Olumiant ® (baricitinib)

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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.

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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

  • 2531 (total PYE=2247.4) patients who received at least 1 dose of BARI, or
  • 889 (total PYE=252.7) patients who received placebo.1,2

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

    Patients should be screened for tuberculosis (TB) before starting baricitinib therapy.3

    • Baricitinib should not be given to patients with active TB.3
    • Anti-TB therapy should be considered prior to initiation of Baricitinib in patients with previously untreated latent TB.3

    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


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