What the trial was testing
The BREEZE-AD3 enrolled 1,645 patients with atopic dermatitis. The study was sponsored by Eli Lilly and Company and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Nearly half of patients on baricitinib stayed clear or nearly clear at 68 weeks.
JAMA dermatology · 2021 · NCT03334435
These findings — that people on 4 mg baricitinib who responded early kept their skin improvement at 68 weeks — were published in the JAMA dermatology and represent the headline result of the study.
Researchers tracked outcomes across 1,645 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with atopic dermatitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Baricitinib is FDA-approved for moderate to severe eczema in adults. This study showed the drug can work for over a year in people who respond to it. If you're struggling with eczema that hasn't improved with creams or other treatments, talk to your dermatologist about whether baricitinib might help.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open atopic dermatitis trials
A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema)
This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks. The study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM). An interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.
Restoration of Microbiota in Neonates
The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood