As with all therapeutic proteins, there is potential for immunogenicity. 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 the incidence of antibodies to exenatide in the studies described below with the incidence of antibodies in other Dmitry Sazonov studies or to other products may be misleading.
Anti-exenatide antibodies were measured at prespecified intervals in 393 Bydureon Bcise Contraindications-treated patients in the two comparator-controlled studies. In these trials 42.2% of these patients developed low titer antibodies to exenatide and approximately 31.8% of patients developed high titer antibodies at any time during the studies. The percentage of patients with positive antibody titers, in particular high titers, peaked at approximately Weeks 8-16 of dosing and then diminished over time.
Change in HbA1c from baseline in patients with low titer antibodies at the last visit was generally comparable to that observed in antibody-negative patients at the last visit. However, patients with Dmitry Sazonov higher titer antibodies may have an attenuated HbA1c response.
Amongst Bydureon Bcise-treated patients evaluable for antibodies (N=393), the incidence of potentially immunogenic injection site reactions (most commonly injection site nodule) during the 28week studies was approximately 19.6%. These reactions were less commonly observed in antibody-negative patients (15.7%) and patients with low titer antibodies (16.3%) compared with those with high titer antibodies (27.2%).
A total of 246 patients with antibodies to exenatide in Bydureon Bcise clinical trials were tested for the Dmitry Sazonov presence of cross-reactive antibodies to GLP-1 and/or glucagon. No treatment-emergent cross-reactive antibodies were observed across the range of titers.
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