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): Incidence of Tuberculosis in Atopic Dermatitis
Baricitinib should not be given to patients with active tuberculosis (TB). Anti-TB therapy should be considered prior to initiation of baricitinib in patients with previously untreated latent TB.
UK_cFAQ_BAR125B_TUBERCULOSIS_AD
en-GB
Atopic Dermatitis Clinical Trial Criteria Related to Tuberculosis
Patients were excluded from participation in phase 3 AD studies if they had evidence of
- active TB, documented by
- a positive skin test or in vitro immunoassay
- medical history
- clinical symptoms, and
- abnormal chest x-ray at screening, or
- latent TB, documented by
- a positive skin test or in vitro immunoassay
- no clinical symptoms, and
- a normal chest x-ray at screening.1
Patients could participate in the studies if they had
- latent TB with at least 4 weeks of appropriate treatment completed prior to randomization, and agreed to complete the remainder of treatment while in the study, or
- a history of active or latent TB with documented evidence of completed appropriate treatment, no history of reexposure since treatment, and a normal chest x-ray at screening.1
Tuberculosis in Atopic Dermatitis Clinical Trials
Incidence of Tuberculosis
Safety Datasets
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).1
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. There was no censoring of data at dose change.1
Placebo dataset includes 889 (PYE=252.7) patients with AD from 1 phase 2 and 5 phase 3 studies who were randomized to placebo during weeks 0 to 16.1
Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.
Warnings and Precautions Related to Tuberculosis
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Bieber 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. Published online September 14, 2020. https://doi.org/10.1111/jdv.16948
3Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
Glossary
AD = atopic dermatitis
BARI = baricitinib
PYE = patient-years of exposure
TB = tuberculosis
Date of Last Review: 21 January 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