Olumiant ® (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Olumiant® (baricitinib): Risk and comorbid COVID-19 in atopic dermatitis patients

Eli Lilly and Company has not studied the use of baricitinib in patients with atopic dermatitis and COVID-19 nor in atopic dermatitis patients at risk of contracting COVID-19.

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Baricitinib and COVID-19

Baricitinib is not approved for the treatment of coronavirus disease 2019 (COVID-19), COVID-19 pneumonia, or COVID-19. Please see local labeling for approved indications.

COVID-19 risk in patients with atopic dermatitis treated with baricitinib

Although baricitinib (BARI) is being studied for the treatment of COVID-19 in hospitalized patients, it is unknown if patients treated with baricitinib for atopic dermatitis (AD) are at a greater risk of both contracting COVID-19 and potentially having COVID-19 related complications.1,2

Efficacy and safety of baricitinib in patients with atopic dermatitis and COVID-19

An analysis of the efficacy and safety of baricitinib in patients with AD and COVID-19 has not been conducted. 

Baricitinib infection-related warnings and precautions

COVID-19 is an active respiratory disease, which is typically mild and may also lead to acute respiratory distress syndrome or other medical complications that can be lethal. Please note the important BARI infection-related warnings and precautions listed below for consideration.

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.3

The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.3

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.3

Upper respiratory tract infections are very common (≥ 1/10) reported adverse drug reactions with BARI.  

In atopic dermatitis clinical trials, the frequency of pneumonia was uncommon.3

Clinical use

The treating physician may use the information provided, the patient’s past medical history and concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options, and monitor appropriately.

Clinical management

Relevant reviews and guidelines on the management of atopic dermatitis during the COVID-19 pandemic are provided in the references below.4-6

Infectious disease resources

For the most current information regarding COVID-19, please refer to the WHO, ECDC and the EADV websites:

References

1Adaptive COVID-19 Treatment Trial 2 (ACTT-2). ClinicalTrials.gov identifier: NCT04401579. Updated August 13, 2020. Accessed August 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04401579

2A study of baricitinib (LY3009104) in participants with COVID-19 (COV-BARRIER). ClinicalTrials.gov identifier: NCT04421027. Updated June 9, 2021. Accessed June 14, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04421027

3Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

4Yim RM, Singh I, Armstrong AW. Updates on treatment guidelines for psoriasis, atopic dermatitis (eczema), hidradenitis suppurativa, and acne/rosacea during the COVID-19 pandemic. Dermatol Online J. 2020;26(10): https://escholarship.org/uc/item/0j5150df

5Ricardo JW, Lipner SR. Considerations for safety in the use of systemic medications for psoriasis and atopic dermatitis during the COVID-19 pandemic. Dermatol Ther. 2020;e13687. http://dx.doi.org/10.1111/dth.13687

6Torres T, Puig L. Managing cutaneous immune-mediated diseases during the COVID-19 pandemic. Am J Clin Dermatol. 2020;21(3):307-311. http://dx.doi.org/10.1007/s40257-020-00514-2

Date of Last Review: 11 November 2020


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