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Olumiant ® (baricitinib)
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What was the incidence of tuberculosis with Olumiant® (baricitinib) in patients with atopic dermatitis?
Patients should be screened for tuberculosis. No tuberculosis (TB) infections have been reported in the AD trials.
- How to address the risk of tuberculosis in patients using baricitinib?
- What was the Incidence of Tuberculosis in Atopic Dermatitis Clinical Trials?
- How have patients been managed in the Atopic Dermatitis Clinical Trial (regarding Tuberculosis)?
How to address the risk of tuberculosis in patients using baricitinib?
Patients should be screened for tuberculosis (TB) before starting therapy.1
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.1
Serious and sometimes fatal infections have been reported in patients receiving other JAK inhibitors.1
The risks and benefits of treatment should be carefully considered prior to initiating baricitinib in patients with active, chronic or recurrent infections.1
If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.1
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age, baricitinib should only be used if no suitable treatment alternatives are available.1
What was the Incidence of Tuberculosis in Atopic Dermatitis Clinical Trials?
What are the data that have been evaluated? (Safety Datasets)
The All BARI AD safety dataset includes 2636 (total PYE=4628.4) patients with atopic dermatitis (AD) from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received baricitinib at a variety of doses, including
- baricitinib 1 mg (n=605, patient years of exposure [PYE]=441.5)
- baricitinib 2 mg (n=1703, PYE=2420.9), and
- baricitinib 4 mg (n=1012, PYE=1766.8).2,3
Includes all patients who were exposed to any baricitinib 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.3
Placebo dataset includes 743 (PYE=211.8) patients with AD from 1 phase 2 and 5 phase 3 studies who were randomized to placebo during weeks 0 to 16.4
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.
What was the Incidence of Tuberculosis?
There were no cases of TB in the AD clinical trial program among the
- 2636 (total PYE=4628.4) patients who received at least 1 dose of baricitinib, or
- 743 (total PYE=211.8) patients who received placebo.3
How have patients been managed in the Atopic Dermatitis Clinical Trial (regarding 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.2
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.2
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Bieber T, Katoh N, Simpson EL, et al. Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 and up to 3.9 years treatment: an updated integrated analysis of 8 clinical trials. Poster presented at: 31st Annual European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy.
4Bieber 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
Date of Last Review: 09 September 2022