Matches in SemOpenAlex for { <https://semopenalex.org/work/W2980942385> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W2980942385 endingPage "255" @default.
- W2980942385 startingPage "246" @default.
- W2980942385 abstract "Abstract This was a randomized, single‐blind, single‐dose, 3‐arm parallel‐group study. Healthy subjects were randomized to receive ABP 710 (n = 50) or infliximab reference product (RP) sourced from the United States (infliximab US; n = 50) or the European Union (infliximab EU; n = 50) 5 mg/kg intravenously over 2 hours. The primary endpoint was area under the serum concentration–time curve from time 0 extrapolated to infinity (AUC inf ) for the comparison of ABP 710 to infliximab US and infliximab EU. Secondary endpoints included safety, tolerability, and immunogenicity. AUC inf was similar across the 3 groups, showing similarity of ABP 710 to infliximab RP as well as similarity of infliximab US with infliximab EU. Geometric mean ratio of AUC inf was 0.89 between ABP 710 and infliximab US, 1.00 between ABP 710 and infliximab EU, and 1.11 between infliximab US and infliximab EU. All 90% confidence intervals of the geometric mean ratios were fully contained within the prespecified standard pharmacokinetic equivalence criteria range of 0.80 to 1.25. Treatment‐related adverse events were mild to moderate and reported for 83.7%, 86.0%, and 83.7% of subjects in the ABP 710, infliximab US, and infliximab EU treatment groups, respectively; incidence of antidrug antibody rates observed across the 3 groups were similar. Results of this study demonstrated pharmacokinetic similarity of ABP 710 with infliximab RP following a single 5‐mg/kg intravenous injection. The safety and tolerability of ABP 710 and infliximab RP were comparable. These results add to the totality of evidence providing further support that the proposed biosimilar ABP 710 is similar to infliximab RP. (Trial ID: ACTRN12614000903684.)" @default.
- W2980942385 created "2019-10-25" @default.
- W2980942385 creator A5017619328 @default.
- W2980942385 creator A5051124193 @default.
- W2980942385 creator A5064943069 @default.
- W2980942385 creator A5078338953 @default.
- W2980942385 date "2019-10-19" @default.
- W2980942385 modified "2023-10-16" @default.
- W2980942385 title "Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single‐Blind, Single‐Dose, Parallel‐Group Study in Healthy Subjects" @default.
- W2980942385 cites W1516626166 @default.
- W2980942385 cites W2038607314 @default.
- W2980942385 cites W2066953275 @default.
- W2980942385 cites W2111913995 @default.
- W2980942385 cites W2132071446 @default.
- W2980942385 cites W2480028188 @default.
- W2980942385 cites W2512170617 @default.
- W2980942385 cites W2921300065 @default.
- W2980942385 cites W2945934714 @default.
- W2980942385 cites W4251433980 @default.
- W2980942385 doi "https://doi.org/10.1002/cpdd.738" @default.
- W2980942385 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7027815" @default.
- W2980942385 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31628783" @default.
- W2980942385 hasPublicationYear "2019" @default.
- W2980942385 type Work @default.
- W2980942385 sameAs 2980942385 @default.
- W2980942385 citedByCount "5" @default.
- W2980942385 countsByYear W29809423852020 @default.
- W2980942385 countsByYear W29809423852021 @default.
- W2980942385 countsByYear W29809423852022 @default.
- W2980942385 countsByYear W29809423852023 @default.
- W2980942385 crossrefType "journal-article" @default.
- W2980942385 hasAuthorship W2980942385A5017619328 @default.
- W2980942385 hasAuthorship W2980942385A5051124193 @default.
- W2980942385 hasAuthorship W2980942385A5064943069 @default.
- W2980942385 hasAuthorship W2980942385A5078338953 @default.
- W2980942385 hasBestOaLocation W29809423851 @default.
- W2980942385 hasConcept C112705442 @default.
- W2980942385 hasConcept C126322002 @default.
- W2980942385 hasConcept C168563851 @default.
- W2980942385 hasConcept C17991360 @default.
- W2980942385 hasConcept C197934379 @default.
- W2980942385 hasConcept C203092338 @default.
- W2980942385 hasConcept C2777138892 @default.
- W2980942385 hasConcept C2778375690 @default.
- W2980942385 hasConcept C42404028 @default.
- W2980942385 hasConcept C59491497 @default.
- W2980942385 hasConcept C71924100 @default.
- W2980942385 hasConcept C90924648 @default.
- W2980942385 hasConceptScore W2980942385C112705442 @default.
- W2980942385 hasConceptScore W2980942385C126322002 @default.
- W2980942385 hasConceptScore W2980942385C168563851 @default.
- W2980942385 hasConceptScore W2980942385C17991360 @default.
- W2980942385 hasConceptScore W2980942385C197934379 @default.
- W2980942385 hasConceptScore W2980942385C203092338 @default.
- W2980942385 hasConceptScore W2980942385C2777138892 @default.
- W2980942385 hasConceptScore W2980942385C2778375690 @default.
- W2980942385 hasConceptScore W2980942385C42404028 @default.
- W2980942385 hasConceptScore W2980942385C59491497 @default.
- W2980942385 hasConceptScore W2980942385C71924100 @default.
- W2980942385 hasConceptScore W2980942385C90924648 @default.
- W2980942385 hasFunder F4320307105 @default.
- W2980942385 hasIssue "2" @default.
- W2980942385 hasLocation W29809423851 @default.
- W2980942385 hasLocation W29809423852 @default.
- W2980942385 hasLocation W29809423853 @default.
- W2980942385 hasOpenAccess W2980942385 @default.
- W2980942385 hasPrimaryLocation W29809423851 @default.
- W2980942385 hasRelatedWork W1981336058 @default.
- W2980942385 hasRelatedWork W1993762334 @default.
- W2980942385 hasRelatedWork W2587157414 @default.
- W2980942385 hasRelatedWork W2774189845 @default.
- W2980942385 hasRelatedWork W2914211697 @default.
- W2980942385 hasRelatedWork W2914532353 @default.
- W2980942385 hasRelatedWork W2924476097 @default.
- W2980942385 hasRelatedWork W3010465489 @default.
- W2980942385 hasRelatedWork W4229777120 @default.
- W2980942385 hasRelatedWork W4385064586 @default.
- W2980942385 hasVolume "9" @default.
- W2980942385 isParatext "false" @default.
- W2980942385 isRetracted "false" @default.
- W2980942385 magId "2980942385" @default.
- W2980942385 workType "article" @default.