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Updated: Sep 30, 2025

An Alternative and Validated Injection Method for Accessing the Subretinal Space via a Transcleral Posterior Approach
Published on: December 7, 2016
Pharmacokinetics of Subcutaneous Dupilumab Injection With an Autoinjector Device or Prefilled Syringe
Yehuda Z Cohen1, Xiaojia Zhang2, Binfeng Xia1
1Sanofi, Bridgewater, New Jersey, USA.
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.
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