The only IL-13 biologic with 6 years of safety data for patients with moderate-to-severe atopic dermatitis3-7§
- No new safety signals over 6 years4-6§
Adbry is strongly recommended by AAD and AAAAI guidelines as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients1,2
Week 16 Safety
Demonstrated safety profile
Adverse reactions occurring in ≥1% through Week 163
q2w=every 2 weeks; TCS=topical corticosteroid.
*Pooled analysis of ECZTRA 1 and 2.
† Analysis of ECZTRA 3 in which patients were on background TCS therapy.
‡ Adbry 600 mg or placebo at Week 0, followed by Adbry 300 mg or placebo q2w.
§ Upper respiratory tract infection cluster includes upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, and nasopharyngitis; mainly reported as the 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 increase.
NOwarnings for arthralgia, psoriasis, psoriatic arthritis, or visual impairment including blindness* in the Prescribing Information
NOrequirement for initial lab testing or ongoing lab monitoring
NOboxed warning
NOadverse reactions for facial redness, facial reactions, or herpes zoster in the Prescribing Information
NOcitrate in ingredients
NOnew safety signals over 6 years3-6
*Associated with conjunctivitis, keratitis, or blepharitis.
Long-Term Safety
Proven, long-term safety profile4
Overall frequency of most common AEs (≥2%) occurring more frequently with Adbry compared to placebo (up to 4.5 years)4*
- Discontinuation rates due to adverse events remained low4,5‡
AE=adverse event; IR=incidence rate (n/100PYE); PYE=patient-years of exposure.
*Pooled safety analysis set included patients from ECZTRA 1-3 and 5-8. † Safety analysis set combining the parent trials with the subsequent ECZTEND trial including patients from first dose of Adbry until end of Adbry exposure or the ECZTEND data cut-off (April 30, 2022). ‡ Discontinuation rate was 5.3% (IR 2.7). § Up to 1 year in parent trials plus up to 5 years in ECZTEND.
Long-term safety
Through 5 years in the open-label, long-term extension trial ECZTEND*:
- The long-term safety profile was consistent with the safety profile observed up to Week 163
- Anti-drug-antibody (ADA) responses were not associated with any impact on Adbry exposure or safety3
*ECZTEND was an open-label, multicenter, long-term extensions trial that further assessed the safety of ADBRY for up to 5 years of treatment in adults and pediatric subjects 12 years of age and older with moderate-to-severe atopic dermatitis who had previously participated in ADBRY trials. The safety data in ECZTEND reflect exposure to ADBRY in 1672 subjects who received 300 mg of ADBRY every two weeks (Q2W), including 1422 exposed for at least 52 weeks, 1184 exposed for at least 104 weeks, 701 exposed for at least 156 weeks, and 33 exposed for at least 264 weeks.