Influence of premedication and ATA status on infusion-related reactions. (A) Incidence of IRRs by category (all IRRs and those reported as SAEs, grade 3/4, or leading to treatment discontinuation) among patients in the safety population (N = 55), according to whether the first dose of combination therapy was administered before or after a protocol amendment requiring premedication with antihistamines and corticosteroids. Inset, ATA incidence among immunogenicity-evaluable patients (N = 48) before and after the amendment. (B) ATA status of patients in each IRR category in the population of 54 patients with any ATA assessment (42 ATA⁺ at any time during the study and12 ATA⁻ throughout the study). IRR, infusion-related reaction; SAE, serious adverse event.