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Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness
DC Field | Value | Language |
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dc.contributor.author | 천재희 | - |
dc.date.accessioned | 2021-12-28T17:06:57Z | - |
dc.date.available | 2021-12-28T17:06:57Z | - |
dc.date.issued | 2021-08 | - |
dc.identifier.issn | 0741-238X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/186942 | - |
dc.description.abstract | Introduction: Long-term, real-world safety and effectiveness data are required to support biosimilar use. This analysis pooled 5-year findings from observational studies of infliximab biosimilar CT-P13 treatment in patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and ankylosing spondylitis (AS). Methods: Patients enrolled in the CT-P13 4.2, 4.3, or 4.4 Korea/European Union registries were analysed if they had initiated infliximab treatment with CT-P13 (CT-P13 group) or had switched from reference infliximab to CT-P13 (switched to CT-P13 group). The primary objective was to investigate long-term safety by evaluating adverse events of special interest (AESIs) per the CT-P13 risk-management plan. Incidence rates per 100 patient-years (PYs) were calculated. Additional long-term safety endpoints, immunogenicity (assessments optional), and effectiveness were evaluated. Results: Overall, 736 patients (642 CT-P13; 94 switched to CT-P13) were analysed. Median (range) exposure to CT-P13 was 19.433 (0.03-63.11) months overall. The incidence of treatment-emergent adverse events was 69.0% (CT-P13 group) and 60.6% (switched to CT-P13 group). Infusion-related reaction/hypersensitivity/anaphylactic reaction was the most frequent AESI overall, with an incidence of 4.3828 per 100 PY (95% confidence interval: 3.3603-5.6185). For most AESIs, incidence rates per 100 PY were broadly comparable between treatment groups, considering overlapping 95% confidence intervals. At baseline, 42/445 (9.4%) and 21/59 (35.6%) evaluable patients in the CT-P13 and switched to CT-P13 groups, respectively, were antidrug antibody (ADA)-positive. After CT-P13 treatment during the study, 188/425 (44.2%) evaluable patients had ≥ 1 ADA-positive result, including 147/425 (34.6%) patients with negative or no ADA results reported at baseline. Effectiveness tended to increase over time for all indications. Conclusion: The analysis did not identify any new safety findings for patients with RA, IBD, and AS treated with CT-P13 for up to 5 years in those who were infliximab-naïve at CT-P13 initiation, or those who had switched from reference infliximab to CT-P13. Trial registration: ClinicalTrials.gov identifiers: NCT02557295 (CT-P13 4.2; retrospectively registered on 23 September 2015); NCT02326155 (CT-P13 4.3; retrospectively registered on 25 December 2014); NCT02557308 (CT-P13 4.4; retrospectively registered on 23 September 2015). | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Health Communications | - |
dc.relation.isPartOf | ADVANCES IN THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal | - |
dc.subject.MESH | Arthritis, Rheumatoid* / drug therapy | - |
dc.subject.MESH | Biosimilar Pharmaceuticals* / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Inflammatory Bowel Diseases* / drug therapy | - |
dc.subject.MESH | Infliximab / therapeutic use | - |
dc.subject.MESH | Spondylitis, Ankylosing* / drug therapy | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jae Hee Cheon | - |
dc.contributor.googleauthor | Seongsu Nah | - |
dc.contributor.googleauthor | Hyoun Woo Kang | - |
dc.contributor.googleauthor | Yun Jeong Lim | - |
dc.contributor.googleauthor | Sang-Hoon Lee | - |
dc.contributor.googleauthor | Sang Joon Lee | - |
dc.contributor.googleauthor | Sung Hyun Kim | - |
dc.contributor.googleauthor | Na Hyun Jung | - |
dc.contributor.googleauthor | Jeong Eun Park | - |
dc.contributor.googleauthor | Yeo Jin Lee | - |
dc.contributor.googleauthor | Da Bee Jeon | - |
dc.contributor.googleauthor | Yeon Mi Lee | - |
dc.contributor.googleauthor | Jong Min Kim | - |
dc.contributor.googleauthor | Sung-Hwan Park | - |
dc.identifier.doi | 10.1007/s12325-021-01834-3 | - |
dc.contributor.localId | A04030 | - |
dc.relation.journalcode | J00048 | - |
dc.identifier.eissn | 1865-8652 | - |
dc.identifier.pmid | 34250583 | - |
dc.identifier.url | https://link.springer.com/article/10.1007%2Fs12325-021-01834-3 | - |
dc.subject.keyword | Ankylosing spondylitis | - |
dc.subject.keyword | CT-P13 | - |
dc.subject.keyword | Crohn’s disease | - |
dc.subject.keyword | Effectiveness | - |
dc.subject.keyword | Infliximab biosimilar | - |
dc.subject.keyword | Long-term | - |
dc.subject.keyword | Post-marketing observational study | - |
dc.subject.keyword | Rheumatoid arthritis | - |
dc.subject.keyword | Safety | - |
dc.subject.keyword | Ulcerative colitis | - |
dc.contributor.alternativeName | Cheon, Jae Hee | - |
dc.contributor.affiliatedAuthor | 천재희 | - |
dc.citation.volume | 38 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 4366 | - |
dc.citation.endPage | 4387 | - |
dc.identifier.bibliographicCitation | ADVANCES IN THERAPY, Vol.38(8) : 4366-4387, 2021-08 | - |
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