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): Opportunistic Infections in Atopic Dermatitis

Cases of opportunistic infections were rare in the baricitinib atopic dermatitis clinical trials.

Identification of Potential Opportunistic Infections

Potential OIs were identified using a list of MedDRA preferred terms, created to align with the consensus recommendations for reporting of OIs in clinical trials used to treat immune-mediated inflammatory diseases.1 There were 3 modifications to this approach:

  1. Candidiasis infections involving only the oral cavity and pharynx were not considered OIs, only confirmed infection of the esophagus or below met the criteria for OI.

  2. Localized HZ infections were not considered OIs, only multidermatomal and/or disseminated infections were considered OIs.

  3. Treatment-emergent, active TB infections were summarized separately from OIs.

The cases of potential OIs were medically reviewed internally by 2 separate reviewers to determine whether they met the definition of confirmed OI.2

Opportunistic Infections in Atopic Dermatitis Clinical Trials

Safety Dataset Description

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).2,3

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.2,3

Incidence of Opportunistic Infections in Atopic Dermatitis

In the All BARI AD safety dataset, 4 (IR=0.2) patients had an OI, 3 cases of multidermatomal HZ and 1 case of recurrent HZ infections. Of these 4 cases

  • 0 were reported as serious

  • 2 led to temporary interruption, and

  • 0 led to permanent discontinuation of study drug.2,3

Among the 889 patients (PYE=252.7) who received placebo, 1 OI was reported (toxoplasmosis eye infection) during the 16-week placebo-controlled period. The event was reported as serious but did not result in temporary interruption or permanent discontinuation of study treatment.2,3

Warning and Precautions Related to Infections and Viral Reactivation

Infections

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, in treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.4

The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.4

If an infection develops, the patient should be monitored carefully and baricitinib therapy should be temporarily interrupted if the patient is not responding to standard therapy. Baricitinib treatment should not be resumed until the infection resolves.4

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

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.4

If a patient develops herpes zoster, baricitinib treatment should be temporarily interrupted until the episode resolves.4

Further information on these topics is available in section 4.8 of the Olumiant Summary of Product Characteristics.

References

1. Winthrop KL, Novosad SA, Baddley JW, et al. Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance. Ann Rheum Dis. 2015;74(12):2107-16. http://dx.doi.org/10.1136/annrheumdis-2015-207841

2. Bieber 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

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

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

Glossary

AD = atopic dermatitis

BARI = baricitinib

DNA = deoxyribonucleic acid

HBV = hepatitis B virus

HZ = herpes zoster

IR = incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

OI = opportunistic infection

PYE = patient-years of exposure

RNA = ribonucleic acid

TB = tuberculosis

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: February 19, 2021


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