Neutralizing antibodies (NAbs) to Ustekinumab are anti-drug antibodies (ADAs) produced by the immune system in response to the administration of Ustekinumab, a monoclonal antibody that targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23). These NAbs can significantly diminish the therapeutic efficacy of Ustekinumab by preventing the drug from binding to its target cytokines or by hindering downstream signaling pathways essential for modulating immune responses in chronic inflammatory diseases.
In a clinical setting, the detection and monitoring of NAbs to Ustekinumab are critical for optimizing biologic treatment strategies. NAb formation can lead to treatment failure, loss of clinical response, or the emergence of adverse effects, especially in patients with conditions such as psoriasis or inflammatory bowel disease. Therapeutic drug monitoring (TDM) and NAb assays, like the SHIKARI® T-CAP NAb Assay, are valuable tools that provide insights into drug efficacy, compliance, and immunogenicity. These assays help clinicians determine if loss of drug response is due to immunogenicity or pharmacokinetic variation.
In research applications, studying NAbs to Ustekinumab enhances our understanding of biologic drug immunogenicity and supports the development of less immunogenic formulations. It also contributes to safety and efficacy assessments in biosimilar development. Routine NAb screening in both clinical trials and real-world practice aids in characterizing immune responses, guiding dose adjustments, and identifying patients who may benefit from alternative therapies.
This product is manufactured in Turkey by Matriks Biotek.