Strongly recommended by AAD and AAAAI guidelines as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients^1,2

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ABOUT ADBRY

In atopic dermatitis, IL-13 signaling is one of the drivers of dysregulated immune response⁸

In chronic atopic dermatitis:

IL-13 is overexpressed in both lesional and nonlesional
skin⁹
Overexpression of IL-13 contributes to the
vicious cycle of inflammation, microbiome dysbiosis,
pruritus, and skin-barrier dysfunction^8,10
Expression of IL-13 in skin correlates with increased
disease severity^9,11

IL-13 cytokine

Chronic, underlying inflammation in atopic dermatitis requires a
LONG-TERM TREATMENT APPROACH^23,24

Adbry mechanism of action

Adbry—the first fully human, high-affinity monoclonal antibody that specifically targets IL-13 and leaves the natural function of the decoy receptor intact^6,12

Adbry is a fully human IgG4 monoclonal antibody that specifically binds to human IL-13, a naturally occurring cytokine of the type II immune response, and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).⁶
Adbry selectively inhibits IL-13 interaction with the type II receptor complex (IL-13Rα1/IL-4Rα), preventing IL-13–induced inflammatory responses in the skin.⁶

Adbry is not an immunosuppressant or steroid. There is no requirement for initial lab testing
or ongoing lab monitoring in the Prescribing Information.

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MECHANISM OF ACTION

Watch the Adbry MOA Video

Clinical Trial Efficacy Data

The efficacy of Adbry was extensively studied up to 52 weeks in 3 clinical trials⁶

VIEW CLINICAL RESULTS

Demonstrated Long-Term Safety Through 52 Weeks

The safety of Adbry was demonstrated in 5 robust clinical trials that included nearly 2000 patients^3,6

SEE SAFETY RESULTS

INDICATION

ADBRY^® (tralokinumab-Idrm) injection is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older 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.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis and angioedema have occurred after administration of ADBRY. If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to antihelminth treatment, discontinue treatment with ADBRY until the infection resolves.
Risk of Infection with Live Vaccines: ADBRY may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ADBRY, complete all age appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines during treatment with ADBRY. Limited data are available regarding coadministration of ADBRY with non-live vaccines.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%) are upper respiratory infections, conjunctivitis, injection site reactions, and eosinophilia.

USE IN SPECIFIC POPULATIONS

Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is present in breast milk. The effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown.
Pediatric Use: Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.

References:

1. Davis DMR, et al. J Am Acad Dermatol. 2024:90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102 2. AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel, et al. Ann Allergy Asthma Immunol. 2024;132(3):274-312. doi:10.1016/j.anai.2023.11.009 3. Data on file. LEO Pharma Inc. 4. Blauvelt A, et al. Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control. Poster presented at: 32nd annual Congress of the European Academy of Dermatology and Venereology (EADV): October 11-14, 2023; Berlin, Germany. 5. Blauvelt A, et al. Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years. Poster presented at: 44th Annual Fall Clinical Dermatology Congress: October 24-27, 2024; Las Vegas, NV. 6. ADBRY. Prescribing information. LEO Pharma Inc. 7. Reich K, et al. Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials. Poster presented at: Revolutionizing Atopic Dermatitis (RAD) Conference; April 29-May 1, 2023; Washington, DC. 8. Bieber T. Allergy. 2020;75(1):54-62. doi:10.1111/all.13954 9. Tsoi LC, et al. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018 10. Kim BE, et al. Clin Immunol. 2008;126(3):332-337. doi:10.1016/j.clim.2007.11.006 11. Szegedi K, et al. J Eur Acad Dermatol Venereol. 2015;29(11):2136-2144. doi:10.1111/jdv.13160 12. Popovic B, et al. J Mol Biol. 2017;429(2):208-219. doi:10.1016/j.jmb.2016.12.005 13. Wollenberg A, et al. Br J Dermatol. 2021;184(3):437-449. doi:10.1111/bjd.19574 14. Silverberg JI, et al. Br J Dermatol. 2021;184(3):450-463. doi:10.1111/bjd.19573 15. Simpson EL, et al. JAMA Dermatol. 2018;154(8):903-912. doi:10.1001/jamadermatol.2018.1572 16. Soung J, et al. Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis. Poster presented at: Winter Clinical Dermatology Conference; February 16-19, 2024; Miami, FL. 17. Paller AS, et al. JAMA Dermatol. 2023;159(6):596-605. doi:10.1001/jamadermatol.2023.0627 18. Hanifin JM, et al. Exp Dermatol. 2001;10(1):11-18. doi:10.1034/j.1600-0625.2001.100102.x 19. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353-1357. doi:10.1111/bjd.13662 20. Chopra R, et al. Br J Dermatol. 2017;177(5):1316-1321. doi:10.1111/bjd.15641 21. Futamura M, et al. J Am Acad Dermatol. 2016;74(2):288-294. doi:10.1016/j.jaad.2015.09.062 22. Phan NQ, et al. Acta Derm Venereol. 2012;92(5):502-507. doi:10.2340/00015555-1246 23. Silverberg JI, et al. Dermatol Clin. 2017;35(3):327-334. doi:10.1016/j.det.2017.02.005 24. Weidinger S, et al. Nat Rev Dis Primers. 2018;4(1):1. doi:10.1038/s41572-018-0001-z