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 parasitic 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.5
Patients
With Atopic Dermatitis and Preexisting Parasitic Infections
An
analysis of the efficacy and safety of BARI in patients with moderate
to severe AD and preexisting parasitic infections has
not been conducted.
One
patient (0.4%) reported a preexisting lice infestation in the placebo
arm of the BARI monotherapy study (BREEZE-AD1) and 1 patient (1.1%)
reported a preexisting parasite stool test positive in the BARI 4 mg
arm of the BARI in combination with TCS study (BREEZE-AD4). No
patients reported preexisting parasitic infections in the
pivotal phase 3 trials BREEZE-AD2, BREEZE-AD5, and BREEZE-AD7.5
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.