0 321

Cited 25 times in

Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study

DC Field Value Language
dc.contributor.author천재희-
dc.date.accessioned2019-07-23T06:48:33Z-
dc.date.available2019-07-23T06:48:33Z-
dc.date.issued2019-
dc.identifier.issn0140-6736-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/170314-
dc.description.abstractBACKGROUND: The infliximab biosimilar CT-P13 was approved for use in Crohn's disease after clinical comparison with originator infliximab in ankylosing spondylitis and rheumatoid arthritis; however, concerns about such indication extrapolation have been expressed. This study investigated whether CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy. METHODS: In this randomised, multicentre, double-blind, phase 3 non-inferiority study, we enrolled patients with active Crohn's disease who had not responded to, or were intolerant to, non-biological treatments. Patients were randomly assigned (1:1:1:1) to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. Patients received 5 mg/kg CT-P13 or infliximab at weeks 0, 2, 6, and then every 8 weeks up to week 54. The primary endpoint was the proportion of patients with a decrease of 70 points or more in Crohn's Disease Activity Index (CDAI) from baseline to week 6. A non-inferiority margin of -20% was set (CT-P13 was non-inferior to infliximab if the lower limit of the two-sided 95% CI for the treatment difference was greater than -20). This trial is registered with ClinicalTrials.gov, number NCT02096861, and is completed. FINDINGS: Between Aug 20, 2014, and Feb 15, 2017, 308 patients were assessed for eligibility, and 220 patients were enrolled: 111 were randomly assigned to initiate CT-P13 (56 to the CT-P13-CT-P13 group and 55 to the CT-P13-infliximab group) and 109 to initiate infliximab (54 to the infliximab-infliximab group and 55 to the infliximab-CT-P13 group). CDAI-70 response rates at week 6 were similar for CT-P13 (77 [69·4%, 95% CI 59·9 to 77·8] of 111) and infliximab (81 [74·3%, 95% CI 65·1 to 82·2] of 109; difference -4·9% [95% CI -16·9 to 7·3]), thereby establishing non-inferiority. Over the total study period, 147 (67%) patients experienced at least one treatment-emergent adverse event (36 [64%] in the CT-P13-CT-P13 group, 34 [62%] in the CT-P13-infliximab group, 37 [69%] in the infliximab-infliximab group, and 40 [73%] in the infliximab-CT-P13 group). INTERPRETATION: This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn's disease. Biosimilar CT-P13 could be a new option for the treatment of active Crohn's disease. FUNDING: Celltrion, Pfizer.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfLANCET-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAntibodies, Monoclonal/adverse effects-
dc.subject.MESHAntibodies, Monoclonal/therapeutic use-
dc.subject.MESHBiosimilar Pharmaceuticals/adverse effects-
dc.subject.MESHBiosimilar Pharmaceuticals/therapeutic use-
dc.subject.MESHCrohn Disease/drug therapy-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Substitution-
dc.subject.MESHFemale-
dc.subject.MESHGastrointestinal Agents/adverse effects-
dc.subject.MESHGastrointestinal Agents/therapeutic use-
dc.subject.MESHHumans-
dc.subject.MESHInfliximab/adverse effects-
dc.subject.MESHInfliximab/therapeutic use-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHSeverity of Illness Index-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHYoung Adult-
dc.titleEfficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorByong Duk Ye-
dc.contributor.googleauthorMarina Pesegova-
dc.contributor.googleauthorOlga Alexeeva-
dc.contributor.googleauthorMarina Osipenko-
dc.contributor.googleauthorAdi Lahat-
dc.contributor.googleauthorAndriy Dorofeyev-
dc.contributor.googleauthorSigal Fishman-
dc.contributor.googleauthorOlena Levchenko-
dc.contributor.googleauthorJae Hee Cheon-
dc.contributor.googleauthorMaria Lia Scribano-
dc.contributor.googleauthorRadu-Bogdan Mateescu-
dc.contributor.googleauthorKang-Moon Lee-
dc.contributor.googleauthorChang Soo Eun-
dc.contributor.googleauthorSang Joon Lee-
dc.contributor.googleauthorSung Young Lee-
dc.contributor.googleauthorHo Ung Kim-
dc.contributor.googleauthorStefan Schreiber-
dc.contributor.googleauthorHeather Fowler-
dc.contributor.googleauthorRaymond Cheung-
dc.contributor.googleauthorYoung-Ho Kim-
dc.identifier.doi10.1016/S0140-6736(18)32196-2-
dc.contributor.localIdA04030-
dc.relation.journalcodeJ02152-
dc.identifier.eissn1474-547X-
dc.identifier.pmid30929895-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0140673618321962-
dc.contributor.alternativeNameCheon, Jae Hee-
dc.contributor.affiliatedAuthor천재희-
dc.citation.volume393-
dc.citation.number10182-
dc.citation.startPage1699-
dc.citation.endPage1707-
dc.identifier.bibliographicCitationLANCET, Vol.393(10182) : 1699-1707, 2019-
dc.identifier.rimsid62986-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.