Anti-certolizumab antibodies are anti-drug antibodies (ADAs) produced by the immune system in response to treatment with certolizumab pegol, a PEGylated monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α). As with other biologic therapies, administration of certolizumab may trigger the production of neutralizing or non-neutralizing antibodies, which can interfere with the drug’s pharmacologic activity. Neutralizing anti-certolizumab antibodies can block the binding of the therapeutic to TNF-α, reducing clinical efficacy and potentially leading to treatment failure or loss of response.
The development of anti-certolizumab antibodies is monitored as part of therapeutic drug monitoring (TDM) protocols, especially in patients showing suboptimal response or adverse effects. Detecting and quantifying these antibodies can inform adjustments in dosing, guide the switch to an alternative biologic, and help prevent misinterpretation of pharmacokinetic data. Anti-certolizumab antibody assays are often conducted alongside serum drug level testing to assess immunogenicity and ensure therapeutic effectiveness.
In clinical research and routine care, identifying anti-certolizumab antibodies is crucial for improving patient outcomes in autoimmune conditions like rheumatoid arthritis and Crohn’s disease, where certolizumab is widely used. Early detection of immune responses allows clinicians to optimize biologic treatment strategies, minimize adverse effects, and tailor interventions to individual patient immunogenic profiles.
This product is manufactured in Turkey by Matriks Biotek.