Olumiant ® (baricitinib)

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What is the incidence rate of herpes zoster with Olumiant® (baricitinib) treatment for atopic dermatitis?

Of the 2531 patients treated across all baricitinib doses studied in atopic dermatitis, the incidence rate of herpes zoster was 2.3 per 100 patient-years of exposure.

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Baricitinib Label Information Related to Herpes Zoster

Warnings and Precautions Related Viral Reactivation

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies. In rheumatoid arthritis clinical studies, herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.1

If a patient develops herpes zoster, treatment should be temporarily interrupted until the episode resolves.1

Adverse Drug Reaction of Herpes Zoster

Frequency of herpes zoster was very rare (<1/10,000) in atopic dermatitis. 

    The frequency is based on integrated data from1

    • clinical trials and/or
    • postmarketing setting.

    Clinical Trial Protocol Information Related to Herpes Zoster

    Clinical Trial Exclusion Criteria Related to Herpes Zoster

    Live vaccines, including HZ vaccination, were prohibited during the phase 3 studies of BARI for the treatment of AD. Patients were excluded from the studies if they

    • were exposed to HZ vaccination within 4 weeks of planned randomization
    • had symptomatic HZ infection within 12 weeks prior to study entry, or
    • had history of disseminated or complicated HZ, defined as
      • multidermatomal involvement
      • ophthalmic zoster
      • central nervous system involvement, or
      • postherpetic neuralgia.2,3

    In the phase 3 clinical trials, patients were encouraged to receive a HZ vaccine, if eligible based on local guidelines, at least 4 weeks prior to randomization.3

    Herpes Zoster During Clinical Trials

    During the clinical trials, if a patient developed symptomatic HZ, investigators were instructed to

    • interrupt study treatment, and
    • resume study treatment when all skin lesions had crusted and resolved.3

    Herpes Zoster in Atopic Dermatitis Clinical Trials

    The integrated datasets used to evaluate cases of HZ are described in more detail in Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials.

    Prior Herpes Zoster and Vaccination in Baricitinib-Treated Patients

    Of the 2531 patients treated across all BARI doses studied in AD

    • 116 (4.6%) had a prior case of HZ, and
    • 112 (4.8%) had received the HZ vaccine.3

    Treatment-Emergent Herpes Zoster

    Incidence rates were calculated as the number of patients with an event per 100 patient-years of exposure time, with exposure censored at time of event.3

    Placebo-Controlled Period

    Through the 16-week placebo-controlled period, the proportion of patients with treatment-emergent HZ was not significantly different between the BARI 2 mg and BARI 4 mg groups compared to placebo group. There were more HZ cases in the BARI 2 mg group than the BARI 4 mg (p≤.05).2,3 Summary of Herpes Zoster in the Atopic Dermatitis Clinical Trials provides more details on HZ in the AD clinical trials for all integrated safety datasets.

    All Baricitinib-Treated Patients With Extended Data

    Of the 2531 patients treated across all BARI doses studied in AD, 53 (IR=2.3) had a treatment-emergent case of HZ. Of the 53 HZ events

    • 96% of cases were mild to moderate in severity
    • 0 were reported as SAEs
    • 3 cases were multidermatomal, and
    • 1 case was disseminated.2,3

    See Summary of Herpes Zoster in the Atopic Dermatitis Clinical Trials for more details.

    Summary of Herpes Zoster in the Atopic Dermatitis Clinical Trials2,3

     

     

     

     

     

     

     

     

     

     

     

    BARI 2 mg Placebo-Controlleda
    n (adj %)b

    BARI 4 mg Placebo-Controlleda
    n (adj %)b

    BARI 2 vs 4a
    n (adj %)b

    BARI 2 vs 4 ext
    n (adj %)b [adj IR]

    All BARI AD
    n (%) [IR]

     

    Placebo
    n=889

    BARI 2 mg
    n=721

    Placebo
    n=743

    BARI 4 mg
    n=489

    BARI 2 mg
    n=576

    BARI 4 mg
    n=489

    BARI 2 mg
    n=576

    BARI 4 mg
    n=489

    All doses
    N=2531

    Herpes Zoster

    3 (0.3)

    6 (0.8)

    3 (0.3)

    0

    6 (0.8)c

    0

    16 (2.5) [3.8]

    8 (1.5) [1.8]

    53 (2.1) [2.3]

    Serious AE

    0

    0

    0

    0

    0

    0

    0

    0

    0

    Led to temp int

    1 (0.1)

    5 (0.7)

    1 (0.1)

    0

    5 (0.7)c

    0

    8 (1.3) [1.9]

    5 (1.0) [1.1]

    27 (1.1) [1.2]

    Led to perm D/C

    0

    0

    0

    0

    0

    0

    0

    0

    1 (0.0) [0.0]

    Treated w/ antiviral

    2 (0.2)

    4 (0.6)

    2 (0.2)

    0

    4 (0.6)

    0

    13 (2.2) [3.2]

    8 (1.5) [1.8]

    43 (1.7) [1.8]

    Recovered or resolved

    2 (0.2)

    5 (0.6)

    2 (0.2)

    0

    5 (0.6)c

    0

    15 (2.3) [3.5]

    7 (1.3) [1.5]

    50 (2.0) [2.2]

    Abbreviations: AD = atopic dermatitis; adj = adjusted; AE = adverse event; BARI = baricitinib; ext = extended; IR = incidence rate; perm D/C = permanent discontinued; temp int = temporary interruption; w/ = with.

    aData through 16-week placebo-controlled period.

    bFor the integrated controlled analysis sets where the randomized ratio of patients receiving BARI to placebo or BARI to active control is not the same across all the integrated studies (example 2:1:1:1 vs 1:1:1:1), the study-size adjusted percentages were calculated for the AEs to provide appropriate direct comparisons between treatment groups. 

    cp≤.05 vs BARI 4 mg.

    Integrated Safety Analysis Datasets

    Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials2,3

    Analysis Set

    Description

    BARI 2 mg Placebo-Controlled

    Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, BREEZE- AD5, and BREEZE-AD7

    Compares BARI 2 mg vs placebo

    Includes patients with AD from 1 phase 2 and 5 phase 3 studies who were randomized to

    • BARI 2 mg (n=721, PYE=210.6), or
    • placebo (n=889, PYE=252.7).

    Treatment period was 0 to 16 weeks.

    BARI 4 mg Placebo-Controlled

    Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, and BREEZE-AD7

    Compares BARI 4 mg vs placebo

    Includes patients with AD from 1 phase 2 and 4 phase 3 studies who were randomized to

    • BARI 4 mg (n=489, PYE=147.1), or
    • placebo (n=743, PYE=211.8).

    Treatment period was 0 to 16 weeks.

    BARI 2 mg vs 4 mg

    Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7

    Compares BARI 2 mg vs BARI 4 mg through 16 weeks

    Includes patients with AD from 1 phase 2 and 4 phase 3 studies who were randomized to

    • BARI 2 mg (n=576, PYE=169.1), or
    • BARI 4 mg (n=489, PYE=147.1).

    Treated for 0 to 16 weeks during the placebo-controlled period.

    BARI 2 mg vs 4 mg Extended

    Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD7, and extension study BREEZE-AD3

    Compares BARI 2 mg vs BARI 4 mg including extended evaluations

    Includes patients with AD from 1 phase 2 and 4 phase 3 studies and any further exposure for those patients in the phase 3 extension study, BREEZE-AD3, who were randomized to

    • BARI 2 mg (n=576, PYE=425.5), or
    • BARI 4 mg (n=489, PYE=459.3).

    Data censored at dose or treatment change (rescue, dose switch, or re-randomization to a different BARI dose or placebo) for BREEZE-AD4 and BREEZE-AD3.

    All BARI AD

    Studies: JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7, and extension studies BREEZE-AD3, BREEZE-AD6

    No between-group comparisons

    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.

    Abbreviations: AD = atopic dermatitis; BARI = baricitinib; PYE = patient-years of exposure.

    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.

    References

    1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

    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. 2021;35(2):476-485. https://doi.org/10.1111/jdv.16948

    3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

    Date of Last Review: 22 January 2021


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