Why carry out this study?

Two studies evaluated bioequivalence, safety, and immunogenicity of a single mirikizumab dose administered subcutaneously by autoinjector or prefilled syringe (PFS) in healthy participants, including comparison across three injection sites (abdomen, arm, thigh).

Use of an autoinjector to administer therapeutic biologics subcutaneously can improve patient adherence and dose accuracy compared with a PFS, but it is important to ensure that both devices deliver similar concentration given potential differences in the delivery devices.

What was learned from the study?

Administering mirikizumab by autoinjector was bioequivalent to PFS at the 200-mg subcutaneous (SC) dose used for maintenance treatment in patients with ulcerative colitis (UC), and bioequivalent for area under concentration versus time curve (AUC) parameters with a slight increase in maximum observed drug concentration (Cmax) at the higher 300-mg SC dose used for maintenance treatment in patients with Crohn’s disease (CD), with minimal impact on safety.

Availability of an autoinjector option for mirikizumab maintenance therapy may be preferred by some patients with UC or CD, owing to ease of use by patients or caregivers, dosing accuracy, and may encourage improved treatment adherence over long treatment durations.