Adbry Tralokinumab is a fully human monclonal IgG4 antibody that potently and specifically neutralizes IL-13. IL-13 has an important role in atopic dermatitis pathogenesis.
Atopic dermatitis (eczema) is a chronic inflammatory skin disease. It can affect sleep, psychosocial activities and health related quality of life. The symptoms of many patients are not controlled with current treatment regimens. Adbry Tralokinumab blocks IL-13 in patients with eczema whose over expression has been shown to reduce epithelial integrity by means of downregulation of the skin barrier. Atopic dermatitis severity is associated with increased IL-13. Dupilumab inhibits both IL-4 and IL-13 and has shown improvement in patients suffering from eczema, although the relative contribution of each of these is unclear.
Adbry Tralokinumab blocks IL-13 only and a recent phase 2b study investigated the efficacy, safety and tolerability of it in adults with moderate to severe eczema.
Conclusions of the study reported in The Journal of Allergy and Clinical Immunology, January 2019 showed:
- Adbry Tralokinumab demonstrated clinically significant improvements by 2 index scores (Eczema Area Severity Index and Investigator’s Global Assessment) in patients with moderate to severe atopic dermatitis.
- The improvements in the Eczema Area Severity Index was evident at week 4 and maintained beyond week 12. The improvements were observed with increasing doses of tralokinumab. Treatment with Adbry tralokinumab was 150mg or 300mg every 2 weeks.
Serum biomarkers were used to identify participants with increased dipeptidyl peptidase-4 (DPP-4) and periostin. Serum biomarkers are being used increasingly for injectable biologic medications. For instance, Nucala and Fasenra, which are both used for asthma, use eosinophil counts greater than 150 before starting treatment. The study showed that participants who have higher levels of DPP-4 and periostin, responded better to tralokinumab.
Tralokinumab also showed an acceptable safety and tolerability profile. The most common events were upper respiratory infections and headaches, the majority of events were mild to moderate.
In conclusion, Adbry tralokinumab appears to provide and sustained improvements in disease symptoms in participants with atopic dermatitis. The greatest improvement was seen in participants treated with 300mg of tralokinumab; participants with increased IL-13 activity (DPP-4 and periostin), demonstrated further improvements in treatment response, supporting a key role for IL-13 in the pathological mechanisms of eczema. Phase 3 studies will be needed to confirm these findings.
There is no release date or brand name for this and the cost has yet to be determined. With many recent biological medications being available, the average out of pocket cost is approximately $3,000/month before insurance. So likely this will follow along those lines if it eventually FDA approved.
Update January 12, 2021
Adbry (tralokinumab) as been FDA approved for moderate to severe atopic dermatitis. An initial dose of 600 mg followed by 300 mg administered every other week is recommended. It comes as a 150mg injection. It is administered by subcutaneous injection. Leo Pharma will be manufacturing the medication. There were a number of clinical trials, 3 randomized, double blind placebo-controlled, ECZTRA 1,2 & 3 that showed its efficacy in subjects 18 years of age and older with moderate to severe atopic dermatitis not adequately controlled by topical medications.