Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
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 (AUCinf; 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 (Cmax), safety, and immunogenicity.
To cite this abstract in AMA style:Kaur P, Chow V, Zhang N, Krishnan E. Pharmacokinetic Similarity of ABP 710 Relative to Infliximab: Results from a Randomized, Single-Blind, Single-Dose, Parallel Group Study in Healthy Subjects [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). 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/. Accessed May 20, 2019.
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