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FOR US
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PROFESSIONALS

Strongly recommended by AAD as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients1

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SAFETY 

The safety of Adbry® was evaluated in an extensive clinical program8

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.8

  • 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 year8
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  • 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 328
Percentage pie charts of Adbry safety population at baseline

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.8

*Includes other or missing data.

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ADVERSE REACTIONS

Demonstrated safety profile

Adverse reactions occurring in ≥1% through Week 168

Chart comparing the adverse reactions experienced by the Adbry monotherapy group and the Adbry + TCS as-needed group through Week 16.
  • Not an immunosuppressant or steroid
  • Has no boxed warning
  • No requirement for initial lab testing or ongoing lab monitoring8
  • No requirement for females to be on contraception in the Prescribing Information8

 

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 period8,10

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, respectively8

In a pooled analysis of 5 studies (initial treatment period, Adbry n=1582, placebo n=669)10:
  • Most AEs (>90%) were mild or moderate in severity. The majority of AEs were recovered/resolved for Adbry (61%) and placebo (63%)10*
     
  • Of the conjunctivitis cases that occurred, 2% were severe. The majority (98%) were mild to moderate and resolved during treatment10†

*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.

Summary of safety in ECZTEND up to 4.5 years10

Overall frequency of most common AEs (≥2%) occurring more frequently with Adbry compared to placebo10*

Table displaying adverse event frequencies during Adbry®'s initial treatment period compared to placebo.
  • Long-term safety with Adbry for up to 4.5 years was generally similar to the parent trials’ initial treatment period with respect to overall frequency of most common AEs (≥2.0%)

 

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.
†Study size–adjusted % and IR.
‡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).
§According to MedDRA preferred term.
Incidence rate (n/100PYE): for IR calculations, patient exposure was censored at the time of first event.

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Adbry Dosing and Administration

Explore flexible dosing with Adbry8

EXPLORE DOSING
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Support for Your Patients

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