Cited 97 times in
Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
DC Field | Value | Language |
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dc.contributor.author | 천재희 | - |
dc.date.accessioned | 2018-03-26T17:08:34Z | - |
dc.date.available | 2018-03-26T17:08:34Z | - |
dc.date.issued | 2015 | - |
dc.identifier.issn | 1747-4124 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/157233 | - |
dc.description.abstract | OBJECTIVE: To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea. METHODS: This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. RESULTS: No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. CONCLUSION: CT-P13 was well tolerated and efficacious in patients with IBD. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Taylor & Francis | - |
dc.relation.isPartOf | EXPERT REVIEW OF GASTROENTEROLOGY & HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adolescent | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Anti-Inflammatory Agents/adverse effects | - |
dc.subject.MESH | Anti-Inflammatory Agents/therapeutic use* | - |
dc.subject.MESH | Antibodies, Monoclonal/adverse effects | - |
dc.subject.MESH | Antibodies, Monoclonal/therapeutic use* | - |
dc.subject.MESH | Biosimilar Pharmaceuticals/adverse effects | - |
dc.subject.MESH | Biosimilar Pharmaceuticals/therapeutic use* | - |
dc.subject.MESH | Colitis, Ulcerative/diagnosis | - |
dc.subject.MESH | Colitis, Ulcerative/drug therapy* | - |
dc.subject.MESH | Colitis, Ulcerative/immunology | - |
dc.subject.MESH | Crohn Disease/diagnosis | - |
dc.subject.MESH | Crohn Disease/drug therapy* | - |
dc.subject.MESH | Crohn Disease/immunology | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Gastrointestinal Agents/adverse effects | - |
dc.subject.MESH | Gastrointestinal Agents/therapeutic use* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infliximab/adverse effects | - |
dc.subject.MESH | Infliximab/therapeutic use* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Product Surveillance, Postmarketing | - |
dc.subject.MESH | Remission Induction | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Severity of Illness Index | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Tumor Necrosis Factor-alpha/antagonists & inhibitors* | - |
dc.subject.MESH | Tumor Necrosis Factor-alpha/immunology | - |
dc.subject.MESH | Young Adult | - |
dc.title | Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Sang Hyoung Park | - |
dc.contributor.googleauthor | Young-Ho Kim | - |
dc.contributor.googleauthor | Ji Hyun Lee | - |
dc.contributor.googleauthor | Hyeok Jin Kwon | - |
dc.contributor.googleauthor | Suck-Ho Lee | - |
dc.contributor.googleauthor | Dong Il Park | - |
dc.contributor.googleauthor | Hyung Kil Kim | - |
dc.contributor.googleauthor | Jae Hee Cheon | - |
dc.contributor.googleauthor | Jong Pil Im | - |
dc.contributor.googleauthor | You Sun Kim | - |
dc.contributor.googleauthor | Sung Young Lee | - |
dc.contributor.googleauthor | Sang Joon Lee | - |
dc.identifier.doi | 10.1586/17474124.2015.1091309 | - |
dc.contributor.localId | A04030 | - |
dc.relation.journalcode | J00881 | - |
dc.identifier.eissn | 1747-4132 | - |
dc.identifier.pmid | 26395533 | - |
dc.identifier.url | http://www.tandfonline.com/doi/abs/10.1586/17474124.2015.1091309 | - |
dc.subject.keyword | CT-P13 | - |
dc.subject.keyword | Crohn’s disease | - |
dc.subject.keyword | South Korea | - |
dc.subject.keyword | biosimilar | - |
dc.subject.keyword | efficacy | - |
dc.subject.keyword | inflammatory bowel disease | - |
dc.subject.keyword | infliximab | - |
dc.subject.keyword | post-marketing study | - |
dc.subject.keyword | safety | - |
dc.subject.keyword | switching | - |
dc.subject.keyword | ulcerative colitis | - |
dc.contributor.alternativeName | Cheon, Jae Hee | - |
dc.contributor.affiliatedAuthor | Cheon, Jae Hee | - |
dc.citation.volume | 9 | - |
dc.citation.number | Suppl 1 | - |
dc.citation.startPage | 35 | - |
dc.citation.endPage | 44 | - |
dc.identifier.bibliographicCitation | EXPERT REVIEW OF GASTROENTEROLOGY & HEPATOLOGY, Vol.9(Suppl 1) : 35-44, 2015 | - |
dc.identifier.rimsid | 41793 | - |
dc.type.rims | ART | - |
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