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Olumiant Summary of Product Characteristics (SmPC)
Olumiant® ▼(baricitinib): Efficacy and Safety in Patients with Comorbid Demyelinating Disorders
Analyses of the efficacy and safety of BARI in patients with moderate to severe RA and comorbid demyelinating disorders have not been conducted.
Criteria Related to Demyelinating Disorders in the Baricitinib
disorders, as defined by the Standardized MedDRA Demyelination Query
(SMQ) 20000154 narrow preferred terms, were not specific exclusion
criteria in the 4 phase 3 BARI clinical trials, RA-BEAM, RA-BEACON,
RA-BUILD, and RA-BEGIN. However, patients were excluded if they had a
history or presence of a serious or unstable illness that, in the
opinion of the investigator, could
a risk when taking an investigational product, or
of the patients treated with BARI had a pre-existing condition or
historical diagnosis of demyelinating disorders in the 4 phase 3 BARI
Recommendations For Patients with Demyelinating Disorders
cannot provide a recommendation on whether to use BARI in a patient
with demyelinating disorders. The treating physician may use the
information provided, the patient’s prior medical history and
concomitant medications, and other individual factors, in formulating
an assessment and approach. The treating physician should consider
potential risks and benefits of treatment options, and monitor
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
= Medical Dictionary for Regulatory Activities
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:August 31, 2020
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