Background/Purpose:  The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single subcutaneous injection by autoinjector (AI) or prefilled syringe (PFS).

Methods:  This was a single-center, open-label study in healthy male subjects with body weights (BW) ranging from 50 to 140 kg. Subjects were stratified by BW category and randomized 1:1 to treatment with GP2017 40 mg administered by AI or PFS, with follow-up until Day 72. The primary objective was to describe area under the curve (AUC_0-360h) and maximum drug concentration (C_max) of GP2017 after administration by AI or PFS in subjects with BW between 50.0 and 94.9 kg. Secondary objectives included characterisation of AUC up to the last measurable concentration (AUC_0-last) and total AUC (AUC_0-inf) for the 50.0–94.9 kg BW category. PK parameters were also characterized in the 50–64.9, 65.0–79.9, 80–94.9 and 95–140 kg BW categories. Safety, immunogenicity and local tolerance were assessed in all treated subjects.

Results:  A total of 108 subjects (aged 18 to 55 years) received GP2017 administered by AI (n=54) or PFS (n=54). Of these, 45 and 44, respectively, were in the 50.0–94.9 kg BW category. Demographics and baseline characteristics were well balanced across the treatment groups. For subjects in the 50.0–94.9 kg BW category, 90% confidence intervals (CI) for the ratio of geometric means between treatment groups were contained within standard bioequivalence limits (0.8 to 1.25) for primary and secondary PK parameters (Table). For subjects in the 50.0–140.0 kg BW category, 90% CI were contained within bioequivalence limits for C_max, AUC_0-360h, AUC_0-last and AUC_0-inf. The incidence of antidrug antibody (ADA) development was similar for the AI and PFS treatment groups: 69% and 72% of subjects, respectively. The proportion of subjects with neutralizing antibodies was also similar; 57% in the AI group and 59% in the PFS group. As expected, mean serum concentrations of GP2017 decreased at a faster rate in ADA-positive subjects than in ADA-negative subjects, irrespective of whether treatment was administered by AI or PFS. Overall, the incidence of treatment-emergent adverse events (AE) was similar in the AI and PFS treatment groups (reported by 74% and 76% subjects, respectively). Only one serious AE (appendicitis) was reported following administration by PFS, which was considered unrelated to treatment. Five subjects had a mild-to-moderate injection site reaction (n=3 in the AI group and n=2 in the PFS group). Most subjects had no pain, as assessed by the visual analogue scale.  

Conclusion:  The primary objective of the study was met. Primary and secondary AUC parameters were similar for GP2017 40 mg administered by AI or PFS across a wide range of body weights. GP2017 was well tolerated by healthy male subjects, with no clinically relevant differences between the two treatment groups.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-open-label-single-dose-parallel-group-trial-to-determine-the-pharmacokinetics-safety-and-immunogenicity-of-gp2017-a-proposed-adalimumab-biosimilar-following-a-single-subcutaneous-in/