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): Use in Patients With Atopic Dermatitis and Preexisting Fungal Infections

The safety of baricitinib in patients with moderate to severe atopic dermatitis and a preexisting fungal infection have not been studied.

Overview of BREEZE-AD Phase 3 Placebo-Controlled Clinical Trials

The efficacy and safety of BARI has been evaluated in the following placebo-controlled trials in adult patients with moderate to severe AD

  • BREEZE-AD1 (N=624) and BREEZE-AD2 (N=615) compared BARI 1 mg, 2 mg, or 4 mg monotherapy to placebo in adult patients with inadequate response to TCS.1

  • BREEZE-AD4 (N=500) compared BARI 1 mg, 2 mg, or 4 mg in combination with TCS vs placebo with TCS in adult patients who were inadequate responders to, intolerant of, or contraindicated for cyclosporine.2

  • BREEZE-AD5 (N=440) compared BARI 1 mg or 2 mg monotherapy to placebo in adult patients with inadequate response to TCS.3

  • BREEZE-AD7 (N=329) compared BARI 2 mg or 4 mg in combination with TCS vs placebo with TCS in adult patients with inadequate response to topical medications.4

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.

BREEZE-AD Clinical Trial Criteria

Patients were excluded from enrollment in the BREEZE-AD studies if they had a current or recent clinically serious viral, bacterial, fungal, or parasitic infection within 4 weeks of randomization that, in the opinion of the investigator, posed an unacceptable risk to the patient while participating in the study.5

Patients With Atopic Dermatitis and Preexisting Fungal Infections

An analysis of the efficacy and safety of BARI in patients with moderate to severe AD and preexisting fungal infections has not been conducted.

The numbers of patients in the pivotal phase 3 BREEZE-AD trials with moderate to severe AD and a preexisting fungal infection are presented in Table 1.

Table 1. Summary of Patients With Preexisting Fungal Infections in Phase 3 BREEZE-AD Trials (ITT Population)5

Monotherapy Studies

 

BREEZE-AD1
(N=624)

Placebo
(N=249)

BARI 1 mg
(N=127)

BARI 2 mg
(N=123)

BARI 4 mg
(N=125)

Tinea pedis, n (%)

0

0

0

2 (1.6)

Onychomycosis, n (%)

0

2 (1.6)

1 (0.8)

0

Vaginal infectiona, n (%)

1 (1.0)

0

0

0

BREEZE-AD2
(N=615)

Placebo
(N=244)

BARI 1 mg
(N=125)

BARI 2 mg
(N=123)

BARI 4 mg
(N=123)

Body tinea, n (%)

0

1 (0.8)

0

0

Tinea infection, n (%)

1 (0.4)

0

0

0

Tinea pedis, n (%)

1 (0.4)

1 (0.8)

0

0

BREEZE-AD5
(N=440)

Placebo
(N=147)

BARI 1 mg
(N=147)

BARI 2 mg
(N=146)

NA

Onychomycosis, n (%)

2 (1.4)

1 (0.7)

1 (0.7)

NA

Tinea cruris, n (%)

1 (0.7)

0

0

NA

Vulvovaginal candidiasisb, n (%)

1 (1.5)

0

0

NA

Combination Studies

 

BREEZE-AD4
(N=463)

Placebo
(N=93)

BARI 1 mg
(N=93)

BARI 2 mg
(N=185)

BARI 4 mg
(N=92)

Fungal infection, n (%)

1 (1.1)

0

0

0

Onychomycosis, n (%)

0

1 (1.1)

1 (0.5)

0

Vulvovaginal candidiasisc, n (%)

1 (2.3)

0

1 (1.9)

0

BREEZE-AD7
(N=329)

Placebo
(N=109)

NA

BARI 2 mg
(N=109)

BARI 4 mg
(N=111)

Dermatophytosis of nail, (n (%)

0

NA

2 (1.8)

0

Tinea pedis, n (%)

1 (0.9)

NA

1 (0.9)

1 (0.9)

Tinea cruris, n (%)

0

NA

1 (0.9)

0

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; ITT = intent-to-treat; NA = not applicable.

a Denominator adjusted because gender-specific event for females: N=101 (Placebo), N=49 (BARI 1 mg), N=41 (BARI 2 mg), N=42 (BARI 4 mg).

b Denominator adjusted because gender-specific event for females: N=67 (Placebo), N=72 (BARI 1 mg), N=77 (BARI 2 mg).

c Denominator adjusted because gender-specific event for females: N=44 (Placebo), N=35 (BARI 1 mg), N=52 (BARI 2 mg), N=35 (BARI 4 mg).

Warnings and Precautions Related to 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.6

The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.6

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.6

References

1. Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020;183(2):242-255. http://dx.doi.org/10.1111/bjd.18898

2. A long-term study of baricitinib (LY3009104) with topical corticosteroids in adults with moderate to severe atopic dermatitis that are not controlled with cyclosporine or for those who cannot take oral cyclosporine because it is not medically advisable (BREEZE-AD4). ClinicalTrials.gov identifier: NCT03428100. Updated January 3, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03428100

3. Simpson E, Forman S, Silverberg J, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results from a randomized, double-blinded, placebo-controlled phase 3 clinical trial (BREEZE-AD5). Abstract presented at: Revolutionizing Atopic Dermatitis (RAD) Virtual Symposium; April 5, 2020. Accessed April 5, 2020.

4. Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7). Abstract presented at: European Academy of Dermatology and Venereology 28th Congress; October 9-13, 2019; Madrid, Spain.

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

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

Glossary

AD = atopic dermatitis

BARI = baricitinib

TCS = topical corticosteroids

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: June 15, 2020


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