Neutralizing antibodies (NAbs) to eculizumab are anti-drug antibodies that inhibit the therapeutic efficacy of the biologic by preventing it from binding to its target, complement protein C5. These NAbs interfere with the drug-target interaction by steric hindrance or inhibition of downstream signaling, potentially leading to the loss of eculizumab’s pharmacological function. In some cases, NAbs can cross-react with endogenous proteins, causing unintended physiological effects or life-threatening adverse reactions.
In both research and clinical settings, the detection and monitoring of eculizumab NAbs are critical. NAb assays, such as competitive ligand-binding methods, are used to assess whether patients have developed NAbs that reduce drug binding efficacy. These assays are vital tools in drug development and post-marketing surveillance to ensure patient safety and therapeutic effectiveness. Monitoring NAb levels can guide clinicians in adjusting treatment strategies, particularly in patients with suboptimal responses or emerging resistance to therapy.
Additionally, therapeutic drug monitoring (TDM) complements NAb testing by assessing serum drug levels and overall treatment adherence. In combination, NAb assays and TDM support personalized treatment regimens, help mitigate immunogenicity-related complications, and ensure continued efficacy of eculizumab, especially in chronic treatment scenarios like paroxysmal nocturnal hemoglobinuria (PNH) or neuromyelitis optica spectrum disorder (NMOSD).
This product is manufactured in Turkey by Matriks Biotek.