From the FDA Drug Label
The effect of severe renal impairment or moderate to severe hepatic impairment on the pharmacokinetics of tralokinumab-ldrm is unknown. The FDA drug label does not answer the question.
From the Research
Tralokinumab has not been associated with microalbuminuria as a reported side effect, and therefore, it is not recommended to monitor for microalbuminuria specifically due to tralokinumab use. Microalbuminuria, which is the presence of small amounts of albumin in the urine indicating early kidney damage, is not listed among the known adverse effects of tralokinumab in clinical trials or post-marketing surveillance 1. Tralokinumab is a monoclonal antibody that targets interleukin-13 (IL-13) and is primarily used to treat moderate-to-severe atopic dermatitis. The most common side effects of tralokinumab include upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.
If a patient taking tralokinumab develops microalbuminuria, it would be prudent to investigate other potential causes such as diabetes, hypertension, or other medications known to affect kidney function. Regular monitoring of kidney function is always advisable when on long-term medication therapy. Some studies have shown that urine albumin-to-creatinine ratio (UACR) is a reliable test for detecting microalbuminuria, and it can be used to predict renal disease progression in patients with diabetes 2, 3. However, these studies do not provide evidence that tralokinumab is associated with microalbuminuria.
In terms of monitoring kidney function, some studies suggest that serum biomarkers such as TNF receptor 1, kidney injury molecule 1, CD27 antigen, α-1-microglobulin, and syndecan-1 may be useful in predicting renal disease progression in patients with type 1 diabetes 1. However, these findings are not directly related to tralokinumab use, and more research is needed to determine the clinical significance of these biomarkers in patients taking tralokinumab.
Some key points to consider when monitoring patients taking tralokinumab include:
- Regular monitoring of kidney function is always advisable when on long-term medication therapy
- Investigation of other potential causes of microalbuminuria, such as diabetes or hypertension, is recommended if microalbuminuria is detected
- Consultation with a nephrologist may be warranted to determine the underlying cause of microalbuminuria
- There is no specific recommendation to monitor for microalbuminuria specifically due to tralokinumab use, based on current evidence 4, 5.