Tralokinumab-ldrm

(Adbry®)

Adbry®

Drug updated on 10/25/2024

Dosage FormInjection (subcutaneous; 150 mg/mL, 300 mg/2 mL)
Drug ClassInterleukin-13 antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age 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.

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Summary
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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • At week 26, 79% of participants treated with TransCon PTH (parathyroid hormone) achieved the composite primary efficacy endpoint of maintaining normal albumin-adjusted serum calcium levels, independence from conventional therapy, and no increase in study drug, compared to 5% in the placebo group (p < 0.0001).
  • TransCon PTH significantly improved health-related quality of life, as indicated by the SF (surface factor)-36 Physical Functioning subscale (p = 0.0347) and all key secondary endpoint HPES domain scores (all p < 0.01), showing enhanced well-being and reduced hypoparathyroidism-related symptoms. 4. 93% of participants on TransCon PTH achieved independence from conventional therapy, with no comparable data provided for the placebo group.
  • The most common adverse events for tralokinumab included nasopharyngitis, respiratory events, and atopic dermatitis, with no significant difference in the overall incidence of adverse events compared to placebo (RCTs (OR) = 1.00, 95% RR 9.50, 95 % CI 2.31-39.03 (CI): 0.85-1.18, P = 1.00).
  • Tralokinumab was well tolerated, though there was an increased risk of conjunctivitis compared to placebo, and no significant short-term safety concerns were identified, although long-term safety evidence remains uncertain.
  • Tralokinumab was evaluated in both pediatric and adult populations with moderate-to-severe atopic dermatitis (TCS). In children and adolescents, the drug's efficacy and safety were assessed, showing significant improvements in clinical outcomes, while adults also demonstrated notable benefits from treatment. No specific subgroup analyses regarding age, gender, or comorbidities were reported in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Adbry (tralokinumab-ldrm) Prescribing Information.2024LEO Pharma Inc., Madison, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines