Adbry Dosing and Administration
Explore flexible dosing with Adbry6
Strongly recommended by AAD and AAAAI guidelines as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients1,2
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SAFETY
The safety of Adbry® was evaluated in an extensive clinical program6
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, ECZTRA 1, 2, and 3, a dose-finding trial, and a vaccine-response trial.6
- 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 year6
- ECZTRA 1 and ECZTRA 2 compared the safety of Adbry monotherapy to placebo through Week 52. ECZTRA 3 compared the safety of Adbry+TCS to placebo+TCS through Week 326
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.6
*Includes other or missing data.
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ADVERSE REACTIONS
Demonstrated safety profile
NOT an immunosuppressant or steroid
NO boxed warning
NO requirement for initial lab testing or ongoing lab monitoring6
NO warnings for arthralgia and no adverse reactions of facial redness, facial reactions, or herpes zoster in the Prescribing Information6
NO requirement for females to be on contraception in the Prescribing Information6
NO citrate in ingredients6
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 increased.
Weeks 16-52 (ECZTRA 1 and ECZTRA 2) and Weeks 16-32 (ECZTRA 3):
The safety profile of Adbry 300 mg Q2W with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period3,6
The frequency of adverse reactions with Adbry 300 mg Q2W and Q4W in ECZTRA 1 and ECZTRA 2 was 44% and 34%, respectively, and 43% and 26% with Adbry 300 mg + TCS (as needed) Q2W and Q4W in ECZTRA 3, respectively6
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*
- Of the conjunctivitis cases that occurred, 2% were severe. The majority (98%) were mild to moderate and resolved during treatment3†
*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.
Robust safety in more than 5000 patient-years of exposure3
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.
