Please use a minimum of three unique search words
Our search is configured to only display links relevant to answer your question. For the best results please use specific and relevant keywords that accurately reflect the information you are seeking.
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Olumiant ® (baricitinib)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
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.
UK_cFAQ_BAR062A_COMORBID_DEMYELINATING_DISORDERS_RA
en-GB
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
See Standardized MedDRA Demyelination Query (SMQ) 20000154 Narrow Preferred Terms for a listing of the narrow preferred terms used to define demyelinating disorders.
Acute disseminated encephalomyelitis | Marchiafava-Bignami disease |
Acute haemorrhagic leukoencephalitis | Multiple sclerosis |
Anti-myelin –associated glycoprotein associated polyneuropathy | Multiple sclerosis relapse |
Autoimmune demyelinating disease | Multiple sclerosis relapse prophylaxis |
Chronic inflammatory demyelinating polyradiculoneuropathy | Myelitis transverse |
Clinically isolated syndrome | Myoclonic epilepsy and ragged-red fibres |
Concentric sclerosis | Neuromyelitis optica spectrum disorder |
Demyelinating polyneuropathy | Neuropathy, ataxia, retinitis pigmentosa syndrome |
Demyelination | Noninfectious myelitis |
Encephalitis periaxialis diffusa | Noninfective encephalomyelitis |
Encephalomyelitis | Optic neuritis |
Expanded disability status scale score decreased | Osmotic demyelination syndrome |
Expanded disability status scale score increased | Primary progressive multiple sclerosis |
Guillain-Barre syndrome | Progressive multifocal leukoencephalopathy |
Hypergammaglobulinaemia benign monoclonal | Progressive multiple sclerosis |
Leukoencephalomyelitis | Progressive relapsing multiple sclerosis |
Leukoencephalopathy | Relapsing-remitting multiple sclerosis |
Lewis-Summer syndrome | Secondary progressive multiple sclerosis |
MELAS syndrome | Toxic leukoencephalopathy |
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.
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
BARI = baricitinib
MedDRA = Medical Dictionary for Regulatory Activities
RA = rheumatoid arthritis
Date of Last Review: 31 August 2020
Contact Lilly
Call or Email us
If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com
Available Mon - Fri, 10am - 4pm, excluding Bank Holidays