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SAFETY RESULTS

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 (Trial 1, Trial 2, and Trial 3), a dose-finding trial, and a vaccine-response trial1

Pie chart: Safety population at baseline. 57% male, 43% female. Demographic data: 67% white, 21% Asian, 9% black.
  • 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
  • Trial 1 and Trial 2 compared the safety of Adbry monotherapy to placebo through Week 52. Trial 3 compared the safety of Adbry+TCS to placebo+TCS through Week 321

SAFETY: WEEKS 0-16 (TRIALS 1, 2, AND 3)

Adverse reactions identified in the pool of 3 trials (Trials 1, 2, and 3) that occurred at a rate of at least 1% in the Adbry 300 mg every other week monotherapy group and the Adbry 300 mg every other week+TCS group were all at a higher rate than placebo during the first 16 weeks of treatment.1

Table: safety weeks 0-16 (trials 1,2, and 3) data.

 

*

Pooled analysis of Trial 1 and Trial 2.

Analysis of Trial 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.

ll

Conjunctivitis cluster includes conjunctivitis and allergic conjunctivitis.

Injection site reaction cluster includes pain, erythema, and swelling.

#

Eosinophilia cluster includes eosinophilia and eosinophil count increased.

 

  • In the monotherapy trials (Trials 1 and 2) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.7% in the Adbry 300 mg every other week group and 0% of the placebo group. In the concomitant TCS trial (Trial 3) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.8% in the Adbry 300 mg every other week+TCS group and 0% of the placebo+TCS group1
  • The most common adverse reactions leading to discontinuation in the Adbry group compared to the placebo group were injection site reaction (0.3% v. 0%) and eosinophilia (0.3% v. 0%) in Trials 1 and 2; and injection site reaction (0.4% v. 0%) and conjunctivitis (0.4% v. 0%) in Trial 31

 

SAFETY: WEEKS 16-52 (TRIAL 1 AND 2) AND WEEKS 16-32 (TRIAL 3)

The safety profile of Adbry 300 mg every other week with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period. In addition, the frequency of adverse reactions with Adbry 300 mg every other week and every 4 weeks in Trials 1 and 2 was 44% and 34%, respectively, and 43% and 26% with Adbry 300 mg+TCS every other week and every 4 weeks in Trial 3, respectively.

 

Adbry has no boxed warning and no requirement for initial lab testing or ongoing lab monitoring in the Prescribing Information.1


 

Learn About Adbry Administration 

 

 

Reference: 1. Adbry Prescribing Information, LEO Pharma.