Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series
Background CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and...
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description | Background
CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area.
Aim
We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
Methods
Seventeen subjects diagnosed with Crohn’s disease (CD,
n
= 8) or ulcerative colitis (UC,
n
= 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients’ characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction.
Results
Male–female ratio was 1.8. Mean age was 35.4 years (range 15–57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period.
Conclusions
CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed. |
doi_str_mv | 10.1007/s10620-014-3392-z |
format | Article |
fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1942219058</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A712944003</galeid><sourcerecordid>A712944003</sourcerecordid><originalsourceid>FETCH-LOGICAL-c542t-99f92d8bfe3ed770af0d11e39eb596c36e19534c31fd3b7ec6f9190e559733633</originalsourceid><addsrcrecordid>eNqFkk1v1DAQhiMEokvhB3BBlrhwIMVjx86a2zYUqFSJSrRny3HGraskXuys-nHhr-Pslk-BkA8z8jzveEZ-i-I50AOgtH6TgEpGSwpVybli5d2DYgGi5iUTcvmwWFCQOQeQe8WTlK4opaoG-bjYY4IzCSAWxdem96O3pidHN2uMHkeLJDgyXSI5T9u0OStPgb8mhhz6kPzgexPJFMjx6Hp_4wfTEj-SUzNl8ZTItZ8utzUzDGYK8ZYchmvsyTuf0CR8S1akyZF8nl9LT4tHzvQJn93H_eL8_dFZ87E8-fThuFmdlFZUbCqVcop1y9Yhx66uqXG0A0CusBVKWi4RlOCV5eA63tZopVOgKAqhas4l5_vFq13fdQxfNpgmPfhkse_NiGGTNKiKsawQy_-jshbLmsMSMvryD_QqbOKYF9lSAJWk7Cd1YXrUfnRhisbOTfWqBqaqitJ5woO_UPl0OHgbRnQ-3_8mgJ3AxpBSRKfXMf9GvNVA9ewPvfOHzv7Qsz_0Xda8uB940w7Y_VB8N0QG2A5IuTReYPxlo392_QbRl8G4</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1675114602</pqid></control><display><type>article</type><title>Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Kang, Yun-Seong ; Moon, Hyoung Ho ; Lee, Seung Eun ; Lim, Yun Jeong ; Kang, Hyoun Woo</creator><creatorcontrib>Kang, Yun-Seong ; Moon, Hyoung Ho ; Lee, Seung Eun ; Lim, Yun Jeong ; Kang, Hyoun Woo</creatorcontrib><description>Background
CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area.
Aim
We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
Methods
Seventeen subjects diagnosed with Crohn’s disease (CD,
n
= 8) or ulcerative colitis (UC,
n
= 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients’ characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction.
Results
Male–female ratio was 1.8. Mean age was 35.4 years (range 15–57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period.
Conclusions
CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.</description><identifier>ISSN: 0163-2116</identifier><identifier>EISSN: 1573-2568</identifier><identifier>DOI: 10.1007/s10620-014-3392-z</identifier><identifier>PMID: 25326115</identifier><identifier>CODEN: DDSCDJ</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adolescent ; Adult ; Antibodies, Monoclonal - therapeutic use ; Antigen-antibody reactions ; Arthritis ; Biochemistry ; Biological products ; Biosimilar Pharmaceuticals - therapeutic use ; Care and treatment ; Complications and side effects ; Female ; Gastroenterology ; Hepatology ; Humans ; Inflammatory Bowel Diseases - drug therapy ; Infliximab ; Male ; Medical records ; Medicine ; Medicine & Public Health ; Middle Aged ; Monoclonal antibodies ; Oncology ; Original Article ; Retrospective Studies ; Rheumatoid factor ; Transplant Surgery ; Ulcerative colitis ; Young Adult</subject><ispartof>Digestive diseases and sciences, 2015-04, Vol.60 (4), p.951-956</ispartof><rights>Springer Science+Business Media New York 2014</rights><rights>COPYRIGHT 2015 Springer</rights><rights>Springer Science+Business Media New York 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c542t-99f92d8bfe3ed770af0d11e39eb596c36e19534c31fd3b7ec6f9190e559733633</citedby><cites>FETCH-LOGICAL-c542t-99f92d8bfe3ed770af0d11e39eb596c36e19534c31fd3b7ec6f9190e559733633</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10620-014-3392-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10620-014-3392-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25326115$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kang, Yun-Seong</creatorcontrib><creatorcontrib>Moon, Hyoung Ho</creatorcontrib><creatorcontrib>Lee, Seung Eun</creatorcontrib><creatorcontrib>Lim, Yun Jeong</creatorcontrib><creatorcontrib>Kang, Hyoun Woo</creatorcontrib><title>Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series</title><title>Digestive diseases and sciences</title><addtitle>Dig Dis Sci</addtitle><addtitle>Dig Dis Sci</addtitle><description>Background
CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area.
Aim
We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
Methods
Seventeen subjects diagnosed with Crohn’s disease (CD,
n
= 8) or ulcerative colitis (UC,
n
= 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients’ characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction.
Results
Male–female ratio was 1.8. Mean age was 35.4 years (range 15–57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period.
Conclusions
CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antigen-antibody reactions</subject><subject>Arthritis</subject><subject>Biochemistry</subject><subject>Biological products</subject><subject>Biosimilar Pharmaceuticals - therapeutic use</subject><subject>Care and treatment</subject><subject>Complications and side effects</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Infliximab</subject><subject>Male</subject><subject>Medical records</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Retrospective Studies</subject><subject>Rheumatoid factor</subject><subject>Transplant Surgery</subject><subject>Ulcerative colitis</subject><subject>Young Adult</subject><issn>0163-2116</issn><issn>1573-2568</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqFkk1v1DAQhiMEokvhB3BBlrhwIMVjx86a2zYUqFSJSrRny3HGraskXuys-nHhr-Pslk-BkA8z8jzveEZ-i-I50AOgtH6TgEpGSwpVybli5d2DYgGi5iUTcvmwWFCQOQeQe8WTlK4opaoG-bjYY4IzCSAWxdem96O3pidHN2uMHkeLJDgyXSI5T9u0OStPgb8mhhz6kPzgexPJFMjx6Hp_4wfTEj-SUzNl8ZTItZ8utzUzDGYK8ZYchmvsyTuf0CR8S1akyZF8nl9LT4tHzvQJn93H_eL8_dFZ87E8-fThuFmdlFZUbCqVcop1y9Yhx66uqXG0A0CusBVKWi4RlOCV5eA63tZopVOgKAqhas4l5_vFq13fdQxfNpgmPfhkse_NiGGTNKiKsawQy_-jshbLmsMSMvryD_QqbOKYF9lSAJWk7Cd1YXrUfnRhisbOTfWqBqaqitJ5woO_UPl0OHgbRnQ-3_8mgJ3AxpBSRKfXMf9GvNVA9ewPvfOHzv7Qsz_0Xda8uB940w7Y_VB8N0QG2A5IuTReYPxlo392_QbRl8G4</recordid><startdate>20150401</startdate><enddate>20150401</enddate><creator>Kang, Yun-Seong</creator><creator>Moon, Hyoung Ho</creator><creator>Lee, Seung Eun</creator><creator>Lim, Yun Jeong</creator><creator>Kang, Hyoun Woo</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20150401</creationdate><title>Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series</title><author>Kang, Yun-Seong ; Moon, Hyoung Ho ; Lee, Seung Eun ; Lim, Yun Jeong ; Kang, Hyoun Woo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c542t-99f92d8bfe3ed770af0d11e39eb596c36e19534c31fd3b7ec6f9190e559733633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antigen-antibody reactions</topic><topic>Arthritis</topic><topic>Biochemistry</topic><topic>Biological products</topic><topic>Biosimilar Pharmaceuticals - therapeutic use</topic><topic>Care and treatment</topic><topic>Complications and side effects</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Infliximab</topic><topic>Male</topic><topic>Medical records</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Retrospective Studies</topic><topic>Rheumatoid factor</topic><topic>Transplant Surgery</topic><topic>Ulcerative colitis</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kang, Yun-Seong</creatorcontrib><creatorcontrib>Moon, Hyoung Ho</creatorcontrib><creatorcontrib>Lee, Seung Eun</creatorcontrib><creatorcontrib>Lim, Yun Jeong</creatorcontrib><creatorcontrib>Kang, Hyoun Woo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Digestive diseases and sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kang, Yun-Seong</au><au>Moon, Hyoung Ho</au><au>Lee, Seung Eun</au><au>Lim, Yun Jeong</au><au>Kang, Hyoun Woo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series</atitle><jtitle>Digestive diseases and sciences</jtitle><stitle>Dig Dis Sci</stitle><addtitle>Dig Dis Sci</addtitle><date>2015-04-01</date><risdate>2015</risdate><volume>60</volume><issue>4</issue><spage>951</spage><epage>956</epage><pages>951-956</pages><issn>0163-2116</issn><eissn>1573-2568</eissn><coden>DDSCDJ</coden><abstract>Background
CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area.
Aim
We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center.
Methods
Seventeen subjects diagnosed with Crohn’s disease (CD,
n
= 8) or ulcerative colitis (UC,
n
= 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients’ characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction.
Results
Male–female ratio was 1.8. Mean age was 35.4 years (range 15–57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period.
Conclusions
CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>25326115</pmid><doi>10.1007/s10620-014-3392-z</doi><tpages>6</tpages></addata></record> |
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subjects | Adolescent Adult Antibodies, Monoclonal - therapeutic use Antigen-antibody reactions Arthritis Biochemistry Biological products Biosimilar Pharmaceuticals - therapeutic use Care and treatment Complications and side effects Female Gastroenterology Hepatology Humans Inflammatory Bowel Diseases - drug therapy Infliximab Male Medical records Medicine Medicine & Public Health Middle Aged Monoclonal antibodies Oncology Original Article Retrospective Studies Rheumatoid factor Transplant Surgery Ulcerative colitis Young Adult |
title | Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series |
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