Background/Purpose:   ABP 710, a biosimilar candidate to infliximab, has the same amino acid sequence as infliximab, an anti-TNF therapy. Analytical and biofunctional comparisons between ABP 710 and infliximab have been conducted and completed. This report describes the results of a study comparing pharmacokinetics (PK) of ABP 710 and infliximab sourced from the United States.

Methods:   This was a single-blind, single-dose, parallel-group study among healthy adults, 18 to 45 years of age and with a body mass index of 18 to 30 kg/m². Subjects were randomized to receive a 5 mg/kg intravenous (IV) infusion of either ABP 710 or infliximab after pretreatment with an antihistamine and acetaminophen 30 minutes prior to the start of the infusion. The primary objective was demonstration of PK similarity of ABP 710 to infliximab based on area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC_inf; primary endpoint). PK equivalence was deemed achieved if the geometric mean (GM) ratio and its 90% confidence interval (CI) fell within the range of 0.80 and 1.25. Secondary endpoints included maximum observed serum concentration (C_max), safety, and immunogenicity.

Results:   Pharmacokinetics: A total of 49 subjects received ABP 710 and 50 subjects received infliximab. Following a single dose, the adjusted least square (LS) GM of AUC_inf and C_max for ABP 710 were 33559 µg·h/mL and 123 µg/mL. The adjusted LS GM of AUC_inf and C_max for infliximab were 37523 µg·h/mL and127 µg/mL. Ratios of adjusted LS GM (90% CIs) between ABP 710 and infliximab for AUC_inf and C_max were 0.894 (0.812–0.985) and 0.972 (0.917–1.030). The 90% CIs of these ratios were fully contained within the 0.80 to 1.25 interval, confirming PK similarity between ABP 710 and infliximab. Safety: There were no deaths, serious adverse events, or treatment-emergent adverse events (TEAEs) leading to discontinuation from the study. The incidence of TEAEs was similar in the two treatment groups (ABP 710: 83.7%; infliximab: 86.0%). The majority of TEAEs were mild or moderate. The most frequently reported TEAEs were somnolence, headache, nasopharyngitis, upper respiratory tract infection, nausea, and lethargy. Immunogenicity: All subjects tested negative for antidrug antibody (ADA) prior to dosing. At the end of study (Day 57), 40% subjects in the ABP 710 group and 32% in the infliximab group were positive for binding ADAs, and 13% subjects in the ABP 710 group and 10% in the infliximab group were positive for neutralizing ADAs.

Conclusion:  Results of this phase 1 study demonstrate PK similarity between ABP 710 and infliximab following a single 5 mg/kg IV infusion in healthy subjects. The safety and immunogenicity profile were similar among the treatment groups.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pharmacokinetic-similarity-of-abp-710-relative-to-infliximab-results-from-a-randomized-single-blind-single-dose-parallel-group-study-in-healthy-subjects/