Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study
•High costs limit rituximab wide off-label administration in IgG4-related disease•Biosimilars are used in alternative to originators in many autoimmune disorders•Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease•This study first reports on a rituximab biosimilar in IgG4-relat...
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| Veröffentlicht in: | European journal of internal medicine 2021-02, Vol.84, p.63-67 |
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| container_title | European journal of internal medicine |
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| creator | Della-Torre, Emanuel Lanzillotta, Marco Campochiaro, Corrado Di-Colo, Giulia Mancuso, Gaia Capurso, Gabriele Falconi, Massimo Dagna, Lorenzo |
| description | •High costs limit rituximab wide off-label administration in IgG4-related disease•Biosimilars are used in alternative to originators in many autoimmune disorders•Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease•This study first reports on a rituximab biosimilar in IgG4-related disease
Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit its wide off-label administration. European and US regulatory agencies have recently approved rituximab biosimilars for the treatment of different rheumatologic and hematological conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.
Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O) to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months. Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months. Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).
Thirty-eight patients were included in this study. Thirty-three patients (87%) were naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B. After six months, 21 patients (60%) achieved disease remission. The median serum IgG4 concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients. Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration were observed in 14 patients (37%). These results are in line with our previous experience with RTX-O.
The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab originator for the treatment of IgG4-RD. |
| doi_str_mv | 10.1016/j.ejim.2020.12.006 |
| format | Article |
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Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit its wide off-label administration. European and US regulatory agencies have recently approved rituximab biosimilars for the treatment of different rheumatologic and hematological conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.
Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O) to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months. Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months. Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).
Thirty-eight patients were included in this study. Thirty-three patients (87%) were naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B. After six months, 21 patients (60%) achieved disease remission. The median serum IgG4 concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients. Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration were observed in 14 patients (37%). These results are in line with our previous experience with RTX-O.
The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab originator for the treatment of IgG4-RD.</description><identifier>ISSN: 0953-6205</identifier><identifier>EISSN: 1879-0828</identifier><identifier>DOI: 10.1016/j.ejim.2020.12.006</identifier><identifier>PMID: 33386207</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents ; B-cells ; biosimilar ; Biosimilar Pharmaceuticals ; Cohort Studies ; Humans ; IgG4 ; IgG4-related disease ; Immunoglobulin G4-Related Disease ; Prospective Studies ; Rituximab ; therapy ; Treatment Outcome</subject><ispartof>European journal of internal medicine, 2021-02, Vol.84, p.63-67</ispartof><rights>2020</rights><rights>Copyright © 2020. Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-c3fb2bf9d3d548bc6eabd0bf66f45c6d212f9864cb24797d55907db6d898734e3</citedby><cites>FETCH-LOGICAL-c422t-c3fb2bf9d3d548bc6eabd0bf66f45c6d212f9864cb24797d55907db6d898734e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejim.2020.12.006$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33386207$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Della-Torre, Emanuel</creatorcontrib><creatorcontrib>Lanzillotta, Marco</creatorcontrib><creatorcontrib>Campochiaro, Corrado</creatorcontrib><creatorcontrib>Di-Colo, Giulia</creatorcontrib><creatorcontrib>Mancuso, Gaia</creatorcontrib><creatorcontrib>Capurso, Gabriele</creatorcontrib><creatorcontrib>Falconi, Massimo</creatorcontrib><creatorcontrib>Dagna, Lorenzo</creatorcontrib><title>Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study</title><title>European journal of internal medicine</title><addtitle>Eur J Intern Med</addtitle><description>•High costs limit rituximab wide off-label administration in IgG4-related disease•Biosimilars are used in alternative to originators in many autoimmune disorders•Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease•This study first reports on a rituximab biosimilar in IgG4-related disease
Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit its wide off-label administration. European and US regulatory agencies have recently approved rituximab biosimilars for the treatment of different rheumatologic and hematological conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.
Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O) to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months. Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months. Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).
Thirty-eight patients were included in this study. Thirty-three patients (87%) were naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B. After six months, 21 patients (60%) achieved disease remission. The median serum IgG4 concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients. Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration were observed in 14 patients (37%). These results are in line with our previous experience with RTX-O.
The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab originator for the treatment of IgG4-RD.</description><subject>Antibodies, Monoclonal, Murine-Derived</subject><subject>Antirheumatic Agents</subject><subject>B-cells</subject><subject>biosimilar</subject><subject>Biosimilar Pharmaceuticals</subject><subject>Cohort Studies</subject><subject>Humans</subject><subject>IgG4</subject><subject>IgG4-related disease</subject><subject>Immunoglobulin G4-Related Disease</subject><subject>Prospective Studies</subject><subject>Rituximab</subject><subject>therapy</subject><subject>Treatment Outcome</subject><issn>0953-6205</issn><issn>1879-0828</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kDtvFDEUhS0ESpaQP0CBXCbFLH7MeDyIBq1CEikSFKG2_LgGr2bGi-1ZsS2_PF5tSEl1paNzjs79EHpPyZoSKj5u17AN05oRVgW2JkS8Qisq-6EhksnXaEWGjjeCke4cvc15SwjtCeFn6JxzLqver9DfG--D1faA9exw1h7KAUePUyjLnzBpg02IOUxh1AlfbR6b75Rc4zDj-5-3bZNg1AUcdiGDzvCpluBoMqS9LiHOesS7FPMObAl7wHEHczNqAyO28VdMBeeyuMM79MbrMcPl871AP77ePG7umodvt_ebLw-NbRkrjeXeMOMHx13XSmMFaOOI8UL4trPCMcr8IEVrDWv7oXddN5DeGeHkIHveAr9AV6feuun3ArmoKWQL46hniEtWNdbKVhA5VCs7WW2dnxN4tUsVRjooStSRvdqqI3t1ZK8oU5V9DX147l_MBO4l8g92NXw-GaB-uQ-QVLYBZgsupIpIuRj-1_8EGBCWZw</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Della-Torre, Emanuel</creator><creator>Lanzillotta, Marco</creator><creator>Campochiaro, Corrado</creator><creator>Di-Colo, Giulia</creator><creator>Mancuso, Gaia</creator><creator>Capurso, Gabriele</creator><creator>Falconi, Massimo</creator><creator>Dagna, Lorenzo</creator><general>Elsevier 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>7X8</scope></search><sort><creationdate>202102</creationdate><title>Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study</title><author>Della-Torre, Emanuel ; Lanzillotta, Marco ; Campochiaro, Corrado ; Di-Colo, Giulia ; Mancuso, Gaia ; Capurso, Gabriele ; Falconi, Massimo ; Dagna, Lorenzo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-c3fb2bf9d3d548bc6eabd0bf66f45c6d212f9864cb24797d55907db6d898734e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Antibodies, Monoclonal, Murine-Derived</topic><topic>Antirheumatic Agents</topic><topic>B-cells</topic><topic>biosimilar</topic><topic>Biosimilar Pharmaceuticals</topic><topic>Cohort Studies</topic><topic>Humans</topic><topic>IgG4</topic><topic>IgG4-related disease</topic><topic>Immunoglobulin G4-Related Disease</topic><topic>Prospective Studies</topic><topic>Rituximab</topic><topic>therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Della-Torre, Emanuel</creatorcontrib><creatorcontrib>Lanzillotta, Marco</creatorcontrib><creatorcontrib>Campochiaro, Corrado</creatorcontrib><creatorcontrib>Di-Colo, Giulia</creatorcontrib><creatorcontrib>Mancuso, Gaia</creatorcontrib><creatorcontrib>Capurso, Gabriele</creatorcontrib><creatorcontrib>Falconi, Massimo</creatorcontrib><creatorcontrib>Dagna, Lorenzo</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>European journal of internal medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Della-Torre, Emanuel</au><au>Lanzillotta, Marco</au><au>Campochiaro, Corrado</au><au>Di-Colo, Giulia</au><au>Mancuso, Gaia</au><au>Capurso, Gabriele</au><au>Falconi, Massimo</au><au>Dagna, Lorenzo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study</atitle><jtitle>European journal of internal medicine</jtitle><addtitle>Eur J Intern Med</addtitle><date>2021-02</date><risdate>2021</risdate><volume>84</volume><spage>63</spage><epage>67</epage><pages>63-67</pages><issn>0953-6205</issn><eissn>1879-0828</eissn><abstract>•High costs limit rituximab wide off-label administration in IgG4-related disease•Biosimilars are used in alternative to originators in many autoimmune disorders•Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease•This study first reports on a rituximab biosimilar in IgG4-related disease
Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit its wide off-label administration. European and US regulatory agencies have recently approved rituximab biosimilars for the treatment of different rheumatologic and hematological conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.
Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O) to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months. Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months. Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).
Thirty-eight patients were included in this study. Thirty-three patients (87%) were naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B. After six months, 21 patients (60%) achieved disease remission. The median serum IgG4 concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients. Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration were observed in 14 patients (37%). These results are in line with our previous experience with RTX-O.
The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab originator for the treatment of IgG4-RD.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>33386207</pmid><doi>10.1016/j.ejim.2020.12.006</doi><tpages>5</tpages></addata></record> |
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| subjects | Antibodies, Monoclonal, Murine-Derived Antirheumatic Agents B-cells biosimilar Biosimilar Pharmaceuticals Cohort Studies Humans IgG4 IgG4-related disease Immunoglobulin G4-Related Disease Prospective Studies Rituximab therapy Treatment Outcome |
| title | Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study |
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