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Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results

Journal of Asthma Sep 29, 2019

Martin UJ, Fuhr R, Forte P, et al. - In the open-label AMES study, researchers compared autoinjectors (AI) with accessorized prefilled syringes (APFS) for benralizumab pharmacokinetic exposure after delivery of a single subcutaneous dose of 30 mg. Participants were 180 healthy adult men and women. They randomized the participants to one of two devices (AI or APFS) and 3 injection site (upper arm, abdomen, or thigh) combinations. Stratification of randomization by weight (< 70 kg, 70–84.9 kg, and ≥ 85 kg) was done. On days 1, 8, 29, and 57, they measured blood eosinophil counts. They found similar benralizumab pharmacokinetic exposure between AI and APFS. With both devices, consistent blood eosinophil count reduction was detected. Thus, the use of either AI or APFS for benralizumab administration was supported, this offers increased choice, flexibility, and convenience to patients and physicians for potential at-home administration.
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