Olumiant ® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Incidence of Demyelinating Disorders in Atopic Dermatitis

Demyelinating disorders are not listed as an adverse drug reactions in atopic dermatitis patients treated with baricitinib.

BREEZE-AD Phase 3 Clinical Trial Exclusion Criteria Related to Demyelinating Disorders

Patients were excluded if they had any serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking BARI or interfere with the interpretation of data.1

All BARI AD Dataset Description

The All BARI AD safety dataset includes 2531 (total PYE=2247.4) patients with AD from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received BARI at a variety of doses, including

  • BARI 1 mg (n=538, PYE=245.9)

  • BARI 2 mg (n=1580, PYE=1129.5), and

  • BARI 4 mg (n=914, PYE=872.8).

Includes all patients who were exposed to any BARI dose at any time during the studies, either from randomization or from switch or rescue from placebo. No censoring of data at dose change.1,2

Incidence of Demyelinating Disorders in the All BARI AD Dataset 

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

In the All BARI AD safety dataset, there was 1 (0%; IR=0.0) TEAE of hypergammaglobulinaemia benign monoclonal, which occurred in the 2-mg treatment group.1

The broad search of terms that was completed resulted in no cases of multiple sclerosis.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. Bieber T, Thyssen JP, Reich K, et al. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. J Eur Acad Dermatol Venereol. 2021;35(2):476-485. https://doi.org/10.1111/jdv.16948

Glossary

AD = atopic dermatitis

BARI = baricitinib

IR = incidence rate

PT = preferred term

PYE = patient-years of exposure

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.

Date of Last Review: February 04, 2021


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

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request