Therapeutic choices and disease activity after 2years of treatment with cladribine: An Italian multicenter study (CladStop)
Background and purposeCladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the in...
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| creator | Schiavetti, Irene Signori, Alessio Albanese, Angela Frau, Jessica Cocco, Eleonora Lorefice, Lorena Sonia di Lemme Fantozzi, Roberta Centonze, Diego Landi, Doriana Girolama Marfia Signoriello, Elisabetta Lus, Giacomo Zecca, Chiara Gobbi, Claudio Iodice, Rosa Malimpensa, Leonardo Cordioli, Cinzia Ferraro, Diana Ruscica, Francesca Pasquali, Livia Repice, Anna Immovilli, Paolo Ferrò, Maria Teresa Bonavita, Simona Massimiliano Di Filippo Abbadessa, Gianmarco Govone, Flora Sormani, Maria Pia |
| description | Background and purposeCladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited.MethodsThis retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2‐year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2‐year treatment course.ResultsA total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12‐month follow‐up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p |
| doi_str_mv | 10.1111/ene.16250 |
| format | Article |
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However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited.MethodsThis retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2‐year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2‐year treatment course.ResultsA total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12‐month follow‐up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p < 0.001). Furthermore, patients with relapses during cladribine treatment were more likely to start new therapies, whereas older patients were less likely. The safety profile of cladribine was favorable, with lymphopenia being the primary registered adverse event.ConclusionsThis study provides insights into therapeutic choices and disease activity following cladribine treatment. It highlights cladribine's effectiveness in reducing relapse rates and disability progression, reaffirming its favorable safety profile. Real‐world data, aligned with previous reports, draw attention to ocrelizumab and natalizumab as common choices after cladribine. However, larger, prospective studies for validation and a more comprehensive understanding of cladribine's long‐term impact are necessary.</description><identifier>ISSN: 1351-5101</identifier><identifier>EISSN: 1468-1331</identifier><identifier>DOI: 10.1111/ene.16250</identifier><language>eng</language><publisher>Oxford: John Wiley & Sons, Inc</publisher><subject>Cladribine ; Health services ; Lymphopenia ; Multiple sclerosis ; Patients ; Safety</subject><ispartof>European journal of neurology, 2024-06, Vol.31 (6)</ispartof><rights>2024. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Schiavetti, Irene</creatorcontrib><creatorcontrib>Signori, Alessio</creatorcontrib><creatorcontrib>Albanese, Angela</creatorcontrib><creatorcontrib>Frau, Jessica</creatorcontrib><creatorcontrib>Cocco, Eleonora</creatorcontrib><creatorcontrib>Lorefice, Lorena</creatorcontrib><creatorcontrib>Sonia di Lemme</creatorcontrib><creatorcontrib>Fantozzi, Roberta</creatorcontrib><creatorcontrib>Centonze, Diego</creatorcontrib><creatorcontrib>Landi, Doriana</creatorcontrib><creatorcontrib>Girolama Marfia</creatorcontrib><creatorcontrib>Signoriello, Elisabetta</creatorcontrib><creatorcontrib>Lus, Giacomo</creatorcontrib><creatorcontrib>Zecca, Chiara</creatorcontrib><creatorcontrib>Gobbi, Claudio</creatorcontrib><creatorcontrib>Iodice, Rosa</creatorcontrib><creatorcontrib>Malimpensa, Leonardo</creatorcontrib><creatorcontrib>Cordioli, Cinzia</creatorcontrib><creatorcontrib>Ferraro, Diana</creatorcontrib><creatorcontrib>Ruscica, Francesca</creatorcontrib><creatorcontrib>Pasquali, Livia</creatorcontrib><creatorcontrib>Repice, Anna</creatorcontrib><creatorcontrib>Immovilli, Paolo</creatorcontrib><creatorcontrib>Ferrò, Maria Teresa</creatorcontrib><creatorcontrib>Bonavita, Simona</creatorcontrib><creatorcontrib>Massimiliano Di Filippo</creatorcontrib><creatorcontrib>Abbadessa, Gianmarco</creatorcontrib><creatorcontrib>Govone, Flora</creatorcontrib><creatorcontrib>Sormani, Maria Pia</creatorcontrib><title>Therapeutic choices and disease activity after 2years of treatment with cladribine: An Italian multicenter study (CladStop)</title><title>European journal of neurology</title><description>Background and purposeCladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited.MethodsThis retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2‐year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2‐year treatment course.ResultsA total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12‐month follow‐up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p < 0.001). Furthermore, patients with relapses during cladribine treatment were more likely to start new therapies, whereas older patients were less likely. The safety profile of cladribine was favorable, with lymphopenia being the primary registered adverse event.ConclusionsThis study provides insights into therapeutic choices and disease activity following cladribine treatment. It highlights cladribine's effectiveness in reducing relapse rates and disability progression, reaffirming its favorable safety profile. Real‐world data, aligned with previous reports, draw attention to ocrelizumab and natalizumab as common choices after cladribine. However, larger, prospective studies for validation and a more comprehensive understanding of cladribine's long‐term impact are necessary.</description><subject>Cladribine</subject><subject>Health services</subject><subject>Lymphopenia</subject><subject>Multiple sclerosis</subject><subject>Patients</subject><subject>Safety</subject><issn>1351-5101</issn><issn>1468-1331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNqNjM1OwzAQhC0EEuXnwBusxAUOadcxbituqKKCM71XW2ejuErtYG9AES-PDzwAc5mR5ptR6k7jXBctOPBcL2uLZ2qmn5brShujz0s2VldWo75UVzkfEbFe1ThTP7uOEw08infguugdZ6DQQOMzU2YgJ_7LywTUCieoJ6aUIbYgiUlOHAS-vXTgemqSP_jAz_AS4F2o9xTgNPbluVBlm2VsJnjYFPJD4vB4oy5a6jPf_vm1ut--7jZv1ZDi58hZ9sc4plCqvUGr18auEM3_qF_FHFPt</recordid><startdate>20240601</startdate><enddate>20240601</enddate><creator>Schiavetti, Irene</creator><creator>Signori, Alessio</creator><creator>Albanese, Angela</creator><creator>Frau, Jessica</creator><creator>Cocco, Eleonora</creator><creator>Lorefice, Lorena</creator><creator>Sonia di Lemme</creator><creator>Fantozzi, Roberta</creator><creator>Centonze, Diego</creator><creator>Landi, Doriana</creator><creator>Girolama Marfia</creator><creator>Signoriello, Elisabetta</creator><creator>Lus, Giacomo</creator><creator>Zecca, Chiara</creator><creator>Gobbi, Claudio</creator><creator>Iodice, Rosa</creator><creator>Malimpensa, Leonardo</creator><creator>Cordioli, Cinzia</creator><creator>Ferraro, Diana</creator><creator>Ruscica, Francesca</creator><creator>Pasquali, Livia</creator><creator>Repice, Anna</creator><creator>Immovilli, Paolo</creator><creator>Ferrò, Maria Teresa</creator><creator>Bonavita, Simona</creator><creator>Massimiliano Di Filippo</creator><creator>Abbadessa, Gianmarco</creator><creator>Govone, Flora</creator><creator>Sormani, Maria Pia</creator><general>John Wiley & Sons, Inc</general><scope>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope></search><sort><creationdate>20240601</creationdate><title>Therapeutic choices and disease activity after 2years of treatment with cladribine: An Italian multicenter study (CladStop)</title><author>Schiavetti, Irene ; Signori, Alessio ; Albanese, Angela ; Frau, Jessica ; Cocco, Eleonora ; Lorefice, Lorena ; Sonia di Lemme ; Fantozzi, Roberta ; Centonze, Diego ; Landi, Doriana ; Girolama Marfia ; Signoriello, Elisabetta ; Lus, Giacomo ; Zecca, Chiara ; Gobbi, Claudio ; Iodice, Rosa ; Malimpensa, Leonardo ; Cordioli, Cinzia ; Ferraro, Diana ; Ruscica, Francesca ; Pasquali, Livia ; Repice, Anna ; Immovilli, Paolo ; Ferrò, Maria Teresa ; Bonavita, Simona ; Massimiliano Di Filippo ; Abbadessa, Gianmarco ; Govone, Flora ; Sormani, Maria Pia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-proquest_journals_30518357003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Cladribine</topic><topic>Health services</topic><topic>Lymphopenia</topic><topic>Multiple sclerosis</topic><topic>Patients</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schiavetti, Irene</creatorcontrib><creatorcontrib>Signori, Alessio</creatorcontrib><creatorcontrib>Albanese, Angela</creatorcontrib><creatorcontrib>Frau, Jessica</creatorcontrib><creatorcontrib>Cocco, Eleonora</creatorcontrib><creatorcontrib>Lorefice, Lorena</creatorcontrib><creatorcontrib>Sonia di Lemme</creatorcontrib><creatorcontrib>Fantozzi, Roberta</creatorcontrib><creatorcontrib>Centonze, Diego</creatorcontrib><creatorcontrib>Landi, Doriana</creatorcontrib><creatorcontrib>Girolama Marfia</creatorcontrib><creatorcontrib>Signoriello, Elisabetta</creatorcontrib><creatorcontrib>Lus, Giacomo</creatorcontrib><creatorcontrib>Zecca, Chiara</creatorcontrib><creatorcontrib>Gobbi, Claudio</creatorcontrib><creatorcontrib>Iodice, Rosa</creatorcontrib><creatorcontrib>Malimpensa, Leonardo</creatorcontrib><creatorcontrib>Cordioli, Cinzia</creatorcontrib><creatorcontrib>Ferraro, Diana</creatorcontrib><creatorcontrib>Ruscica, Francesca</creatorcontrib><creatorcontrib>Pasquali, Livia</creatorcontrib><creatorcontrib>Repice, Anna</creatorcontrib><creatorcontrib>Immovilli, Paolo</creatorcontrib><creatorcontrib>Ferrò, Maria Teresa</creatorcontrib><creatorcontrib>Bonavita, Simona</creatorcontrib><creatorcontrib>Massimiliano Di Filippo</creatorcontrib><creatorcontrib>Abbadessa, Gianmarco</creatorcontrib><creatorcontrib>Govone, Flora</creatorcontrib><creatorcontrib>Sormani, Maria Pia</creatorcontrib><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>European journal of neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schiavetti, Irene</au><au>Signori, Alessio</au><au>Albanese, Angela</au><au>Frau, Jessica</au><au>Cocco, Eleonora</au><au>Lorefice, Lorena</au><au>Sonia di Lemme</au><au>Fantozzi, Roberta</au><au>Centonze, Diego</au><au>Landi, Doriana</au><au>Girolama Marfia</au><au>Signoriello, Elisabetta</au><au>Lus, Giacomo</au><au>Zecca, Chiara</au><au>Gobbi, Claudio</au><au>Iodice, Rosa</au><au>Malimpensa, Leonardo</au><au>Cordioli, Cinzia</au><au>Ferraro, Diana</au><au>Ruscica, Francesca</au><au>Pasquali, Livia</au><au>Repice, Anna</au><au>Immovilli, Paolo</au><au>Ferrò, Maria Teresa</au><au>Bonavita, Simona</au><au>Massimiliano Di Filippo</au><au>Abbadessa, Gianmarco</au><au>Govone, Flora</au><au>Sormani, Maria Pia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Therapeutic choices and disease activity after 2years of treatment with cladribine: An Italian multicenter study (CladStop)</atitle><jtitle>European journal of neurology</jtitle><date>2024-06-01</date><risdate>2024</risdate><volume>31</volume><issue>6</issue><issn>1351-5101</issn><eissn>1468-1331</eissn><abstract>Background and purposeCladribine tablets, a purine analogue antimetabolite, offer a unique treatment regimen, involving short courses at the start of the first and second year, with no further treatment needed in years 3 and 4. However, comprehensive evidence regarding patient outcomes beyond the initial 24 months of cladribine treatment is limited.MethodsThis retrospective, multicenter study enrolled 204 patients with multiple sclerosis who had completed the 2‐year course of cladribine treatment. The primary outcomes were therapeutic choices and clinical disease activity assessed by annualized relapse rate after the 2‐year treatment course.ResultsA total of 204 patients were enrolled; most patients (75.4%) did not initiate new treatments in the 12 months postcladribine. The study found a significant reduction in annualized relapse rate at the 12‐month follow‐up after cladribine completion compared to the year prior to starting therapy (0.07 ± 0.25 vs. 0.82 ± 0.80, p < 0.001). Furthermore, patients with relapses during cladribine treatment were more likely to start new therapies, whereas older patients were less likely. The safety profile of cladribine was favorable, with lymphopenia being the primary registered adverse event.ConclusionsThis study provides insights into therapeutic choices and disease activity following cladribine treatment. It highlights cladribine's effectiveness in reducing relapse rates and disability progression, reaffirming its favorable safety profile. Real‐world data, aligned with previous reports, draw attention to ocrelizumab and natalizumab as common choices after cladribine. However, larger, prospective studies for validation and a more comprehensive understanding of cladribine's long‐term impact are necessary.</abstract><cop>Oxford</cop><pub>John Wiley & Sons, Inc</pub><doi>10.1111/ene.16250</doi></addata></record> |
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| source | Wiley Online Library - AutoHoldings Journals; Wiley Online Library Open Access; PubMed Central |
| subjects | Cladribine Health services Lymphopenia Multiple sclerosis Patients Safety |
| title | Therapeutic choices and disease activity after 2years of treatment with cladribine: An Italian multicenter study (CladStop) |
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