Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Insidens av demyeliniserande störningar i det kliniska utvecklingsprogrammet

Demyeliniserande sjukdomar anges inte i produktresumén som biverkningar för baricitinib.

Description of the All BARI RA Dataset

The All BARI RA safety dataset includes patients with RA (N=3770) from 1 phase 1, 3 phase 2, 5 phase 3 studies, and 1 phase 3 extension study who received BARI at a variety of doses, including

  • BARI 4 mg (n=3392)

  • BARI 2 mg (n=1068), and

  • other BARI dosages not evaluated in confirmatory studies.1,2

Patients had to have received at least 1 dose of BARI and could have received different doses throughout the trials. Evaluation time period is all exposure time points including after rescue or changes in study drug through February 13, 2018 unless otherwise specified.2

All BARI RA safety dataset includes information regarding unapproved dosages, that do not match the current labeling for BARI.

Incidence of Demyelinating Disorders in the All BARI RA Dataset

Identification of demyelinating disorders in the BARI clinical program was based on the SMQ 20000154 narrow PTs. For a listing of the narrow PTs, see Table 1.

In the All BARI RA safety dataset, there was 1 TEAE of hypergammaglobulinaemia benign monoclonal which occurred in the 2-mg treatment group. The EAIR based on the 1 confirmed case is 0.00 per 100 patient-years of exposure.1

The single TEAE was of mild severity, not serious, not related to study drug, and did not cause study drug discontinuation.1

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

Abbreviations:  MedDRA = Medical Dictionary for Regulatory Activities; SMQ = standardized MedDRA query.

References

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

2. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

PT = preferred term

QD = daily

RA = rheumatoid arthritis

SMQ = standardized MedDRA query

TEAE = treatment-emergent adverse event

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 2019 M04 19

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