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 to BARI 4 mg daily upon study entry.2

Switching to Baricitinib Did Not Require a Washout Period: RA-BEAM and RA-BEYOND

In both RA-BEAM and RA-BEYOND, the switch from adalimumab to BARI 4 mg occurred 14 days after the previous adalimumab dose without a required washout period per study protocol.2,3

Summary of Efficacy and Safety After Switching: RA-BEAM and RA-BEYOND

In RA-BEAM and RA-BEYOND, switching from adalimumab to BARI was associated with statistically significant within-group improvements in disease control as assessed by the CDAI and the SDAI, without an increase in

  • overall TEAEs

  • SAEs, or

  • infections.2

Patients Stopped Biologic DMARD Therapy Prior to Randomization in Phase 3 Study RA-BEACON

RA-BEACON evaluated BARI vs PBO, 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

  • etanercept

  • anakinra

  • infliximab

  • tocilizumab

  • certolizumab

  • adalimumab

  • golimumab, or

  • abatacept.3

Patients previously treated with rituximab could not have had a dose within 6 months of randomization.3

Therapeutic Indication

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

References

1. 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

2. Taylor PC, Keystone E, Ortmann R, et al. Efficacy and safety of switching from adalimumab to baricitinib: phase 3 data in patients with rheumatoid arthritis [abstract 1591]. Arthritis Rheumatol. 2016;68 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-switching-from-adalimumab-to-baricitinib-phase-3-data-in-patients-with-rheumatoid-arthritis/

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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

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

Glossary

BARI = baricitinib

bDMARD = biologic disease-modifying antirheumatic drug

CDAI = Clinical Disease Activity Index

csDMARD = conventional synthetic disease-modifying antirheumatic drug

MTX = methotrexate

PBO = placebo

RA = rheumatoid arthritis

SAE = serious adverse event

SDAI = Simplified Disease Activity Index

TEAE = treatment-emergent adverse event

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.

Datum fӧr senaste ӧversyn 2017 M07 25

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