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PK / PD of an antibody in the skin

Study Title: "An exploratory study to investigate the distribution of secukinumab (AIN457) in the interstitial fluid of the skin using open flow microperfusion after a single subcutaneous injection of 300 mg in healthy volunteers and psoriatic patients"

Initial situation:

The sponsor, Novartis Pharma AG, has developed the antibody "secukinumab". Secukinumab is a monoclonal antibody (a protein that specifically binds to another molecule), which selectively stops  the effect of an endogenous protein called interleukin-17A (IL- 17A). IL-17A plays a role in many different types of inflammatory diseases such as psoriasis. Clinical studies with patients have already proved its effect. This study aimed to determine the concentration of the antibody and its effect on local inflammatory markers directly at the site of action in the skin (dermis) by using dermal open flow microperfusion (dOFM).

Methods:

The concentration of the antibody in the skin and in the serum of healthy volunteers and psoriatic patients on day 8 and day 15 was determined following a single-dose subcutaneous injection of the antibody. The concentrations of selected inflammatory markers (cytokines) in the skin and in serum were examined on days 1, 8 and 15.

Results:

Antibodies and inflammatory markers were successfully detected in the skin by dOFM. The study showed that on day 8 and 15 after the injection, a sufficiently high and stable concentration of the antibody is achieved at the proposed site of action (skin). The measurement of inflammatory markers revealed reduced levels in lesional skin. The effect of the antibody at the planned site of action was detected by using open flow microperfusion.

The details of the study were presented at several international conferences (e.g. AAPS National Biotechnology Conference 2014, Society for Investigative Dermatology 2014).

 

 

 

A healthy participant with 12 probes for dermal open flow microperfusion on day 15 of the study. The probes provide information about the drug concentration (in this case, the antibody concentration) and the effect on inflammation markers in lesional skin.
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