A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris® ) in healthy male subjects
© 2020 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd..
OBJECTIVES: ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double-blind, three-arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizumab reference product (RP) in healthy adult male subjects.
METHODS: Eligible subjects aged 18-45 years were randomized to receive a 300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU). Primary PK endpoint was area under the total serum concentration-time curve from 0 to infinity (AUC0-∞ ); primary PD endpoint was area between the effect curve (ABEC) of CH50-time data.
RESULTS: The geometric mean of PK and PD parameters were similar between ABP 959 versus eculizumab US and eculizumab EU; PK and PD similarity was established based on 90% confidence intervals of the geometric mean ratio being within prespecified equivalence margin of 0.8 and 1.25. The incidence of treatment-emergent adverse events was similar across groups. The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
CONCLUSIONS: This study demonstrated PK and PD similarity of ABP 959 to eculizumab RP; safety and immunogenicity profiles were also similar.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:105 |
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| Enthalten in: |
European journal of haematology - 105(2020), 1 vom: 05. Juli, Seite 66-74 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chow, Vincent [VerfasserIn] |
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| Links: |
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| Themen: |
A3ULP0F556 |
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| Anmerkungen: |
Date Completed 17.06.2021 Date Revised 17.06.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/ejh.13411 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM30783106X |
|---|
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| 041 | |a eng | ||
| 100 | 1 | |a Chow, Vincent |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris® ) in healthy male subjects |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 17.06.2021 | ||
| 500 | |a Date Revised 17.06.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd. | ||
| 520 | |a OBJECTIVES: ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double-blind, three-arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizumab reference product (RP) in healthy adult male subjects | ||
| 520 | |a METHODS: Eligible subjects aged 18-45 years were randomized to receive a 300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU). Primary PK endpoint was area under the total serum concentration-time curve from 0 to infinity (AUC0-∞ ); primary PD endpoint was area between the effect curve (ABEC) of CH50-time data | ||
| 520 | |a RESULTS: The geometric mean of PK and PD parameters were similar between ABP 959 versus eculizumab US and eculizumab EU; PK and PD similarity was established based on 90% confidence intervals of the geometric mean ratio being within prespecified equivalence margin of 0.8 and 1.25. The incidence of treatment-emergent adverse events was similar across groups. The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies | ||
| 520 | |a CONCLUSIONS: This study demonstrated PK and PD similarity of ABP 959 to eculizumab RP; safety and immunogenicity profiles were also similar | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a ABP 959 | |
| 650 | 4 | |a biosimilar | |
| 650 | 4 | |a eculizumab | |
| 650 | 4 | |a paroxysmal nocturnal hemoglobinuria | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents, Immunological |2 NLM | |
| 650 | 7 | |a eculizumab |2 NLM | |
| 650 | 7 | |a A3ULP0F556 |2 NLM | |
| 700 | 1 | |a Pan, Jean |e verfasserin |4 aut | |
| 700 | 1 | |a Chien, David |e verfasserin |4 aut | |
| 700 | 1 | |a Mytych, Daniel T |e verfasserin |4 aut | |
| 700 | 1 | |a Hanes, Vladimir |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:105 |g year:2020 |g number:1 |g day:05 |g month:07 |g pages:66-74 |
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