Olumiant ® (baricitinib)

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What was the incidence of tuberculosis in the atopic dermatitis clinical development program?

No tuberculosis (TB) infections have been reported in the AD trials. Baricitinib should not be given to patients with active TB. Consider anti-TB therapy prior to initiation of baricitinib treatment in patients with previously untreated latent TB.


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

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.2

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).1,2

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.2

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 16.3

    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

    Patients should be screened for tuberculosis (TB) before starting baricitinib therapy.4

    • Baricitinib should not be given to patients with active TB.4
    • Anti-TB therapy should be considered prior to initiation of Baricitinib in patients with previously untreated latent TB.4


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

    2Bieber 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.

    3Bieber 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

    4Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.


    AD = atopic dermatitis

    BARI = baricitinib

    PYE = patient-years of exposure

    TB = tuberculosis

    Date of Last Review: 09 September 2022

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