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.
IMPORTANT SAFETY INFORMATION
- 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 in patients treated with ADBRY. Limited data are available regarding coadministration of ADBRY with non-live vaccines.
- 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: The safety and effectiveness of ADBRY have not been established in pediatric patients.
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.