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