Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 유대현 | - |
dc.date.accessioned | 2019-12-08T19:11:02Z | - |
dc.date.available | 2019-12-08T19:11:02Z | - |
dc.date.issued | 2018-08 | - |
dc.identifier.citation | MABS, v. 10, no. 6, page. 934-943 | en_US |
dc.identifier.issn | 1942-0862 | - |
dc.identifier.issn | 1942-0870 | - |
dc.identifier.uri | https://www.tandfonline.com/doi/full/10.1080/19420862.2018.1487912 | - |
dc.identifier.uri | https://repository.hanyang.ac.kr/handle/20.500.11754/119695 | - |
dc.description.abstract | This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan (R)), or European Union-sourced RTX (EU-RTX; MabThera (R)) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC(0-last)), AUC from time zero to infinity (AUC(0-)), and maximum concentration (C-max) after two infusions. The primary efficacy endpoint was change from baseline to week 24 in Disease Activity Score using 28 joints-C-reactive protein (DAS28-CRP). Pharmacodynamics, immunogenicity, and safety were also assessed. 372 patients were randomly assigned to CT-P10 (n=161) or RTX (n=211 [US-RTX, n=151; EU-RTX, n=60]). For the co-primary pharmacokinetic endpoints, 90% confidence intervals (CI) for ratios of geometric means (CT-P10/US-RTX, CT-P10/EU-RTX or EU-RTX/US-RTX) all fell within the equivalence margin of 80-125%. Adjusted least squares (LS) mean (standard error) change from baseline in DAS28-CRP at week 24 was -2.13 (0.175) for CT-P10 and -2.09 (0.176) for RTX. The 95% CI (-0.29, 0.21) of the estimated treatment difference between CT-P10 and RTX (-0.04) was entirely within the efficacy equivalence margin of +/- 0.5. Pharmacodynamics, immunogenicity, and safety profiles were similar for CT-P10 and RTX. The pharmacokinetics of CT-P10, US-RTX, and EU-RTX were equivalent. CT-P10 and RTX were also equivalent in terms of efficacy and displayed similar pharmacodynamic, immunogenicity, and safety profiles up to week 24. | en_US |
dc.description.sponsorship | This work was supported by CELLTRION, Inc. (Incheon, South Korea). | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | TAYLOR & FRANCIS INC | en_US |
dc.subject | Rituximab | en_US |
dc.subject | CT-P10 | en_US |
dc.subject | rheumatoid arthritis | en_US |
dc.subject | equivalence | en_US |
dc.subject | biosimilar | en_US |
dc.title | Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial | en_US |
dc.type | Article | en_US |
dc.relation.no | 6 | - |
dc.relation.volume | 10 | - |
dc.identifier.doi | 10.1080/19420862.2018.1487912 | - |
dc.relation.page | 934-943 | - |
dc.relation.journal | MABS | - |
dc.contributor.googleauthor | Park, Won | - |
dc.contributor.googleauthor | Bozic-Majstorovic, Ljubinka | - |
dc.contributor.googleauthor | Milakovic, Dragana | - |
dc.contributor.googleauthor | Berrocal Kasay, Alfredo | - |
dc.contributor.googleauthor | Chalouhi El-Khouri, Elias | - |
dc.contributor.googleauthor | Irazoque-Palazuelos, Fedra | - |
dc.contributor.googleauthor | Cons Molina, Francisco Fidencio | - |
dc.contributor.googleauthor | Shesternya, Pavel | - |
dc.contributor.googleauthor | Miranda, Pedro | - |
dc.contributor.googleauthor | Yoo, Dae Hyun | - |
dc.relation.code | 2018005745 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | dhyoo | - |
dc.identifier.orcid | http://orcid.org/0000-0002-0643-4008 | - |
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