Immunogenicity
pyrexia, anaphylaxis, urticaria
ANAPHYLAXIS, SEQUELAE, HYPERSENSITIVITY, URTICARIA
Of 50 patients treated with GO, 12 (24.0%) had positive ADAs against GO at baseline. This was likely due to pre-existing host antibodies that were cross-reactive with GO. There was no treatment-boosted ADA response.Treatment-induced ADA was detected in 6 (12.0%) patients. No patients experienced anaphylaxis, hypersensitivity, or other clinical sequelae related to ADA. Among the 6 patients positive for treatment-induced ADA, 2 (33.3%) experienced an infusion-related reaction, both pyrexia (grade 1 and grade 3). Among the 44 patients negative for treatment-induced ADA, 7 (15.9%) patients experienced infusion-related reactions. All were grade 1 or 2, except for 1 instance of grade 3 urticaria.Of the 18 patients who had positive ADAs against GO, none were positive for NAbs at baseline; therefore, no patients had a treatment-boosted response. Treatment-induced NAbs were detected in 1 (2.0%) patient.