Bioequivalence of Canakinumab Injected Subcutaneously via an Autoinjector Device or a Prefilled Safety Syringe Device in Healthy Subjects

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Abstract

Canakinumab, a high-affinity human anti-interleukin-1β monoclonal antibody, is being used for the treatment of a broad spectrum of inflammatory diseases. This phase 1 study compared the relative bioavailability of a single dose of subcutaneous canakinumab either self-administered with an autoinjector (AI) or administered by a health care professional (HCP) with a prefilled safety syringe (SS) in healthy subjects. The study enrolled 80 subjects randomized 1:1 to receive 150 mg/mL of a liquid formulation of canakinumab via an AI or SS into either the thigh or abdomen. The geometric mean ratio (90% confidence interval [CI]) of Cmax was 1.09 (0.97-1.21), AUClast was 1.06 (0.96-1.17), and AUCinf was 1.05 (0.94-1.18) for the AI versus SS. The 2-sided 90%CIs that compared self-administration with the AI versus administration by an HCP using the SS were entirely within the bioequivalence limits of 80%-125%. Two subjects in the AI group and 1 in the SS group experienced mild injection-site reactions. No immunogenicity response was detected in the 307 samples analyzed for immunogenicity. No discontinuations because of adverse events were reported in this trial. Canakinumab administration with an AI or SS has a comparable bioavailability, meeting bioequivalence criteria.

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