Skip to content

Explore the Adbry Virtual Booth: Visit Now

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 trial

Safety population at baseline
  • 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 year
  • 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 32

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

 

*

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 group
  • 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 3

 

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


 

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.

 

 

Learn About Adbry Administration 

 

 

References: 1. Adbry Prescribing Information, LEO Pharma. 2. Simpson E, Merola JF, SIlverberg JI, Zachariae R, Olsen CK, Wollenberg A. Safety of specifically targeting interleukin 13 with tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomised, double-blind, placebo-controlled phase 3 and phase 2 trials. Poster (P0218) presented online at: 29th Congress of European Academy of Dermatology and Venereology; October 29-31, 2020.