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Olumiant ® (baricitinib)
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Olumiant® (baricitinib): Safety in Patients with Comorbid Demyelinating Disorders
Analysis of the safety of BARI in patients with moderate to severe RA and comorbid demyelinating disorders have not been conducted.
Exclusion Criteria Related to Demyelinating Disorders in the Baricitinib Clinical Trials
Demyelinating 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
- constitute a risk when taking an investigational product, or
- interfere with the interpretation of data.1
Acute disseminated encephalomyelitis
Acute haemorrhagic leukoencephalitis
Anti-myelin –associated glycoprotein associated polyneuropathy
Multiple sclerosis relapse
Autoimmune demyelinating disease
Multiple sclerosis relapse prophylaxis
Chronic inflammatory demyelinating polyradiculoneuropathy
Clinically isolated syndrome
Myoclonic epilepsy and ragged-red fibres
Neuromyelitis optica spectrum disorder
Neuropathy, ataxia, retinitis pigmentosa syndrome
Encephalitis periaxialis diffusa
Expanded disability status scale score decreased
Osmotic demyelination syndrome
Expanded disability status scale score increased
Primary progressive multiple sclerosis
Progressive multifocal leukoencephalopathy
Hypergammaglobulinaemia benign monoclonal
Progressive multiple sclerosis
Progressive relapsing multiple sclerosis
Relapsing-remitting multiple sclerosis
Secondary progressive multiple sclerosis
Marburg’s variant multiple sclerosis
Tumefactive multiple sclerosis
Patients with Comorbid Demyelinating Disorders
None of the patients treated with BARI had a pre-existing condition or historical diagnosis of demyelinating disorders in the 4 phase 3 BARI clinical trials.1
Clinical Recommendations For Patients with Demyelinating Disorders
Lilly 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 appropriately.
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
BARI = baricitinib
MedDRA = Medical Dictionary for Regulatory Activities
RA = rheumatoid arthritis
Date of Last Review: 31 August 2020