Pharmacokinetics of Subcutaneous Dupilumab Injection With an Autoinjector Device or Prefilled Syringe.

Abstract

Dupilumab, a human monoclonal antibody against interleukin‐4 receptor alpha, has demonstrated efficacy and an acceptable safety profile in adult and pediatric patients with moderate‐to‐severe atopic dermatitis (AD) and other type 2 inflammatory diseases. Dupilumab is available in 200‐ and 300‐mg strengths as a prefilled syringe with a needle shield (PFS‐S), and more recently as an autoinjector (AI) device. This study was designed to assess the pharmacokinetic (PK) comparability of a single subcutaneous (SC) dose of dupilumab 200 mg, delivered by 2 different devices, AI (test) versus PFS‐S (reference). A total of 130 healthy male and female participants were enrolled in this phase 1 parallel design study, with 128 evaluable for PK. Following dupilumab 200‐mg SC injection, dupilumab exposure in serum was similar for both AI and PFS‐S. The geometric mean ratios of PK parameters with 90% confidence intervals were 1.08 (0.97‐1.21) for maximum serum concentration (Cmax) and 1.11 (0.96‐1.28) for area under the serum concentration–time curve until the last quantifiable concentration (AUClast). Dupilumab administration by both devices was well tolerated, and there were no serious adverse events, or severe treatment‐emergent adverse events experienced during the study. Overall, exposure to dupilumab 200 mg was comparable when administered via the AI or PFS‐S devices in healthy male and female study participants.