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Approved for patients ages 12 years and older. Click here for different pediatric patient dosing.

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SAFETY 

The safety of Adbry was evaluated in an extensive clinical program1

The safety of Adbry was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis, including three phase 3 studies, ECZTRA 1, 2, and 3, a dose-finding trial, and a vaccine-response trial.1

  • In these 5 atopic dermatitis trials, 1964 subjects were treated with subcutaneous injections of Adbry, with or without concomitant topical corticosteroids (TCS). A total of 807 subjects were treated with Adbry for at least 1 year1
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  • ECZTRA 1 and ECZTRA 2 compared the safety of Adbry monotherapy to placebo through Week 52. ECZTRA 3 compared the safety of Adbry+TCS to placebo+TCS through Week 321
Percentage pie charts of Adbry safety population at baseline

In terms of comorbid conditions, 39% of the subjects had asthma, 49% had hay fever, 36% had food allergy, and 21% had allergic conjunctivitis at baseline.1

*Includes other or missing data.

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ADVERSE REACTIONS

Demonstrated safety profile through 52 weeks

Adbry demonstrated safety in 5 extensive clinical trials.

 

Adverse reactions occurring in ≥1% of the Adbry monotherapy or combination therapy group through Week 161

Chart: adverse reactions in ECZTRA 1 & 2 and ECZTRA 3

*Pooled analysis of ECZTRA 1 and ECZTRA 2.
†Analysis of ECZTRA 3 in which subjects were on background TCS therapy.
‡Adbry 600 mg or placebo at Week 0, followed by Adbry 300 mg or placebo every other week.
§Upper respiratory tract infection cluster includes upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, and nasopharyngitis; mainly reported as common cold.
||Conjunctivitis cluster includes conjunctivitis and allergic conjunctivitis.
Injection site reaction cluster includes pain, erythema, and swelling.
#Eosinophilia cluster includes eosinophilia and eosinophil count increased.

 Adbry is not an immunosuppressant or steroid. There is no requirement for initial lab testing or ongoing lab monitoring in the Prescribing Information.

Weeks 16-52 (ECZTRA 1 and ECZTRA 2) and Weeks 16-32 (ECZTRA 3):
The safety profile of Adbry 300 mg Q2W with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period1,3

The frequency of adverse reactions with Adbry 300 mg Q2W and Q4W in ECZTRA 1 and ECZTRA 2 was 44% and 34%, respectively, and 43% and 26% with Adbry 300 mg + TCS (as needed) Q2W and Q4W in ECZTRA 3, respectively1

In a pooled analysis of 5 studies (initial treatment period, Adbry n=1582, placebo n=669)3:
  • Most AEs (>90%) were mild or moderate in severity. The majority of AEs were recovered/resolved for Adbry (61%) and placebo (63%)3*
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  • Of the conjunctivitis cases that occurred, 2% were severe. The majority (98%) were mild to moderate and resolved during treatment3†
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  • The percentage of patients treated with Adbry who experienced skin infection requiring systemic treatment was 2.6% vs 5.5% of patients treated with placebo3*
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*Initial treatment period (Week 0 to 16) in a pooled analysis of ECZTRA 1, 2, 3, 5, and a phase 2b study. Adjusted percentages calculated using Cochran-Mantel-Haenszel (CMH) weights.

†The incidence of conjunctivitis was 7.5% for Adbry versus 3.1% placebo. Two cases of conjunctivitis led to permanent discontinuation.

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Adbry Dosing and Administration

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