Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects
This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials...
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| Published in | Clinical and translational science Vol. 14; no. 4; pp. 1280 - 1291 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
John Wiley & Sons, Inc
01.07.2021
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1752-8054 1752-8062 1752-8062 |
| DOI | 10.1111/cts.12967 |
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| Abstract | This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. |
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| AbstractList | This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC
); AUC from time zero to the last quantifiable concentration (AUC
); and maximum serum concentration (C
). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC
, AUC
, and C
were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC0-inf ); AUC from time zero to the last quantifiable concentration (AUC0-last ); and maximum serum concentration (Cmax ). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC0-inf , AUC0-last , and Cmax were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars.This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC0-inf ); AUC from time zero to the last quantifiable concentration (AUC0-last ); and maximum serum concentration (Cmax ). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC0-inf , AUC0-last , and Cmax were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC 0–inf ); AUC from time zero to the last quantifiable concentration (AUC 0–last ); and maximum serum concentration (C max ). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC 0–inf , AUC 0–last , and C max were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. Abstract This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. |
| Author | Jang, In‐Jin Park, Min Kyu Yoon, Seok Kyu Lee, SeungHwan Kim, Min‐Gul Lee, Sang Joon Kim, Sung Hyun Yu, Kyung‐Sang Lim, Hyeong‐Seok Cha, Jung Bin Furst, Daniel E. Keystone, Edward Bae, Yun Ju Kwon, In Sun Kay, Jonathan Hong, Jang Hee Cho, Doo‐Yeoun Chung, Jae Yong Park, Min Soo Ghim, Jong‐Lyul |
| AuthorAffiliation | 14 Mount Sinai Hospital University of Toronto Toronto Canada 3 Chungnam National University Hospital Daejeon Korea 8 Seoul National University Bundang Hospital Seongnam Korea 11 University of California Los Angeles California USA 1 Seoul National University College of Medicine and Hospital Seoul Korea 7 Severance Hospital Yonsei University College of Medicine Seoul Korea 5 Chungbuk National University Hospital Cheongju Korea 9 Inje University Busan Paik Hospital Busan Korea 15 University of Massachusetts Medical School and UMass Memorial Medical Center Worcester Massachusetts USA 12 University of Washington Seattle Washington USA 10 Celltrion, Inc. Incheon Korea 13 University of Florence Florence Italy 2 Asan Medical Center College of Medicine University of Ulsan Seoul Korea 4 College of Medicine Jeonbuk National University Jeonbuk Korea 6 CHA Bundang Medical Center CHA University Seongnam Korea |
| AuthorAffiliation_xml | – name: 3 Chungnam National University Hospital Daejeon Korea – name: 8 Seoul National University Bundang Hospital Seongnam Korea – name: 13 University of Florence Florence Italy – name: 15 University of Massachusetts Medical School and UMass Memorial Medical Center Worcester Massachusetts USA – name: 7 Severance Hospital Yonsei University College of Medicine Seoul Korea – name: 9 Inje University Busan Paik Hospital Busan Korea – name: 4 College of Medicine Jeonbuk National University Jeonbuk Korea – name: 5 Chungbuk National University Hospital Cheongju Korea – name: 10 Celltrion, Inc. Incheon Korea – name: 12 University of Washington Seattle Washington USA – name: 2 Asan Medical Center College of Medicine University of Ulsan Seoul Korea – name: 11 University of California Los Angeles California USA – name: 1 Seoul National University College of Medicine and Hospital Seoul Korea – name: 14 Mount Sinai Hospital University of Toronto Toronto Canada – name: 6 CHA Bundang Medical Center CHA University Seongnam Korea |
| Author_xml | – sequence: 1 givenname: Kyung‐Sang surname: Yu fullname: Yu, Kyung‐Sang organization: Seoul National University College of Medicine and Hospital – sequence: 2 givenname: In‐Jin surname: Jang fullname: Jang, In‐Jin organization: Seoul National University College of Medicine and Hospital – sequence: 3 givenname: Hyeong‐Seok surname: Lim fullname: Lim, Hyeong‐Seok organization: University of Ulsan – sequence: 4 givenname: Jang Hee surname: Hong fullname: Hong, Jang Hee organization: Chungnam National University Hospital – sequence: 5 givenname: Min‐Gul surname: Kim fullname: Kim, Min‐Gul organization: Jeonbuk National University – sequence: 6 givenname: Min Kyu surname: Park fullname: Park, Min Kyu organization: Chungbuk National University Hospital – sequence: 7 givenname: Doo‐Yeoun surname: Cho fullname: Cho, Doo‐Yeoun organization: CHA University – sequence: 8 givenname: Min Soo surname: Park fullname: Park, Min Soo organization: Yonsei University College of Medicine – sequence: 9 givenname: Jae Yong surname: Chung fullname: Chung, Jae Yong organization: Seoul National University Bundang Hospital – sequence: 10 givenname: Jong‐Lyul surname: Ghim fullname: Ghim, Jong‐Lyul organization: Inje University Busan Paik Hospital – sequence: 11 givenname: SeungHwan surname: Lee fullname: Lee, SeungHwan organization: Seoul National University College of Medicine and Hospital – sequence: 12 givenname: Seok Kyu surname: Yoon fullname: Yoon, Seok Kyu organization: University of Ulsan – sequence: 13 givenname: In Sun surname: Kwon fullname: Kwon, In Sun organization: Chungnam National University Hospital – sequence: 14 givenname: Sang Joon surname: Lee fullname: Lee, Sang Joon organization: Celltrion, Inc – sequence: 15 givenname: Sung Hyun surname: Kim fullname: Kim, Sung Hyun organization: Celltrion, Inc – sequence: 16 givenname: Yun Ju surname: Bae fullname: Bae, Yun Ju organization: Celltrion, Inc – sequence: 17 givenname: Jung Bin surname: Cha fullname: Cha, Jung Bin organization: Celltrion, Inc – sequence: 18 givenname: Daniel E. surname: Furst fullname: Furst, Daniel E. organization: University of Florence – sequence: 19 givenname: Edward surname: Keystone fullname: Keystone, Edward organization: University of Toronto – sequence: 20 givenname: Jonathan surname: Kay fullname: Kay, Jonathan email: jonathan.kay@umassmemorial.org organization: University of Massachusetts Medical School and UMass Memorial Medical Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33503313$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_2217_imt_2021_0271 crossref_primary_10_1002_jcph_6139 crossref_primary_10_1007_s12325_024_03100_8 crossref_primary_10_2217_imt_2022_0181 crossref_primary_10_1111_bcp_14850 crossref_primary_10_2147_DDDT_S317382 crossref_primary_10_1080_13543784_2022_2035359 crossref_primary_10_1007_s40261_021_01107_5 crossref_primary_10_1080_17425255_2023_2270407 crossref_primary_10_1080_14712598_2022_2117546 crossref_primary_10_1002_cpt_3031 crossref_primary_10_1080_14712598_2024_2377300 crossref_primary_10_1093_rheumatology_keab460 crossref_primary_10_1007_s12325_021_01929_x |
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| Copyright | 2021 Celltrion, Inc. published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. 2021 Celltrion, Inc. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. 2021. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| DocumentTitleAlternate | PK EQUIVALENCE OF CT‐P17 AND ADALIMUMAB |
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| Notes | Funding information This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Previous presentation: The manuscript has not been previously published and the manuscript is not under consideration elsewhere. Selected results from this study were presented in a poster at the American College of Rheumatology (ACR) Convergence 2020. https://acrabstracts.org/abstract/pharmacokinetics-and-safety-of-ct-p17-a-proposed-high-concentration-100-mg-ml-adalimumab-biosimilar-in-comparison-with-eu-approved-adalimumab-and-us-licensed-adalimumab-results-of-a-phase-1-rand/ |
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| Title | Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects |
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