Olumiant ® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Incidence of Reactive Arthritis and Enthesitis in Atopic Dermatitis

No patients reported treatment-emergent reactive arthritis or enthesitis during the baricitinib atopic dermatitis development program.

Reactive Arthritis and Enthesitis

Reactive arthritis is a form of inflammatory arthritis manifested by joint inflammation secondary to an infection in another part of the body. Infections at the onset of reactive arthritis are mainly urogenital and digestive. The use of antibiotics, NSAIDs, and intra-articular injections of steroids and DMARDs are common treatment options for reactive arthritis.1

Enthesitis is the inflammation of the entheses, the insertion sites of tendons and ligaments to the bone surface. Enthesitis often responds to NSAIDs.2

Clinical Trial Exclusion Criteria Related to Reactive Arthritis and Enthesitis

Patients were excluded if they had

  • a current or recent clinically serious infection

  • received IV antibiotics for an infection, within the past 4 weeks of randomization, or

  • any other active or recent infection within 4 weeks of randomization that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.3

Patients were also excluded if they had

received an intra-articular corticosteroid injection within 2 weeks prior to study entry, or within 6 weeks prior to planned randomization.3

  • have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring

Lastly, patients were excluded if they had

  • a history of a serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking the investigational product or interfere with the interpretation of data.3

Reactive Arthritis and Enthesitis in the Baricitinib Atopic Dermatitis Development Program

The integrated datasets used to evaluate cases of reactive arthritis and enthesitis are described in Table 1.

No patients reported treatment-emergent reactive arthritis or enthesitis during the BARI AD development program.3

Table 1. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials3

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

1. Wendling D, Prati C, Chouk M. et al. Reactive arthritis: treatment challenges and future perspectives. Curr Rheumatol Rep. 2020;22(7):29. https://doi.org/10.1007/s11926-020-00904-9

2. Schett G, Lories RJ, D'Agostino MA, et al. Enthesitis: from pathophysiology to treatment. Nat Rev Rheumatol. 2017;13(12):731-741. https://doi.org/10.1038/nrrheum.2017.188

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

Glossary

AD = atopic dermatitis

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

IV = intravenous

NSAID = nonsteroidal anti-inflammatory drug

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: July 17, 2020


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