In this article we will discuss Ramucirumab (25). So, let’s get started.
Immunogenicity
As with all therapeutic proteins, there is the potential for immunogenicity. In clinical trials, 53/884 (6%) of
Ramucirumab-treated patients with post baseline serum samples tested positive for treatment-emergent anti-ramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). However, this assay has limitations in detecting Anti ramucirumab antibodies in the presence of ramucirumab; therefore, the incidence of antibody development may not have been reliably determined. Neutralizing antibodies were detected in 9 of the 53 patients who tested positive for treatment emergent anti-ramucirumab antibodies.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally,
the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and
underlying disease. For these reasons, comparison of incidence of antibodies to Ramucirumab with the incidences of
antibodies to other products may be misleading.