OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis
Abstract Objectives Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-w...
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| Veröffentlicht in: | Rheumatology (Oxford, England) England), 2022-04, Vol.61 (4), p.1518-1528 |
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| creator | Maccora, Ilaria Lombardi, Niccolò Crescioli, Giada Bettiol, Alessandra Bonaiuti, Roberto Pagnini, Ilaria Maniscalco, Valerio Marrani, Edoardo Mastrolia, Maria Vincenza Ravaldi, Claudia Consolini, Rita Cattalini, Marco Vannacci, Alfredo Simonini, Gabriele |
| description | Abstract
Objectives
Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.
Methods
This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.
Results
A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).
Conclusion
Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA. |
| doi_str_mv | 10.1093/rheumatology/keab572 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2552978588</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/rheumatology/keab572</oup_id><sourcerecordid>2552978588</sourcerecordid><originalsourceid>FETCH-LOGICAL-c393t-e32442edb15a631b8fb834ec4315bc1579b1dac7390b55d9374e9a455cbeb0243</originalsourceid><addsrcrecordid>eNqNkLtOwzAUhi0EgnJ5A4Q8soT6SpKxlFslBAMwR7Zz2h5I4mInIDbegTfkSQhqqRiZzhm-_6KfkEPOTjjL5TDMoatN6ys_ex8-g7E6FRtkwNWpSJiUYnP9C7VDdmN8YoxpLrNtsiOVSCXX2YDg3dn95HwyuqVfH580gKmSNx-qksIrltA4oH5KfcAZNn1WoK2nFn3EGisTaBm6GY1v2Lo5xYY-da_QYAUUS_QL087RURPaecAW4z7ZmpoqwsHq7pHHy4uH8XVyc3c1GY9uEidz2SbQ11UCSsu1OZXcZlObSQVO9X2t4zrNLS-NS2XOrNZlLlMFuVFaOwuWCSX3yPHSdxH8SwexLWqMDqrKNOC7WAitRZ5mOst6VC1RF3yMAabFImBtwnvBWfEzcvF35GI1ci87WiV0toZyLfpdtQeGS8B3i_9ZfgNJYJAh</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2552978588</pqid></control><display><type>article</type><title>OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Alma/SFX Local Collection</source><creator>Maccora, Ilaria ; Lombardi, Niccolò ; Crescioli, Giada ; Bettiol, Alessandra ; Bonaiuti, Roberto ; Pagnini, Ilaria ; Maniscalco, Valerio ; Marrani, Edoardo ; Mastrolia, Maria Vincenza ; Ravaldi, Claudia ; Consolini, Rita ; Cattalini, Marco ; Vannacci, Alfredo ; Simonini, Gabriele</creator><creatorcontrib>Maccora, Ilaria ; Lombardi, Niccolò ; Crescioli, Giada ; Bettiol, Alessandra ; Bonaiuti, Roberto ; Pagnini, Ilaria ; Maniscalco, Valerio ; Marrani, Edoardo ; Mastrolia, Maria Vincenza ; Ravaldi, Claudia ; Consolini, Rita ; Cattalini, Marco ; Vannacci, Alfredo ; Simonini, Gabriele</creatorcontrib><description>Abstract
Objectives
Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.
Methods
This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.
Results
A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).
Conclusion
Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA.</description><identifier>ISSN: 1462-0324</identifier><identifier>EISSN: 1462-0332</identifier><identifier>DOI: 10.1093/rheumatology/keab572</identifier><identifier>PMID: 34273158</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adalimumab - adverse effects ; Antirheumatic Agents - adverse effects ; Arthritis, Juvenile - drug therapy ; Biosimilar Pharmaceuticals - adverse effects ; Child ; Cohort Studies ; Drug Substitution - methods ; Etanercept - adverse effects ; Female ; Glass ; Humans ; Prospective Studies ; Treatment Outcome</subject><ispartof>Rheumatology (Oxford, England), 2022-04, Vol.61 (4), p.1518-1528</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-e32442edb15a631b8fb834ec4315bc1579b1dac7390b55d9374e9a455cbeb0243</citedby><cites>FETCH-LOGICAL-c393t-e32442edb15a631b8fb834ec4315bc1579b1dac7390b55d9374e9a455cbeb0243</cites><orcidid>0000-0001-6418-3254</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,1579,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34273158$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maccora, Ilaria</creatorcontrib><creatorcontrib>Lombardi, Niccolò</creatorcontrib><creatorcontrib>Crescioli, Giada</creatorcontrib><creatorcontrib>Bettiol, Alessandra</creatorcontrib><creatorcontrib>Bonaiuti, Roberto</creatorcontrib><creatorcontrib>Pagnini, Ilaria</creatorcontrib><creatorcontrib>Maniscalco, Valerio</creatorcontrib><creatorcontrib>Marrani, Edoardo</creatorcontrib><creatorcontrib>Mastrolia, Maria Vincenza</creatorcontrib><creatorcontrib>Ravaldi, Claudia</creatorcontrib><creatorcontrib>Consolini, Rita</creatorcontrib><creatorcontrib>Cattalini, Marco</creatorcontrib><creatorcontrib>Vannacci, Alfredo</creatorcontrib><creatorcontrib>Simonini, Gabriele</creatorcontrib><title>OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis</title><title>Rheumatology (Oxford, England)</title><addtitle>Rheumatology (Oxford)</addtitle><description>Abstract
Objectives
Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.
Methods
This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.
Results
A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).
Conclusion
Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA.</description><subject>Adalimumab - adverse effects</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Arthritis, Juvenile - drug therapy</subject><subject>Biosimilar Pharmaceuticals - adverse effects</subject><subject>Child</subject><subject>Cohort Studies</subject><subject>Drug Substitution - methods</subject><subject>Etanercept - adverse effects</subject><subject>Female</subject><subject>Glass</subject><subject>Humans</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><issn>1462-0324</issn><issn>1462-0332</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkLtOwzAUhi0EgnJ5A4Q8soT6SpKxlFslBAMwR7Zz2h5I4mInIDbegTfkSQhqqRiZzhm-_6KfkEPOTjjL5TDMoatN6ys_ex8-g7E6FRtkwNWpSJiUYnP9C7VDdmN8YoxpLrNtsiOVSCXX2YDg3dn95HwyuqVfH580gKmSNx-qksIrltA4oH5KfcAZNn1WoK2nFn3EGisTaBm6GY1v2Lo5xYY-da_QYAUUS_QL087RURPaecAW4z7ZmpoqwsHq7pHHy4uH8XVyc3c1GY9uEidz2SbQ11UCSsu1OZXcZlObSQVO9X2t4zrNLS-NS2XOrNZlLlMFuVFaOwuWCSX3yPHSdxH8SwexLWqMDqrKNOC7WAitRZ5mOst6VC1RF3yMAabFImBtwnvBWfEzcvF35GI1ci87WiV0toZyLfpdtQeGS8B3i_9ZfgNJYJAh</recordid><startdate>20220411</startdate><enddate>20220411</enddate><creator>Maccora, Ilaria</creator><creator>Lombardi, Niccolò</creator><creator>Crescioli, Giada</creator><creator>Bettiol, Alessandra</creator><creator>Bonaiuti, Roberto</creator><creator>Pagnini, Ilaria</creator><creator>Maniscalco, Valerio</creator><creator>Marrani, Edoardo</creator><creator>Mastrolia, Maria Vincenza</creator><creator>Ravaldi, Claudia</creator><creator>Consolini, Rita</creator><creator>Cattalini, Marco</creator><creator>Vannacci, Alfredo</creator><creator>Simonini, Gabriele</creator><general>Oxford University Press</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>7X8</scope><orcidid>https://orcid.org/0000-0001-6418-3254</orcidid></search><sort><creationdate>20220411</creationdate><title>OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis</title><author>Maccora, Ilaria ; Lombardi, Niccolò ; Crescioli, Giada ; Bettiol, Alessandra ; Bonaiuti, Roberto ; Pagnini, Ilaria ; Maniscalco, Valerio ; Marrani, Edoardo ; Mastrolia, Maria Vincenza ; Ravaldi, Claudia ; Consolini, Rita ; Cattalini, Marco ; Vannacci, Alfredo ; Simonini, Gabriele</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-e32442edb15a631b8fb834ec4315bc1579b1dac7390b55d9374e9a455cbeb0243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adalimumab - adverse effects</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Arthritis, Juvenile - drug therapy</topic><topic>Biosimilar Pharmaceuticals - adverse effects</topic><topic>Child</topic><topic>Cohort Studies</topic><topic>Drug Substitution - methods</topic><topic>Etanercept - adverse effects</topic><topic>Female</topic><topic>Glass</topic><topic>Humans</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maccora, Ilaria</creatorcontrib><creatorcontrib>Lombardi, Niccolò</creatorcontrib><creatorcontrib>Crescioli, Giada</creatorcontrib><creatorcontrib>Bettiol, Alessandra</creatorcontrib><creatorcontrib>Bonaiuti, Roberto</creatorcontrib><creatorcontrib>Pagnini, Ilaria</creatorcontrib><creatorcontrib>Maniscalco, Valerio</creatorcontrib><creatorcontrib>Marrani, Edoardo</creatorcontrib><creatorcontrib>Mastrolia, Maria Vincenza</creatorcontrib><creatorcontrib>Ravaldi, Claudia</creatorcontrib><creatorcontrib>Consolini, Rita</creatorcontrib><creatorcontrib>Cattalini, Marco</creatorcontrib><creatorcontrib>Vannacci, Alfredo</creatorcontrib><creatorcontrib>Simonini, Gabriele</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Rheumatology (Oxford, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maccora, Ilaria</au><au>Lombardi, Niccolò</au><au>Crescioli, Giada</au><au>Bettiol, Alessandra</au><au>Bonaiuti, Roberto</au><au>Pagnini, Ilaria</au><au>Maniscalco, Valerio</au><au>Marrani, Edoardo</au><au>Mastrolia, Maria Vincenza</au><au>Ravaldi, Claudia</au><au>Consolini, Rita</au><au>Cattalini, Marco</au><au>Vannacci, Alfredo</au><au>Simonini, Gabriele</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis</atitle><jtitle>Rheumatology (Oxford, England)</jtitle><addtitle>Rheumatology (Oxford)</addtitle><date>2022-04-11</date><risdate>2022</risdate><volume>61</volume><issue>4</issue><spage>1518</spage><epage>1528</epage><pages>1518-1528</pages><issn>1462-0324</issn><eissn>1462-0332</eissn><abstract>Abstract
Objectives
Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.
Methods
This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.
Results
A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).
Conclusion
Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>34273158</pmid><doi>10.1093/rheumatology/keab572</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-6418-3254</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Rheumatology (Oxford, England), 2022-04, Vol.61 (4), p.1518-1528 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Adalimumab - adverse effects Antirheumatic Agents - adverse effects Arthritis, Juvenile - drug therapy Biosimilar Pharmaceuticals - adverse effects Child Cohort Studies Drug Substitution - methods Etanercept - adverse effects Female Glass Humans Prospective Studies Treatment Outcome |
| title | OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis |
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