Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Effektivitet och säkerhet hos patienter med komorbid demyeliniserande sjukdom

Analyser av BARIs effekt och säkerhet hos patienter med måttlig till svår RA och comorbid demyeliniserane sjukdom har inte utförts.

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 Table 1 for a listing of the narrow preferred terms used to define demyelinating disorders.

Table 1. Standardized MedDRA Demyelination Query (SMQ) 20000154 Narrow Preferred Terms1

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

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

Glossary

BARI = baricitinib

MedDRA = Medical Dictionary for Regulatory Activities

RA = rheumatoid arthritis

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 2020 M08 31


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