Adbry Dosing and Administration
Explore flexible dosing options with Adbry1
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.1
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.1
*Includes other or missing data.
*Pooled analysis of ECZTRA 1 and ECZTRA 2.
†Analysis of ECZTRA 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.
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 period1,3
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, respectively1
*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.
ADBRY® (tralokinumab-ldrm) injection is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
Please see Full Prescribing Information.
1. Adbry Prescribing Information, LEO Pharma. 2. Wollenberg A, Blauvelt A, Guttman-Yassky E, et al; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021;184(3):437-449. 3. Data on file. LEO Pharma. 4. Langley R, Reich K, Simpson E, et al. Long-term improvements in disease severity, itch, and quality of life after 3 years of tralokinumab treatment in adults with moderate-to-severe atopic dermatitis. Poster presented at 4th Annual Revolutionizing Atopic Dermatitis Conference, April 9-11, 2022. 5. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1): 54-62. 6. Tsoi LC, Rodriguez E, Degenhardt F, et al. Atopic dermatitis is an IL-13-dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. 7. Kim BE, Leung DYM, Boguniewicz M, Howell MD. Loricrin and involucrin expression is down-regulated by Th2 cytokines through STAT-6. Clin Immunol. 2008;126(3):332-337. 8. Szegedi K, Lutter R, Res PC, et al. Cytokine profiles in interstitial fluid from chronic atopic dermatitis skin. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2136-44. 9. Silverberg JI, Kantor R. The role of interleukins 4 and/or 13 in the pathophysiology and treatment of atopic dermatitis. Dermatol Clin. 2017;35(3):327-334. 10. Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1. 11. Popovic B, Breed J, Rees DG, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of biding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219. 12. Silverberg JI, Toth D, Bieber T, et al; ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. 13. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001;10(1):11-18. 14. Leshem YA, Hajar T, Hanifin J, Simpson E. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357. 15. Chopra R, Vakharia PP, Sacotte R, et al. Severity strata for Eczema Area and Severity Index (EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD, Atopic Dermatitis Severity Index and body surface area in adolescents and adults with atopic dermatitis. Br J Dermatol. 2017;177(5):1316-1321. 16. Futamura M, Leshem YA, Thomas KS, et al. A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: many options, no standards. J Am Acad Dermatol. 2016;74(2):288-294. 17. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):449-581.