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SAFETY 
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

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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.
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.