CT-P13 Subcutaneous Formulation Shows Comparable Pharmacokinetics and Safety via Autoinjector and Pre-filled Syringe
核心洞察
A study published in *Clinical and Translational Science* found that the pharmacokinetics and safety of subcutaneous CT-P13 (Zymfentra), an infliximab biosimilar, are comparable whether administered via autoinjector or pre-filled syringe.
The open-label, single-dose study included 147 healthy participants who were randomized to receive CT-P13 either through autoinjection or pre-filled syringe, with comparable drug exposure observed in both groups.
Safety profiles were similar between the two administration methods, with comparable rates of adverse events, suggesting that both autoinjectors and pre-filled syringes are viable options for subcutaneous CT-P13 administration.
Celltrion's CT-P13 (Zymfentra), a biosimilar to infliximab (Remicade), demonstrates similar pharmacokinetics and safety profiles when administered subcutaneously via autoinjector and pre-filled syringe. The findings, published in Clinical and Translational Science, support the interchangeability of these administration methods for the subcutaneous formulation.
The randomized, open-label, single-dose study, conducted at Chungnam National University Hospital in South Korea, enrolled 147 healthy volunteers. Participants were randomized in a 1:1 ratio to receive a single 120 mg dose of subcutaneous CT-P13 via either autoinjector (test group) or pre-filled syringe (reference group). Blood samples were collected over 96 hours to assess pharmacokinetic parameters.
Comparable Pharmacokinetics
The study revealed that the geometric mean ratios for AUCinf (area under the curve) were 94.15% for the test drug (autoinjector) and 92.48% for the reference drug (pre-filled syringe). These results indicate comparable drug exposure between the two administration methods. Immunogenicity was also similar, with rates of approximately 97.22% and 98.65% in the test and reference groups, respectively.
Similar Safety Profiles
The safety profiles were also comparable between the two groups. Adverse events (AEs) were reported in 55.56% of individuals in the autoinjector group and 55.41% in the pre-filled syringe group. The most frequently reported treatment-emergent AEs (TEAEs) in the autoinjector group included increased C-reactive protein and increased blood creatine phosphokinase. In the pre-filled syringe group, the most common TEAEs were increased C-reactive protein, blood creatine phosphokinase, and alanine aminotransferase.
Clinical Implications
CT-P13, a biosimilar to infliximab, is approved in Europe for rheumatoid arthritis (搜索), ankylosing spondylitis (搜索), psoriatic arthritis (搜索), psoriasis (搜索), Crohn's disease (搜索) (CD), and ulcerative colitis (搜索) (UC). In the United States, an intravenous formulation of infliximab was approved by the FDA in 2016, and a subcutaneous formulation of CT-P13 was submitted for approval in January 2023. Phase 3 trials have demonstrated higher clinical remission rates in patients treated with the subcutaneous formulation compared to placebo in Crohn's disease (62% vs 32%) and ulcerative colitis (43% vs 21%).
The availability of both autoinjector and pre-filled syringe options for subcutaneous CT-P13 provides flexibility for patients and healthcare providers. The study's findings support the use of either administration method, based on patient preference and convenience.