Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial
DC Field | Value | Language |
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dc.contributor.author | Suh, Chang-Hee | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.contributor.author | Berrocal Kasay, Alfredo | - |
dc.contributor.author | Chalouhi El-Khouri, Elia | - |
dc.contributor.author | Cons Molina, Francisco Fidenci | - |
dc.contributor.author | Shesternya, Pavel | - |
dc.contributor.author | Miranda, Pedro | - |
dc.contributor.author | Medina-Rodriguez, Francisco G. | - |
dc.contributor.author | Wiland, Piotr | - |
dc.contributor.author | Jeka, Slawomir | - |
dc.contributor.author | Chavez-Corrales, Jose | - |
dc.contributor.author | Linde, Thomas | - |
dc.contributor.author | Hrycaj, Pawel | - |
dc.contributor.author | Abello-Banfi, Mauricio | - |
dc.contributor.author | Hospodarskyy, Ihor | - |
dc.contributor.author | Jaworski, Janusz | - |
dc.contributor.author | Piotrowski, Mariusz | - |
dc.contributor.author | Brzosko, Marek | - |
dc.contributor.author | Krogulec, Marek | - |
dc.contributor.author | Shevchuk, Sergii | - |
dc.contributor.author | Calvo, Armando | - |
dc.contributor.author | Andersone, Daina | - |
dc.contributor.author | Park, Won | - |
dc.contributor.author | Shim, Seung Cheol | - |
dc.contributor.author | Lee, Sang Joon | - |
dc.contributor.author | Lee, Sung Young | - |
dc.date.accessioned | 2021-08-02T12:27:14Z | - |
dc.date.available | 2021-08-02T12:27:14Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2019-02 | - |
dc.identifier.issn | 1173-8804 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/15063 | - |
dc.description.abstract | The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (- 2.7 and - 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. NCT02149121. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ADIS INT LTD | - |
dc.title | Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.1007/s40259-018-00331-4 | - |
dc.identifier.scopusid | 2-s2.0-85061185514 | - |
dc.identifier.wosid | 000458935400007 | - |
dc.identifier.bibliographicCitation | BIODRUGS, v.33, no.1, pp.79 - 91 | - |
dc.relation.isPartOf | BIODRUGS | - |
dc.citation.title | BIODRUGS | - |
dc.citation.volume | 33 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 79 | - |
dc.citation.endPage | 91 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | INADEQUATE RESPONSE | - |
dc.subject.keywordPlus | METHOTREXATE | - |
dc.identifier.url | https://link.springer.com/article/10.1007/s40259-018-00331-4 | - |
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